Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates – GlobeNewswire

Regulated information

Regulatory authorities approve JTA PhaseIII study in osteoarthritic knee pain and ALLOB PhaseIIb study in difficult fractures

Gosselies, Belgium, 23March 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 PhaseIII clinical study targeting osteoarthritic knee pain and the PhaseIIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.

Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.

Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies, said Miguel Forte, CEO, Bone Therapeutics. This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.

The JTA-004 phase III study is a controlled, randomized, double-blind study. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study expects to enrol 676patients with mild to moderate symptomatic knee osteoarthritis in approximately 20centres in 7European countries and Hong Kong SAR.

The ALLOB Tibial Fracture PhaseIIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enrol approximately 178patients in approximately 40sites in up to 7European countries.

About JTA-004

JTA-004 is companys next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phaseII study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F20, the global market leader in osteoarthritis treatment.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About ALLOB and Bone Therapeutics proprietary, scalable cell therapy manufacturing process

ALLOB is the companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells. These cells are derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves the consistency, scalability, cost effectiveness and ease of use of the ALLOB platform. This optimized production process significantly increases the production yield, generating 100,000 of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the healthcare site. The process does therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization compared to an autologous approach. Bone Therapeutics has implemented the optimized production process to produce clinical batches for the upcoming Phase IIb clinical trial in patients with tibial difficult-to-heal fractures.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: 44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics receives Clinical Trial Application (CTA) approval for next clinical studies of its two lead candidates - GlobeNewswire

Global transcutaneous electrical nerve stimulation market is expected to grow with a healthy CAGR over the forecast period from 2019-2025 – PRNewswire

NEW YORK, March 23, 2020 /PRNewswire/ --

The report on the global transcutaneous electrical nerve stimulation market provides qualitative and quantitative analysis for the period from 2017 to 2025.

Read the full report: https://www.reportlinker.com/p05874196/?utm_source=PRN

The report predicts the global transcutaneous electrical nerve stimulation market to grow with a healthy CAGR over the forecast period from 2019-2025. The study on transcutaneous electrical nerve stimulation market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and RoW for the period of 2017 to 2025.

The report on transcutaneous electrical nerve stimulation market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global transcutaneous electrical nerve stimulation market over the period of 2017 to 2025. Moreover, the report is a collective presentation of primary and secondary research findings.

Porter's five forces model in the report provides insights into the competitive rivalry, supplier and buyer positions in the market and opportunities for the new entrants in the global transcutaneous electrical nerve stimulation market over the period of 2017 to 2025. Further, IGR- Growth Matrix gave in the report brings an insight into the investment areas that existing or new market players can consider.

Report Findings1) Drivers Growing adoption of transcutaneous electrical nerve stimulation therapy for pain management Rising prevalence of osteoporosis-related joint, bone, or muscle problems is increasing the demand for pain therapy2) Restraints Lack of skilled or trained professionals for the therapy3) Opportunities Growing pool of cancer patients worldwide and increasing use of terms for the treatment of severe cancer-related pain

Research Methodology

A) Primary ResearchOur primary research involves extensive interviews and analysis of the opinions provided by the primary respondents. The primary research starts with identifying and approaching the primary respondents, the primary respondents are approached include1. Key Opinion Leaders associated with Infinium Global Research2. Internal and External subject matter experts3. Professionals and participants from the industry

Our primary research respondents typically include1. Executives working with leading companies in the market under review2. Product/brand/marketing managers3. CXO level executives4. Regional/zonal/ country managers5. Vice President level executives.

B) Secondary ResearchSecondary research involves extensive exploring through the secondary sources of information available in both the public domain and paid sources. At Infinium Global Research, each research study is based on over 500 hours of secondary research accompanied by primary research. The information obtained through the secondary sources is validated through the crosscheck on various data sources.

The secondary sources of the data typically include1. Company reports and publications2. Government/institutional publications3. Trade and associations journals4. Databases such as WTO, OECD, World Bank, and among others.5. Websites and publications by research agencies

Segment CoveredThe global transcutaneous electrical nerve stimulation market is segmented on the basis of surgery procedures, product, and end user.

The Global Transcutaneous Electrical Nerve Stimulation Market by Surgery Procedures Direct Nerve Repair Nerve Grafting Stem Cell Therapy

The Global Transcutaneous Electrical Nerve Stimulation Market by Product Portable Desktop

The Global Transcutaneous Electrical Nerve Stimulation Market by End User Hospital Clinics Others

Company Profiles Medtronic plc Boston Scientific Corporation Abbott Laboratories Nevro Corp NeuroMetrix, Inc. Uroplasty, Inc. Cogentix Medical, Inc. Bioness,Inc. electroCore, Inc.

What does this report deliver?1. Comprehensive analysis of the global as well as regional markets of the transcutaneous electrical nerve stimulation market.2. Complete coverage of all the segments in the transcutaneous electrical nerve stimulation market to analyze the trends, developments in the global market and forecast of market size up to 2025.3. Comprehensive analysis of the companies operating in the global transcutaneous electrical nerve stimulation market. The company profile includes analysis of product portfolio, revenue, SWOT analysis and latest developments of the company.4. IGR- Growth Matrix presents an analysis of the product segments and geographies that market players should focus to invest, consolidate, expand and/or diversify.

Read the full report: https://www.reportlinker.com/p05874196/?utm_source=PRN

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Global transcutaneous electrical nerve stimulation market is expected to grow with a healthy CAGR over the forecast period from 2019-2025 - PRNewswire

Signature gathering halted for $5.5 billion stem cell initiative – Capitol Weekly

News

by DAVID JENSEN posted 03.22.2020

Backers of a $5.5 billion stem cell research initiative in California have suspended their efforts to gather signatures to place it on the November ballot, but are expressing confidence that the proposal will qualify.

In response to questions from the California Stem Cell Report, the campaign said it had run afoul of statewide bans on public gatherings. Voter signatures on petitions to place the initiative on the ballot generally require small gatherings in public places.

Weve suspended all signature gathering for the time being. Sarah Melbostad.

The proposal is intended to refinance the California stem cell agency, which has spent nearly all of the $3 billion it was provided by voters in 2004. It will begin to close its doors next fall unless more funding is provided.

Sarah Melbostad, a spokeswoman forCalifornians for Stem Cell Research, released a statement that said,In keeping with the governors statewide order for non-essential businesses to close and residents to remain at home, weve suspended all signature gathering for the time being.

The statement continued,Were proud of our team and proud of the promising and significant number of signatures weve gathered to date demonstrating strong support amongst voters. Were confident that we still have time to qualify and plan to proceed accordingly.

To qualify for the ballot, the valid signatures of 623,212 registered voters are needed. Large numbers of signatures are usually disqualified during the certification process. So tens of thousands of signatures or more beyond the minimum are invariably necessary.

The halt to signature gathering affects other potential ballot measures this fall.

The campaign originally expected to have the signatures gathered by the end of April. The campaign did not respond to a question concerning the number of signatures that it has on hand now.

The California Stem Cell Report understands that petition circulation companies throughout the state are calling in their signatures next week. At that point, reliable figures may be available. The halt to signature gathering affects other potential ballot measures this fall.

The halt to signature gathering affects other potential ballot measures this fall.

Here is the full text of the campaigns statement:In keeping with the Governors statewide order for non-essential businesses to close and residents to remain at home, weve suspended all signature gathering for the time being.

As the COVID-19 issue is updating daily, if not hourly, we at the campaign are monitoring the situation very closely and will comply with all statewide, regional and local ordinances.

Were proud of our team and proud of the promising and significant number of signatures weve gathered to date demonstrating strong support amongst voters.

Were confident that we still have time to qualify and plan to proceed accordingly.

When faced with this current situation, were reminded every day how important this initiative is to save and improve the lives of millions of Californians living with chronic diseases and conditions, such as cancer, Alzheimers, heart disease, HIV/AIDS, kidney disease and more.Editors Note: DavidJensenis a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report,where this story first appeared.He has published more than 4,000 items on California stem cell matters in the past 15 years.

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Signature gathering halted for $5.5 billion stem cell initiative - Capitol Weekly

Cellphone tracking could help stem the spread of coronavirus. Is privacy the price? – Science Magazine

Phone apps promise to identify the recent contacts of people with COVID-19 more quickly and thoroughly.

By Kelly ServickMar. 22, 2020 , 1:30 PM

IT IS POSSIBLE TO STOP THE EPIDEMIC. Thats the message splashed atopa websitebuilt by a University of Oxford team this week to share new research on the spread of the novel coronavirus. Below that hopeful statement comes a big caveat: To stop the virus spread, health officials need to find and isolate the contacts of infected peoplelots of themand fast. Such contact tracing is a mainstay of infectious disease control. But the Oxford team is one of several now advocating for a new approach: tapping into cellphone location data to track the spread of infection and warn people who may have been exposed.

Several governments in Asia have tried that approach in ways that would run afoul of privacy laws in many other countries. China, for example, has reportedly relied on mass surveillance of phones to classify individuals by their health status and restrict their movements. Now, research teams in Europe and the United States are considering less invasive ways to collect and share data about infections, and some are already developing and testing coronavirus-specific phone apps. Governments, meanwhile, are scrambling to figure out how these potential pandemic-fighting tools could work within data privacy laws and without losing the support of an already wary public.

We dont live in a culture of public trust when it comes to data, says David Leslie, an ethicist at the Alan Turing Institute who studies the governance of data-driven technologies. We live in this age that has been called the age of surveillance capitalism, where our data is abused and exploited. But, he adds, authorities and the public will have to weigh the value of privacy against the possibility that data collection could save millions of lives. These are not normal times.

Tracing the people an infected person recently came near requires widespread testing to diagnose infections in the first place. That testing has been painfully slow to ramp up in the United States and parts of Europeto say nothing of countries elsewhere with fewer resources. Even as more tests become available, state and local health departments may not be able to interview every patient and follow up with every contact. And even the most painstaking interview cant reveal contacts or places that a person just doesnt remember.

The virus that is causing the pandemic, severe acute respiratory syndrome coronavirus 2, poses a particular challenge, says Oxford infectious disease epidemiologist Christophe Fraser. So far, it appears that nearly half of transmissions happen before an infected person has symptoms. That means the virus can spread for days before health authorities even learn of a spreader. No matter how many resources you put into [contact tracing], its never going to keep ahead of the virus, he says. Its always going to be one or two generations ahead.

Fraser and his colleagues have watched U.K. coronavirus cases climb in recent weeks while new cases in China plummeted. Two postdoctoral researchers in his lab described their families in China using a phone app that told them when and where it was safe to go out. We thought, Well, what would we do, if we [built] an app?

Fraser, with Oxford clinician David Bonsall and colleagues, designed a mathematical simulation of how instantaneous digital contact tracing would influence the spread of the virus. To stop the epidemic, health officials must reduce the virusreproductive numberthe average number of people each infected person transmits the virus toto less than one. When the team modeled a scenario in which contacts were notified the instant a person tested positive, it was possible to push the reproductive rate of the virus below that threshold, the team reported in a preprint this week.

It became obvious to us that this was solving a major problem, says Fraser, who adds that his team is advising several European governments, including the United Kingdoms, on digital tracking. The U.K. National Health Service announced on 19 March that it was developing a coronavirus contact tracing app.

At its simplest, digital contact tracing might work like this: Phones log their own locations; when the owner of a phone tests positive for COVID-19, a record of their recent movements is shared with health officials; owners of any other phones that recently came close to that phone get notified of their risk of infection and are advised to self-isolate. But designers of a tracking system will have to work out key details: how to determine the proximity among phones and the health status of users, where that information gets stored, who sees it, and in what format.

Digital contact tracing systems are already running in several countries, but details are scarce and privacy concerns abound. Protests greeted Israeli Prime Minister Benjamin Netanyahus rollout this week of a surveillance program that uses the countrys domestic security agency to track the locations of people potentially infected with the virus. South Korea has released detailed information on infected individualsincluding their recent movementsviewable through multiple private apps that send alerts to users in their vicinity. Theyre essentially texting people, saying, Hey, theres been a 60-year-old woman whos positive for COVID. Click this for more information about her path, says Anne Liu, a global health expert at Columbia University. She warns that the South Korean approach risks unmasking and stigmatizing infected people and the businesses they frequent.

But digital tracking is probably identifying more contacts than you would with traditional methods, Liu says. A contact-tracing app might not have much impact in a city where a high volume of coronavirus cases and extensive community transmission has already shuttered businesses and forced citizens inside, she adds. But it could be powerful in areas, such as in sub-Saharan Africa, that are at an earlier stage of the outbreak, and where isolating potential cases could avert the need to shut down all schools and businesses. If you can package this type of information in a way that protects individual privacy as best you can, it can be something positive, she says.

In countries with strict data privacy laws, one option for collecting data is to ask telecommunications and other tech companies to share anonymous, aggregated information theyve already gathered. Laws in the United States and the European Union are very specific about how app and device users must consent to the use of their dataand how much information companies must disclose about how thosedata will be used, stored, and shared. Working within those constraints, mobile carriers in Germany and Italy have started to sharecellphone location data with health officials in an aggregated, anonymized format. Even though individual users arent identified, the data could reveal general trends about where and when people are congregating and risk spreading infection.

Google and Facebook are both in discussions with the U.S. government about sharing anonymized location data, The Washington Post reported this week. U.S. companies have to deal with a patchwork of state and federal privacy regulations, says Melissa Krasnow, a privacy and data security partner at VLP Law Group. App and devicemakers could face user lawsuits for sharing data in a way that wasnt originally specified in their terms of serviceunless federal or local officials pass legislation that would free them from liability. Now youve got a global pandemic, so you would think that [you] would be able to use this information for the global good, but you cant, Krasnow says. Theres expectations about privacy.

Another option is to start fresh with a coronavirus-specific app that asks users to voluntarily share their location and health data. For example, a basic symptom-checking app could do more than just keeping people who dont need urgent care out of overstretched emergency rooms, says Samuel Scarpino, an epidemiologist at Northeastern University. Health researchers could use also use location data from the app to estimate the size of an outbreak. That could be done, I think, without risking being evil, he says.

For Scarpino, the calculus changes if governments want to track the movements of a specific person who has coronavirus relative to the paths of other people, as China and South Korea have apparently done. That kind of tracking could easily swing towards a privacy violation that isnt justified by the potential public health benefit, he says.

In Germany, which has some of Europes strictest data privacy protections, the government can compel a technology company to share location data on an individual in the interest of national security, says Sebastian Golla, a legal scholar at the Johannes Gutenberg University of Mainz who studies data protection law. But indiscriminate mass tracking of individuals lacks a legal basis, he says. To track people who have or might have coronavirus, Germany and other European countries would need to pass laws specifying how data collection would be restricted to a certain population, for a certain time, and for a certain purpose.

Such laws could be on the way. On 21 March, Frankfurter Allgemeine Zeitung reported that the German health ministry had drafted changes to a law called the Infection Protection Act to allow, among other things, the tracking of people who were in contact with those infected with the coronavirus.

Several emerging projects aim to set up voluntary, privacy-conscious phone tracking systems. This week, a team led by computer scientist Ramesh Raskar at the Massachusetts Institute of Technology released a prototype of an app called Private Kit: Safe Paths. The app stores up to 28 days of a users GPS location data, logged every 5 minutes. If the user tests positive for coronavirus, they can choose to share their recent data with health officials to identify and publicize the places where others may have been at risk of infection.

A future iteration of the app, soon to be released, would compare a users recent locations against the path of an infected person and alert them of potential contact. Users wouldnt learn anything else about the infected personnot their age, their sex, or their geographic path. The team, which includes collaborators from Harvard University and the Mayo Clinic, is in discussions with a dozen cities and nations in all parts of the world, about running pilot trials of the app, Raskar says.

Another app in development in Germany relies partly on location data that Google already stores for its account holders. A person who tests positive could use the appcalled GeoHealthto donate their location history. That data would then be anonymized and stored on a central server, says Gernot Beutel, a stem cell transplant physician at Hannover Medical School who is co-developing the technology. A data analytics platform designed by the software company Ubilabs would compare users movement history to that of infected people, and the app would show them color-coded alerts based on how recently they may have encountered the virus. Though a combination of GPS tracking, wireless network data, and connections between phones via Bluetooth, Beutel says the app should be able to detect when a phone comes within 1 meter of another phone.

Making data submissions voluntary and anonymizing data are good options to maintain civil rights. Its a clean way of legally doing it, Golla says. But such apps will reduce the spread of disease only if a lot of people use them. Liu cautions that because a tracking app cant capture every possible source of infection, it risks creating a false sense of security for users. Just because you dont see a dot on a map where a contact might have been doesnt mean that areas that dont have dots dont have infected people.

Raskars team is working to figure out how many people would need to use the Private Kit app for it to be effective at controlling disease spread. He cant say how many people have downloaded the prototype; the researchers dont collect that information for privacy reasons, he says. Beutel is hopeful that the urgency of the pandemic will inspire much of the population to lay bare their movements and health status. People give their stem cells for patients that need a stem cell transplantation. They give their blood, he says. We hope that people think about the crisis, and are willing to give their data.

With reporting by Catherine Matacic.

Original post:
Cellphone tracking could help stem the spread of coronavirus. Is privacy the price? - Science Magazine

Stem cells may give a respite to COVID-19 infected – The Hindu

While stem cell treatment is not a technique to eradicate or fix coronavirus completely, there is proof to help the idea that infected patients, under the treatment, might be more receptive to survive the disease.

That's because, stem cells oppose viral infection due to the presence of specific qualities known as interferon gamma invigorated qualities (ISGs). These are present in stem cells before their separation process happens. Thus, stem cells can be expected to survive even if they are transferred into a patient with confirmed infection of coronavirus, as per Vipul Jain, CEO, Advancells, a research firm focusing on therapeutic applications of regenerative medicine.

Mr Jain said, Even medical science has determined how influenza virus A/H5N1, with a history of causing intense lung injury, was destroyed by human mesenchymal stromal cells (MSCs) in a mouse. Going back to basics has only expanded the chances of positive outcome.''

Mesenchymal stromal cells (MSCs) are those stem cells which can separate into an assortment of cell types. There are several other properties of MSCs which make them suitable for clinical trials, such as they have ability to reduce inflammation thus regulating the immune system back to healthy and an extraordinary capacity to find the damaged tissues in human body. They can even speed up the recovery of those damaged tissues.

For instance, to achieve desired outcome, specialists have used enormous quantities of MSCs with one patient in Baoshan (Yunnan) who got 3 implantations of 50 million umbilical blood cord derived MSCs, while every Beijing patients got 1 mixture of 1 million cells for every kilogram of weight.

According to Advancells observations, MSCs can be acquired from fat, which implies that everybody can use his/her cells, abolishing any contamination or fatalities. In any case, extending them to the amount required for implantation, takes 2 to 3 weeks which is why it is valuable to cryo-conserve (process of preserving cells prone to damage) an individual reservoir of MSCs, that would permit to get to an early and progressively beneficial treatment.

It may be noted that, some 14 trials have been conducted using stem cells to treat coronavirus patients in China. They recommended stem cells may be the option to fix the extreme organ damage brought about by the virus.

MSCs can lessen the overproduction of immunity cells caused as a response to the virus and lower down the levels of inflammatory substances. Thus, bringing the weak framework and the whole body back to its ordinary state,'' Mr. Jain said.

What can be securely said at this stage following this spearheading study, as per Advancells, is that MSCs demonstrate extraordinary potential to turn into an important part of eradicating something so huge coronavirus itself.

Commenting on India scenario, he further said, Sadly, India is slow in terms of awareness, also it is tough to convince ICMR with innovative ideas. China had used it and all patients who have gone for stem cell therapy were recovered. Israel just announced they would start a stem cell pilot for treating coronavirus.

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Stem cells may give a respite to COVID-19 infected - The Hindu

Global Flow Cytometry Market to Register Impressive Growth, Demand Upheld by Cancer and Stem Cell Research, Says Fact.MR – Bio-IT World

Global flow cytometry market is expected to grow at a staggering CAGR of 11.4% during the forecast period (2020-2025).

DUBLIN 2, IRELAND - Mar 23, 2020 - Increased adoption of flow cytometry is an important development in the field of cell biology. Flow cytometry is a widely accepted method in detecting cancers, cell signaling, tumor characterization, fluorescent protein detection and protein-protein interaction. Moreover, flow cytometry is being increasingly used in stem-cell research where scientists examine cell conversions.

On the back of the aforementioned factors, the global flow cytometry market is set to get leveraged in the future. A staggering CAGR of 11.4% is projected for the forecast period 2020-2025, and the market is anticipated to surpass a valuation of US$ 8,119.6 Mn by the end of the forecast period.

Key Takeaways of Global Flow Cytometry Market Study

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The global flow cytometry market shows immense potential for future growth. The widespread application of flow cytometry in important life science disciplines such as cancer detection and stem cell research is expected to boost the global flow cytometry markets prospects in the future, concludes a Fact.MR analyst.

Acquisitions to Supplement Market Growth

The global flow cytometry market is dominated by the following players: Becton Dickinson & Company, Merck & Co., Inc., Beckman Coulter, Inc., Thermo Fisher Scientific Inc., SYSMEX CORPORATION, Alere Inc., Miltenyi Biotec, Bio-Techne, Agilent Technologies, Inc. & Bio-Rad Laboratories, Inc. Merck & Co. who constitute the maximum share of the market. The company invests in acquisitions that provide opportunities to supplement organic growth and strengthen product portfolios. Another player, Benton Dickinson and Company, offers Flow Cytometry Instruments, Software, Antibodies and Instruments. These products include BD FACSVerse, BDFACSCelesta and BD LSRFortessa. The company is a leading manufacturer and supplier of flow cytometry devices, antibodies and software.

>>> To Get more insights on flow cytometry market, visit-https://www.factmr.com/report/4633/flow-cytometry-market

About Fact.MR

Expert analysis, actionable insights, and strategic recommendations of the veteran research team at Fact.MR helps clients from across the globe with their unique business intelligence requirements. With a repository of over a thousand reports and 1 million+ data points, the team has scrutinized the healthcare sector across 50+ countries for over a decade. The team provides unmatched end-to-end research and consulting services. Fact.MR's latestmarket research reportsand industry analysis help businesses navigate challenges and take critical decisions with confidence and clarity amidst breakneck competition.

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Global Flow Cytometry Market to Register Impressive Growth, Demand Upheld by Cancer and Stem Cell Research, Says Fact.MR - Bio-IT World

Global Stem Cell Banking Storage Market scrutinized in the new analysis – WhaTech Technology and Markets News

Global Stem Cell Banking Storage Market 2020 Research Report Analysis, Economic Growth, Sales, Segments, Demand, Size, Share, Forecast to 2026

The research report on the Worldwide Stem Cell Banking Storage Market 2020 has been conducted across a series of industries in various zones to offer deep insightful and comprehensive information. The study report on the Stem Cell Banking Storage market provides a blend of qualitative as well as quantitative data which mainly concentrating on the distinct aspects like Stem Cell Banking Storage market developments, risk factors, competitors challenges and new opportunities available in the respective market.

Report: marketsresearch.biz/report/est-sample

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Global Stem Cell Banking Storage market report offers in-depth information about the major market players

CCBCCBRViaCordEsperiteVcanbioBoyalifeLifeCellCrioestaminalRMS RegrowCordlife GroupPBKM FamiCordcells4lifeBeikebiotechStemCyteCryo-cellCellsafe Biotech GroupPacifiCordAmericordKrioFamilycordCryo Stemcell

Global Stem Cell Banking Storage Market Segmentation By Type

Umbilical Cord Blood Stem CellEmbryonic Stem CellAdult Stem CellOther

Global Stem Cell Banking Storage Market Segmentation By Application

Diseases TherapyHealthcare

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AlloVir Expands Its Research Collaboration with Baylor College of Medicine to Discover and Develop Allogeneic, Off-the-Shelf, Virus-Specific T-Cell…

CAMBRIDGE, Mass & HOUSTON--(BUSINESS WIRE)-- AlloVir, a late-clinical stage T-cell immunotherapy company, today announced the expansion of its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19. With AlloVirs proprietary technology, in addition to targeting SARS-CoV-2, the investigational virus specific T-cell therapy may also address other coronavirus (CoV) strains including SARS-CoV, MERS-CoV, and also the endemic CoVs that commonly afflict immunocompromised patients. AlloVir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the companys multi-respiratory virus investigational therapy, ALVR106, which is designed to address other devastating and life-threatening community-acquired respiratory viruses.

Given the worldwide coronavirus pandemic and risks to immunocompromised patients now and in the future, we believe it is our responsibility to leverage our scientific expertise and allocate resources for an allogeneic, off-the-shelf, coronavirus-specific T-cell program, said Ann Leen, Ph.D., AlloVir Co-Founder, Chief Scientific Officer, and Professor of Pediatrics at Baylor College of Medicine. Together with Baylor College of Medicine we have already advanced two highly innovative allogeneic, off-the-shelf, multi-virus specific T-cell investigational immunotherapies. We believe we can apply this same approach to develop a cell therapy to treat and prevent coronavirus infections and diseases in immunocompromised patients.

AlloVir and Baylor College of Medicine are leading the way in the clinical development of novel immunotherapies designed to restore natural T-cell immunity to fight off viral infections and diseases in immunocompromised patients, including recipients of stem cell and solid organ transplants, said Michael Dilling, Executive Director of Baylor Licensing Group within Baylor College of Medicine Ventures. Expanding upon this collaboration and technology platform to treat and possibly prevent other emerging life-threatening community-acquired virus infections and diseases is a natural extension of our partnership.

About AlloVirs Approach:

T cells are vital to the immune systems ability to detect and kill virus-infected cells. In healthy individuals, virus-specific T cells form a critical component of the bodys natural defense system and provide protection against thousands of disease-causing viruses.

However, these viruses can go unchecked in immunocompromised patients, such as those undergoing hematopoietic stem cell transplantation (HSCT), solid organ transplantation, and cancer treatment; in patients with HIV infection; and in the elderly. Typically, when viruses attack immunocompromised patients, standard of care therapies do not address the underlying problem of a weakened immune system and, therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

AlloVir uses natural immune stimulant proteins called cytokines combined with non-harmful fragments of the virus to activate and expand naturally occurring cells against target viruses. These cells are then provided to immunocompromised patients in order to restore natural T-cell immunity to prevent and/or treat associated viral infections and diseases. AlloVir has developed a proprietary manufacturing process that allows for a bank of virus-specific T cells to be developed from a small number of carefully chosen, healthy, virus-immune, third-party donors. AlloVirs virus-specific T-cells therapies do not require exact immunological matching to patients, allowing hundreds of patients to be treated with virus-specific T-cells manufactured from a single donor. AlloVirs therapies can be stored in a frozen state and thus supplied rapidly and globally as an off-the-shelf therapy for patients suffering from, or at risk for, one or more viral infections and diseases.

About AlloVir

AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVirs lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received the companys lead allogeneic T-cell therapy, Viralym-M, demonstrated a predefined criteria for a complete or partial clinical response, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms. The company plans to initiate pivotal and proof-of-concept studies with Viralym-M in 2020 for treatment and prevention of severe and life-threatening viral infections and diseases.

AlloVirs second allogeneic, off-the-shelf, multi-virus specific T-cell therapy, ALVR106, targets four common and devastating community-acquired respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus (Vasileiou, Haematologica, 2019). The company anticipates initiating clinical studies with ALVR106 in 2020.

AlloVirs investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.

For more information visit http://www.allovir.com

About ElevateBio

ElevateBio, LLC, is a Cambridge-based biotechnology company, established to create and operate a broad portfolio of cell and gene therapy companies with leading academic researchers, medical centers and entrepreneurs. ElevateBio builds companies by providing scientific founders with fully integrated bench-to-bedside capabilities including world-class scientists, manufacturing facilities, drug developers and commercial expertise. ElevateBio BaseCamp, a company-owned Cell and Gene Therapy Center of Innovation, will serve as the R&D, process development and manufacturing hub across the entire ElevateBio portfolio while also supporting selected strategic partners. For more information, visit http://www.elevate.bio.

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Lukes Medical Center, part of CHI St. Lukes Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook (http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter (http://twitter.com/BCMHouston).

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AlloVir Expands Its Research Collaboration with Baylor College of Medicine to Discover and Develop Allogeneic, Off-the-Shelf, Virus-Specific T-Cell...

eTheRNA Launches an International Consortium and Starts Development of Cross-strain Protective CoV-2 mRNA Vaccine for High Risk Populations – BioSpace

NIEL, Belgium, March 24, 2020 /PRNewswire/ -- eTheRNA Immunotherapies nv ('eTheRNA' or 'The Company'), a clinical-stage company developing vaccines and immunotherapies from its proprietary mRNA TriMix platform, today announced that a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course.

Administered intranasally, the proposed vaccine is intended primarily for high risk populations such as healthcare workers and families of confirmed cases. It is also designed to be protective against future variations of the virus by targeting conserved epitopes from the whole CoV-2 genome. eTheRNA and its partners EpiVax, Nexelis, REPROCELL and CEV* have extensive experience in the mRNA vaccine field and this will help accelerate progress towards clinical trials with patient enrolment expected in early 2021.

Steven Powell, eTheRNA's CEO, explained the aims of the consortium: "Viral variation means traditional medicinal and preventive vaccine approaches may fall short when confronted with seasonal or outbreak situations. A vaccine to defend against current and future outbreaks of coronavirus and other respiratory viral pathogens should be robust against viral genome changes, provide a platform that enables rapid introduction of a new viral target, be easy and safe to administer and be scaleable and suitable for stockpiling. The innovative vaccine program we have started with our partners incorporates all of these essential features."

Traditional vaccines are based on generating an antibody response to outer surface viral protein targets. However, viral variation may greatly reduce the effectiveness of this approach. For example, the SARS-CoV-2 outer surface spike protein (S) is less than 40% homologous to SARS-CoV-1. Furthermore, it has also been reported in several cases that vaccines with suboptimal antibody response (too low or not neutralizing) have facilitated viral entry and been linked to disease enhancement.

The eTheRNA consortium's approach selects conserved epitopes from the whole viral genome. Creating a vaccine that mounts a strong cellular (T cell) based response against these epitopes offers a better chance to overcome viral variability. Intranasal delivery has been chosen since the mucosa of the upper respiratory tract are the immune system's primary line of defense. A strong nasal T cell effector and memory response is claimed to fight viral replication, colonization of the lung and thus disease. mRNA has also been demonstrated to induce strong T cell responses by intranasal delivery.

The development programme has been initiated and is focused on a vaccine candidate that integrates 3 different technologies:

"While valuable initiatives and strong support are being deployed into the development of medicinal and vaccine solutions for immediate use against SARS-CoV-2, it is also important that development of solutions for the longer term should also start as soon as possible," concluded Powell. "Our target is to bring this into clinical testing in early 2021."

Information for editors

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company developing innovative immunotherapies from its proprietary mRNA TriMix platform. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is developing products for the treatment of cancer and infectious disease.

About TriMix

The TriMix platform, on which eTheRNA's immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells through inducing a T-cell response. Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clinical benefits in advanced melanoma patients.

About EpiVax

EpiVax is a 21-year old privately held biotechnology company located in Providence, Rhode Island. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, lead in the fields of immunogenicity risk assessment and computational vaccinology with expertise in T cell epitope prediction, immune modulation, and rapid vaccine design. EpiVax's broad portfolio of projects includes vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. EpiVax's proprietary in silico immunogenicity screening toolkits for therapeutics and vaccines, ISPRI and iVAX, are employed in advancing the research of a global roster of companies. Visit http://www.epivax.com for more information.

About Nexelis

With unrivaled expertise in immunology on both sides of the client/CRO relationship, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products. Visit http://www.nexelis.com for more information.

About REPROCELL

REPROCELL was established in 2003 to accelerate medical research via cutting-edge stem cell and human tissue-based technologies, including the use of novel transfection reagents and RNA-based methods for the generation of induced pluripotent stem cells. REPROCELL has further diversified its portfolio of products and services to include predictive drug discovery services in human fresh tissues, technologies for the manufacture of bioengineered human tissues, industry-leading gene editing technology and one of the largest commercial repositories of ethically sourced human tissue. Visit http://www.reprocell.com for more information.

About CEV

The Centre for the Evaluation of Vaccination (CEV) of the University of Antwerp, headed by Prof. Pierre Van Damme, is a clinical trial centre specialized in the conduct of vaccine trials. It has performed Phase I until Phase IV clinical trials in all age groups. The CEV is internationally known for its professional and qualitative vaccine clinical trial facility and organisation and is therefore a regular partner in vaccine clinical trials, i.e. for EU funded clinical trials, for investigator-driven vaccine trials as well as for industry funded clinical trials. For more information visit https://www.uantwerpen.be/en/research-groups/centre-for-evaluation-vaccination/

Contact information

media@etherna.be

Or

Richard HayhurstRHAprMobile +44 (0)7711-821-527richard@rhapr.eu

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SOURCE eTheRNA

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eTheRNA Launches an International Consortium and Starts Development of Cross-strain Protective CoV-2 mRNA Vaccine for High Risk Populations - BioSpace

Triangle headliners: Roundup of events (most of them virtual) through March 31 – WRAL Tech Wire

WRAL TechWire keeps tabs on the latest and greatest meetups, panels, workshops, conferences, application deadlines and all things happening in the North Carolina startup/tech world.The Headliners is a multi-part weekly roundup of upcoming events to add to your calendar. Below is a list of March events in Raleigh, Durham, Chapel Hill and the greater Triangle area. To find out whats happening this month in cities outside of the Triangle, check out part two of the Headliners column. Another post highlights events in April. Meetups that occur regularly are listed here.

If youd like your event to be included, feel free to send me an email.

Also, check out a full range of events on TechWires interactive calendar, along with our comprehensive resource guide for startups in the Triangle.

Last week, we kept a running list of canceled or postponed events due to coronavirus concerns. Check it for last weeks updates. The following list is our lineup of Triangle events through the end of Marchmost have been switched to a virtual format in light of social distancing recommendations.

This monthly webinar series hosts a global health professional who will share insights and advice for advancing your career. This months webinar features Kimberly Thigpen Tart of the National Institute for Environmental Health Sciences.

In this virtual session, IT leaders at NC TECH member companies will discuss relevant topics and best practices in their field. Brighthouse Financial CIO Jeff Hughes will facilitate the discussion.

This online meeting convenes CISOs, VPs and director-level security leaders from NC TECH member companies. A roundtable discussion will be facilitated by Bill Dupre, director of security at Railinc Corp.

Leadership Raleigh is a leadership development program run by the Raleigh Chamber of Commerce. Applications for the next cohort are due on May 8. Join this information session to hear from Leadership Raleigh alumni about their experience.

The Ladies That UX Durham meetup is hosting a virtual lunch where the community can network and discuss UX topics.

Join the Code for Chapel Hill meetup to network with like-minded individuals and work on civic hacking projects. Meetings are held every two weeks on Tuesdays.

1 Million Cups, presented by Kauffman, is a weekly informal pitch event for the startup community. Join for free coffee and entrepreneurial support as local startups deliver their presentations.

In this webinar, StrongKey COO Jake Kise will outline the top preventative measures for protecting your businesss data as teams transition to remote work amid the coronavirus pandemic.

RTI Innovation Advisors is hosting a webinar with tips and best practices on designing virtual workshops, hosting online collaboration sessions and using virtual tools to manage projects.

NC IDEA LABS is a four-week customer discovery program that helps idea-stage entrepreneurs take their first steps toward building a successful startup. The next cohort will run from May 26 to June 19, and applications are due on April 15. Attend this webinar to learn more about the program and how to write a competitive application.

This month, LaunchBios Larger Than Life Science event (usually held in Durham) is going virtual, allowing life science entrepreneurs from anywhere in the world to join and hear from experts discussing regenerative medicine and stem cell research. More TechWire coverage here.

Join Startup Summit to hear from Barfield Revenue Consulting Founder and CEO Will Barfield on startup recruiting.

This 14-week summer accelerator provides NC State entrepreneurs with funding, resources and guidance to build their startups.

This free bi-monthly event offers a space for local tech professionals to build connections and find potential job opportunities.

This weekly meetup brings together developers, IT professionals and tech enthusiasts who are interested in the Google Cloud Platform.

The 12-week RIoT Accelerator Program connects early-stage IoT startups with an industry consortium of more than 80 companies to learn, partner and bring your product to market. The summer 2020 cohort will run from May 26 to August 14 in Raleigh.

UNCs CUBE program involves one year of specialized programming with one-on-one coaching, connecting with a network of social entrepreneurs and venture development resources. Note: Applications have been extended to March 30.

Bring your ideas and opinions to the next Midtown Techies meetup. Events are held on the last Tuesday of every month.

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Triangle headliners: Roundup of events (most of them virtual) through March 31 - WRAL Tech Wire