The market research report is a perfect tool for digging deep into critical aspects of the Global Animal Stem Cell Therapy Market and closely understanding factors that influence its growth. Our research analysts are experienced enough to provide you the right information about the global Animal Stem Cell Therapy market to help your business propel forward in the coming years. What makes us different from other market researchers is our high level of analysis that helps you to identify key opportunities available in the global Animal Stem Cell Therapy market. The report provides every bit of information about the global Animal Stem Cell Therapy market related to major market segments, vendor landscape, geographical growth, and other significant factors.

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We deliver market intelligence according to your requirements. This report can be customized as per your business needs. We meet client expectations with the help of our peerless pre-execution, execution, and post-execution engagement models. Our analysts offer quantified B2B research on market threats and opportunities. They also provide qualitative analysis of the global Animal Stem Cell Therapy market.

Get detailed segmentation of the global Animal Stem Cell Therapy market according to type of product and application. The report also covers important technologies used and services provided by leading companies of the global Animal Stem Cell Therapy market. It provides details about latest industry trends observed in different market segments. By providing market forecasts of each segment in terms of volume and revenue, the report enables market players to focus on high-growth areas of the global Animal Stem Cell Therapy market.

The authors of the report profile leading companies of the global Air Purifiers market, such as

Medivet Biologics LLC, VETSTEM BIOPHARMA, J,ARM, U.S. Stem Cell, Inc, VetCell Therapeutics, Celavet Inc., Magellan Stem Cells, Kintaro Cells Power, Animal Stem Care, Animal Cell Therapies, Cell Therapy Sciences, Animacel

They provide details about important activities of leading players in the competitive landscape.

Market Segmentation

By Product

DogsHorsesOthers

By Application

Veterinary HospitalsResearch Organization

A market research study is incomplete without regional analysis, and we are well aware of it. That is why, the report includes a comprehensive and all-inclusive study that solely concentrates on the geographical growth of the global Animal Stem Cell Therapy market. The study also includes accurate estimations about market growth at the global, regional, and country levels. It empowers you to understand why some regional markets are flourishing while others are seeing a decline in growth. It also allows you to focus on geographies that hold the potential to create lucrative prospects in the near future.

Regions Covered in the Global Animal Stem Cell Therapy Market:

Using the competitive analysis offered in the report, players can gain sound understanding of certain behaviors of other market participants. This equips them to make the required changes in their marketing strategies and improve their business tactics to strongly position themselves in the global Animal Stem Cell Therapy market. With detailed mapping of the vendor landscape, the report highlights highly competitive areas of the global Animal Stem Cell Therapy market. The report also talks about the nature of the vendor landscape and reasons supporting it. It profiles some of the prominent names in the Animal Stem Cell Therapy industry.

Few of the questions answered through the report

(1) How will the global Animal Stem Cell Therapy market perform during the forecast period? What will be the market size in terms of value and volume?

(2) Which segment will drive the global Animal Stem Cell Therapy market? Which regional market will show extensive growth in the future? What are the reasons?

(3) How will the market dynamics change because of the impact of future market opportunities, restraints, and drivers?

(4) What are the key strategies adopted by players to sustain themselves in the global Animal Stem Cell Therapy market?

(5) How will these strategies influence the market growth and competition?

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Key Picks from TOC

Market Overview: It begins with scope of products offered in the global Animal Stem Cell Therapy market and ends with a chapter on global market size by production and revenue.

Market Competition: Here, the report explains various competitive situations and trends and gives estimations of market share by manufacturer vis--vis revenue and production.

Market Share by Region: In this section is included a study on the production of Animal Stem Cell Therapy in different regions and countries. Each geographical market studied in the report is analyzed on the basis of gross margin, price, revenue, and production.

Company Profiles: This section is entirely dedicated for company profiling where leading market players are evaluated on the basis of different factors.

Global Animal Stem Cell Therapy Market Forecast

Research Methodology

We follow an ideal mix of primary and secondary research methodologies. One of the most extensive stages in our research process is information procurement. Under information analysis, we map and analyze all the information procured by our analysts. This step also involves analyzing data discrepancies found across different data sources. In order to deduce viable conclusions, we place data points at appropriate market spaces. Validation is the final and a very important step before the publishing of the report. We employ an intricately designed process for validation and re-validation to finalize data points for their use in final calculations.

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About Us:QYR Consulting established as a research firm in 2007 and have since grown into a trusted brand amongst many industries. Over the years, we have consistently worked toward delivering high-quality customized solutions for wide range of clients ranging from ICT to healthcare industries. With over 50,000 satisfied clients, spread over 80 countries, we have sincerely strived to deliver the best analytics through exhaustive research methodologies.

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Animal Stem Cell Therapy Market Size, Key Manufacturers, Sales, Demand, Application Forecasts And Opportunities By 2025 - ToplatestDailynews

No longer just for professional athletes, these are the stem cell and regenerative medicine options DCs need to know about

The health care landscape continues to evolve at a dizzying pace. Insurance deductibles are increasing, and this has placed a financial burden on patients who are required to self-pay for necessary and yet uncovered services.

The opioid crisis has left physicians with limited clinical options to treat chronic pain and dysfunction. At the same time, pressure has been placed on health care providers to provide affordable alternatives to invasive procedures that provide limited clinical options with high failure rates. This confluence of supply and demand has resulted in the growth of emerging therapies in the field of stem cell and regenerative medicine. These therapies are bringing hope to patients and new opportunities to health care providers who deliver them.

Regenerative medicine is the process of replacing or regenerating cells and tissues to restore normal function. Initially popularized by professional athletes, these therapies have become mainstream. More than 27 million Americans suffer from osteoarthritis today, and in 2030 25% of U.S. adults will be diagnosed with osteoarthritis. The global regenerative medicine market is predicted to reach more than $100 billion by 2022.

These moderately-invasive regenerative procedures are eclipsing traditional highly-invasive procedures, such as hip and knee implantation, which will have a global market of $35 million over the same period.

There are four primary regenerative medicine options:

Irritant therapies include prolotherapy, ozone and prolozone. Theyincludeadding multipleirritatingsubstances along with numbing agents into degenerated or injured joints, and areas of pain.

These therapies cause inflammation to kick-start regeneration by stimulating the body to send in macrophages, which are cells that ingest and destroy theirritantsolution and trigger the healing response. Irritant therapies are an excellenttreatmentfor all forms of musculoskeletal and joint pain includingchronic neck and back pain, and rotator cuff injuries.

The effect of irritant therapies is analogous to jump-starting the battery in a tractor to get the engine to turn over.

Protease inhibition therapy eliminates the factors causing cartilage degradation, tissue breakdown, inflammation and pain. It cleans and protects joints. It is most commonly used for patients with osteoarthritis (OA) and degenerative disc disease (DDD).

It includes therapies such as alpha-2-macroglobulin (A2M) and interleukin-1 receptor antagonist protein (IRAP). A2M and IRAP are proteins found naturally in our blood. They act as protease inhibitors by binding to and inactivating damaging proteases in the body. Proteases are catabolic enzymes that break larger molecules into smaller units. Proteases trapped in the joints catabolize cartilage and break it down, causing arthritis. A2M is a large protein made in the liver. It blocks activity for all known molecules that cause cartilage breakdown. It works like a Venus flytrap by having a bait-and-trap mechanism on two sides.

Once the proteases are bound on both sides, the molecule initiates a suicide cascade and dies, allowing it to be flushed out of the area by the body.

The binding effect of protease inhibition therapy is analogous to de-weeding a garden and tilling the soil before planting.

A fibronectin-aggrecan complex test (FACT) may be used to determine the presence of FAC, which is a biomarker or indicator of cartilage breakdown caused by proteases. FAC is a unique molecular complex that is specific for painful inflammation of the spine and cartilage.

A small sample of fluid is taken from the joint or disc and sent to a lab for testing. The test looks for the presence of FAC in the fluid sample and determines where you are: FAC+ or FAC-. FAC+ patients are identified as ideal candidates for A2M injections and have a 90% rate of responding to the A2M therapy.

Stem cell therapy is focused on concentrating the workhorses of regeneration and restoration of tissues: stem cells. This results in greater cell signaling and cell recruitment than other regenerative therapies. Stem cells are known as mesenchymal signaling cells. They are considered pluripotent, which means they are undifferentiated and can replicate into various cell and tissue types.

Stem cells are found in bone marrow, the soft spongy tissue found at the center of large bones. Introducing stem cells into an injured area initiates the healing response, repairing damaged tissue by growing new, healthy tissue. The most common stem cell therapies include bone marrow aspirate concentrate (BMA), nanofat and stromal vascular fraction.

Injecting stem cells into an injured area is analogous to planting seeds in a garden.

Growth factor therapies are focused on cell signaling and cell recruitment. Blood is made up of white blood cells, red blood cells, and platelets that are suspended in plasma. Platelets are most widely known for their ability to clot blood. Platelets are also highly rich in growth factors that are proteins that stimulate healing. When an injury occurs, platelets become activated, migrate to the site of injury and release growth factors.

Growth factor therapies are the most popular provider choice for the low-cost regeneration of tissues and include platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM). The therapy includes drawing the patients blood followed by centrifugation to concentrate the platelets and exclude other unwanted blood products.

Another type of growth factor therapy is amniotic fluid growth factor (GF) injection therapy. Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. Human amniotic fluid is sourced from consenting mothers during full-term C-sections. It contains over 200 growth factors, cytokines and proteins. The therapeutic use of amniotic fluid is regulated by the FDA. It must be tested for disease and may not include any viable cells. Amniotic fluid GF therapy has both anti-inflammatory and anti-microbial properties and includes naturally-occurring hyaluronic acid for lubrication. It is most commonly used to promote the repair and reconstruction of soft tissues including cartilage and tendons.

Exosomes are being heralded as the next frontier of growth factor therapies. While they are not cells, exosomes play a vital role in the communication and rejuvenation of all the cells in the body. Exosomes are extracellular vesicles, or small bubbles, released from cells, especially from stem cells. These culture-expanded cell secretions are derived from human placental tissue. They allow for cell-to-cell communication, transporting molecules that are important regulators of intracellular information. Exosomes act as a food source for stem cells and prolong their activity. Exosomes are anti-inflammatory and include more than 300 growth factors, cytokines and proteins.

Patients with Lyme disease, burns, chronic inflammation, autoimmune disease and other chronic degenerative diseases may benefit from including exosomes in their treatment regimen. The application of growth factor therapies is analogous to applying fertilizer to a garden to help the crop grow and flourish.

Moving stem cell and regenerative medicine forward in the treatment algorithm may eliminate the need for other ineffective or potentially harmful therapies. These therapies provide new hope for patients whose only alternatives have been long-term medication, steroid injections, and costly and time-consuming surgery and rehab.

Stem cell and regenerative medicine therapies may only be provided by licensed medical professionals following all appropriate rules and regulations. An understanding of these emerging therapies and the benefits they may provide is essential as the collaboration between doctors of medicine and chiropractic increases and we join forces to combat chronic pain, dysfunction and disease.

MARK SANNA, DC, ACRB LEVEL II, FICC, is a member of the Chiropractic Summit and a board member of the Foundation for Chiropractic Progress. He is the president and CEO of BreakthroughCoaching, and can be reached at mybreakthrough.com or800-723-8423.

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A primer: stem cell and regenerative medicine as 'the' emerging therapy - Chiropractic Economics

The 23rd Annual Meeting is expected to be the Societys largest ever, and attendees are encouraged to register early and to reserve their hotel rooms as soon as possible.

MILWAUKEE (PRWEB) December 02, 2019

Registration is now open for the American Society of Gene & Cell Therapys (ASGCT) 23rd Annual Meeting, which will be held at the Hynes Convention Center May 12-15, 2020, in Boston. The meeting is the premier event in the field of gene and cell therapy and brings together scientists, physicians, patient advocates, and other stakeholders with the goal of advancing gene and cell therapies to alleviate human disease.

The 23rd Annual Meeting is expected to be the Societys largest ever, and attendees are encouraged to register early and to reserve their hotel rooms as soon as possible as the latter will sell out well before the meeting. An early registration discount is available through April 10, and groups of five or more are eligible for an additional discount. Pre-Meeting Workshops and the Closing Night Reception can be added to annual meeting registration.

Abstract submission for the 23rd Annual Meeting is now open and runs through January 29.International attendees can generate invitation letters online to apply for a VISA immediately after registering or submitting an abstract. More information about registration is available on the annual meeting website.

Hotel blocks for the Sheraton Boston Hotel and Boston Marriott Copley Place are also available now. ASGCT room blocks historically sell out months before the annual meeting, and once the ASGCT block is completely full, there's no guarantee attendees will be able to get the same room rate during the meeting.

More details about annual meeting programming will be posted on the website as they are confirmed. For any questions about the annual meeting, please contact mailto:info@asgct.org [info@asgct.org __title__ ].

About ASGCTThe American Society of Gene & Cell Therapy is the primary professional membership organization for scientists, physicians, patient advocates, and other professionals with interest in gene and cell therapy. Our members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. ASGCT advances knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease to benefit patients and society.

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Registration Opens Today for ASGCT's 23rd Annual Meeting in Boston - PR Web

New Jersey United State, Verified Market Research published research report provides In-depth Research onStem Cell Therapy Market Size and Forecast to 2026. This report offers a complete and deep analysis of the competition, segmentation, dynamics, and geographic progression of the Stem Cell Therapy Market. The development prospects, growth plans, and coercions to Stem Cell Therapy are analysed in depth. The industrial process scrutiny, market share of well-known market players, trade chain structure is offered in this research report.

Global Stem Cell TherapyMarketwas valued at USD 86.62 million in 2016 and is projected to reach USD 221.03million by 2025, growing at a CAGR of 10.97% from 2017 to 2025.

The Stem Cell Therapy industry report lists the leading competitors and provides the game-changing strategic analysis of the key factors driving the market. It has featured the recent trends, technological improvements as well as some significant methodologies for increasing the performance of the businesses. The report provides crucial information on the market status of the Stem Cell Therapy and is a major source of direction and navigation for individuals and companies involved in the industry.

Get | Download Sample Copy @https://www.verifiedmarketresearch.com/download-sample/?rid=24113&utm_source=TMP&utm_medium=009

Key Players Mentioned in the Stem Cell Therapy Market Research Report:

Stem Cell Therapy Market: Competitive Landscape

The market analysis entails a section solely dedicated for major players in the Stem Cell Therapy Market wherein our analysts provide an insight to the financial statements of all the major players along with its key developments product benchmarking and SWOT analysis. The company profile section also includes a business overview and financial information. The companies that are provided in this section can be customized according to the clients requirements.

Stem Cell Therapy Market: Scope of the Report

This report provides an all-inclusive environment of the analysis for the Stem Cell Therapy Market. The market estimates provided in the report are the result of in-depth secondary research, primary interviews and in-house expert reviews. These market estimates have been considered by studying the impact of various social, political and economic factors along with the current market dynamics affecting the Stem Cell Therapy Market growth

Along with the market overview, which comprises of the market dynamics the chapter includes a Porters Five Forces analysis which explains the five forces: namely buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Stem Cell Therapy Market. It explains the various participants, such as system integrates, intermediaries and end-users within the ecosystem of the market. The report also focuses on the competitive landscape of the Stem Cell Therapy Market.

Ask for Discount @https://www.verifiedmarketresearch.com/ask-for-discount/?rid=24113&utm_source=TMP&utm_medium=009

Table of Content

1 Introduction of Stem Cell Therapy Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell Therapy Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell Therapy Market, By Deployment Model

5.1 Overview

6 Stem Cell Therapy Market, By Solution6.1 Overview

7 Stem Cell Therapy Market, By Vertical

7.1 Overview

8 Stem Cell Therapy Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell Therapy Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Stem Cell Therapy Market Analysis by Top Companies, Driver, Existing Trends and Global Forecast by 2026 - The Market Publicist

SAN CARLOS, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc., (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company plans to present at the following conferences in December:

Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at http://ir.iovance.com.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patients own immune cells to attack cancer. TIL cells are extracted from a patients own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the companys TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovances T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit http://www.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our). We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the U.S. and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to successfully submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates that have been granted breakthrough therapy designation (BTD) or regenerative medicine advanced therapy designation (RMAT) by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Companys product pipeline; the successful implementation of the Companys research and development programs and collaborations; the Companys ability to obtain tax incentives and credits; the guidance provided for the Companys future cash, cash equivalent, and short term investment positions; the success of the Companys manufacturing, license or development agreements; the acceptance by the market of the Companys product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Companys control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Companys business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyses of these trials or subgroups within these trials; a slower rate of enrollment may impact the Companys clinical trial timelines; enrollment may need to be adjusted for the Companys trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in the Companys cervical cancer trial may have an adverse effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient populations may result in changes in preliminary clinical results; the Companys ability or inability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical, safety, manufacturing and control requirements; the Companys interpretation of communications with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Companys ability to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development process or review of the Companys product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own facility may adversely affect the Companys potential commercial launch; and additional expenses may decrease our estimated cash balances and increase our estimated capital requirements. A further list and description of the Companys risks, uncertainties and other factors can be found in the Companys most recent Annual Report on Form 10-K and the Companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or http://www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investor Relations Contacts:Annie ChangSolebury Trout646-378-2972achang@troutgroup.com

Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com

Media Relations Contact: Rich AllanSolebury Trout646-378-2958rallan@troutgroup.com

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Iovance Biotherapeutics to Present at Upcoming Investor Conferences in December - BioSpace

NATICK, Mass.--(BUSINESS WIRE)--Aleta Biotherapeutics, a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, today announced that Paul Rennert, Ph.D., President and Chief Scientific Officer, will deliver an oral presentation at the 61st ASH Annual Meeting & Exposition, December 7 10, 2019, Orange County Convention Center, Orlando, FL.

The 61st ASH Annual Meeting will be an important opportunity to present mechanistic studies and extensive in vitro and in vivo results from our novel CD19-anti-CD20 bridging protein technology, said Paul Rennert, Ph.D., President and Chief Scientific Officer of Aleta Biotherapeutics. We look forward to advancing the development of this novel therapy based on the data we will be presenting on December 7.

Oral Presentation DetailsTitle: 252 A Novel CD19-Anti-CD20 Bridging Protein Prevents and Reverses CD19-Negative Relapse from CAR19 T Cell Treatment in vivo Session Name: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: MechanismsPresenter: Paul Rennert, Ph.D.Session Date: Saturday, December 7, 2019Session Time: 2:00 PM - 3:30 PMPresentation Time: 3:15 PMLocation: Orange County Convention Center, Valencia A (W415A)

About Aleta BiotherapeuticsAleta Biotherapeutics is an immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, including currently intractable solid tumors. The company was founded by Paul Rennert and Roy Lobb, who bring extensive scientific and leadership experience in immunology, oncology and drug development to this new enterprise. Aleta has created a unique portfolio of multi-antigen targeting solutions for cell therapy, designed to address the critical issues of CAR-T persistence, tumor antigen loss leading to patient relapse, and tumor antigen heterogeneity. For more information, visit http://www.aletabio.com.

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Aleta Biotherapeutics Announces Oral Presentation at the 61st American Society of Hematology Annual Meeting (ASH) - Business Wire

There are a number of policy changes that can drive change within the implementation of chimeric antigen receptor T-cell therapy, but further innovation is warranted to improve access, said John Sweetenham, MD, professor in the Department of Internal Medicine at UT Southwestern Medical Center and the Associate Director for Clinical Affairs at UTSWs Harold C. Simmons Comprehensive Cancer Center.

There are a number of policy changes that can drive change within the implementation of chimeric antigen receptor (CAR) T-cell therapy, but further innovation is warranted to improve access, said John Sweetenham, MD, professor in the Department of Internal Medicine at UT Southwestern Medical Center and the Associate Director for Clinical Affairs at UTSWs Harold C. Simmons Comprehensive Cancer Center.

Transcript

What policies have helped or hindered the implementation of CAR T-cell therapy?

So, I think just recently, there are a number of policy changes, for which overall, I think going to prove to be helpful. Probably not helpful enough, but I think they certainly caused some improvements. The first one of those is that CMS has recognized that it will fund up to a certain extent CAR T-cell therapy for the license indications, which at the moment are predominantly in B-cell malignancy, but it also has recognized that it is essential to cover the cost of CAR T for any other indications, which are listed in authoritative compendia of which the National Comprehensive Cancer Network, 1, is probably the most respected and best referenced. So, I think those are positive things. The other positive outcome of the recent change in the national coverage determination is that the amount of reimbursement is increased from 50% of cost to 65% of cost.

So, those things are all good and I think they help us provide this treatment to more of our patients. The problem and the hindrance is that it really still falls a very long way short of the true cost of the treatment. The cells themselves cost somewhere between $370,000 to $450,000, and at the moment with the current reimbursement models, the best that we can do if patients are treated as inpatients is to recover about 80% of that by the time we factor in the new technology, add-on payments as well. So, for most big centers, who are performing inpatient CAR T-cell treatments at the moment, they stand to lose at a minimum probably about $100,000 per patient and that is purely on the price of the CAR T cells. So, that doesn't really factor in what will happen if the patient gets toxicity, needs to be admitted to the [intensive care unit], and so on.

So, I think that what I would say is that the recent policy changes have been definitely a step in the right direction. I think that we still have quite a long way to go, but it undoubtedly will slowly improve the access. The other thing that needs to happen on our end is as oncologists, we need to strengthen the evidence base because I think that's the other thing that's lacking. Then perhaps the final thing I'd say, and I'm definitely in a minority with this opinion, but at some level when Medicarewhen CMS decided to increase the new technology add-on payments, under the new policy change for coverage, it was anticipated that there would be a provision in there that it will be coverage with evidence development so that we would be required to prospectively collect evidence for the efficacy. That requirement was dropped, and I think the reasons for that were good because the feeling is that will accelerate access. On the other hand, I think the downside of that is that it was an opportunity for us to get more of the evidence base that we really need.

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Dr John Sweetenham Outlines the Effect of Current Policies on the Implementation of CAR T Therapy - AJMC.com Managed Markets Network

DetailsCategory: DNA RNA and CellsPublished on Monday, 02 December 2019 15:08Hits: 21

Application Being Evaluated Under Accelerated Assessment

BOSTON, MA, USA and LONDON, UK I December 02, 2019 I Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that the European Medicines Agency (EMA) has validated the companys Marketing Authorization Application (MAA) for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy, for the treatment of metachromatic leukodystrophy (MLD). Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

We are pleased that OTL-200 for the treatment of MLD is now under review with the EMA, bringing us another step closer to potentially making an approved gene therapy treatment a reality for children and families affected by this devastating and rapidly progressing disease, said Mark Rothera, president and chief executive officer of Orchard Therapeutics. We are committed to working with the EMA as they evaluate our application. Due to the nature of the disease and the urgency to treat those affected by MLD, we have also been working diligently in parallel to make OTL-200, if approved, available to patients in the EU as quickly as possible, while continuing our efforts to expand patient access outside the EU.

Orchard previously announced in November 2019 that the EMA had granted accelerated assessment for OTL-200. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated, not counting clock stops when applicants are requested to provide additional information.

About MLD and OTL-200 Metachromatic leukodystrophy (MLD) is a rare and life-threatening inherited disease of the bodys metabolic system occurring in approximately one in every 100,000 live births. MLD is caused by a mutation in the arylsulfatase-A (ARSA) gene that results in the accumulation of sulfatides in the brain and other areas of the body, including the liver, the gallbladder, kidneys, and/or spleen. Over time, the nervous system is damaged and patients with MLD will experience neurological problems such as motor, behavioral and cognitive regression, severe spasticity and seizures, finding it more and more difficult to move, talk, swallow, eat and see. Currently, there are no effective treatments for MLD. In its late infantile form, mortality at 5 years from onset is estimated at 50% and 44% at 10 years for juvenile patients.1 OTL-200 is an ex vivo, autologous, hematopoietic stem cell-based gene therapy being studied for the treatment of MLD. OTL-200 was acquired from GSK in April 2018 and originated from a pioneering collaboration between GSK and the Hospital San Raffaele and Fondazione Telethon, acting through their joint San Raffaele-Telethon Institute for Gene Therapy in Milan, initiated in 2010.

About Orchard Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.

Orchards portfolio of ex vivo, autologous, hematopoietic stem cell (HSC) based gene therapies includes Strimvelis, a gammaretroviral vector-based gene therapy and the first such treatment approved by the European Medicines Agency for severe combined immune deficiency due to adenosine deaminase deficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies are all based on lentiviral vector-based gene modification of autologous HSCs and include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD), transfusion-dependent beta-thalassemia (TDT) and mucopolysaccharidosis type I (MPS-I), as well as an extensive preclinical pipeline. Strimvelis, as well as the programs in MLD, WAS and TDT were acquired by Orchard from GSK in April 2018 and originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy initiated in 2010.

Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.

1 Mahmood et al. Metachromatic Leukodystrophy: A Case of Triplets with the Late Infantile Variant and a Systematic Review of the Literature. Journal of Child Neurology 2010, DOI: http://doi.org/10.1177/0883073809341669

SOURCE: Orchard Therapeutics

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Orchard Therapeutics Announces the Filing and Validation of Marketing Authorization Application by European Medicines Agency for OTL-200 for the...

Researchers at the University of Cologne have identified Cav2.3 channels as a new mechanism for the development of Parkinson disease which may be the beginning of a new targeted therapy. The findings were published in Nature Communications.1

Parkinson disease is the second most common neurodegenerative disease in which a specific population of dopamine-producing nerve cells in the mid-brain die off selectively. The resulting lack of dopamine then leads to symptoms such as resting tremors, muscle stiffness, and problems executing voluntary movement. It affects more than 6 million people worldwide and is strongly age-dependent.2

It has previously been found that at the cellular level, disturbances in the calcium-dependent signaling pathways are integral to the development of Parkinson disease. Calcium plays a key role in many cellular signaling pathways, and its concentration is therefore regulated very precisely in the cell.2

Deregulation of the calcium balance causes disturbances of the intracellular signaling cascades, which can lead to cell death. Researchers have now shown that excessive calcium influx through specific ion channels, Cav2.3 channels of the so-called R-type, can contribute significantly to the development of Parkinson disease.1

Researchers were able to prevent the death of dopamine-producing nerve cells by genetically switching off the activity of the Cav2.3 channels. The ion channel Cav2.3 has so far not been associated with Parkinson disease. Further research on dopamine-producing neurons, which have developed from human so-called induced pluripotent stem cells, shows that signaling cascades similar to those that cause Parkinson sensitivity in the animal models are also active in human neurons.1

It had been previously hypothesized that another calcium channel, Cav1.3, plays a central role in the development of Parkinson disease. However, a recently completed clinical trial in which Cav1.3 channels were blocked did not show protection against Parkinson disease.2

This new study provides evidence as to why this clinical trial failed to show protective effects and suggests that selective Cav2.3 inhibitors should be tested as a drug to treat Parkinson disease, the authors concluded.2

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Channel in Nerve Cell May be Key in Unlocking Parkinson Disease Therapy - Pharmacy Times

Around 2 million Americans are affected by traumatic brain injuries each and every year. Traumatic brain injuries cause inflammation and cell death within the brain and those suffering from a head injury quite often experience lifelong memory loss, and even epilepsy. However, a group of researchers from the University of California has developed a new kind of cell therapy that gives hope to these patients.

In the study, published in Nature Communications earlier this month, the UCI team explains how it successfully transplanted embryonic progenitor cells into the brains of mice with traumatic brain injury. What the researchers discovered is the transplanted neurons moved to the injury where new connections were formed with those brain cells that were injured.

Within just one month, they saw promising results. Not only were the mice showing signs of improved memory, but the cell transplants also stopped the mice from developing epilepsy. This was quite a significant result as more than half the mice that werent treated with new interneurons did develop the disease.

While inhibitory neurons are involved in many aspects of memory, that are highly susceptible to dying after a brain injury. While we cannot stop interneurons from dying, it was exciting to find that we can replace them and rebuild their circuits, said Robert Hunt, Ph.D., lead author of the study and assistant professor of anatomy and neurobiology at UCI School of Medicine.

In 2018, Hunt and his colleagues used a similar approach to restore memory in mice. However, back then the therapy was used to improve the memory of newborn mice born with a genetic disorder. But this new study was a huge leap for the researchers. The idea to regrow neurons that die off after a brain injury is something that neuroscientists have been trying to do for a long time, said Hunt.

To test their observations even further, the team used a drug in which to silence the transplanted neurons. It was exciting to see the animals memory problems come back after we silenced the transplanted cells because it showed that the new neurons really were the reason for the memory improvement, said junior specialist and first author of the study, Bingyao Zhu.

If this same treatment used in mice can be applied to humans, it could make a huge difference in the quality of life for those individuals. Next on the horizon is to create interneurons using human stem cells.

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New Cell Therapy Gives Traumatic Brain Injury Patients Hope - TrendinTech