Stem Cell Cartilage Regeneration Market Size, Global Analytical Overview, Key Players, Regional Demand, Trends and Forecast To 2026 – Bulletin Line

The report on the Stem Cell Cartilage Regeneration market provides a view of the current proceeding within the Stem Cell Cartilage Regeneration market. Further, the report also takes into account the impact of the COVID-19 global pandemic on the Stem Cell Cartilage Regeneration market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Stem Cell Cartilage Regeneration market over the forecast period (2020-2026) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.

This Report covers following Leading Companies associated in Stem Cell Cartilage Regeneration Market:-

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The Stem Cell Cartilage Regeneration Market research aims to geographically analyse micro markets with respect to individual growth rate, prospects and overall industry contributions. The report strategically analyses the key players and in-depth review of their core competencies. This also tracks and analyses strategic developments within the Stem Cell Cartilage Regeneration Market sector, such as partnerships, collaborations, and agreements; mergers and acquisitions; new product launches and R&D activities.

Primary and secondary research methodologies have been used to formulate this report. This Report Provides an in-depth study analysing the current and future demands of this Market also it provides the overview, definition, cost structure, segmentation, recent developments, application, and industry chain analysis, CAGR growth, and Porters Five Forces Analysis, demand. The report has offered an all-inclusive analysis of the global Market taking into consideration all the pivotal aspects like growth factors, Market developments, future prospects, and trends.

KEY REGIONS AND COUNTRIES COVERED IN GLOBAL Stem Cell Cartilage Regeneration Market REPORT:

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Key Questions Answered in the Report:-

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Stem Cell Cartilage Regeneration Market Size, Global Analytical Overview, Key Players, Regional Demand, Trends and Forecast To 2026 - Bulletin Line

Covid-19 Impact on Global Stem Cell Assay Market Set Explosive Growth By 2019 2027 | Merck & Co., Thermo Fisher Scientific, GE Healthcare,…

Stem Cell Assay Market 2019 Global Industry Research report presents an in-depth analysis of the Stem Cell Assay market size, growth, share, segments, manufacturers, and technologies, key trends, market drivers, challenges, standardization, deployment models, opportunities, future roadmap and 2027 forecast.

Global Stem Cell Assay Market 2019 Industry Research Report is an expert and inside and out examination on the flow condition of the Global Stem Cell Assay industry. In addition, investigate report sorts the worldwide Stem Cell Assay market by top players/brands, area, type and end client. This report likewise examines the different Factors impacting the market development and drivers, further reveals insight into market review, key makers, key received by them, size, most recent patterns and types, income, net edge with provincial examination and figure.

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List Of TOP KEY PLAYERS in Stem Cell Assay Market Report areMerck & Co., Thermo Fisher Scientific, GE Healthcare, Agilent Technologies, Bio-Rad Laboratories, Promega Corporation, Cell Biolabs, PerkinElmer, Miltenyi Biotec, HemoGenix, Bio-Techne Corporation, STEMCELL Technologies, and Cellular Dynamics International.

Scope of Report:

The global Stem Cell Assay market is anticipated to rise at a considerable rate during the forecast period, between 2019 and 2027. In 2019, the market was growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

This report covers present status and future prospects for Stem Cell Assay Market forecast till 2027. Market Overview, Development, and Segment by Type, Application and Region. Global Market by company, Type, Application and Geography. The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses Stem Cell Assay market trends, size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

Stem Cell Assay Market Research Report provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Stem Cell Assay Market global industry research report is a professional and in-depth study on the market size, growth, share, trends, as well as industry analysis. According to the details of the consumption figures, the global Stem Cell Assay market forecast 2027.

Market by Region:

North America (U.S., Canada, Mexico)

Europe (Germany, U.K., France, Italy, Russia, Spain etc.)

Asia-Pacific (China, India, Japan, Southeast Asia etc.)

South America (Brazil, Argentina etc.)

Middle East and Africa (Saudi Arabia, South Africa etc.)

KEY BENEFITS FOR STAKEHOLDERS

The Stem Cell Assay report provides extensive qualitative insights on the potential and niche segments or regions exhibiting favourable growth.

The report provides an extensive analysis of the current and emerging market trends and opportunities in the global Stem Cell Assay market.

A comprehensive analysis of the factors that drive and restrict the growth of the Stem Cell Assay market is provided.

An extensive analysis of the Stem Cell Assay market is conducted by following key product positioning and monitoring the top competitors within the market framework.

The report provides detailed qualitative and quantitative analysis of current trends and future estimations that help evaluate the prevailing market opportunities.

The report also focuses on global major leading industry players of Global Stem Cell Assay market providing information such as company profiles, product picture and specification, price, capacity, cost, production, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis is also carried out. With tables and figures helping analyze worldwide Global Stem Cell Assay market, this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market. The Global Stem Cell Assay market development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Main Aspects covered in the Report

Overview of the Stem Cell Assay market including production, consumption, status and forecast and market growth.

2014-2018 historical data and 2019-2027 market forecast.

Geographical analysis including major countries.

Overview the product type market including development.

Overview the end-user market including development.

Research objectives:

To understand the structure of Stem Cell Assay market by identifying its various sub segments.

Focuses on the key global Stem Cell Assay manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Stem Cell Assay with respect to individual growth trends, future prospects, and their contribution to the total market.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

To project the consumption of Stem Cell Assay submarkets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

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Detailed TOC of Global Stem Cell Assay Market Study 2019-2027:

1 Industry Overview

1.1 Stem Cell Assay Industry

Figure Stem Cell Assay Industry Chain Structure

1.1.1 Overview

1.1.2 Development of Stem Cell Assay

1.2 Market Segment

1.2.1 Upstream

Table Upstream Segment of Stem Cell Assay

1.2.2 Downstream

Table Application Segment of Stem Cell Assay

Table Global Stem Cell Assay Market 2019-2027, by Application, in USD Million

1.3 Cost Analysis

2 Industry Environment (PEST Analysis)

2.1 Policy

2.2 Economics

2.3 Sociology

2.4 Technology

3 Stem Cell Assay Market by Type

3.1 By Type

3.1.1 Pigment Grade

Table Major Company List of Pigment Grade

3.1.2 Metallurgical Grade

Table Major Company List of Metallurgical Grade

3.1.3 Refractory Grade

Table Major Company List of Refractory Grade

3.1.4 Others

Table Major Company List of Others

3.2 Market Size

Table Global Stem Cell Assay Market 2014-2018, by Type, in USD Million

Figure Global Stem Cell Assay Market Growth 2014-2018, by Type, in USD Million

Table Global Stem Cell Assay Market 2014-2018, by Type, in Volume

Figure Global Stem Cell Assay Market Growth 2014-2018, by Type, in Volume

3.3 Market Forecast

Table Global Stem Cell Assay Market Forecast 2019-2027, by Type, in USD Million

Table Global Stem Cell Assay Market Forecast 2019-2027, by Type, in Volume

4 Major Companies List

4.1 Elementis (Company Profile, Sales Data etc.)

4.1.1 Elementis Profile

Table Elementis Overview List

4.1.2 Elementis Products & Services

4.1.3 Elementis Business Operation Conditions

Table Business Operation of Elementis (Sales Revenue, Sales Volume, Price, Cost, Gross Margin)

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At last, the report gives the inside and out examination of Stem Cell Assay Market took after by above, which are useful for organizations or individual for development of their present business or the individuals who are hoping to enter in Stem Cell Assay industry.

About us:

Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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Covid-19 Impact on Global Stem Cell Assay Market Set Explosive Growth By 2019 2027 | Merck & Co., Thermo Fisher Scientific, GE Healthcare,...

BCLI: Phase 3 ALS Data Expected by the End of November 2020 – Zacks Small Cap Research

By David Bautz, PhD

NASDAQ:BCLI

READ THE FULL BCLI RESEARCH REPORT

Business Update

Topline Data from Phase 3 ALS Trial Before End of November 2020

BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). A total of 200 patients were randomized 1:1 to receive NurOwn or placebo in the randomized, double blind, placebo controlled, multi-dose trial. Cells were extracted once from each patient prior to treatment, with all administrations of NurOwn derived from the same extraction of cells due to a cryopreservation process the company developed for long-term storage of mesenchymal stem cells (MSC). Just as with the companys prior studies, there was a 3-month run-in period prior to the first treatment with two additional NurOwn treatments occurring two and four months following the first treatment. The company is focusing the trial on faster-progressing ALS patients since those patients demonstrated superior outcomes in the Phase 2 trial of NurOwn. The primary outcome of the trial is the ALSFRS-R score responder analysis and we now anticipate topline results before the end of November 2020.

Update on Phase 2 Progressive Multiple Sclerosis Trial

BrainStorm is currently conducting a Phase 2 clinical trial of NurOwn in patients with progressive multiple sclerosis (MS) (NCT03799718). The trial is an open label, single arm study that is enrolling patients with progressive MS with Expanded Disability Status Scale (EDSS) scores of 3.0 6.5. The primary endpoint of the study is the safety and tolerability of three doses of NurOwn with secondary endpoints examining the timed 25-foot walking speed or 9-hole peg test (both validated MS clinical outcome assessments) along with paired cerebrospinal fluid (CSF) and blood biomarker analysis. The National Multiple Sclerosis Society awarded the company a $0.5 million grant to help fund the study.

The trial is now fully enrolled and we anticipate dosing to be completed for all patients by the end of 2020. While the company had previously considered performing an interim analysis, since topline data would be available soon after an interim analysis could be performed the company has decided against performing an interim analysis and will instead report topline data for all 20 patients when it becomes available.

NurOwn Derived Exosomes Show Promise in Preclinical ARDS Study

On July 23, 2020, BrainStorm announced the successful completion of the first milestone in developing an exosome-based platform for the treatment of severe acute respiratory distress syndrome (ARDS) caused by COVID-19. Exosomes are small vesicles (30-150 nm) that are secreted by all cell types. Exosomes from mesenchymal stem cells (MSCs), from which NurOwn is derived, can penetrate into deep tissues and deliver various bioactive molecules. In addition, they can be delivered both intravenously or intratracheally.

BrainStorm conducted a preclinical study of MSC-derived exosomes in a mouse model of lipopolysaccharide (LPS)-induced ARDS. Treatment with intratracheally administered exosomes resulted in a statistically significant improvement in various lung functions, including functional lung recovery and decreased lung damage, as judged by the lung disease severity score (P=0.03). In addition, they led to a reduction in a number of pro-inflammatory cytokines. Lastly, exosomes derived from MSC-NTF cells were superior to exosomes derived from nave MSC from the same donor.

We anticipate the results being submitted to a peer reviewed journal for publication and the company is currently deciding whether to initiate a clinical trial program in COVID-19 patients with ARDS.

Financial Update

On August 5, 2020, BrainStorm announced financial results for the second quarter of 2020. As anticipated, the company did not report any revenues during the second quarter of 2020. Net R&D expenses for the second quarter of 2020 were $5.7 million, compared to $3.6 million for the second quarter of 2019. The increase was primarily due to an increase in payroll and stock-based compensation and a decrease in support from the Israel Innovation Authority (IIA) and California Institute for Regenerative Medicine (CIRM) along with a decrease in costs related to the Phase 3 and Phase 2 clinical trials. Excluding participation from the IIA and CIRM, R&D expenses were $6.0 million in the second quarter of 2020, compared to $6.5 million in the second quarter of 2019. G&A expenses for the second quarter of 2020 were $1.7 million, compared to $1.3 million in the second quarter of 2019. The increase was primarily due to increased payroll and stock-based compensation.

The company exited the second quarter of 2020 with approximately $16.2 million in cash, cash equivalents, and short-term investments. Subsequent to the end of the quarter, the company raised gross proceeds of approximately $13.7 million from the $50 million ATM facility entered into in March 2020 through the sale of 945,082 shares at an average price of $14.48 per share. In addition, the company raised gross proceeds of approximately $6.3 million from the exercise of warrants. We estimate that the company currently has approximately $35 million in cash, cash equivalents, and short-term investments.

As of July 31, 2020, the company had approximately 31.5 million shares outstanding and, when factoring in warrants and stock options, a fully diluted share count of approximately 37.0 million.

Conclusion

The countdown is on to the topline data release for the Phase 3 ALS trial, with those results expected before the end of November 2020. Even with the great run the stock has had since its recent lows in March 2020, we continue to view the shares as undervalued as we currently forecast peak sales for NurOwn of >$1 billion in ALS, >$500 million in MS, and >$2 billion in Alzheimers disease. We recently made a slight change to our model, in which we decreased the discount rate from 17% to 13%, and combined with the recent financing activity has resulted in an increase to our valuation to $33 per share.

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BCLI: Phase 3 ALS Data Expected by the End of November 2020 - Zacks Small Cap Research

Edited Transcript of BLCM.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT – Yahoo Finance

Houston Aug 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Bellicum Pharmaceuticals Inc earnings conference call or presentation Thursday, August 6, 2020 at 9:00:00pm GMT

Bellicum Pharmaceuticals, Inc. - CFO

Bellicum Pharmaceuticals, Inc. - President, CEO & Director

* Nicholas M. Abbott

Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology

Greetings, and welcome to the Bellicum Pharmaceuticals 2Q 2020 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. Thursday, August 6, 2020.

I would now like to turn the conference over to Stephen Jasper from Westwicke. Please go ahead.

Thank you. Good afternoon, everyone, and thank you for joining the call. With me today on the call is Rick Fair, Bellicum's President and Chief Executive Officer; and Atabak Mokari, Chief Financial Officer. Later, during the Q&A session, Aaron Foster, Head of Research, will also be available.

Earlier this afternoon, Bellicum released financial results for the second quarter and 6 months ended June 30, 2020. If you have not received this release or if you'd like to be added to the distribution list, you can do so on the Investor Relations page of the company's website.

As a reminder, today's conference call will include forward-looking statements made under the Private Securities Litigation Reform Act of 1995, including statements regarding Bellicum's research and development plans, clinical trials, plans regarding regulatory filings, review and approval of its product candidates, commercialization expectations and our financial outlook. These forward-looking statements involve a number of risks and uncertainties and reflect Bellicum's opinions only as of the date of this call. Bellicum undertakes no obligation to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Actual results may differ from those indicated by these forward-looking statements due to numerous factors, including those discussed in the Risk Factors section of Bellicum's Form 10-K for the year ended December 31, 2019, and 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission.

And now I will turn the call over to Rick Fair, Bellicum's President and CEO.

Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [3]

Thanks, Stephen. Good afternoon, everyone, and thanks for joining us. On our call today, I'll provide an update on our GoCAR pipeline, and Atabak will update you on our financial results. Before I talk about our individual programs, let me briefly remind you how GoCAR is differentiated from other cell therapy approaches. Our platform is unique in 2 distinct ways. First, we've engineered GoCAR to deliver more potent and durable efficacy relative to current generation cell therapies. We believe we can accomplish this primarily through our coactivation domain, MyD88, CD40 or MC. We believe MC signaling can boost effector cell proliferation and survival, enhance functional persistence by resisting exhaustion in the suppressive tumor microenvironment and stimulate the cancer patients' own immune system to attack tumors.

Second, we've engineered GoCAR for higher performance relative to current generation cell therapies, potentially offering superior control via our molecular switch technology. Other cell therapies behave unpredictably due to their autonomous activity, but GoCAR anti-tumor effects can be controlled by the scheduled intermittent administration of rimiducid. GoCAR activity can be dialed up or down by adjusting the interval between rimiducid doses or suspending further rimiducid administration. In our dual-switch product candidates, we can further improve controllability by incorporating our CaspaCIDe safety switch, which would -- can rapidly eliminate cells when triggered to manage acute toxicities if they occur.

We believe our GoCAR platform may address many of the shortcomings of current cell therapies. Our preclinical investigations have demonstrated some of these potential benefits, and we are now observing supportive evidence of these effects in the clinic. We are pursuing 2 strategic paths to establish clinical proof of concept: First, we are targeting solid tumors, where the effects of MC signaling may help overcome the challenges of the hostile tumor microenvironment, T cell exhaustion and heterogeneous antigen expression that have confounded previous CAR-T efforts. Our 2 solid tumor CAR-T -- GoCAR-T candidates, or BPX-601, targeting PSCA, and BPX-603 targeting HER2.

Our second strategy is the pursuit of an allogeneic off-the-shelf cell therapy. We believe that our GoCAR platform has the potential to drive proliferation and persistence of allogeneic immune cells and to stimulate a host immune response, both of which will be critical to delivering effective off-the-shelf therapies. We seek to demonstrate the value of our approach with our BCMA GoCAR-NK.

Let me now provide an update on each of these programs. BPX-601 targets prostate stem cell antigen or PSCA. The clinical data we have presented to date from an ongoing Phase I/II dose escalation trial in pancreatic cancer have shown encouraging safety, biologic activity, and biomarker data that supports the hypothesized benefits of the GoCAR platform in solid tumors. Specifically, we are particularly encouraged by observations of tumor infiltration, GoCAR-T mediated immunomodulation, persistence of cells for up to 9 months and changes in gene expression in the tumor microenvironment, consistent with a productive CAR-T cell immune response.

We are now enrolling Cohort 5C, our first-in-human evaluation of repeat rimiducid dosing. Our preclinical experience suggests that regular rimiducid dosing can reactivate and expand GoCAR-T cells in the presence of tumor antigen over time, without creating T cell exhaustion and thus, maximize the clinical efficacy potential. We plan to present interim results for this cohort at a medical meeting by the end of this year.

Like many others, we have experienced the COVID-19 related impact on screening and enrollment, which may impact the number of patients and duration of follow-up that we will present. In addition, primarily due to COVID-19 restrictions at our study sites, we have been unable to date to collect post-treatment biopsies in Cohort 5C, limiting to some degree what we can assess in these patients. We will continue to work with our investigators to overcome these COVID-19 obstacles to the extent possible, and are in the process of adding a few more sites to the study to increase prescreening activity.

Looking ahead, we have submitted a protocol amendment to the FDA with several modifications to the study. Upon FDA and IRB clearance of this amendment, we plan to expand eligibility to third-line pancreatic cancer patients, which we believe will enable more prescreening. Second, informed by the risk-benefit profile we've observed to date, we will extend dose escalation to 10 million cells per kilogram. Lastly, we will add a cohort of patients with hormone refractory, metastatic castration-resistant prostate cancer. Assuming prompt FDA clearance of this amendment, we expect to begin enrollment under this amended protocol later this year. Based on the data we've seen so far and the proposed study amendments, we remain optimistic about BPX-601, both as a product candidate and as proof-of-concept for our GoCAR platform.

Now let me update you on BPX-603. This program is Bellicum's first dual-switch product candidate, which has been designed to target solid tumors that express HER2. Academic CAR-T trials targeting HER2 have demonstrated clinical activity and reasonable safety. We believe that our dual switch technology in BPX-603 may be uniquely suited to improve upon these earlier efforts by driving greater efficacy through MC signaling and providing an extra layer of safety via our switch platform.

The FDA recently cleared our IND for BPX-603, and we are currently in study start-up to initiate a Phase I/II clinical trial later this year. The trial is a traditional 3 plus 3 dose escalation followed by Phase II expansions in multiple HER2-positive cancers. Dose escalation will begin at 100,000 cells per kilogram in a basket of HER2-positive solid tumors, and patients will be sequentially enrolled throughout dose escalation. Patients will receive standard Flu/Cy conditioning followed by BPX-603 cells. The first patient in each dose cohort will be followed without subsequent treatment, while the remaining patients in each cohort will receive weekly rimiducid to either dose-limiting toxicity or disease progression. We are excited to get this study underway, and we'll keep you posted on our progress.

Now let's move to our BCMA GoCAR-NK program. CAR-NK cells represent an intriguing next wave in the evolution of cell therapy, so we are excited about the potential for our first off-the-shelf GoCAR-NK candidate. NK cells may be particularly well suited for allogeneic cell therapy since they have innate cytotoxicity with low propensity for causing graft-versus-host disease.

We presented encouraging preclinical data from our NK discovery program at the 2019 SITC meeting and published a paper on this work, Blood Advances, this year in May. The data showed that our GoCAR platform synergizes with secreted IL-15 to enhance NK cell proliferation, survival and cytotoxic function. In addition, GoCAR-NK cells expressing our MC coactivation domain and IL-15 resulted in superior in vivo efficacy in multiple preclinical tumor models. Based on these initial investigations, we believe that GoCAR-NK cells have the potential to be a best-in-class off-the-shelf cell therapy. We selected BCMA as the target for our initial program since it is, well validated from autologous CAR-T studies, and we expect cell therapy to play a major role in multiple myeloma treatment.

The next step for the field is to deliver similar clinical benefit with an off-the-shelf therapy, which may provide faster and more certain time to treatment, greater scalability, convenience and a lower cost to manufacture. Based on our preclinical findings, we believe that GoCAR-NK may deliver more durable efficacy than other off-the-shelf cell therapy strategies. We will seek to demonstrate this in our development program. Our preclinical development is ongoing, and we expect to present additional data for this program by the end of 2020.

That concludes the summary of our programs. So let me now turn the call over to Atabak for a review of our financial results.

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Atabak Mokari, Bellicum Pharmaceuticals, Inc. - CFO [4]

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Thank you, Rick. R&D expenses were $11.8 million for the second quarter of 2020 compared to $20 million for the second quarter of 2019. The reduction in expenses in the second quarter of 2020 was primarily due to reduced expenses related to reduced RIVO-CEL-related activities, reduced expenses resulting from the April 2020 manufacturing facility sale and the reduction in force that was implemented during the second half of 2019. These reduced expenses were partially offset by increased expenses related to our GoCar-T and GoCAR-NK programs.

General and administrative expenses were $3.8 million for the second quarter of 2020 compared to $7.5 million during the comparable period in 2019. The lower expenses in the second quarter of 2020 was primarily due to the reduction in RIVO-CEL-related commercialization activities and the effect of the reduction in force that reduced employee-related charges.

Bellicum reported a net loss of $43.2 million for the second quarter of 2020 compared to a net loss of $26.9 million for the comparable period in 2019. The second quarter 2020 results included a noncash loss of $30.7 million related to the change in fair value of warrant liability and net gain on dispositions of $3.8 million due to the manufacturing facility sale.

Turning to our balance sheet. As of June 30, 2020, cash, cash equivalents and restricted cash totaled $68 million. In the second quarter, we had a cash loss from operations of approximately $14.2 million, which was a decrease from prior quarters given the steps we have taken to streamline the organization.

In April, Bellicum closed a transaction in which the MD Anderson Cancer Center acquired our manufacturing facility in Houston for $15 million. Concurrent with the transaction, Bellicum repaid $7 million of its Oxford Finance debt obligation.

Based on current operating plans, Bellicum expects cash utilization of $55 million to $65 million for the full year 2020 compared to cash loss from operations of approximately $30.5 million for the 6 months ended June 30, 2020. We believe that the current cash resources will be sufficient to meet operating requirements into the second half of 2021.

And now I'll hand the call back over to Rick.

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [5]

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Thanks, Atabak. Reviewing our accomplishments so far in 2020, I'm pleased by the advancement of our GoCAR pipeline across our 3 programs. I'm particularly enthusiastic as we anticipate an increasing number of potential data milestones. Over the next 24 months, for BPX-601, we expect to present 2 updates in pancreatic cancer and our first data in prostate cancer. For BPX-603, we expect steady start in our first patient from dose escalation. And for our GoCAR-NK program, we expect multiple preclinical presentations and IND submission.

I remain excited about Bellicum's future, the potential of our GoCAR pipeline and look forward to updating you on our future progress, including our first-in-human data with repeat rimiducid dosing and preclinical data on our GoCAR-NK program later this year.

I'll now open the call to questions. Operator?

================================================================================

Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from the line of Jim Birchenough with Wells Fargo Securities.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [2]

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It's Nick on for Jim. And keeping us on the toes there with a new way to register and address all of your question. So the first thing, Rick, on 601. So has there been any readthrough from emerging repeat dose rimiducid data that's sort of led to this, I think, what we'd interpret as a renewed interest in expanding the 601 program?

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [3]

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No, I think the expansion in the prostate, which is probably what you're referring to, Nick, is -- been a long-standing interest of ours. And I think we've now -- we're approaching the end of the dose escalation that we initiated in pancreatic cancer and now's the time to explore an expansion mode, a different tumor type. I think we all acknowledge that pancreatic cancer is a very challenging tumor. And we certainly don't want to miss a signal by not looking a little more broadly. So I think this is really just fulfillment of the previously articulated plan.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [4]

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Okay. And then, in terms of the patients that you'll be enrolling with prostate cancer, do they have to fail the specific number of lines of treatment? And then, just from a perspective of this is a very bone-centric cancer, do you have preclinical data that supports that 601 is able to penetrate bone mets?

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [5]

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Yes. On your first question, eligibility inclusion criteria, patients have to have received an anti-androgen therapy and either received or are ineligible for a taxane. And then for the subsets of patients that qualify, either MSI-high for anti-PD-1 or BRCA mutant for PARP inhibitor have to have received those therapies as well. So it's a later line patient population.

As far as bone mets, I don't think we have any specific preclinical data for BPX-601, but we will certainly be looking at the translational data as we embark and treat the patients in the study.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [6]

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And then just on 603, you gave us some outlines on -- of the trial design, so 3 plus 3, those patients. So is that the first patient at every dose level would not receive rimiducid?

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [7]

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Yes, that's correct. The -- so it's a traditional 3 plus 3 design with some modifications, and that's certainly one of them. So you would expect in each cohort and dose level in each of the study, the first patient would receive cells only, and the second 2 patients in the absence of a dose-limiting toxicity would receive cells plus weekly rimiducid.

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Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [8]

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And so presumably that first patient then will stay in the hospital, be intensively monitored. Do you have -- I mean, what -- can you discuss what the triggers are for administering the rapalog to activate the kill switch?

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [9]

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I think in summary, depending on the toxicity, it's essentially failure of standard of care. So these patients, as you say, will be admitted and will be monitored carefully. The on-target, off tumor effects that you'd be most interested in with this antigen, of course, are cardiopulmonary. So certainly, we'll be active monitoring. And if adverse events occur, they'll be treated with standard of care for whatever the adverse event. And then if standard of care fails, then they'll receive tensile and the small molecule activator of the safety switch in this construct.

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Operator [10]

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Our next question comes from the line of Kit Ma with Jefferies.

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Wai Kit Ma, Jefferies LLC, Research Division - Equity Associate [11]

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This is Kit. I'm on for Biren. I'm wondering what type of response can we expect with BPX-601 in the current trial. What will be the bar to move this forward into Phase II trial?

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Richard A. Fair, Bellicum Pharmaceuticals, Inc. - President, CEO & Director [12]

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Sure. Thanks, Kit. So it depends on the tumor type, of course. I think what we've said about pancreatic cancer is that you'd need to see something like a 15% response rate with a 6-month duration of response to be meaningful activity in the setting and be worth expansion in prostate cancer, probably a bit higher on the response rate, something more like a 30% to 35% response rate with similar durability to be a meaningful candidate to advance. So those are the thresholds that we're looking at.

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Operator [13]

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(Operator Instructions) Our next question comes from the line of Wangzhi Li with Landenburg.

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Wangzhi Li, Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology [14]

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Edited Transcript of BLCM.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT - Yahoo Finance

H.C. Wainwright Keeps Their Buy Rating on Lineage Cell Therapeutics (LCTX) – Smarter Analyst

H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Lineage Cell Therapeutics (LCTX) today and set a price target of $7.00. The companys shares closed last Thursday at $0.92.

According to TipRanks.com, Pantginis is a 5-star analyst with an average return of 28.3% and a 53.4% success rate. Pantginis covers the Healthcare sector, focusing on stocks such as Applied Genetic Technologies, Actinium Pharmaceuticals, and Iovance Biotherapeutics.

Lineage Cell Therapeutics has an analyst consensus of Strong Buy, with a price target consensus of $4.67.

See todays analyst top recommended stocks >>

The company has a one-year high of $1.67 and a one-year low of $0.53. Currently, Lineage Cell Therapeutics has an average volume of 1.27M.

Based on the recent corporate insider activity of 11 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of LCTX in relation to earlier this year.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Lineage Cell Therapeutics, Inc. operates as a clinical-stage biotechnology company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. The companys programs are based on two core proprietary technology platforms: cell replacement and cell and drug delivery. Its cell replacement platform creates new cells and tissues with its pluripotent and progenitor cell technologies. The companys cell and drug delivery programs are based upon its proprietary HyStem cell and drug delivery matrix technology. It engages in the research and development of regenerative medicine or therapeutic products for advancement in the field of oncology, orthopedics, retinal and neurological diseases and disorders, blood and vascular system diseases and disorders, blood plasma volume expansion, diagnostic products for the early detection of cancer and hydrogel products that may be used in surgery and products for human embryonic stem cell research. The company was founded by Judith Segall, Hal Sternberg, Paul E. Segall and Harold D. Waitz on November 30, 1990 and is headquartered in Alameda, CA.

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H.C. Wainwright Keeps Their Buy Rating on Lineage Cell Therapeutics (LCTX) - Smarter Analyst

Researchers Using Models To Understand COVID-19, Other News – Bio-IT World

August 7, 2020 |Researchers are continuing to analyze COVID-19 through several models. A new mouse model is being developed in China to test and confirm the efficacy of a potential vaccine, while a researcher in the US is using computer models to understand the structure of the virus.

Literature Updates

Researchers in China have developed anew mouse modelof COVID-19 infection that may help facilitate testing of vaccines and therapeutics. The model, which has been used to test and confirm the protective efficacy of a COVID-19 vaccine candidate, is described in a recent article published in Science. Efforts to study virus infection and evaluate vaccines in mice have up to now required mice to be engineered to express human ACE2. This represents a new approach where a strain of SARS-CoV-2 seen in the clinic is adapted in the mouse respiratory tractto develop a mutant version that was able to replicate and cause disease in young and aged mice; both groups showed pneumonia and inflammatory responses after intranasal infection, clinical features seen in human patients. DOI: 10.1126/science.abc4730

In an article in Research Ideas and Outcomes, a researcher at The Catholic University of America(Washington, D.C.) details how he has used computer models to understand the structure of the SARS-CoV-2 virus on the molecular level and try to figure out how the virus functions. It describes how antibodies found in the first SARS outbreak in 2002 (80R and m396) were reengineered to fit the new virus using computer simulation, and points to the discovery that sequence differences prevent 80R and m396 from binding to COVID-19which could pave the way to engineering new antibodies that are effective. Docking experiments utilizing supercomputers at the Texas Advanced Computing Centerand Pittsburgh Supercomputer Centershowed that amino acid substitutions in 80R and m396 should increase binding interactions between the antibodies and SARS-CoV-2. The in-silico analysis could fast-track passive immunity that could prevent infection for several months. DOI: 10.3897/rio.6.e55281

Researchers at the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Scienceshave used X-ray crystallography to determine and analyze the precise structure of the complex of the Nsp16 and Nsp10 coronavirus proteins. They report in Nature Communications that theyve identified a deep canyon on the surface of the protein complex where binding of the viral RNA occurs, and a cap is installed. A cap is a special structure of SARS-CoV-2 that allows the virus to infect the human body and multiply within it. Targeting the canyon by inhibitors that suppress the activity of the Nsp16 and Nsp10 protein complex may, in the future, serve as drugs to combat many coronaviruses. DOI: 10.1038/s41467-020-17495-9

Researchers from the Perelman School of Medicine at the University of Pennsylvaniahave identified a protein called histone deacetylase 3 (HDAC3) as the orchestrator of the immune system's inflammation response to infection. This has implications for COVID-19 as well as other diseases such as cancer, heart disease and diabetes where the rise-and-fall in inflammatory factors go unchecked. Using both specially cultured cells and small animal models, HDAC3 was found to be directly involved in the production of agents that help kill off harmful pathogens as well as the restoration of homeostasis. Their work, published in Nature, shows that some of the methods being tested to fight harmful inflammation that target molecules like HDAC3 could have unintended and deadly consequences. The non-enzymatic functions of HDAC3, which have been previously under-appreciated, are responsible for the production of cytokine storma highly lethal phenomenon widely reported in patients infected with COVID-19. DOI: 10.1038/s41586-020-2576-2

Virologists in the College of Veterinary Medicine at Kansas State Universityhave published a study in Science Translational Medicineshowing a possible therapeutic treatment for COVID-19. It reveals how small molecule protease inhibitors show potency against human coronaviruses, including SARS-CoV-2 and Middle East respiratory syndrome coronavirus (MERS-CoV). These coronavirus 3C-like proteases (aka 3CLpro) are strong therapeutic targets, they say, because they play vital roles in coronavirus replication. In their study, optimized coronavirus 3CLpro inhibitors blocked replication of the human coronaviruses MERS-CoV and SARS-CoV-2 in cultured cells and in a mouse model for MERS. Co-collaborators on the research are at Wichita State University, the University of Iowa and the University of Kansas. DOI: 10.1126/scitranslmed.abc5332

Brazilian researchers have shown that artificial intelligence can increase the effectiveness of drug repositioning or repurposing research for psychiatric and neurological disorders, and the novel drug screening approachwill now be used in another study with the aim of repurposing drugs to treat COVID-19. In a study published back in May in Translational Psychiatry, they correlated information on genes associated with these disorders and drugs approved for use in treating other diseases that might potentially inhibit or activate these genes. That study identified 63 drugs targeting 31 genes and potential candidates for testing against Alzheimer's disease, Parkinson's disease, Huntington's disease, depression, anxiety, bipolar disorder, schizophrenia and autism. A total of 1,588 genes were correlated with 722 drugs. They used a machine learning approach known as network medicinean emerging field that combines systems biology and network science to understand how genes interact in disease and healthto investigate the molecular characteristics and mechanisms of the psychiatric and neurological disorders. The group used IBM Watson for Drug Discoveryas well as programs developed in their own laboratory to mine information in more than 20 million scientific articles published over the last 50 years. DOI: 10.1038/s41398-020-0827-5

One of the immune system's oldest branches, called complement, may be influencing the severity of COVID disease, according to researchers at Columbia UniversityIrving Medical Center. Among other findings linking complement to COVID, the researchers found that people with age-related macular degenerationa disorder caused by overactive complementare at greater risk of developing severe complicationsand dying from COVID. The connection with complement suggests that existing drugs that inhibit the complement system could help treat patients with severe disease. The study published in Nature Medicine. The authors also found evidence that clotting activity is linked to COVID severity and that mutations in certain complement and coagulation genes are associated with hospitalization of COVID patients. Findings stem from an earlier finding that coronaviruses are masters of viral mimicry, particularly with proteins involved in coagulation and proteins that make up complement. DOI: 10.1038/s41591-020-1021-2

SARS-CoV-2presents at least six strainsand, despite its mutations, shows little variability (approximately seven mutations per sample, less than half that of common influenza)good news for the researchers working on a viable vaccine, which was shared by scientists at the University of Bologna (Italy) in Frontiers in Microbiology. Results drew from an analysis of 48,635 coronavirus genomes that were isolated by researchers in labs across the world. They then mapped the spread and mutations of the virus during its journey to all continents. Treatments under development, including a vaccine, might be effective against all the virus strains, the authors conclude. DOI: /10.3389/fmicb.2020.01800

Researchers affiliated with the Optics and Photonics Research Center(Brazil) advocate for photodynamic therapy to combat secondary infections in COVID-19 patientsin an article published in Photodiagnosis and Photodynamic Therapy. The technique combines light and a photosensitizing chemical substance to kill microorganisms in the respiratory tract. The compounds interact with light to produce a highly reactive oxygen species that kills viruses and bacteria by oxidizing their membranes. When the patient inhales these substances, the drug can be activated with extracorporeal light, which then attacks pathogens in the airways. Photodynamic therapy cannot be used to attack SARS-CoV-2 directly but it can be used as a treatment for COVID-19 coinfections caused by bacteria and other viruses, they argue. Several studies have already been conducted on the use of photodynamic therapy to treat pneumonia, skin cancer, and other diseases, and a new study is about to begin in partnership with researchers at the University of Torontoin Canada that will evaluate its use in cases of pneumonia in pigs. DOI: 10.1016/j.pdpdt.2020.101804

Luring SARS-CoV-2 with a decoyan engineered, fee-floating receptor proteinbinds the virus and blocks infection, suggests a study published in Science. Administering a decoy based on ACE2, the receptor protein on the surface of the cell to which the coronavirus binds, might neutralize infection as well as rescue lost ACE2 activity and directly treat aspects of COVID-19, the researchers say. As a potential therapeutic agent, a decoy receptor would have an advantage over other drugs because to evade it the virus would have to mutate in a way that makes it less infectious. The decoy, unlike ACE2, would be optimized for the binding role. After examining more than 2,000 ACE2 mutations and creating cells with the mutant receptors on their surfaces, researchers found a combination of three mutations that created a receptor that bound to the virus 50 times more strongly. They then made a soluble version of the engineered receptor. The strong affinity between the virus and the decoy receptorrivaling the best antibodies identified to datehas been verified by the U.S. Army Medical Research Institute of Infectious Diseasesas well as at the University of Illinois. The decoy receptor is now being tested in mice and exploring how it bonds to other coronaviruses with potential to become future pandemics if they cross from bats to humans. DOI: 10.1126/science.abc0870

In another study published in Science, scientists show that memory helper T cells that recognize common cold coronaviruses also recognize matching sites on SARS-CoV-2. That may explain why some people have milder COVID-19 cases than others, they speculate. Immune reactivity may translate to different degrees of protection, with those having a strong T cell response afforded the opportunity to mount a much quicker and better response. The work builds on previous reports from around the globe that many people never exposed to SARS-CoV-2 had T cells that reacted to the virus. For this study, researchers found that unexposed individuals can produce a range of memory T cells that are equally reactive against SARS-CoV-2 and four types of common cold coronaviruses. They additionally found that pre-existing immune memory was directed not only at the SARS-CoV-2's spike protein, which most vaccine candidates are targeting, but also other SARS-CoV-2 proteins. It might therefore be possible to take advantage of this cross-reactivity with multiple viral targets to further enhance vaccine potency. DOI: 10.1126/science.abd3871

Researchers at Yale University School of Medicine have developed a new mouse modelto study SARS-CoV-2 infection and disease, aiding in the discovery that key antiviral signaling proteinsmay not protect the lungs but rather cause much of the tissue damage associated with COVID-19. To create their alternative mouse model, the animals were first infected with a different, harmless virus carrying the human ACE2 gene that enabled the SARS-CoV-2 to replicate and induced an inflammatory response like that observed in COVID-19 patients. The infected mice also rapidly developed neutralizing antibodies against SARS-CoV-2. When the mice lacking the key components of the type I interferon pathway were infected, they were no worse at controlling SARS-CoV-2 infection, but they also recruited fewer inflammatory immune cells into their lungs. This indicates that type I interferonscurrently being used as a treatment for COVID-19dont restrict SARS-CoV-2 replication and may play a pathological role in COVID-19 respiratory inflammation. The early timing of interferon-based treatment will be important for it to provide protection and benefit, they say. Results published in the Journal of Experimental Medicine. DOI: 10.1084/jem.20201241

Genes thought to play a role in how the SARS-CoV-2 virus infects human cells are active in embryos as early as the second week of pregnancy, say scientists at the University of Cambridgeand the California Institute of Technology. The researchers say this could mean embryos are susceptible to COVID-19 if the mother gets sick, potentially affecting the chances of a successful pregnancy. To examine the risks, they cultured human embryos through the stage they normally implant in the body of the mother to look at the expression of key genes. Findings included patterns of expression of ACE2 (providing the genetic code for the SARS-CoV-2 receptor) and TMPRSS2 (providing the code for a molecule that cleaves both the viral spike protein and the ACE2 receptor), allowing infection to occur. These genes were expressed during key stages of the embryo's development, and in parts of the embryo that go on to develop into tissues that interact with the maternal blood supply for nutrient exchange. The study, published in Open Biology, reports the finding of the RNA messengers. Researchers emphasize the importance of women planning for a family to try to reduce their risk of infection. DOI: 10.1098/rsob.200162

Initial data from mice suggest thatSARS-CoV-2 might not be targeting taste buds, as has been suspected due to reports of some COVID-19 patients losing their sense of smell and/or taste. University of Georgia researchers report in ACS Pharmacology & Translational Sciencethat they found ACE2 (a receptor on the surface of some cells, including those of the human tongue) was enriched in cells that give the tongue its rough surface, but couldn't be found in most taste bud cells. That means the virus probably doesnt cause taste loss through direct infection of these cells. Instead, taste buds might be damaged by inflammation caused by the infection. They also showed that other viruses that affect taste, including the flu virus, might affect different tongue cell types. Based on an analysis of mice at different developmental stages and previous studies in humans, it also appears possible that fetuses have distinct susceptibilities to SARS-CoV-2 infection at different stages. DOI: 10.1021/acsptsci.0c00062

The latest paper about the Moderna-NIH vaccine mRNA-1273 that recently entered phase 3 human trials published in Nature, describing both preclinical resultsand the carefully engineered spike protein that mimics the infection-spreading part of the SARS-CoV-2 virus. The investigational vaccine induced neutralizing antibodies in mice when given as two intramuscular injections of a 1-microgram (mcg) dose three weeks apart; mice given two injections of the 1-mcg dose and later challenged with SARS-CoV-2 virus either five or 13 weeks after the second injection were protected from viral replication in the lungs and nose. Importantly, mice challenged seven weeks after only a single dose of 1 mcg or 10 mcg of mRNA-1273 were protected against viral replication in the lung. The investigational vaccine also induced robust CD8 T-cell responses. Years of earlier research into coronaviruses was critical for the fastest-ever progression (66 days) from virus genome sequencing to vaccine testing in humans. The spike protein is a shapeshifter, changing its structure before and after fusing with cells. The immune system responds best when the spike protein is in its prefusion shape, so researchers reengineered the protein in two key places to lock it into that shape. Using small genetic modifications to the gene sequence that encodes for the protein, they essentially made part of the spring-loaded portion of the molecule more rigidthe same tactic successfully used back in 2017 to stabilize the shape-shifting spike protein for MERS-CoV. The protein engineering work was led by a team at The University of Texasat Austin. Other collaborating institutions on the preclinical work were the University of North Carolina at Chapel Hill and Vanderbilt University Medical Centerin Nashville. DOI: /10.1038/s41586-020-2622-0

A team of chemists from HSE University and the Zelinsky Institute of Organic Chemistry(Russia) used molecular modelling to find out that two well-known medicationsdisulfiram (for alcoholism) and neratinib (experimental drug for breast cancer)can be used to fight SARS-CoV-2, as reported in Mendeleev Communications. The classical docking process used for molecular modeling doesnt work in SARS-CoV-2, so they instead used an on-top docking method that they invented shortly before the pandemic. It involved investigating the entire surface of the Mpro target protein with many medications and hoping big calculation powers would return useful dockings. The potential drugs were taken from a database of FDA-approved medications and the research team's own algorithms were used for modelling. In tests performed at Reaction Biology Corp., a certified laboratory in the U.S., both disulfiram and neratinib were found to inhibit Mpro, although the latter was deemed insufficient for clinical use. The main achievement is demonstration of the new on-top docking approach in returning realistic and controllable results. DOI: 10.1016/j.mencom.2020.07.004

In Molecular Systems Biology, researchers at Uppsala University(Sweden) have described the presence of angiotensin I converting enzyme 2 (ACE2)thought to be the key protein used by the SARS-CoV-2 virus for host cell entry and development of COVID-19throughout the human body. In contrast to previous studies, theirs shows that no or very little ACE2 protein is present in the normal respiratory system. The article presents a large-scale, systematic evaluation of ACE2 expression in more than 150 cell types, at both messenger RNA (mRNA) and protein levels. The fact that ACE2 has limited expression in respiratory epithelial cells highlights the need for further study of the biological mechanisms responsible for COVID-19 infection and disease progression, they say. The expression profiles in previous studies indicating that ACE2 is highly expressed in the human lung have not been reliably presented along with tissues and organs from the entire human body or based on several different datasets at mRNA and protein levels. For this study, immunohistochemical analysis of 360 normal lung samples from an extended patient cohort was based on the Human Protein Atlas resource. Two different antibodies, which were stringently validated, were used. DOI: 10.15252/msb.20209610

Industry Updates

Oxford Nanoporelaunched its novel LamPORE SARS-CoV-2 test and announced an agreement with the UKs Department of Health and Social Care, to make an initial 450,000 LamPORE tests available for use by a number of NHS testing laboratories. As well as providing a large number of tests for existing labs, the program will help the UK to understand the different use cases for the technology, for example the potential asymptomatic screening of frontline staff. Because of its scalability, LamPORE has the potential to provide both large-scale screening to detect the virus in broader populations, and rapid, focused, localized analysis. LamPORE is designed to be deployed on Oxford Nanopores desktop device (GridION) or palm-sized device (MinION Mk1C), providing the capacity of processing up to 15,000 saliva or swab RNA samples a day or 2,000 samples a day respectively. It is well suited to use in a central laboratory for high-throughput sample processing, or near-community pop-up lab. LamPORE results can be generated in under two hours. Oxford Nanopore is currently also developing LamPORE to test for multiple pathogens within a single sample, including influenza A (H1N1 and H3N2), influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2. This is intended to allow healthcare professionals to distinguish between these infections, better manage expected winter pressures on the NHS and guide public health and clinical management of these diseases at a time of traditionally heightened pressure on health services. Press release.

The AI-powered nonprofit startup Reboot Rx has launched the Reboot: COVID-Cancer Project, a free, publicly accessible resource for researchers and physicians to quickly find and review data on COVID-19 and cancer. Cancer patients are among those with the highest risk of dying from COVID-19. From over 170,000 published studies and registered clinical trials, Reboot Rx has identified the 850 that are most relevant for cancer patients with COVID-19. The Reboot: COVID-Cancer Project provides crucial insights into treatment responses and mortality rates to understand how cancer patients are uniquely vulnerable to COVID-19. Through this effort, Reboot Rx is helping researchers and physicians pursue the most effective treatments. Press release.

Thermo Fisher Scientific has launched a new, highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group, a global leader in laboratory automation and liquid handling. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources. The Amplitude Solution utilizes Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, a fast, highly sensitive multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The company will submit this new end-to-end solution to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) and plans to secure additional authorizations globally. Press release.

P33, Open Commons Consortium(OCC) and MATTER have launched the Chicagoland COVID-19 Data Commons(CCC), a centralized data platform created in partnership with regional healthcare providers, to help clinicians, researchers and community advocates understand how the disease behaves within the Chicagoland population. P33, a private-sector led initiative promoting inclusive tech growth in Chicagoland; the OCC, a builder of data commons and data-sharing ecosystems; and MATTER, healthcare startup incubator, partnered to create the Chicagoland COVID-19 Data Commons to understand the pandemic, measure Chicagoland's regional response and build a helpful decision-making tool for local government. COVID-19 has already had a devastating impact on our communities. In Chicago, there have been almost 60,000+ cases of COVID-19 identified residents and almost 140,000+ in Illinois. The impact has been particularly hard on black and Latinx communities. The OCC, MATTER and P33 are engaging hospitals and nonprofits in Chicagoland that are serving patients impacted by the disparities of COVID to include their clinical data in the CCC, ensuring accurate representation of the data across all zip codes in Chicago. Participating health systems and hospitals include Rush University Hospital, University of Chicago, University of Illinois Chicago, St Anthony Hospital, Sinai Health System, Medical Home Network, NorthShore University Health Systems, Community Health, and Illinois Association of Free and Charitable Clinics. Press release.

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Researchers Using Models To Understand COVID-19, Other News - Bio-IT World

Photobiomodulation shows the power of light – Ophthalmology Times

Special to Ophthalmology Times Age-related macular degeneration (AMD) is an eye disease that leads to vision loss and can cause blindness.

The dry form affects 80% of individuals with AMD; it tends to progress more slowly than the wet type and results in a subsequent loss of visual acuity.1

At present, there is no approved treatment or cure for the dry form. In dry AMD, drusen form beneath the macula, causing a progressive loss of central vision over time.

Related: ASRS 2020: Augmented-reality headset provides vision for AMD patients

However, several studies with strong and moderate evidence in the past 5 years have shown encouraging results in treating eye diseases, such as AMD,11,12 retinopathy of prematurity, and diabetic macular edema, with a technique known as photobiomodulation (PBM).7-10

PBM has also been used in the last 20 years for musculoskeletal pain, injury, dysfunction, and wound healing; to improve acute muscle performance and reduce muscle damage after exercise;7 and for neuropathic pain, lymphedema, and oral mucositis1,3-15

PBM, or low-level light therapy, is the application of monochromatic light to a part of the body with the aim of repairing tissues and reducing inflammation, edema, and pain.7

The process is not a heat therapy, but is more akin to photosynthesis in plants. Light, in the far red and near-infrared spectral range, can stimulate the cells, which leads to a cascade of photochemical reactions.

The low-powered light is absorbed locally by the cytochrome c oxidase; mitochondrial energy is then produced by releasing oxygen, which results in increased adenosine triphosphate concentration and reduced oxidative stress.

This photochemical reaction then activates enzymes and second messengers, leading to a cellular and, indirectly, systemic response by tissues that have not absorbed photons.1,16,17

PBM can be used in acute and chronic eye diseases such as dry AMD, as mitochondrial dysfunction and oxidative stress play a key role in many macular diseases.1,7,11

The technique does not worsen the disease, has no side effects, and is completely noninvasive.1,18 The protocol we use provides a combination of 9 PBM therapies.

Related: Vision-related qualities of life: Impacts of advanced AMD

PBM is performed through a medical device which applies light-emitting diodes (LEDs) to stimulate cellular function and improve energy production.

Each cycle of therapy delivers wavelengths between 590 nm and 850 nm for 4 minutes per eye. The PBM cycles are completed in approximately 1 month.

Clinical outcomes are determined using an optical coherence tomography (OCT) test; an Amsler grid, to detect wavy, broken, or distorted lines; a Pelli-Robson chart, for assessment of contrast sensitivity; a Snellen chart, for far visual acuity (VA); and a Jaeger chart, for near VA. The outcomes are measured at the end of the PBM procedure, after 3 months and after 6 months.

The clinical results of a case after PBM are shown in Figure 1. Nine PBM cycles were administered to a patient over 1 month.

After 1 month and 6 months, the OCT scan showed reduced drusen. The patient obtained subjectively improved vision, less eye strain, more color contrast, higher definition, and better far and near uncorrected VA. Contrast sensitivity improved from 1.8 to 2.0. Outcomes remained stable at the 6-month follow-up.

Related: ASRS 2020: What Aviceda's lead candidate AVD-104 may mean for dry AMD

This case demonstrates a successful noninvasive treatment with improved quality of vision in dry AMD. Irradiation could, therefore, offer a new, noninvasive, adverse effectfree means of stimulating retinal stem cells to regenerate.

PBM is a treatment whereby quality of vision is improved and not worsened in some patients suffering from dry AMD, leading to better VA and contrast sensitivity and a less damaged macular profile.

Overall, these results are encouraging and indicate how protocols could be consolidated in the future.

Promoting cellular regeneration by using light waves represents a challenge in ophthalmology.

To date, there are no approved theories for many retinal diseases. Intriguingly, this protocol seems to offer an extremely promising approach to prevent VA from worsening and to promote tissue repair in the dry form of AMD. Moreover, the approach has the enormous advantage of being entirely noninvasive.

Related: Characterizing local retinal layer changes in AMD

According to this hypothesis, at certain wavelengths, irradiation could regenerate retinal cells.

Thus, modulated light can offer a novel, valid therapeutic approach for dry AMD, which may facilitate the repair of damaged tissues in the retina and promote the survival and function of epithelial cells within the retinal pigmented epithelium.19

Miorica Bertelli, OD, and Elena Scaffidi, MS, contributed to this report.

About the authorRoberto Pinelli, MDe:pinelli@seri-lugano.ch Roberto Pinelli, MD, is founder of the Switzerland Eye Research Institute in Lugano.

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REFERENCES1. Markowitz SN, Devenyi RG, Munk MR, et al. A double-masked, randomized, sham-controlled, single-center study with photobiomodulation for the treatment of dry age-related macular degeneration. Retina. Published online August 9, 2019. doi:10.1097/IAE.0000000000002632

2. Forte R, Cennamo G, Finelli ML, Bonavolont P, de Crecchio G, Greco GM. Combination of flavonoids with Centella asiatica and Melilotus for diabetic cystoid macular edema without macular thickening. J Ocul Pharmacol Ther. 2011;27(2):109-113. doi:10.1089/jop.2010.0159

3. Khoo HE, Ng HS, Yap WS, Goh HJH, Yim HS. Nutrients for prevention of macular degeneration and eye-related diseases. Antioxidants (Basel). 2019;8(4):85. doi:10.3390/antiox8040085

4. Pawlowska E, Szczepanska J, Koskela A, Kaarniranta K, Blasiak J. Dietary polyphenols in age-related macular degeneration: protection against oxidative stress and beyond. Oxid Med Cell Longev. 2019;2019:9682318. doi:10.1155/2019/9682318

5. Riva A, Togni S, Franceschi F, et al. The effect of a natural, standardized bilberry extract (Mirtoselect) in dry eye: a randomized, double blinded, placebo-controlled trial. Eur Rev Med Pharmacol Sci. 2017;21(10):2518-2525.

6. Tao Y, Chen T, Yang GQ, Peng GH, Yan ZJ, Huang YF. Anthocyanin can arrest the cone photoreceptor degeneration and act as a novel treatment for retinitis pigmentosa. Int J Ophthalmol. 2016;9(1):153-158. doi:10.18240/ijo.2016.01.25

7. Hamblin MR. Photobiomodulation or low-level laser therapy. J Biophotonics. 2016;9(11-12):1122-1124. doi:10.1002/jbio.201670113

8. Merry G, Devenyi R, Dotson R, Markowitz SN, Reyes SV. Treatment of dry age-related macular degeneration with photobiomodulation. Paper presented at: Association for Research and Vision in Ophthalmology 2012; May 7, 2012; Fort Lauderdale, FL.

9. Natoli R, Valter K, Barbosa M, et al. 670nm photobiomodulation as a novel protection against retinopathy of prematurity: evidence from oxygen induced retinopathy models. PLoS One. 2013;8(8):e72135. doi:10.1371/journal.pone.0072135

10. Tang J, Herda AA, Kern TS. Photobiomodulation in the treatment of patients with non-center-involving diabetic macular oedema. Br J Ophthalmol. 2014;98(8):1013-1015. doi:10.1136/bjophthalmol-2013-304477

11. Ferraresi C, Kaippert B, Avci P, et al. Low-level laser (light) therapy increases mitochondrial membrane potential and ATP synthesis in C2C12 myotubes with a peak response at 3-6 H. Photochem Photobiol. 2015;91(2):411-416. doi:10.1111/php.12397

12. Koev K, Avramov L, Borissova E. Clinical results from low-level laser therapy in patients with autosomal dominant cone-rod dystrophy. J Phys: Conf Ser. 2018;992:012060. https://iopscience.iop.org/article/10.1088/1742-6596/992/1/012060

13. Holanda VM, Chavantes MC, Wu X, Anders JJ. The mechanistic basis for photobiomodulation therapy of neuropathic pain by near infrared laser light. Lasers Surg Med. 2017;49(5):516-524. doi:10.1002/lsm.22628

14. Baxter GD, Liu L, Petrich S, et al. Low level laser therapy (photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017; 17(1):833. doi:10.1186/s12885-017-3852-x

15. Zadik Y, Arany PR, Fregnani ER, et al; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019;27(10):3969-3983. doi:10.1007/s00520-019-04890-2

16. Natoli R, Zhu Y, Valter K, Bisti S, Eells J, Stone J. Gene and noncoding RNA regulation underlying photoreceptor protection: microarray study of dietary antioxidant saffron and photobiomodulation in rat retina. Mol Vis. 2010;16:1801-1822.

17. Gkotsi D, Begum R, Salt T, et al. Recharging mitochondrial batteries in old eyes. Near infra-red increases ATP. Exp Eye Res. 2014;122:50-53. doi:10.1016/j.exer.2014.02.023

18. Huang YY, Chen ACH, Carroll JD, Hamblin MR. Biphasic dose response in low level light therapy. Dose Response. 2009;7(4):358-383. doi:10.2203/dose-response.09-027.Hamblin

19. Saini JS, Temple S, Stern JH. Human retinal pigment epithelium stem cell (RPESC). Adv Exp Med Biol. 2016;854:557-562. doi:10.1007/978-3-319-17121-0_74

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Photobiomodulation shows the power of light - Ophthalmology Times

Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 – Chelanpress

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Adipose Derived Stem Cell Therapy Market: Technological Advancement & Growth Analysis with Forecast to 2026 - Chelanpress

Types of Stem Cell Transplantation | Stem Cell …

Stem cells for transplantation can be collected from the blood, bone marrow or umbilical cord blood. The Packard Childrens Hospitals Stem Cell Transplant program offers a full range of stem cell transplantation options:

Autologous stem cell transplant Healthy stem cells are collected from the patient's own blood or marrow. After treatment, the stored stem cells are infused into the patients blood. The healthy stem cells then find their way to the bone marrow and begin to produce new, healthy cells.

Allogeneic stem cell transplant Healthy stem cells are collected from a related or unrelated donor. New, healthy donor stem cells help restore the blood-forming cells of the patients bone marrow.

Anallogeneic relateddonors stem cells genetically match, as close as possible, that of the patient. The donor may be a brother, sister or parent. Siblings have a 1 in 4 chance of being a match. The degree to which the donor's and patient's tissue match is done by a blood test called HLA typing.

Anallogeneic unrelated donor (URD)is not related to the patient but has similar genetic typing. TheNational Marrow Donor Program (NMDP) makes it possible to find similar matches for patients that do not have a related donor. The NMDP registry is comprised of volunteer donors. New donors are added to the list daily.

Haploidentical stem cell transplant Healthy stem cells are collected from a parent or a related or unrelated donor. This provides a genetic match that is at least half identical to the recipient.

Syngeneic stem cell transplant An identical twin is the stem cell donor. Identical twins have identical genetic types and are a perfect match.

Peripheral stem cell transplant Stem cells are collected from the peripheral blood by apheresis. Apheresis is a process where blood is removed from the patient via an IV catheter, the stem cells are selected out by a machine, and the remainder of the blood is returned to the patient. The process takes 3-4 hours/day for 2-5 days total. The peripheral blood stem cells are most often used in the autologous setting where patients receive their own stem cells.

Cord blood stem cell transplant Stem cells are collected from the umbilical cord/placenta immediately following birth. The cells can be stored (frozen) for future use. This can be from a sibling or unrelated donor. We currently perform related or unrelated cord blood transplants in our program.

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Types of Stem Cell Transplantation | Stem Cell ...

Dr Mukesh Batra: The alternative medicine man – Livemint

After a 3-hour Zoom interview with Dr Batra, the comparison seems to hold good on many counts. He is easily the best-known, most commercially successful homoeopath from India. His network, spanning six countries, is managed by a team of 400 doctors across 225 clinics. In FY18, his company reported 225 crore in revenue. Like the actor, Dr Batras full head of hair defies his age69. But it would be strange if it didnt. After all, his company built a fortune mainly on the back of hair- and skin-care treatments.

In person, Dr Batra is all wit and charm. Think of (our business) as papad," he says. Lots of housewives made papad in India. Then Lijjat came and institutionalized it." Thats what he did with homoeopathy in India, he says: We formalized and corporatized it."

The chat took place over two sittings, with an hours break at lunchtime. Considerable time was spent discussing the efficacy of his treatments. For, homoeopathy hasnt found acceptance amongst the scientific community. Some go so far as to describe it as hokum, offering hope when there isnt any. Over the past decade, regulatory bodies in several countries have declared their reservations. France has announced it will stop reimbursing citizens for homoeopathic treatment expenses from 2021, theres a growing demand in the UK to follow suit. In 2015, a landmark Australian study analysing over 1,800 papers on homoeopathy concluded there was no good quality evidence to support the claim that homoeopathy is effective in treating health conditions".

Dr Batra, however, has a ready retort. A lot of these studies are biased and we shouldnt get carried away by them," he says. Homoeopathy does have its limitations, he accepts: There isnt much it can do for a gunshot wound, for example. But in many chronic psychosomatic cases, it plays a very good role."

But then, he adds, hes used to sceptics. Back in the 1980s, when I would go to a party and say I am a doctor, people would say, Oh very good. When I would tell them I am a homoeopath, they would do a namaste and then say their bye-byes and thank yous."

In recent years though, homoeopathy has found greater public acceptance and political backing in India. And after the covid-19 outbreak in January, the Union ministry of Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) recommended Arsenicum Album 30 as an immunity booster". In the following weeks, Dr Batras network, like numerous politicians, businessmen and members of civil society, distributed the pills in large numbers. There are no clinical trials proving its efficacy against covid-19, Dr Batra agrees. But if a proper trial is done, he adds, you can give the world scientific evidence on the basis of which homoeopathy works for various diseases".

In a normal world, it would have been possible to meet Dr Batra at his clinic off Chowpatty in Mumbai. Its a small office behind Wilson College, where he set up his first clinic with the first electronic medical software in the world". But concessions have to be made for the pandemic.

So, one afternoon, my laptop lit up to the living room of a 150-year-old Portuguese mansion in Aldona, Goa. Dr Batra was sitting on a wooden chair, wearing a cool blue polo-neck. A vintage dining set formed the backdrop, a chandelier suspended above it.

His family had flown to Goa in March for a break from the city, Dr Batra says, agreeing that its not a bad place to be stuck in. Plus, we have a mango tree, so we get the best local mangoes. They are not Alphonsos but they are fabulous."

Dr Batra retired from active practice five years ago. His son Akshay, also a homoeopath, runs the day-to-day operations now. Dr Batra continues to be the face of the brand but more as the chairman emeritus". Meaning, I give advice when asked. If not asked, I keep my mouth shut." Lately, he has been spending time in charity work, photography and on penning his biography.

The story begins in Lucknow. Dr Batras parents were doctors. His father, a homoeopath, was the principal at a local college and mother, an allopath, worked as the deputy health secretary with the Uttar Pradesh government. My parents were busy people," he says. I experienced how medicine was all-consuming and decided that I wont become a doctor at all."

In the late 1950s, Dr Batras father landed a job as the principal of the Bombay Homoeopathy College in Vile Parle, now known as Smt Chandaben Mohanbhai Patel Homoeopathic Medical College. He was just 7 when they moved to Mumbai. After he finished high school, a trustee from his fathers college offered him a seat at the institution. He told me homoeopathy was growing, it will be good for you.... I thought, some people mortgage their land and jewellery with the ambition that their child would become a doctor. Here, I was getting an invitation." Was there no entrance exam? It was a relatively new college, says Dr Batra. They wanted people from good homes."

He didnt start off as a serious" student. But he soon had a change of heart. During my college days, I had developed 28 warts on my face. I had the annual day coming up and was supposed to go up on stage for an address." At his fathers suggestion, he used homoeopathic medicines.Within two days, he says, the warts fell off. There were no scars. It was magical."

After a bachelors degree in homoeopathy, he got another in psychology from Pune University. His first job was at a charitable hospital in Malabar Hill, at age 23. Within a few years, he had gained a reputation as a hard-working, enterprising doctor. In 1982, he set up his first clinic, at Chowpatty.

The next decade was a blur. Between consulting patients, paying off loans and raising two children with his now ex-wife Nalini, he was heading for a burn-out. In 1996, he decided to turn his general practice into a super-speciality. He hired a market research agency, surveyed his patients and identified 14 segments where his treatments had shown good results. Once he stopped general consultation, his patient load fell from 150 to two a day. He had more time to research and spend on each diagnosis. Two years on, he rebranded Positive Health Clinic" to Dr Batras Positive Health Clinic".

It was around this time that Dr Batras association with hair loss and skincare treatment began. He hadnt planned on it, he says. The Drugs and Cosmetics Act has a list of diseases one cant advertise for. Hair and skin are an open category. So we started advertising." Later, Akshay, who also became president of the The Trichological Society, UK, drove a targeted outreach for Dr Batras hair-related treatments. Today, says Dr Batra, over 45% of their 80,000 patients are seeking treatment for hair loss.

In business, he says, he followed the Raj Kapoor model: If his movie did well, put the money in a new one." Soon, he set up a second clinic in Bengaluru. Once successful, he set up more, hiring and training a fleet of doctors, expanding to more cities and later, countries. It has only been onward and upwards since.

For all his success, Dr Batra hasnt escaped bad press. Quora and Reddit threads are littered with criticism of him, trashing the 96.6% treatment success rate" he advertises. One of the most commented threads reads, How big a scam is Dr Batras?"

It pains me a lot to see it happening," he says. But its usually the unhappy customers talking about it, not the happy ones."

Between 2013-18, the Advertising Standards Council of India, an independent watchdog, pulled up Dr Batras several times for misleading advertisements and exaggerated claims. In 2014, it was for claiming to have won an award for being Indias only trusted brand in homoeopathy". In 2017, it was for advertising cures for diseases in violation of the Drugs and Cosmetics Act and Drugs and Magic Remedies (Objectionable Advertisements) Act. In 2018, for advertising a certain gene-targeted therapy that could predict and prevent diseases 15-20 years before they show up".

Dr Batra is convinced it boils down to competition, jealousies". Beyond a point, you cant argue. Its a quasi (judicial) body, not legal. So should I waste my time in controversies or get on with my life?" Dr Batras, he adds, is governed by the food and drugs administration (FDA) and the Central Council of Homoeopathy. We have had no complaints so far."

Asked about the resistance to homoeopathy in the West, he says: The (British) royal family uses homoeopathy. I can send a list of important people in the world who do too."

Popular isnt necessarily effective, is it?

The way homoeopathy medicine is administered in the West differs from India, says Dr Batra. There are more than 300 double-blinded randomized control trials (RCTs) done on asthma, arthritis, etc," he adds. While Mint couldnt independently confirm this claim, several reviews of RCTs in homoeopathy have questioned the procedural rigour and quality of evidence. Dr Batra does agree that for homoeopathy to be established as a scientific system, many more trials are needed.

Today, people are looking at holistic healing. The side effects of allopathy are making a move.... And we have government support too, which we didnt have for so many years. As these things keep evolving, you will see the benefit more and more. And just like we took yoga to the world, we will take homoeopathy too."

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Dr Mukesh Batra: The alternative medicine man - Livemint