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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy…
Posted: August 18, 2020 at 12:50 am
Aug. 17, 2020 11:00 UTC
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including data from the Phase 2/3 Starbeam study (ALD-102) and available data from the Phase 3 ALD-104 study, will be presented at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2020), taking place virtually from August 29 - September 1, 2020.
New Cerebral Adrenoleukodystrophy (CALD) Data at EBMT 2020
Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy (ALD-102 and ALD-104)Presenting Author: Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Womens and Childrens Medicine, University Hospital LeipzigPoster Session & Number: Gene Therapy; ePoster O077
Additional bluebird bio data at EBMT 2020 includes encore presentations from the companys CALD, sickle cell disease (SCD), transfusion-dependent -thalassemia (TDT) and multiple myeloma programs.
Cerebral Adrenoleukodystrophy (CALD) Encore Data at EBMT 2020
Outcomes of allogeneic hematopoietic stem cell transplant in patients with cerebral adrenoleukodystrophy vary by donor cell source, conditioning regimen, and stage of cerebral disease status (ALD-103)Presenting Author: Dr. Jaap Jan Boelens, Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer CenterPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster O106
Multiple Myeloma Correlative Encore Data at EBMT 2020
Markers of initial and long-term responses to idecabtagene vicleucel (ide-cel; bb2121) in the CRB-401 study in relapsed/refractory multiple myelomaPresenting Author: Dr. Ethan G. Thompson, Bristol Myers SquibbPoster Session & Number: CAR-based Cellular Therapy clinical; ePoster A089
Sickle Cell Disease (SCD) Encore Data at EBMT 2020
LentiGlobin for sickle cell disease (SCD) gene therapy (GT): updated results in Group C patients from the Phase 1/2 HGB-206 studyPresenting Author: Dr. Markus Y. Mapara, Director, Adult Blood and Marrow Transplantation Program, Columbia University Medical CenterOral Session & Number: Inborn Errors; O080Date & Time: September 1, 2020; 4:35 4:42 PM CET/10:35 10:42 AM ET
Transfusion-Dependent -Thalassemia (TDT) Encore Data at EBMT 2020
Clinical outcomes following autologous hematopoietic stem cell transplantation with LentiGlobin gene therapy in the Phase 3 Northstar-2 and Northstar-3 studies for transfusion-dependent -thalassemiaPresenting Author: Professor Franco Locatelli, Director, Department of Pediatric Hematology and Oncology, Ospedale Pediatrico Bambino GesPoster Session & Number: Gene Therapy; ePoster O074
LentiGlobin gene therapy treatment of two patients with transfusion-dependent -thalassemia (case report)Presenting Author: Dr. Mattia Algeri, Department of Pediatric Oncohematology - Transplantation Unit and Cell Therapies, Ospedale Pediatrico Bambino GesPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster A328
Cross Indication Encore Data at EBMT 2020
Safety of autologous hematopoietic stem cell transplantation with gene addition therapy for transfusion-dependent -thalassemia, sickle cell disease, and cerebral adrenoleukodystrophyPresenting Author: Dr. Evangelia Yannaki, Director, Gene and Cell Therapy Center, Hematology Department, George Papanicolaou HospitalPoster Session & Number: Gene Therapy; ePoster O078
Abstracts outlining bluebird bios accepted data at EBMT 2020 are available on the Annual Meeting website. On August 29, 2020, at 12:30 PM CET/6:30 AM ET, the embargo will lift for ePosters and oral presentations accepted for EBMT 2020. Presentations will be available for virtual viewing throughout the duration of the live meeting and content will be accessible online following the close of the meeting until November 1, 2020.
About elivaldogene autotemcel (eli-cel, Lenti-D gene therapy) In July 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD). bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for eli-cel for CALD by year-end 2020, and the Biologics License Application (BLA) in the U.S. in mid-2021.
bluebird bio is currently enrolling patients for a Phase 3 study (ALD-104) designed to assess the efficacy and safety of eli-cel after myeloablative conditioning using busulfan and fludarabine in patients with CALD. Contact clinicaltrials@bluebirdbio.com for more information and a list of study sites.
Additionally, bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-304) for patients who have been treated with eli-cel for CALD and completed two years of follow-up in bluebird bio-sponsored studies.
The Phase 2/3 Starbeam study (ALD-102) has completed enrollment. For more information about the ALD-102 study visit: http://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT01896102.
Adrenoleukodystrophy (ALD) is a rare, X-linked metabolic disorder that is estimated to affect one in 21,000 male newborns worldwide. Approximately 40 percent of boys with ALD will develop CALD, the most severe form of ALD. CALD is a progressive neurogenerative disease that involves breakdown of myelin, the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. Symptoms of CALD usually occur in early childhood and progress rapidly, if untreated, leading to severe loss of neurologic function, and eventual death, in most patients.
The European Medicines Agency (EMA) accepted eli-cel gene therapy for the treatment of CALD into its Priorities Medicines scheme (PRIME) in July 2018, and previously granted Orphan Medicinal Product designation to eli-cel.
The U.S. Food and Drug Administration (FDA) granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation for the treatment of CALD.
Eli-cel is not approved for any indication in any geography.
About idecabtagene vicleucel (ide-cel; bb2121) Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, bluebird bio and Bristol Myers Squibbs broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.
In July 2020, Bristol Myers Squibb (BMS) and bluebird bio submitted the Biologics License Application for ide-cel to the U.S. Food and Drug Administration for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel is the first CAR T cell therapy submitted for regulatory review to target BCMA and for multiple myeloma.
Ide-cel was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.
Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between BMS and bluebird bio.
Ide-cel is not approved for any indication in any geography.
About LentiGlobin for Sickle Cell Disease LentiGlobin for sickle cell disease (SCD) is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.
bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel and LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.
SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive crises (VOCs). For adults and children living with SCD, this means painful crises and other life-altering or life-threatening acute complicationssuch as acute chest syndrome (ACS), stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.
LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug status and Regenerative Medicine Advanced Therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for the treatment of SCD.
bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.
bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.
LentiGlobin for SCD is investigational and has not been approved in any geography.
About betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia) The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.
In the HGB-207 clinical study supporting the conditional marketing approval of ZYNTEGLO, the primary endpoint was transfusion independence (TI) by Month 24, defined as a weighted average Hb 9 g/Dl without any RBC transfusions for a continuous period of 12 months at any time during the study after infusion of ZYNTEGLO. Ten patients were evaluable for assessment of TI. Of these, 9/10 (90.0%, 95% CI 55.5-99.7%) achieved TI at last follow-up. Among these nine patients, the median (min, max) weighted average Hb during TI was 12.22 (11.4, 12.8) g/dLl.
TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.
Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.
Non-serious adverse events (AEs) observed during the clinical studies that were attributed to betibeglogene autotemcel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia were considered possibly related to beti-cel.
Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.
The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).
The U.S. Food and Drug Administration granted beti-cel Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. Beti-cel is not approved in the United States.
Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207), NCT03207009 for Northstar-3 (HGB-212).
About bluebird bio, Inc. bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.
bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.
bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.
Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.
Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.
Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for regulatory submissions for beti-cel (marketed as ZYTENGLO in the European Union), eli-cel, ide-cel, and LentiGlobin for SCD, including anticipated endpoints to support regulatory submissions and timing expectations; the companys expectations regarding the potential for the suspension manufacturing process for lentiviral vector; its expectations for commercialization efforts for ZYNTEGLO in Europe; as well as the companys intentions regarding the timing for providing further updates on the development and commercialization of ZYNTEGLO and the companys product candidates. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic and resulting economic conditions will have a greater impact on the companys operations and plans than anticipated; that our amended collaboration with BMS will not continue or be successful; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that our plans for submitting a BLA for LentiGlobin for SCD may be delayed if the FDA does not accept our comparability plans for the use of the suspension manufacturing process for lentiviral vector; the risk that the submission of BLA for ide-cel is not accepted for filing by the FDA or approved in the timeline we expect, or at all; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, including due to delays from the COVID-19 pandemics impact on healthcare systems; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidates, resulting in delay to our anticipated timelines for regulatory submissions, including our applications for marketing approval; the risk that we will encounter challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200817005156/en/
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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy...
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Robotic High-Throughput Biomanufacturing and Functional Differentiation of Human Pluripotent Stem Cells – DocWire News
Posted: August 18, 2020 at 12:50 am
This article was originally published here
bioRxiv. 2020 Aug 3:2020.08.03.235242. doi: 10.1101/2020.08.03.235242. Preprint.
ABSTRACT
Efficient translation of human induced pluripotent stem cells (hiPSCs) depends on implementing scalable cell manufacturing strategies that ensure optimal self-renewal and functional differentiation. Currently, manual culture of hiPSCs is highly variable and labor-intensive posing significant challenges for high-throughput applications. Here, we established a robotic platform and automated all essential steps of hiPSC culture and differentiation under chemically defined conditions. This streamlined approach allowed rapid and standardized manufacturing of billions of hiPSCs that can be produced in parallel from up to 90 different patient-and disease-specific cell lines. Moreover, we established automated multi-lineage differentiation to generate primary embryonic germ layers and more mature phenotypes such as neurons, cardiomyocytes, and hepatocytes. To validate our approach, we carefully compared robotic and manual cell culture and performed molecular and functional cell characterizations (e.g. bulk culture and single-cell transcriptomics, mass cytometry, metabolism, electrophysiology, Zika virus experiments) in order to benchmark industrial-scale cell culture operations towards building an integrated platform for efficient cell manufacturing for disease modeling, drug screening, and cell therapy. Combining stem cell-based models and non-stop robotic cell culture may become a powerful strategy to increase scientific rigor and productivity, which are particularly important during public health emergencies (e.g. opioid crisis, COVID-19 pandemic).
PMID:32793899 | PMC:PMC7418713 | DOI:10.1101/2020.08.03.235242
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Robotic High-Throughput Biomanufacturing and Functional Differentiation of Human Pluripotent Stem Cells - DocWire News
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This revolutionary new coronavirus cure is already saving lives – BGR
Posted: August 18, 2020 at 12:50 am
The novel coronavirus is an incredibly scary illness given the complex way it operates. Its incredibly infectious and it can cause severe complications that can lead to death. It even kills younger patients and people who have no other underlying conditions. And some of the people who manage to recover after what could be a months-long battle with COVID-19 will have to deal with secondary health problems that could last a lifetime. Thats why you should avoid other people as much as possible, wash your hands often, and wear face masks until treatments and vaccines become available and even after that. The good news is that doctors and researchers have not run out of ideas in their quest to beat the novel virus. Plenty of promising therapies are in clinical trials right alongside vaccines, as the world will need therapeutics that can cure the infection as well as drugs that can prevent it. Not all of them are miracle drugs, and remdesivir and dexamethasone are the best examples of that. Theyre drugs that work and can save lives, but they wont save everyone. And weve often told you that we dont even need a single miracle drug. Instead, combinations of effective medicines could reduce complications and the risk of death. But it turns out there may be a drug that does qualify as a miracle COVID-19 cure, one that might save plenty of severe COVID-19 patients.
The promising therapy uses medicinal signaling cells or MSCs, which are found on blood vessels throughout the body, explained Kevin Kimberlin in a Wall Street Journal op-ed. These MSCs pack a powerful 1-2-3 punch, according to the piece. These cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue, Kimberlin wrote.
Thats the kind of combination we havent seen from other drugs, and it could save lives of patients experiencing serious COVID-19 complications. In fact, its already saving lives right now. The report mentions two pilot studies, one from Mount Sinai Hosptial in March and one published in The Lancet in July. MSCs were used to treat 25 critically ill COVID-19 cases between the two studies. 10 people our of 12 survived in the March trial, and 11 people out of 13 lived in the July pilot.
While Kimberlin calls these drugs MSCs in his article, Mesoblast actually has a name for the drug: Remestemcel-L, which is based on mesenchymal lineage adult stem cells. The July study calls them adipose-tissue derived mesenchymal stromal cells (AT-MSC). In other words, were looking at stem cell therapy and weve already reported on the Mount Sinai pilot months ago. Doctors involved with that project said at the time that vaccines will be the miracle drug everyone is waiting for, not stem cell therapy.
Mount Sinai and Mesoblast won FDA clearance and National Institutes of Health funding for a randomized trial on 300 patients that started in May. Researchers found that MSCs can increase the number of T cells and reduce inflammation at the same time. Furthermore, chest X-rays showed that the drugs helped to repair lung tissue, sometimes as soon as 48 hours after therapies began.
MSCs were identified some 30 years ago by Prof. Arnold Caplan and colleagues at Case Western Reserve University, explains Kimberlin, who co-founded Osiris Therapeutics together with Caplan in 1993. These MSCs sound very promising, at least on paper:
When a MSC detects an infection or an injury to those vessels, it transforms into a factory to recruit and pump out immune-modulating and vessel-repair agents. These cells ameliorate crippling and deadly conditions when traditional chemical or biochemical drugs fail.
According to Kimberlin, MSCs therapy also worked in a Mesoblast study on graft-versus-host disease. Up to 80% of affected children can die if steroids dont stop the inflammation. But in an MSCs trial, 160 of 239 patients who did not respond to steroids survived after infusions with MSCs. Their cytokine storm disappeared. Injured tissues normalized, Kimberlin wrote.
Results from the May COVID-19 trial should be available before the end of September. Its unclear how much treatments like this would cost, however, or whether theyre scalable to meet demand. Still, if MSCs are found to be as effective as they were in the early trials, we may soon have the first drugs that can really crush COVID, as Kimberlin puts it.
Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.
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This revolutionary new coronavirus cure is already saving lives - BGR
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Novel CAR T-Cell Therapy Shows Promise in Advanced Hodgkin Lymphoma – Curetoday.com
Posted: August 18, 2020 at 12:50 am
Use of a novel anti-CD30 CAR T-cell therapy following treatment with fludarabine-based lymphodepletion induced a high rate of durable responses in patients with heavily pretreated relapsed or refractory Hodgkin lymphoma, according to data published in Journal of Clinical Oncology.
Results from the parallel phase 1 and phase 2 studies also demonstrated that the CAR T-cell therapy was safe and did not produce any serious or severe side effects.
Researchers from the UNC Lineberger Comprehensive Cancer Center and Baylor College of Medicine administered anti-CD30 CAR T cells to 41 patients with relapsed or refractory Hodgkin lymphoma. All patients underwent lymphodepletion with bendamustine alone, bendamustine and fludarabine, or cyclophosphamide and fludarabine prior to the anti-CD30 CAR T-cell therapy.
Measuring safety was the primary goal of the two parallel studies.
The overall response rate, or the percentage of partial or complete responses to therapy, among 37 evaluable patients was 62%. Thirty-four of the patients received fludarabine-based lymphodepletion 17 of which received it with bendamustine, and the other half received it with cyclophosphamide. Two of these patients were considered to be complete response at infusion and maintained the response, so they were not included in final analysis.
The overall response rate among the remaining patients was 72%, with 59% of patients achieving a complete response. After a median follow-up of 533 days, researchers identified the one-year progression free survival rate to be 36% and the one-year overall survival rate to be 94%.
This is particularly exciting because the majority of these patients had lymphomas that had not responded well to other powerful new therapies, said senior study author Dr. Barbara Savoldo, professor in the Department of Microbiology and Immunology at the UNC School of Medicine, in a press release.
Patients within the study had received a median of seven previous lines of therapy that included checkpoint inhibitors and autologous or allogeneic stem cell therapies, therapies known to be powerful but also tend to come with a host of side effects.
However, treatment with the anti-CD30 CART cells demonstrated a favorable safety profile. Although 10 patients developed cytokine release syndrome, all cases were considered minor.
Patients who received fludarabine-containing lymphodepletion were the only participants in the study to have a response to the anti-CD30 CAR T-cell therapy.
Although CD30 CAR T (cells) showed modest activity in (Hodgkin lymphoma) when infused without lymphodepletion, robust clinical responses were achieved when these cells were infused in hosts lymphodepleted with fludarabine-containing regimens, the authors wrote.
The activity of this new therapy is quite remarkable and while we need to confirm these findings in a larger study, this treatment potentially offers a new approach for patients who currently have very limited options to treat their cancer, said Dr. Jonathan Serody, director of the bone marrow transplant and cellular therapy program at UNC Lineberger Comprehensive Cancer Center, in the release. Additionally, unlike other CAR T-cell therapies, clinical success was not associated with significant complications from therapy. This means this treatment should be available to patients in a clinic setting and would not require patients to be hospitalized, which is critical in our current environment.
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Novel CAR T-Cell Therapy Shows Promise in Advanced Hodgkin Lymphoma - Curetoday.com
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Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line
Posted: August 18, 2020 at 12:50 am
New Jersey, United States,- This detailed market research covers the growth potential of the Stem Cell Therapy Market, which can help stakeholders understand the key trends and prospects of the Stem Cell Therapy market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Stem Cell Therapy market.
The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.
The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:
The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.
Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.
The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.
1.Stem Cell Therapy Market, By Cell Source:
Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources
2.Stem Cell Therapy Market, By Therapeutic Application:
Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications
3.Stem Cell Therapy Market, By Type:
Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications
On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.
The research report offered by Verified Market Research provides an updated insight into the global Stem Cell Therapy market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.
Highlights of the TOC of the Stem Cell Therapy Report:
Overview of the Global Stem Cell Therapy Market
Market competition by Players and Manufacturers
Competitive landscape
Production, revenue estimation by types and applications
Regional analysis
Industry chain analysis
Global Stem Cell Therapy market forecast estimation
This Stem Cell Therapy report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.
Key Questions Addressed in the Report:
What are the key driving and restraining factors of the global Stem Cell Therapy market?
What is the concentration of the market, and is it fragmented or highly concentrated?
What are the major challenges and risks the companies will have to face in the market?
Which segment and region are expected to dominate the market in the forecast period?
What are the latest and emerging trends of the Stem Cell Therapy market?
What is the expected growth rate of the Stem Cell Therapy market in the forecast period?
What are the strategic business plans and steps were taken by key competitors?
Which product type or application segment is expected to grow at a significant rate during the forecast period?
What are the factors restraining the growth of the Stem Cell Therapy market?
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Stem Cell Therapy Market Size and Forecast | Top Key Players Osiris Therapeutics, NuVasive, JCR Pharmaceutical, Pharmicell, Chiesi Pharmaceuticals,…
Posted: August 18, 2020 at 12:50 am
New Jersey, United States,- The Stem Cell Therapy MarketResearch Report byMarket Research Intellect focuses on some of the vital aspects of the market such as Revenue Rate, Market Share, Key Regions, and Production as well as Key Players. This Stem Cell Therapy report also provides the readers with detailed figures at which the Stem Cell Therapy market was valued in the historical year and its expected growth in upcoming years. Besides, the analysis also forecasts the CAGR at which the Stem Cell Therapy is expected to mount and major factors driving the markets growth. All the latest technological innovations, industry trends, and market data are provided in the Global Stem Cell Therapy report for the forecast period. The in-depth view of the Stem Cell Therapy industry on the basis of market size, market growth, opportunities, and development plans offered by the report analysis.
Additionally, this report offers an extensive analysis of the supply chain, regional marketing, opportunities, challenges, and market drivers for the accurate prediction of the global Stem Cell Therapy market. The Stem Cell Therapy report also provides in-depth analysis regarding the methodology and research approach, data sources, and authors of the study. The Stem Cell Therapy report also covers the details about the manufacturing data such as interview record, gross profit, shipment, and business distribution which can aid the consumer to know about the competitive landscape.
Furthermore, the report also offers an in-depth assessment of the Stem Cell Therapy market by highlighting data on several aspects that may include opportunities, market drivers, as well as threats. However, this data can aid providers to make proper decision making before investing in the Stem Cell Therapy market. In addition, the research report has been designed on the basis of an in-depth analysis of the target market along with inputs from market professionals. The report focuses on the comprehensive landscape of the market and growth prospects over the forecast period. The Stem Cell Therapy market report also comprises a broad overview of the major retailers operating in the target market.
Major Companies Profiled in This Stem Cell Therapy Market Report:
Stem Cell Therapy Market Segmentations:
Based on End Users/Application, the market has been segmented into:
Geographically, the Stem Cell Therapy market report is segmented as North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. This analysis report similarly reduces the present, past and future market business strategies, company extent, development, share, and estimate analysis having a place with the predicted circumstances. Moreover, the possible results and the exposure to the enhancement of the Stem Cell Therapy market widely covered in this report.
Stem Cell Therapy Market: Regional Analysis Includes:
Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
Europe(Turkey, Germany, Russia UK, Italy, France)
North America (The United States, Mexico, and Canada)
South America(Brazil etc)
The Middle East and Africa(GCC Countries and Egypt)
This report also describes the key challenges and threats possible. The report presents a full description of the strengths, weaknesses, opportunities, and threats to the Stem Cell Therapy market. The market report provides the analytical tools that help identify the key external and internal factors that should be considered for the growth of the market. The report also helps companies in marketing for tasks like identifying their prospective customers, building relationships with them, and retention.
Key Highlights of the Stem Cell Therapy Market Report:
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Stem Cell Therapy Market Size and Forecast | Top Key Players Osiris Therapeutics, NuVasive, JCR Pharmaceutical, Pharmicell, Chiesi Pharmaceuticals,...
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Global Stem Cell Therapy Market Future Growth Analysis, Business Demand And 2025 Opportunities – Bulletin Line
Posted: August 18, 2020 at 12:50 am
A research report on the global Stem Cell Therapy market offers an in-depth analysis of the market scope and objective of the target market. The report also gives complete information regarding the major market players and segments. This research report provides a precise market prediction for the global and the local market. The Stem Cell Therapy report also sheds light on the market share and market growth rate on the basis of different regions involved in this market.
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Additionally, this report intensely studied the different strategies such as collaboration, expansion, mergers & acquisitions, key player analysis, manufacturing base, as well as share of the leading players. In addition, the Stem Cell Therapy research report also gives comprehensive information regarding the industry size by dividing the market into product, type, as well as application. Likewise, the research study contains the major players that are studied on the basis of their product portfolio, price, revenue, products, gross margin, sales, business, as well as other company data. Also, this study offers an in-depth analysis of the regional marketing, opportunities, challenges, market drivers, and supply chain for the correct forecast of the global Stem Cell Therapy market.
Key Segmentation:
Key Players:Anterogen Co., Ltd. (South Korea), MEDIPOST Co., Ltd. (South Korea), Osiris Therapeutics, Inc. (U.S.) and Pharmicell Co., Ltd.
Types:Based on cell source, the market has been segmented into,
Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources
Key Applications:Based on therapeutic application, the market has been segmented into,
Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications
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The global Stem Cell Therapy market report delivers an appropriate analysis about the research & methodology approach, data sources, and authors of the target market study. Likewise, the Stem Cell Therapy research study also covers the complete details regarding the manufacturing data which may include gross profit, shipment, interview record, and business distribution that can help customer to know about the overall competitive landscape across the world. Similarly, the global Stem Cell Therapy market report also delivers all the regions and countries across the globe that shows a geographical growth status such as pricing structure, market size, as well as value and volume. The research report also covers a complete analysis of the target market segmentation and sub-segments. Additionally, this research study provides an appropriate analysis of the industry trends along with the precise data of market use cases and leading industry trends, and market size by regions.
Likewise, the study also analyzes numerous factors that are influencing the Stem Cell Therapy market from supply and demand side and further evaluates market dynamics that are impelling the market growth over the prediction period. In addition to this, the target market report provides inclusive analysis of the SWOT and PEST tools for all the major regions such as North America, Europe, Asia Pacific, and the Middle East and Africa. The report offers regional expansion of the industry with their product analysis, market share, and brand specifications. Furthermore, the Stem Cell Therapy market study offers an extensive analysis of the political, economic, and technological factors impelling the growth of the global Stem Cell Therapy market across these economies.
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Global Stem Cell Therapy Market Future Growth Analysis, Business Demand And 2025 Opportunities - Bulletin Line
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CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also…
Posted: August 18, 2020 at 12:50 am
HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years
VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company gives full update on all of its HIV programs.
HIV CureThe HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.
CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.
HIV PrEPAs presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIVs access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.
MonotherapySignificantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.
The Company will submit manuscripts for two publications in regards to its findings.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients HIV functional cure.
About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.
About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA to discuss the FDAs request for additional information in order to resubmit its Biologics License Application for this HIV combination therapy.
CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.
CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.
Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CYTODYN CONTACTSInvestors:Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com
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Stem Cell Therapy Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 – Owned
Posted: August 18, 2020 at 12:50 am
New Jersey, United States,- The latest report published by Market Research Intellect on Stem Cell Therapy Market provides crucial market insights along with detailed segmentation analysis. The report examines key driving factors that are expected to drive the growth of the market.
Global Stem Cell Therapy Market Research Report gives knowledgeable information on various market situations, for example, potential development factors, factors controlling the development, market opportunities, and dangers to the worldwide market. Also, the report broadly centers around the competitive analysis of Stem Cell Therapy Market. The competitive analysis segment incorporates key manufacturers, fresh players, providers, market strategies, potential chances, operation landscape, and analysis of the trends of the Stem Cell Therapy market. The market results are centered around the current market scenario. To gauge and predict the degree of competition in this market. This report will likewise support all the manufacturers and speculators to have a superior comprehension of the investments to know where the market is heading.
Key highlights from COVID-19 impact analysis:
Unveiling a brief about the Stem Cell Therapy market competitive scope:
The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.
The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.
Stem Cell Therapy Market, By Type
Stem Cell Therapy Market, By Application
Other important inclusions in the Stem Cell Therapy market report:
A brief overview of the regional landscape:
Reasons To Buy:
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Stem Cell Therapy Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 - Owned
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Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future – Cole of Duty
Posted: June 4, 2020 at 9:21 am
A synopsis of the global canine stem cell therapy market with reference to the global healthcare pharmaceutical industry
Despite the economic and political uncertainty in the recent past, the global healthcare industry has been receiving positive nudges from reformative and technological disruptions in medical devices, pharmaceuticals and biotech, in-vitro diagnostics, and medical imaging. Key markets across the world are facing a massive rise in demand for critical care services that are pushing global healthcare spending levels to unimaginable limits.
A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry. Proactive measures such as healthcare cost containment, primary care delivery, innovation in medical procedures (3-D printing, blockchain, and robotic surgery to name a few), safe and effective drug delivery, and well-defined healthcare regulatory compliance models are targeted at placing the sector on a high growth trajectory across key regional markets.
Parent Indicators Healthcare Current expenditure on health, % of gross domestic product Current expenditure on health, per capita, US$ purchasing power parities (current prices, current PPPs) Annual growth rate of current expenditure on health, per capita, in real terms Out-of-pocket expenditure, % of current expenditure on health Out-of-pocket expenditure, per capita, US$ purchasing power parity (current prices, current PPPs) Physicians, Density per 1000 population (head counts) Nurses, Density per 1000 population (head counts) Total hospital beds, per 1000 population Curative (acute) care beds, per 1000 population Medical technology, Magnetic Resonance Imaging units, total, per million population Medical technology, Computed Tomography scanners, total, per million population
Research Methodology
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XploreMR utilizes a triangulation methodology that is primarily based on experimental techniques such as patient-level data, to obtain precise market estimations and insights on Molecule and Drug Classes, API Formulations and preferred modes of administration. Bottom-up approach is always used to obtain insightful data for the specific country/regions. The country specific data is again analysed to derive data at a global level. This methodology ensures high quality and accuracy of information.
Secondary research is used at the initial phase to identify the age specific disease epidemiology, diagnosis rate and treatment pattern, as per disease indications. Each piece of information is eventually analysed during the entire research project which builds a strong base for the primary research information.
Primary research participants include demand-side users such as key opinion leaders, physicians, surgeons, nursing managers, clinical specialists who provide valuable insights on trends and clinical application of the drugs, key treatment patterns, adoption rate, and compliance rate.
Quantitative and qualitative assessment of basic factors driving demand, economic factors/cycles and growth rates and strategies utilized by key players in the market is analysed in detail while forecasting, in order to project Year-on-Year growth rates. These Y-o-Y growth projections are checked and aligned as per industry/product lifecycle and further utilized to develop market numbers at a holistic level.
On the other hand, we also analyse various companies annual reports, investor presentations, SEC filings, 10k reports and press release operating in this market segment to fetch substantial information about the market size, trends, opportunity, drivers, restraints and to analyse key players and their market shares. Key companies are segmented at Tier level based on their revenues, product portfolio and presence.
Please note that these are the partial steps that are being followed while developing the market size. Besides this, forecasting will be done based on our internal proprietary model which also uses different macro-economic factors such as per capita healthcare expenditure, disposable income, industry based demand driving factors impacting the market and its forecast trends apart from disease related factors.
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Standard Report Structure Executive Summary Market Definition Macro-economic analysis Parent Market Analysis Market Overview Forecast Factors Segmental Analysis and Forecast Regional Analysis Competition Analysis
Target Audience Production Companies Suppliers Channel Partners Marketing Authorities Subject Matter Experts Research Institutions Financial Institutions Market Consultants Government Authorities
Market Taxonomy
The global canine stem cell therapy market has been segmented into:
Product Type: Allogeneic Stem Cells Autologous Stem cells
Application: Arthritis Dysplasia Tendonitis Lameness Others
End User: Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes
Region: North America Latin America Europe Asia Pacific Japan Middle East & Africa
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Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future - Cole of Duty
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