Stem Cell Clinic

Addenbrooke’s becomes first regional centre to offer CAR-T cell treatment for cancer patients – Cambridge Network

The decision to offer the therapy puts Cambridge University Hospitals in the premier league of world class cancer centres.

It also supports progress of the new Cambridge Cancer Research Hospital on the Addenbrookes site, which the Government confirmed in October is included in the second wave of the Hospital Infrastructure Programme (HIP2).

To begin with, the pioneering treatment will be offered to patients with aggressive B-cell lymphomas and acute lymphoblastic leukaemia (ALL) who have relapsed or not responded well to chemotherapy or stem cell treatment.

It is also likely to be offered to cancer patients aged over 70 who are considered to be too high risk to have stem cell transplants.

CAR-T cell therapy can have extremely positive results, but because it can cause unpleasant side effects, it tends to be used when there are few other treatment options available.

CAR-T cell therapy works by re-engineering the patients own immune cells.

Our immune cells, which are called T-cells, circulate around the bloodstream seeking out and destroying any alien intruders, such as infections.

But because cancer cells evolve from our own cells, sometimes our T-cells do not identify them as intruders, and leave them alone.

The new CAR-T cell therapy works by harvesting a patients own T-cells. These are sent to a specialist lab, where they are reprogrammed to express a molecule on their surface, called a Chimeric Antigen Receptor, or CAR, that targets them to the cancer. The reprogrammed cells are grown in a huge numbers over a few weeks and then infused back into the patients body, where they seek out and destroy the cancer. Its a bit like giving immune cells a sat nav.

Until now patients in the east of England needing CAR-T cell therapy have had to make frequent trips to London in preparation for the treatment, which can take another month to administer.

One such patient was Steve Johnson from Bourne who underwent CAR-T cell therapy for relapsed leukaemia at the University College Hospital in London as part of a clinical trial.

Steve explained: "Having the treatment is not pleasant I had a number of fevers and temperature spikes for two weeks after the CAR-T cells were put back in, but I have absolutely no doubt this treatment saved my life and without it I would not be here today."

Steve added: I was lucky for me the trial came at the right time. Having the option to explore and provide revolutionary treatments at places like Addenbrookes and the soon to be built Cambridge Cancer Research Hospital, is vital if we are going to rewrite the story of this devastating illness.

The first patients to be approved for CAR-T cell treatment at Addenbrookes will start having their cells harvested from this week.

Ben Uttenthal, consultant haematologist specialising in CAR-T cell therapy at Addenbrookes, said: This is an exciting new way of treating patients that attacks cancer in a different way from previously available medicines.

"Being able to offer CAR-T cell therapy in our armoury against cancer puts us in the premier league of cancer centres.

It is also a testament to the expertise available across many different specialties in Addenbrookes. Through offering treatments like this, now and in the new Cambridge Cancer Research Hospital, we will be able to benefit cancer patients locally, regionally and nationally.

Initially, the hospital expects to be able to offer CAR-T cell therapy to around 40 patients a year. In the future, treatment is likely to be expanded to include patients with other cancers.

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Addenbrooke's becomes first regional centre to offer CAR-T cell treatment for cancer patients - Cambridge Network

Stem Cell Therapy Market 2020 Industry Size, Trends, Global Growth, Insights And Forecast Research Report 2025 – The Daily Philadelphian

A new Business Intelligence report on the global Stem Cell Therapy Market has recently been added to the Dynamic Report Repository and has been published to provide an exclusive hands-on reference to the various market dynamics that will enable high potential growth in the global Stem Cell Therapy Market. The report presents a market summary, sophisticated TOC, a variety of unique research methodologies, and a research database composed of multiple data sources. This report has been prepared to encourage and guide investor investment with details of the five forces analysis of SWOT, PESTEL and PORTER. This report has been designed with current and past developments in mind that are critical to utilizing profitable predictive developments to ensure steady market growth and uninterrupted survival despite fierce competition in the global Stem Cell Therapy Market.

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A closer look at all growth catalysts and a systematic understanding of the key deterrents that stunt growth. In addition to a global perspective, this report contains identifiable information on growth estimates defined in volume and value-based indices. By carefully measuring the competitive landscape of the global Stem Cell Therapy Market, it categorizes the key players in the sector and encourages novice market participants to set their footholds in the rapid market competition.

This report on the global Stem Cell Therapy Market provides an easily accessible roadmap to assess the league of factors and influencers such as untapped market opportunities and trends pioneering a growth timeline favorable for this market. The thorough and precise market research explanation of this market has awarded a variety of market growth diplomacy and techniques utilized by industry veterans to generate maximum profits in the Stem Cell Therapy Market even in a pandemic such as COVID-19.

The report on the global Stem Cell Therapy Market sets up a detailed overview with relevant references to the market dynamics. Extensive references to the market segment organized by market type and application have been extensively discussed in the report. The volume and value-based growth estimates of the market have been detailed in the report.

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Five-Pointer Guide for Report Investment

1. A rigorous, end-to-end review and analysis of the Stem Cell Therapy Market events and their implications 2. A thorough compilation of broad market segments 3. A complete demonstration of best in-industry practices, mindful business decisions and manufacturer activities that steer revenue sustainability in the global Stem Cell Therapy Market 4. A complete assessment of competition spectrum, inclusive of relevant details about key and emerging players 5. A pin-point review of the major dynamics and dominant alterations that influence growth in the global Stem Cell Therapy Market.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

Reasons to Purchase the report:

1. This report provides insights into the global Stem Cell Therapy Market along with the latest market trends and future forecasts to illustrate the future investment pockets. 2. The potential of the global Stem Cell Therapy Market is determined by understanding the effective trends to increase the companys position in the market. 3. This market report provides insights and detailed impact analysis on key influencers, constraints and opportunities. 4. Five Porter strengths analysis to demonstrate the strengths of suppliers and buyers. 5. The latest developments, market shares and strategies used by key market players

Make An Enquiry About This Report @ https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/691?utm_source=re

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Contact Us :

Ryan Johnson Account Manager Global 3131 McKinney Ave Ste 600, Dallas, TX75204, U.S.A. Phone No.: USA: +1 972-362 -8199/ +91 9665341414

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Stem Cell Therapy Market 2020 Industry Size, Trends, Global Growth, Insights And Forecast Research Report 2025 - The Daily Philadelphian

Mesenchymal stem cells in therapy of coronavirus disease 2019 – a review – DocWire News

This article was originally published here

Sheng Wu Gong Cheng Xue Bao. 2020 Oct 25;36(10):1979-1991. doi: 10.13345/j.cjb.200355.

ABSTRACT

Coronavirus disease 2019 (COVID-19) has spread widely on a large scale in the whole world at present, seriously endangering human health. There are still no effective and specific drugs, so it is urgent to find safe and effective therapeutic methods. Mesenchymal stem cells (MSCs) have many biological functions of powerful immunomodulation and tissue repair and regeneration. As a stem cell therapy, it has the potential to reduce the tissue injury and mortality in severe patients infected with novel coronavirus. At present, many research institutions in China and abroad have started a number of clinical research projects about MSCs in the treatment of COVID-19. In addition, those projects have initially confirmed the safety and effectiveness of this therapy. Therefore, this research field has been proved to have a very good clinical therapy prospect.

PMID:33169564 | DOI:10.13345/j.cjb.200355

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Mesenchymal stem cells in therapy of coronavirus disease 2019 - a review - DocWire News

Global cryotherapy market size to reach USD 6.72 billion by 2026 – GlobeNewswire

November 16, 2020 05:04 ET | Source: Market Study Report, LLC.

Selbyville, Delaware, Nov. 16, 2020 (GLOBE NEWSWIRE) -- According to industry experts, worldwide cryotherapy market is projected to register a y-o-y growth rate of 9.8% during 2020-2026, subsequently accumulating USD 6.72 billion by the end of the forecast period. Increasing burden of cancer globally, growing preference towards minimally invasive procedures, technological advancements, along with expansion of fitness, wellness, and beauty industries are catalyzing the industry growth.

Proceeding further, the research literature offers an expansive view of the overall industry through a country-level analysis of the regional markets. Moreover, in-depth segmentation studies including device type, therapy type, and application scope are provided to identify the top areas for investments that may yield strong returns in the coming years. Besides, it profiles the top players in this field and uncovers the strategies adopted by them to fortify their position at a global level.

For the uninitiated, cryotherapy is a low temperature application for treating malignant tissues or tissue damage called lesions. This therapy is commonly used in treating sprains, muscle pain, swelling, postoperative swelling, and soft tissue damage. It is also considered to have a high efficacy in cancer treatment. Growing demand of the procedure for aforementioned applications is strengthening global cryotherapy industry outlook.

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Procedural effectiveness in treating arthritis, rheumatoid conditions, and cardiovascular ailments, in consort with constant advancements are impelling the market expansion.

On the contrary, lack of clinical evidences regarding the use of argon gas and crypto probes as a definitive standard negatively impacts the cryotherapy business landscape. Moreover, high risk linked with cryogenic gases, and strict regulatory policies will restrain global cryotherapy market expansion. However, benefits like higher success rate over traditional surgery, minor scars, less pain, and reduced hospitalization time will bolster the industry growth in the coming years.

Device type overview:

Global cryotherapy market, based on type, is fragmented into cryogun, gas cylinders, cryoprobes, cryochambers, thermocouple devices, and gas pressure gauges. Cryoprobes and cryoguns segments are likely to showcase strong growth over the forecast period as the proper application of cryogenic gases like carbon dioxide, liquid nitrogen, argon, and dimethyl ether-propane require the utilization of these devices in pain management therapies.

Therapy type outline:

Global cryotherapy industry is categorized into cryosurgery, cryo chamber therapy, and icepack therapy, among which, the foremost segment currently holds majority of the industry share. Paradigm shift towards minimally invasive procedure is fostering the demand for cryosurgery. Further, lower side-effects and faster recovery time are likely to boost segmental share in the coming years.

Application scope:

Global cryotherapy market end-user scope is split into cardiology, oncology, dermatology, ophthalmology, pain management, and gynecology. According to trusted records, oncology segment captured majority industry share in recent past and will continue to showcase strong growth trends over 2020-2026, attributable to escalating number of cancer patients and associated deaths across the globe.

To access a sample copy or view this report in detail along with the table of contents, please click the link below:

https://www.marketstudyreport.com/reports/cryotherapy-market-size-share-trends-industry-analysis-report-by-device-type-cryoguns-cryoprobes-gas-cylinders-cryochambers-gas-pressure-gauges-thermocouple-devices-by-therapy-type-cryosurgery-icepack-therapy-chamber-therapy-by-application-type-and-by-regions-segment-forecast-2020-2026

Regional outlook:

At present, North America is the leading contributor to global cryotherapy market remuneration, owing to presence of a well-established healthcare infrastructure, high per capita expenditure, and huge government investment in healthcare. In fact, national healthcare expenditure of the United States was USD 3 trillion in 2014.

Meanwhile, Asia Pacific cryotherapy market is slated to grow exponentially over the projected timeline. Rising awareness regarding cryotherapy, improving healthcare infrastructure, low treatment cost, and rising accessibility to treatment are contributing to the regional industry expansion.

Global Cryotherapy Market Device Type Sub-Segments (Revenue, USD Million, 2015-2026)

Global Cryotherapy Market Therapy Type Sub-Segments (Revenue, USD Million, 2015-2026)

Global Cryotherapy Market Application Sub-Segments (Revenue, USD Million, 2015-2026)

Global Cryotherapy Market Regional Bifurcation (Revenue, USD Million, 2015-2026)

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

Global Cryotherapy Market Competitive Dashboard (Revenue, USD Million, 2015-2026)

Table of Contents

1. Overview and Scope

1.1. Research goal & scope

1.2. Research assumptions

1.3. Research Methodology

1.3.1. Primary data sources

1.3.2. Secondary data sources

1.4. Key take-aways

1.5. Stakeholders

2. Executive Summary

2.1. Market Definition

2.2. Market Segmentation

3. Industry Insights

3.1. Cryotherapy Market - Industry snapshot

3.2. Cryotherapy Market - Ecosystem analysis

3.3. Cryotherapy Market - Market dynamics

3.3.1. Cryotherapy Market - Market Forces

3.4. Industry analysis - Porter's five force

3.5. Cryotherapy Market PEST analysis, 2019

3.6. Value Chain Analysis

3.7. Cryotherapy Market Industry trends

4. Cryotherapy Market Size and Forecast by Device Type

4.1. Key findings

4.2. Cryoguns

4.2.1. Global market estimates and forecasts, 2015 - 2026

4.3. Cryo Probes

4.3.1. Global market estimates and forecasts, 2015 - 2026

4.4. Gas Cylinders

4.4.1. Global market estimates and forecasts, 2015 - 2026

4.5. Cryo Chambers

4.5.1. Global market estimates and forecasts, 2015 - 2026

4.6. Gas Pressure Gauges

4.6.1. Global market estimates and forecasts, 2015 - 2026

4.7. Thermocouple Devices

4.7.1. Global market estimates and forecasts, 2015 - 2026

5. Cryotherapy Market Size and Forecast by therapy type

5.1. Key Findings

5.2. Cryosurgery

5.2.1. Global market estimates and forecasts, 2015 - 2026

5.3. Icepack Therapy

5.3.1. Global market estimates and forecasts, 2015 - 2026

5.4. Chamber Therapy

5.4.1. Global market estimates and forecasts, 2015 - 2026

6. Cryotherapy Market Size and Forecast by Application Type

6.1. Key Findings

6.2. Oncology

6.2.1. Global market estimates and forecasts, 2015 - 2026

6.3. Cardiology

6.3.1. Global market estimates and forecasts, 2015 - 2026

6.4. Dermatology

6.4.1. Global market estimates and forecasts, 2015 - 2026

6.5. Pain Management

6.5.1. Global market estimates and forecasts, 2015 - 2026

6.6. Ophthalmology

6.6.1. Global market estimates and forecasts, 2015 - 2026

6.7. Gynecology

6.7.1. Global market estimates and forecasts, 2015 - 2026

7. Cryotherapy Market Size and Forecast by Regions

Related Report:

Stem Cell Therapy Market, Technology Potential, Competitive Market Share & Forecast, 2019 2025 Stem Cell Therapy Market will exceed USD 15 billion by 2025, as per a new research report. Increasing research on developing novel therapies and personalized medicines will foster stem cell therapy market growth. For instance, scientists are extensively researching on methods to regenerate healthy heart cells from placenta that can be used in patients after myocardial infarction. This discovery will help to cure patients suffering from cardiovascular diseases and reduce mortality rates. Researchers are further examining different aspects of stem cell therapy for its applications in neurological disorders. Thus, increasing R&D activities to promote developments in stem cell therapy will positively impact the industry growth.

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Global cryotherapy market size to reach USD 6.72 billion by 2026 - GlobeNewswire

Stem Cell Therapy Market 2020 Future Growth Factors and Opportunities by 2025 – PRnews Leader

This new study of the global Stem Cell Therapy Market added to the burgeoning repositories focuses primarily on decisive market influencing factors such as emerging opportunities, striking end-user profiles, supplier environment, technological innovation and supply advanced business intelligence. This is a reference material. Chain management, including production details, demand cycles and the entire manufacturing cycle collectively affecting the growth. The global Stem Cell Therapy Market report shows the relevant data on segment performance, growth potential over the next few years, supplier and manufacturer activity, and is appropriately aligned with consumption and production development. In addition to adding sub-segments to encourage optimal reader understanding, this report clearly identifies types, applications, and technology categories as key segments. In addition, this Stem Cell Therapy Market report allows readers to understand the absolute monetization potential of each segment, thus identifying one segment to demand the greatest investors interest in high returns.

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A thorough assessment of the segment specifications is also elaborately included in the report, clearly highlighting the most dominant segments expected to deviate from revenue maximization in the global Stem Cell Therapy Market through the 2020-25 forecast range. The report also includes details about the assessment presentation by segment. The market has been specifically diversified into dual segments of type and application to maximize the convenience of the reader.

This research representation of the Stem Cell Therapy Market is a thorough combination of important primary and secondary research assumptions. In addition to all this specific developments, the report illuminates the dynamic segmentation of the Stem Cell Therapys market systematically segmented into prominent segments including diversification by type, application, technology, and region. Stem Cell Therapy Market.

The report on the global Stem Cell Therapy Market sets up a detailed overview with relevant references to the market dynamics. Extensive references to the market segment organized by market type and application have been extensively discussed in the report. The volume and value-based growth estimates of the market have been detailed in the report.

Access full research report @ https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market?utm_source=re

Understanding regional growth development

Pursuing regional assessments and growth potential for each of the mentioned sectors, the report on this global Stem Cell Therapy Market identifies not only specific regional hubs in the five key regions highlighted in the report, but also the remarkable growth advances prevalent across the country.

We closely tracked the monetization trends of each segment highlighted in a specific country to derive actionable insights that effectively steer future-ready investment decisions in the global Stem Cell Therapy Market place.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

Global Stem Cell Therapy Market 2020-26: Competitive Landscape Analytical Review

Reasons to Purchase the report:

1. This report provides insights into the global Stem Cell Therapy Market along with the latest market trends and future forecasts to illustrate the future investment pockets. 2. The potential of the global Stem Cell Therapy Market is determined by understanding the effective trends to increase the companys position in the market. 3. This market report provides insights and detailed impact analysis on key influencers, constraints and opportunities. 4. Five Porter strengths analysis to demonstrate the strengths of suppliers and buyers. 5. The latest developments, market shares and strategies used by key market players

Make An Enquiry About This Report @ https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/691?utm_source=re

About Us :

Contact Us :

Ryan Johnson Account Manager Global 3131 McKinney Ave Ste 600, Dallas, TX75204, U.S.A. Phone No.: USA: +1 972-362 -8199/ +91 9665341414

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Stem Cell Therapy Market 2020 Future Growth Factors and Opportunities by 2025 - PRnews Leader

Stem Cell Therapy Market 2020 Trends, Growth Insight, Share, Competitive Analysis, Statistics, Regional and Global Industry Forecast To 2025 – PRnews…

Adroit Market Research delivers well-researched industry-wide information on the Stem Cell Therapy market. It provides information on the markets essential aspects such as top participants, factors driving Stem Cell Therapy market growth, precise estimation of the Stem Cell Therapy market size, upcoming trends, changes in consumer behavioral pattern, markets competitive landscape, key market vendors, and other market features to gain an in-depth analysis of the market. Additionally, the report is a compilation of both qualitative and quantitative assessment by industry experts, as well as industry participants across the value chain. The report also focuses on the latest developments that can enhance the performance of various market segments.

This report strategically examines the micro-markets and sheds light on the impact of technology upgrades on the performance of the Stem Cell Therapy market. The report presents a broad assessment of the market and contains solicitous insights, historical data, and statistically supported and industry-validated market data. The report offers market projections with the help of appropriate assumptions and methodologies. The research report provides information as per the market segments such as geographies, products, technologies, applications, and industries.

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Competitive Landscape: The global Stem Cell Therapy market is highly consolidated due to the presence of a large number of companies across this industry. The report discusses the current market standing of these companies, their past performances, demand and supply graphs, production and consumption patterns, sales network, distribution channels, and growth opportunities in the market. Moreover, it highlights the strategic approaches of the key players towards expanding their product offerings and reinforcing their market presence.

The report analyzes the key elements such as demand, growth rate, cost, capacity utilization, import, margin, and production of the global market players. A number of the factors are considered to analyze the global Stem Cell Therapy Market. The global Stem Cell Therapy Market report demonstrates details of different sections and sub-sections of the global Stem Cell Therapy Market on the basis of topographical regions. The report provides a detailed analysis of the key elements such as developments, trends, projections, drivers, and market growth of the global Stem Cell Therapy Market. It also offers details of the factors directly impacting on the growth of the global Stem Cell Therapy Market. It covers the fundamental ideas related to the growth and the management of the global Stem Cell Therapy Market.

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Global Stem Cell Therapy market is segmented based by type, application and region. Based on Type, the market has been segmented into:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Based on Application, the market has been segmented into:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

Stem Cell Therapy Industry Report addresses different regions like North America, Europe, Asia-Pacific, Middle East & Africa and Latin America. The production value, gross margin analysis, development trend, and Stem Cell Therapy market positioning is explained. The industrial chain study, potential buyers, distributors and traders details are explained. The challenges to the growth and market restraints are explained. The market maturity study, investment scope and gross margin study are profiled. The production process structure, market share, manufacturing cost and Stem Cell Therapy saturation analysis is covered. This will helps the industry aspirants to analysis growth feasibility and development plans. A special highlight on cost structure, import-export scenario and sales channels of Stem Cell Therapy industry is presented. The benchmarking products, dynamic market changes, upstream raw material and downstream buyers analysis are presented. The business trends, key players analysis and product segment study are explained. The regional SWOT analysis, gross margin analysis, application analysis and industry barriers are explained. The value, volume and consumption from 2019-2024 is portrayed. All the essential details like pricing structure of raw materials, labour cost, sales channels and downstream buyers are presented.

Browse complete Stem Cell Therapy market report description and TOC @ https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market?utm_source=PT

Key Questions Answered in the Report: 1. What is the size of the overall Stem Cell Therapy Market and its segments? 2. What are the key segments and sub-segments in the market? 3. What are the key drivers, restraints, opportunities, and challenges of the Stem Cell Therapy Market and how they are expected to impact the market? 4. What are the attractive investment opportunities within the Market? 5. What is the Stem Cell Therapy Market size at the regional and country-level? 6. Who are the key market players and their key competitors? 7. Market value- chain and key trends impacting every node with reference to companies 8. What are the strategies for growth adopted by the key players in Stem Cell Therapy Market? 9. How does a particular company rank against its competitors with respect to revenue, profit comparison, operational efficiency, cost competitiveness, and market capitalization? 10. How financially strong are the key players in Stem Cell Therapy Market (revenue and profit margin, market capitalization, expenditure analysis, investment analysis)? 11. What are the recent trends in Stem Cell Therapy Market? (M&A, partnerships, new product developments, expansions)

Table of Contents Chapter 1 Stem Cell Therapy Market Overview Chapter 2 Global Economic Impact on Industry Chapter 3 Global Market Competition by Manufacturers Chapter 4 Global Production, Revenue (Value) by Region Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions Chapter 6 Global Production, Revenue (Value), Price Trend by Type Chapter 7 Global Market Analysis by Application Chapter 8 Manufacturing Cost Analysis Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers Chapter 10 Marketing Strategy Analysis, Distributors/Traders Chapter 11 Market Effect Factors Analysis Chapter 12 Global Stem Cell Therapy Market Forecast

Adroit Market Research is an India-based business analytics and consulting company. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

Ryan Johnson Account Manager Global 3131 McKinney Ave Ste 600, Dallas, TX 75204, U.S.A Phone No.: USA: +1 972-362 -8199 / +91 9665341414

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Stem Cell Therapy Market 2020 Trends, Growth Insight, Share, Competitive Analysis, Statistics, Regional and Global Industry Forecast To 2025 - PRnews...

BeyondSpring Announces Positive Topline Results from its PROTECTIVE-2 Phase 3 Registrational Trial of Plinabulin in Combination with Pegfilgrastim for…

November 16, 2020 07:00 ET | Source: BeyondSpring, Inc.

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- BeyondSpring(the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced positive topline data from its PROTECTIVE-2 Phase 3 registrational study showing that plinabulin in combination with pegfilgrastim met the primary endpoint with statistically significant improvement in the rate of prevention of Grade 4 neutropenia in Cycle 1 (31.5% vs 13.6%, p=0.0015), as well as achieving statistical significance in all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir.

The PROTECTIVE-2 Phase 3 study is a double-blind, active-controlled, global study that enrolled a total of 221 patients. Patients in the trial were treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose). The primary efficacy endpoint was rate of prevention of Grade 4 neutropenia.

Plinabulin in combination with pegfilgrastim showed a statistically significant improvement compared to pegfilgrastim alone, with topline data summarized below. Data from all 221 patients were analyzed (combination arm n=111, pegfilgrastim arm n=110).

These data clearly demonstrate the potential for this combination to offer superior therapy compared to standard of care in the prevention of CIN, said Douglas W. Blayney, M.D., Professor of Medicine at the Stanford University School of Medicine and the global principal investigator for plinabulin's CIN studies. With current therapy, Grade 4 neutropenia still occurs in more than 80% of patients after chemotherapy, primarily in Week 1 after chemotherapy, which increases Emergency Room visits and hospitalizations due to infection and febrile neutropenia. Grade 4 neutropenia is also associated with increased mortality and reduced long-term survival due to reduction, delay, or interruption of chemotherapy. I would like to thank the participating patients, their families and the BeyondSpring team for their dedicated work to advance this combination therapy for the prevention of CIN in chemotherapy patients.

Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring noted, We are pleased to have received Breakthrough Therapy designation from both the U.S. FDA and China NMPA for the plinabulin combination in CIN, underscoring the unmet medical need and potential benefit of the combination. We are working with regulatory agencies on the NDA submission, which is expected in Q1 2021 and have also begun preparation for commercialization. In addition to Plinabulin being developed as a treatment option for the prevention of CIN, it is also being investigated as a direct anticancer agent in a global Phase 3 trial of plinabulin + docetaxel for non-small cell lung cancer (NSCLC), with final data read-out in 1H 2021.

Conference Call and Webcast Information BeyondSprings management will host a conference call and webcast today at 8:30 a.m. Eastern Time. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13713406. A live webcast will be available on BeyondSprings website atwww.beyondspringpharma.comunderEvents & Presentationsin the Investors section. An archived replay of the webcast will be available for 30 days.

1 Bodey et al. Ann Intern Med 64(2): 328 (1966); 2 Bodey et al. Cancer 41(4): 1610 (1978)

About Plinabulin in PROTECTIVE-2 (Study 106) CIN Study The Phase 3 portion of PROTECTIVE-2 is a double-blind and active controlled global study. It was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + Pegfilgrastim (6 mg, Day 2 dose) versus a single dose of Pegfilgrastim (6 mg, Day 2 dose). TAC is an example of high febrile neutropenia risk chemotherapy; all G-CSF biosimilar studies use TAC in the pivotal studies.

Plinabulin and G-CSFs such as Pegfilgrastim are believed to have complementary mechanisms in preventing chemotherapy-induced neutropenia (CIN). This is a superiority study in CIN efficacy in the rate of prevention of Grade 4 neutropenia, comparing the combination head-to-head against Pegfilgrastim alone. Literature shows that the Grade 4 neutropenia rate for TAC and Pegfilgrastim at 6 mg is 83 to 93 percent, which presents severe unmet medical needs.

The absolute neutrophil count (ANC) data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About Chemotherapy Induced Neutropenia (CIN) Patients receiving chemotherapy typically develop CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or FN), which necessitates ER/hospital visits. The updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, such as Pegfilgrastim, from only high risk patients (chemo FN rate >20%) to intermediate risk patients (FN rate between 10-20%) to avoid hospital/ER visits during the COVID-19 pandemic. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually. Plinabulin is designed to provide protection against the occurrence of CIN and its clinical consequences in week 1, or early onset action after chemotherapy.

About Plinabulin Plinabulin, BeyondSprings lead asset, is an investigational differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate CIN. Plinabulin had received Breakthrough Therapy Designation from China NMPA in CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of plinabulin observed to date have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (ChemandCell Reports, 2019). Plinabulins CIN data highlight the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the potential ability of plinabulin to not only treat CIN with a rapid onset, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Plinabulin currently is in an Expanded Access Program in the U.S.

About BeyondSpring BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSprings lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Investor Contact: Ashley R. Robinson LifeSci Advisors, LLC +1 617-430-7577 arr@lifesciadvisors.com

Media Contact: Darren Opland, Ph.D. LifeSci Communications +1 646-627-8387 darren@lifescicomms.com

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BeyondSpring Announces Positive Topline Results from its PROTECTIVE-2 Phase 3 Registrational Trial of Plinabulin in Combination with Pegfilgrastim for...