Stem Cell Clinic

Autolus Therapeutics presents AUTO1 and AUTO3 data at the 2020 EHA25 Virtual Congress – GlobeNewswire

By adminJune 12, 2020Stem Cell Treatment

Pivotal AUTO1 study in adult ALL patients enrolling

- AUTO1 continued favorable safety profile and high level of clinical activity, pivotal Phase 1b/2 AUTO1-AL1 program in adult ALL initiated and enrolling patients

- AUTO3 profile potentially supports use in a broader outpatient setting

Conference Call and Webcast to be held Friday, June 12, 2020at 7:30 am EDT / 12:30 pm BST

LONDON, June 12, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on its AUTO1 program, the companys CAR T cell therapy being investigated in the ongoing ALLCAR Phase 1 study of relapsed / refractory adult B-Acute Lymphocytic Leukemia (ALL), at the European Hematology Association EHA25 Virtual Congress beginning June 11.

AUTO1 in ALLAs of the data cut-off date ofMay 13, 2020, 19 patients had received AUTO1.AUTO1 was well tolerated, with no patients experiencing Grade 3 CRS. Three patients (16%) with high leukemia burden (>50% blasts) experienced Grade 3 neurotoxicity that resolved swiftly with the application of steroids. Of the 19 patients, 16 (84%) achieved MRD-negative CR.Two out of 16 patients received a transplant while in remission and CD19-negative relapse occurred in 3 (16%) patients. Durability of remissions is encouraging. Event Free Survival (EFS) and Overall Survival (OS) at 6 months are 62% and 72% respectively in all patients, and 76% and 92% respectively in the 13 patients treated with the closed (commercial) process. Median EFS and OS has not been reached, at a median follow up of 12.2 months (range up to 24.4 months).

I am very encouraged by the tolerable safety profile and high level of sustained CRs we have observed with AUTO1 in the ALLCAR19 study that was achieved without subsequent stem cell transplant, said Dr. Claire Roddie,Consultant Hematologist,UCL Cancer Institute and University College London Hospital.

Approximately 60% of adult ALL patients relapse or are refractory to first line therapy and there continues to exist a high unmet need, said Dr. Michael Bishop, MD, Professor of Medicine and Director of the Cellular Therapy Program atUniversity of Chicago Medicine.AUTO1 is a novel CD19 CAR T candidate with a compelling activity and safety profile and has the potential to change standard of care as a curative therapy for r/r ALL.

The data update on AUTO1 presented at this years EHA meeting show an encouraging durability of response without subsequent stem cell transplant and confirm the positive safety profile, said Dr.Christian Itin, chairman and chief executive officer of Autolus.We have started enrolment of patients with r/r aALL in our pivotal Phase 1b/2 AUTO1-AL1 study.

AUTO3 in DLBCLDr. Wendy Osborne presented ALEXANDER Phase 1/2 clinical trial data for AUTO3. This data is consistent with our update on May 29, 2020, with a data cut-off date of April 27, 2020.

These data are very encouraging, in terms of safety and tolerability, with a high level of clinical activity, said Dr. Wendy Osborne,Consultant Hematologist,Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust. We are looking forward to enrolling additional patients in the outpatient cohort.

Dr. Wendy Osborne of Newcastle upon Tyne Hospitals NHS Foundation Trust also discusses AUTO3 data during the American Society of Clinical Oncology (ASCO) Annual Meeting in this video courtesy of the Lymphoma Hub.

Investor call on Friday June 12, 2020Management will host a conference call and webcast at7:30 am EDT/12:30 pm BST to discuss the EHA data. To listen to the webcast and view the accompanying slide presentation, please go to:https://www.autolus.com/investor-relations/news-and-events/events.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4838626. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4838626.

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.

About AUTO1AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL. The company has also now progressed the program to a potential pivotal study, AUTO1-AL1.

About AUTO1-AL1 pivotal studyThe AUTO1-AL1 study will enroll patients with relapsed / refractory ALL. The study will have a short Phase1b component prior to proceeding to a single arm Phase 2 study. The primary end point is overall response rate and the key secondary end points include duration of response MRD negative CR rate and safety. The study will enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the US,UKandEurope.

About AUTO3AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in diffuse large B cell lymphoma in the ALEXANDER clinical trial, with a 20-patient cohort that was initiated in Q2 2020 to assess feasibility of treatment in an outpatient setting.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, including its expected cash runway; the development of Autolus product candidates, including statements regarding the timing of initiation, completion and the outcome of pre-clinical studies or clinical trials and related preparatory work, and the periods during which the results of the studies and trials will become available; Autolus plans to research, develop, manufacture and commercialize its product candidates; the potential for Autolus product candidates to be alternatives in the therapeutic areas investigated; and Autolus manufacturing capabilities and strategy. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. 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 titled "Risk Factors" inAutolus'Annual Report on Form 20-F filed with theSecurities and Exchange CommissiononMarch 3, 2020as well as discussions of potential risks, uncertainties, and other important factors inAutolus'future filings with theSecurities and Exchange Commissionfrom time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Lucinda Crabtree, PhDVice President, Investor Relations and Corporate Communications+44 (0)7587 372 619l.crabtree@autolus.com

Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Susan A. NoonanS.A. Noonan Communications+1-212-966-3650susan@sanoonan.com

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Autolus Therapeutics presents AUTO1 and AUTO3 data at the 2020 EHA25 Virtual Congress - GlobeNewswire

Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market – Cole of Duty

By adminJune 12, 2020Stem Cell Treatment

The Canine Stem Cell Therapy Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Canine Stem Cell Therapy market report covers the worldwide top manufacturers like (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Canine Stem Cell Therapy market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Canine Stem Cell Therapy Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Canine Stem Cell Therapy Market report offers comprehensive assessment of 1) Executive Summary, 2) Market Overview, 3) Key Market Trends, 4) Key Success Factors, 5) Canine Stem Cell Therapy Market Demand/Consumption (Value or Size in US$ Mn) Analysis, 6) Canine Stem Cell Therapy Market Background, 7) Canine Stem Cell Therapy industry Analysis & Forecast 20202026 by Type, Application and Region, 8) Canine Stem Cell Therapy Market Structure Analysis, 9) Competition Landscape, 10) Company Share and Company Profiles, 11) Assumptions and Acronyms and, 12) Research Methodology etc.

Scope of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

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.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Allogeneic Stem Cells Autologous Stem cells

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Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market - Cole of Duty

Stem Cell Therapy – Market Outlook | Recent Trends and Growth Forecast 2020-2025 – CueReport

By adminJune 12, 2020Stem Cell Treatment

New research report on Stem Cell Therapy market, which is a detailed analysis of this business space inclusive of the trends, competitive landscape, and the market size. Encompassing one or more parameters among product analysis, application potential, and the regional growth landscape, Stem Cell Therapy market also includes an in-depth study of the industry's competitive scenario.

Increasing research on developing novel therapies and personalized medicines will foster stem cell therapy market growth. For instance, scientists are extensively researching on methods to regenerate healthy heart cells from placenta that can be used in patients after myocardial infarction. This discovery will help to cure patients suffering from cardiovascular diseases and reduce mortality rates. Researchers are further examining different aspects of stem cell therapy for its applications in neurological disorders. Thus, increasing R&D activities to promote developments in stem cell therapy will positively impact the industry growth.

Stem Cell Therapy Market will exceed USD 15 billion by 2025; as per a new research report.

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Orthopedic segment is anticipated to witness more than 9% growth over the forecast time frame. Substantial growth is attributed to rising accidents and trauma cases across the globe. Stem cell therapy is successfully applicable in treating bone-joint injuries that include spinal and fractured bone defects, ligament tendon, femoral head and osteogenesis imperfecta. Mesenchymal stem cell therapy is preferred in curing orthopedic diseases such as arthritis and osteoporosis due to its ability to differentiate into bones and cartilage. Above mentioned factors will surge segment growth.

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Rising geriatric population will positively influence the industry growth in coming years. Elderly people are susceptible to degenerative diseases such as Parkinson?s and Alzheimer?s disorders. Stem cell therapies offer several benefits over the conventional therapeutic methods that raises its preference for curing degenerative diseases. Recently developed stem cell therapies generate healthy cells by replacing the defective cells through minimally invasive techniques. Therefore, geriatric population rely on stem cell therapies that proves beneficial for the industry growth.

Clinics segment accounted for around 35% revenue share in 2018. Clinics are equipped with advanced medical equipment and skilled professionals that enables it to provide superior quality stem cell therapies. Clinics can deliver specialized stem cell treatment in areas such as cardiovascular, oncology or orthopedics that should prove beneficial for the segmental growth. However, as the treatments offered at clinics are expensive, that may have a short term impact on the segment growth.

Allogenic stem cell therapy segment was valued around USD 3 billion in 2018 and is anticipated to expand substantially in near future. Allogenic transplant completely replaces host cells with donor cells. It also has the potential to eliminate viral reservoirs and genetic alterations. Therefore, allogenic stem cell therapies have been extensively utilized in providing treatment to patients suffering from leukemia and several other life threatening diseases. Thus, benefits offered by allogenic stem cell therapy will surge its demand, thereby propelling segment growth.

Prominent industry players operational in the stem cell therapy include Astellas Pharma, Cellectis, Celyad, ReNeuron Group, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, Novadip Biosciences, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast, and Takeda Pharmaceuticals. These key players adopt several initiatives such mergers, acquisitions and new product launches to sustain market position. Besides these strategies, companies also undertake promotional strategies that enhance their sales. For instance, in June 2018, CESCA Therapeutics announced exhibition at Orthobiologic Institute?s ninth annual PRP and regenerative medicine symposium. This strategy was company?s promotional effort in order to gain attention of customers.

Stem Cell Therapy Market will exceed USD 15 billion by 2025; as per a new research report.

Europe is anticipated to witness around 10% growth during analysis time frame. Substantial growth is attributed to increasing prevalence of chronic diseases in the region. Moreover, the regulatory scenario for stem cell therapies is also improving gradually. Initially stringent regulations lowered the demand for stem cell therapies. However, as people started becoming aware regarding advantages associated with stem cell therapy, its adoption escalated. Above-mentioned factors fosters the regional growth.Prominent industry players operational in the stem cell therapy include Astellas Pharma, Cellectis, Celyad, ReNeuron Group, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, Novadip Biosciences, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast, and Takeda Pharmaceuticals. These key players adopt several initiatives such mergers, acquisitions and new product launches to sustain market position. Besides these strategies, companies also undertake promotional strategies that enhance their sales. For instance, in June 2018, CESCA Therapeutics announced exhibition at Orthobiologic Institute?s ninth annual PRP and regenerative medicine symposium. This strategy was company?s promotional effort in order to gain attention of customers.

Major Highlights from Table of contents are listed below for quick lookup into Stem Cell Therapy Market report

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Stem Cell Therapy Industry Insights

Chapter 4. Company Profiles

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Stem Cell Therapy - Market Outlook | Recent Trends and Growth Forecast 2020-2025 - CueReport

Induction Therapy Optimal for Transplant-Eligible Patients With Multiple Myeloma – AJMC.com Managed Markets Network

By adminJune 12, 2020Stem Cell Treatment

A new large randomized trial indicates induction therapy including lenalidomide is optimal in patients with multiple myeloma who are transplant-eligible. Maintenance with lenalidomide was preferable to observation alone following transplant.

The results, published in the journal Haematologica,1 are intended to give a clearer picture as to the optimal use of immunomodulatory drugs before and after autologous stem cell transplantation (ASCT).

Corresponding author Graham H. Jackson, MD, of the Northern Institute for Cancer Research at Newcastle University, in England, and colleagues explain that immunomodulatory drugs and proteasome inhibitors have led to dramatic improvements in patient outcomes. Those drugs are typically used as induction therapy, after which the standard of care is high-dose melphalan-based chemotherapy with ASCT.

However, key questions still remain.

The optimal approach to induction therapy prior to ASCT and consolidation or maintenance after ASCT in this new era has not yet been defined, they write.

To fill the gap in knowledge, the authors constructed a large, phase 3 trial of 2042 newly diagnosed patients with MM. Patients were randomly assigned to receive induction therapy of cyclophosphamide, thalidomide, and dexamethasone (CTD) or cyclophosphamide, lenalidomide, and dexamethasone (CRD). Patients with suboptimal responses were given additional intensification therapy of cyclophosphamide, bortezomib, and dexamethasone (CVD) prior to ASCT. Following transplantation, patients were randomly assigned either lenalidomide alone or observation alone.

At the end of the study, patients receiving CRD therapy had superior progression-free survival (PFS) and overall survival (OS) compared to those on the CTD regimen. Median PFS on CRD was 36 months, versus 33 months for CTD. Three-year OS was 82.9% for CRD, compared to 77.0% for CTD.

After transplant, patients receiving lenalidomide maintenance therapy had a PFS of 50 months, compared to just 28 months in the observation-only group.

Our results demonstrate the superiority of lenalidomide over thalidomide both in terms of efficacy and tolerability in the context of combination with an alkylating agent (cyclophosphamide), supporting the findings of previously randomized analyses, Jackson and colleagues write.

Six in 10 patients on CRD obtained at least the status of very good partial response (VGPR) after induction, and 82% of patients on the regimen achieved VGPR after ASCT. The authors say these data compare favorably with approaches attempted in other recent studies.

Jackson and co-authors noted that one recent study of daratumumab plus velcade, thalidomide, and dexamethasone (Dara-VTD) did have a higher VGPR post-induction therapy,2 though the authors suggested there are other reasons CRD might still be a better choice for many patients.

In contrast, however, CRD offers an all oral regimen requiring only one hospital visit per month and including only one more expensive agent, lenalidomide, they said. As such, it is comparatively easier to deliver and likely to be cheaper in terms or both drug and administration costs.

In addition to their main findings, Jackson and colleagues noted that the favorability of CRD versus CTD held true across all subgroups analyzed, including those with International Staging System stage III disease, those with high-risk cytogenetics, and those with ultra high-risk cytogenetics.

The best results were achieved when patients received both lenalidomide-based induction therapy and lenalidomide maintenance, they conclude.

References:

Link:
Induction Therapy Optimal for Transplant-Eligible Patients With Multiple Myeloma - AJMC.com Managed Markets Network

Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant…

By adminJune 12, 2020Stem Cell Treatment

BOSTON, June 12, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc.(Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting (EHA). The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in combination with azacitidine (AZA) for the treatment of TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The clinical trial is sponsored by the Groupe Francophone des Mylodysplasies (GFM).

As of the April 1, 2020 data cutoff, the overall response rate (ORR) in 28 evaluable MDS patients was 75%, with a 57% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 9.7 months, the median overall survival (OS) for all enrolled patients (n=52) was 12.1 months and in MDS patients (n=34) was 12.1 months. For patients who remained on treatment for 3 or more cycles of treatment the median OS was higher at 13.7 months versus 2.8 months for patients who were on treatment for fewer than 3 cycles. Relative to baseline, mutant TP53 variant allele frequency (VAF) was decreased in responding patients by 3 cycles of treatment, including 20 (51%) patients who achieved mutant TP53 negativity by next-generation sequencing (NGS).

The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities, said Thomas Cluzeau, M.D., co-lead investigator for the GFM trial. We continue to observe ORR and CR rates in these patients that are substantially higher than the GFMs experience with azacitidine monotherapy. Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation.

Details of the on-demand oral presentation are as follows:

Title: APR-246 Combined with Azacitidine in TP53 Mutated Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia. A Phase 2 Study by the Groupe Francophone des Mylodysplasies (GFM)

Oral Abstract Session: Novel treatments for MDS I

Abstract: S181

About the Clinical Trial

Eligible patients in the Phase Ib/II clinical trial include hypomethylating agent (HMA) nave, TP53 mutated MDS and AML. All enrolled patients were to receive APR-246 as a 4,500 mg fixed dose IV daily for 4 days and AZA over 7 days in 28-day cycles. The primary endpoint of the trial is CR rate.

AboutAprea Therapeutics, Inc.

Aprea Therapeutics, Inc.is a biopharmaceutical company headquartered inBoston, Massachusettswith research facilities inStockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivatemutant tumor suppressor protein, p53. The Companys lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. For more information, please visit the company website atwww.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis.

About p53 and APR-246 (eprenetapopt)

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

APR-246 (eprenetapopt) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.

Forward-Looking StatementCertain information contained in this press release includes forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as predicts, believes, potential, continue, anticipates, estimates, expects, plans, intends, targeting, confidence, may, could, might, likely, will, should or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with theU.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Source:Aprea Therapeutics, Inc.

Link:
Aprea Therapeutics Presents Results From French Phase Ib/II Clinical Trial of APR-246 (Eprenetapopt) and Azacitidine in Patients with TP53 Mutant...

Westerleigh resident is alive because of stem cell therapy by his doctor — for free. Heres his story. – SILive.com

By adminJune 12, 2020Stem Cell Doctors

Stephen Raffone had difficulty breathing. He coughed up sputum and was wheezing. Doctors told him he had chronic obstructive pulmonary disease (COPD), a condition that causes blocked airflow from the lungs.

As a result, he was being treated for stage 4 COPD.

His doctor was also treating him for cellulitis, an inflammatory and painful bacterial skin infection where extremities appear red and swollen and the area can feel hot and tender to the touch, as well as poor circulation.

My legs were beginning to get ulcerated and they were breaking down, said Raffone.

He was administered the Roman Catholic Churchs Last Rites three times several years ago when he was a patient in Richmond University Medical Center.

Raffone, who is now 63, was in need of a lung transplant.

He was a heavy smoker and it took its toll. However, because he was in a weakened state due to other serious health conditions, doctors told him hed never survive the surgery.

The Westerleigh resident, who has been in need of 24-hour care for the last several years, requires the assistance of two nurses who rotate 12-hour shifts.

One, a close family friend, suggested Raffone see a medical specialist who performs stem cell therapy, a procedure where the patients own stem cells are removed, treated and returned to his or her own body after a conditioning regimen.

She contacted Dr. Alexandre M. Scheer of Scheer Medical Wellness and he agreed to see Raffone.

Dr. Alexandre M. Scheer (Courtesy/Stephen Raffone)Staten Island Advance

But since Raffone was unable to leave his home, Scheer visited Raffone for a consultation and to evaluate his condition.

Fast forward a year and a half and Scheer has continued with those visits almost every Saturday free of charge also underwriting the cost for treatments, as well as Uber rides from Manhattan to Staten Island, in order to perform the stem cell procedure.

RAFFONES NURSE SPEAKS

One of Raffones nurses recounted Raffones journey.

She explained that when they started to explore stem cell therapy she placed calls to several doctors, but the biggest thing that jumped out at her was the astronomical cost.

But there was something about Dr. Scheer. And I just knew he was the right one, said the registered nurse for more than 30 years. "He wasnt interested in money. His goal is his patients outcome. Stephen did pay for the first set of treatments, but since then, Dr. Scheer has not taken a dime.

When the patient began treatments, the first therapy was a tremendous boost and then every week after that he was treated for seven weeks. In the beginning, the doctor visited every week and brought whatever supplies was needed. The PRP (platelet rich plasma) treatments are daily.

I draw the blood, I spin the blood," she said. We have a small centrifuge here so it separates the blood. The PRP is given by a nebulizer. It takes about 30 minutes. And once a week he gets a protein enriched plasma, which takes about a half hour, she added.

He has chronic venous ulcerations of the both lower extremities from the knee down, she said.

Raffone has end stage COPD. But since he started the treatments, hes gone to the hospital only once. And he has tested negative for antibody COVID-19.

RAFFONES TREATMENT BEGINS

Raffone was required to install the centrifuge machine with needles and plasma tube, a laboratory device used for the separation of fluids, gas or liquid, based on density. Separation is achieved by spinning a vessel containing material at high speed.

Initially, Dr. Scheer sent a plastic surgeon to my home to perform liposuction, a type of fat-removal procedure used in plastic surgery, where they separate the fat and preserve the stem cells, Raffone said. They did this four times weekly at the beginning. Dr. Scheer has been visiting my home pretty much each week since Sept. 22, 2018. But right now the stem cell therapy is done once a month."

They draw blood out and spin it. Its all done through IV. Right now stem cell infusion is done once a month and daily through a nebulizer. Dr. Scheer does it on Saturday and my nurse and dear friend to Dr. Scheer does it during the week. My house looks like a hospital. Dr. Scheer is keeping me alive and everything is healing up so well, said Raffone.

Stephen Raffone's left leg before stem cell treatment. (Courtesy/Stephen Raffone)Staten Island Advance

Raffone says he wanted to come forward with his account at this time because hes so grateful and especially today when so many negative stories are in the news.

We need some good stories. There are very few people like Dr. Scheer, especially now during the COVID-19 crisis, he said.

My nurse draws the blood and puts it in a centrifuge when the doctor cant make it from the city. But Dr. Scheer is still coming to my house in spite of the COVID-19 crisis," Raffone continued.

Raffone has been confined to a bed one that he says turns you from side to side and upside down. But Dr. Scheer is confident that when restrictions are lifted and physical therapy sessions resume, Raffone will be able to walk.

The stem cell therapy is not only helping to combat Raffones COPD, but it has also helped him with cellulitis on his leg.

Stephen's Raffone healed left leg after stem cell therapy. (Courtesy/Stephen Raffone)Staten Island Advance

Scheer, a staunch supporter of stem cell therapy, has a background in neurosurgery and regenerative medicine. He performs surgery at several surgical centers in Manhattan.

It has to do with the amount of cells your bone marrow," he said. What we do is . . . saturate the body with stem cells. It suppresses the inflammatory response. COVID-19 also is an inflammatory disease. The COVID-19 kills the lungs. So you dont have oxygen going through. The stem cells protect, so you have continual oxygen transfer.

Dr. Scheer, who practices at Sheer Medical Wellness in Manhattan, says you can regenerate yourself.

I want my patients to be fine. I will pay for the patient. Im happy Stephens alive. And then my life is made. Stephen will now be able to walk after physical therapy. He was on 12 liters of oxygen daily. Hes now on two liters. I know his nurse very well and thats how we connected. The stem cell treatment is the appropriate treatment for him. I pay out of pocket because I know the right treatment for his condition," he added.

Dr. Scheer points out in China and in Israel stem cell therapy is the treatment they use for COVID- 19.

Its where you take Eastern and Western medicine and put it together. The patients body and will to live and having the right outlook on life has a lot to do with proper health. Our group is so big. We have 40 different doctors in my practice. Im the medical director, he said. Stem cell treatment is the future of medicine. At $10,000 a treatment, its very expensive. And the number depends on the issue at hand.

THE INITIAL CALL

When Scheer spoke to Raffone, He said I cant get out of bed,' the doctor said. "I drove to Staten Island and I got to know Stephen and his family very well. Its not a one-time treatment. Im seeing him on a weekly basis. There is a relationship that occurs. And thats what matters and thats what keeps people alive. Hope is what keeps them alive. And Im doing this since 2001. The treatment involves platelet enriched plasma that suppresses inflammatory reactions in the lungs. Whats happening is youre able to suppress the inflammatory reaction. His legs and his heart are getting better as well. This is a treatment until we can get him walking.

Scheer says Raffone must undergo physical therapy in oder for him to walk around freely.

And hell be able to travel to my office. Im not giving up on him. Im paying out of pocket. A quarter of my patients, I pay for. Stephen has gone through so much. Hes alive because of stem cell therapy. And due to his lung condition with COVID, he has not contracted it."

Scheer says its been a team effort, with multiple doctors coming into play/

Stephen is keeping himself alive. Im just the tool that can help. I just do the best I can for as many people as I can.

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Westerleigh resident is alive because of stem cell therapy by his doctor -- for free. Heres his story. - SILive.com

Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor – Coast Mountain News

By adminJune 12, 2020Stem Cell Doctors

A Saanich father who fought to grow the data bank of mixed-race stem cell donors has died of leukemia.

Jeremy Chow was diagnosed with acute myeloid leukemia in November 2018. While chemotherapy treatment worked and Jeremy entered remission, doctors advised that stem cell therapy would be the best possible treatment to eradicate the risk of returning cancer cells.

But when Jeremy and his wife Evelyn Chow began their quest to find a match, they learned there were virtually no donors in the national or worldwide registry who matched Jeremys genetic makeup a requirement for a successful stem cell transplant.

READ ALSO: In a fight against cancer, Victoria mans only stem cell match was his own donation

Ironically, Jeremy had applied to become a stem cell donor years earlier. When doctors searched the database they found one unusable match: his own donation. Shocked and saddened by the lack of options, the family spearheaded the Match4Jeremy campaign, organizing stem cell drives and raising awareness of the dire need for mixed race and Asian donors.

On Aug. 8, 2019, the family learned that Jeremys cancer had returned. But the Chows battle to find a match didnt slow down. They worked with the Otherhalf-Chinese Stem Cell Initiative to host an emergency stem cell drive in Vancouver that month.

Despite their tireless efforts, Jeremy did not recover from the second round of cancer. The father of two died on May 30 with his wife at his side.

On a GoFundMe page aimed at raising money for his daughters educations, family friend Jenny Leung says Jeremy fought hard and did it with grace, humour and a positive attitude.

READ ALSO: Stem cell donor with rare genetic makeup needed to save Saanich man after cancer returns

Jeremys priority was always being able to provide and take care of his family, Leung writes. He was so involved with his girls lives, from driving them to their extracurricular activities to attending school fairs, to braiding their hair and explaining to them the importance of a good education.

He was always looking for a way to care for those around him whether it meant sharing knowledge, offering a helping hand, or just being there in any way he could, she added. Jeremy was truly someone to look up to and although he was always supporting others, he rarely asked for anything in return.

While the Chow family fought for a match for Jeremy, their crusade for stem cell donors gained momentum when they realized just how dire the situation was for mixed-race and Asian Canadians. Only three per cent of the Canadian Blood Services stem cell registry is mixed race.

In March 2019, Jeremy spoke with Black Press Media.

If all of this goes well [and] I stay in remission, and the awareness is out there and other people sign up to be donors and other people are getting the help they need, then thats a win, he said.

Donations are being accepted via GoFundMe to support Jeremys family and his daughters future education.

READ ALSO: Victoria couple continues fight for increased diversity in Canadian stem cell registry

Do you have something to add to this story, or something else we should report on? Email:nina.grossman@blackpress.ca

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Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor - Coast Mountain News

Thalassemia Treatment Market: Chelation Therapy to be Highly Lucrative Segment – BioSpace

By adminJune 12, 2020Stem Cell Doctors

Transparency Market Research (TMR)has published a new report titled, Thalassemia Treatment Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026.According to the report, theglobal thalassemia treatment marketwas valued at US$ 842.0 Mn in 2017 and is projected to expand at a CAGR of 7.9% from 2018 to 2026. Increase in R&D investment by key players for developing new drugs for treating thalassemia and rise in demand for chelating therapy are anticipated to fuel the growth of the global market from 2018 to 2026. Asia Pacific and Middle East & Africa are expected to dominate the global market owing to increase in prevalence of thalassemia disorder and high adoption of chelation therapy & blood transfusion for treatment by doctors as well as patients. The market in Asia Pacific is projected to expand at the fastest CAGR during the forecast period. Growth of the market in the region is attributed to large base of private clinics and hospitals, rise in number of thalassemia population requiring chelation therapy services after spleen surgery, and surge in adoption of blood transfusion among patients. The thalassemia treatment market in Latin America is likely to expand at a moderate growth rate during the forecast period.

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Value Added Features in Thalassemia Treatments to Propel Global Market

The global thalassemia treatment market is projected to be driven by value added features offered by various thalassemia drug manufacturing companies in order to streamline the day to day work flow and increase revenue. The thalassemia treatment provides limited range of features and benefits ranging from patient pain heeling remedies to treatment procedures. For instance, very less number of people go for the much beneficial chelation therapy. These features help physicians and nurses to streamline the chelation therapy required for patients to maintain their daily workflow efficiently and effectively. Key players offering thalassemia treatment are coming up with value added features such as bone marrow transplantation, stem cell regeneration, gene editing methodologies, and effective modality features used for drug manufacturing along with creating a prominent candidate molecule for drugs. These features can reduce the overall operating cost and improve the overall effectiveness and efficiency of treatment practices. Companies are focusing on the development of combined drug therapy in their system to effectively integrate chelating therapy or other treatment procedure at an affordable cost. These value added features save time for physicians and help improve thalassemia patient survival performance.

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Chelation Therapy to be Highly Lucrative Segment

Traditionally, blood transfusion based on type of thalassemia treatment was the most commonly used procedure among thalassemia patients. This treatment type was associated with availability of donor and cost of treatment procedure. Moreover, chelation therapy based on thalassemia treatment are priced on perpetual license model and are expensive. Chelation therapy treatment enables patients to practice intensive therapy to treat acute iron overload leading to 90% recovery among thalassemia patients. These chelation therapy based treatments address specific challenges faced during the treatment procedure. The chelation therapy treatment facilitates benefits such as pain relief, and increase in motion of blood flow among patients.

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Asia Pacific Presents Significant Opportunities

North America and Europe accounted for major share of the global thalassemia treatment market in 2017 and are likely to gain market shares by 2026. High rate of immigration from tropical regions, increasing health care budgets by governments, and government initiatives to promote thalassemia treatment technique contributed to the leading share of these regions. Asia Pacific is projected to be the most attractive market for thalassemia treatment, with highest attractiveness index. The market in Asia Pacific is expected to expand at a high CAGR of 9% during the forecast period due to large number of thalassemia patients opting for chelation therapy in developing countries such as India and China. Well-established health care facilities, medical tourism for treatment of thalassemia, and high adoption of blood transfusion safety technique in countries such as Turkey and GCC Countries are likely to drive the market in Middle East & Africa. The market in Latin America is poised to expand at a moderate growth rate during the forecast period.

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Trend of R&D among Leading Players to Increase Geographic Presence

The report also provides profiles of leading players operating in the global thalassemia treatment market. bluebird bio, Inc., Acceleron Pharma, Inc., Novartis AG, Celgene Corporation, and Shire plc (Takeda Pharmaceuticals) are the leading players operating in the global market. Companies operating in the thalassemia treatment market aim to increase geographic presence and research & development through strategic acquisitions and collaborations with leading players in respective domains and region. In December 2017, Shire plc committed to pay approximately US$ 1,409.9 Mn to contract vendors for administering and executing clinical trials. Other prominent players operating in the global thalassemia treatment include Incyte Corporation, Kiadis Pharma, Gamida Cell, Celgene Corporation, and Bellicum Pharmaceuticals.

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Thalassemia Treatment Market: Chelation Therapy to be Highly Lucrative Segment - BioSpace

Amyotrophic Lateral Sclerosis Treatment Market Analysis and Forecast to 2026 || Top Growing Companies are ViroMed Co., Ltd, Ionis Pharmaceuticals,…

By adminJune 12, 2020Stem Cell Doctors

Amyotrophic Lateral Sclerosis Treatment MarketBy Disease Type (Benign Focal Amyotrophy of ALS, Infantile Spinal Muscular Atrophy, Juvenile Spinal Muscular Atrophy, Kugelberg-Welander Disease, Primary Lateral Sclerosis, Progressive Bulbar Palsy, Spinal Muscular Atrophy, Upper Motor Neuron Disease, Werdnig-Hoffman Disease, Wohlfart-Disease), Drug Type (Riluzole and Edaravone (Radicava)), By Distribution Channel (Hospital Pharmacies, and Retail & Online Pharmacies), Treatment type (Chemotherapy, Stem cell therapy) End- User (Hospitals, Homecare, Specialty Clinics, Others), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends & Forecast to 2026

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Few of the major competitors currently working in the amyotrophic lateral sclerosis treatment market are Sanofi (France), Mitsubishi Tanabe Pharma Corporation (Japan), BrainStorm Cell Limited (US), ViroMed Co., Ltd (South Korea), Ionis Pharmaceuticals (US), Genervon Biopharmaceuticals, LLC (US), Biogen (US), ORPHAZYME A/S (Denmark), Orion Pharma (Finland), Kringle Pharma, Inc. (Japan), Aquestive Therapeutics (US), Apotex Inc (Canada), Bausch Health Companies Inc. (Canada), Neuralstem, Inc. (US), Implicit Bioscience (Australia), F. Hoffmann-La Roche Ltd (Switzerland), TREEWAY (Netherlands), CYTOKINETICS, INC. (US), AB Science (France), Advanz Pharmaceutical (Canada) and few among others.

Market Analysis:Global Amyotrophic Lateral Sclerosis Treatment Market

Global amyotrophic lateral sclerosis treatment market is expected to rise gradually to an estimated value of USD 3.6 billion by 2026, registering a CAGR of 21.6% in the forecast period of 2019-2026 with the annual sales of USD 0.75 billion in the year of 2018. This rise in market value can be attributed to the increasing awareness and concerns regarding the health of patients.

Market Definition:Global Amyotrophic Lateral Sclerosis Treatment Market

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease, also known as motor neuron disease (MND) and Lou Gehrigs disease that affects nerve cells (motor neurons) of brain, brain stem and spinal cord that controls voluntary muscles. This disease is progressive in nature.

According to Centers for Disease Control and Prevention, there were approximately 14,000 15,000 people in US in 2016 having ALS, almost more than half of these cases could have been avoided with the availability of proper medical treatment. This significant number is expected to act as a driver to the market growth.

Market Drivers

Market Restraints

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Segmentation: Global Amyotrophic Lateral Sclerosis Treatment Market

By Disease Type

ByDrug Type

By Distribution Channel

By Treatment Type

By End- User

ByGeography

Key Developments in the Market:

Competitive Analysis:

Global amyotrophic lateral sclerosis treatment market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of amyotrophic lateral sclerosis treatment market for global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Primary Respondents

Demand Side: Doctors, Surgeons, Medical Consultants, Nurses, Hospital Buyers, Group Purchasing Organizations, Associations, Insurers, Medical Payers, Healthcare Authorities, Universities, Technological Writers, Scientists, Promoters, and Investors among others.

Supply Side: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, and Regulatory Affairs Managers among others.

Reasons to Purchase this Report

Customization of the Report:

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Amyotrophic Lateral Sclerosis Treatment Market Analysis and Forecast to 2026 || Top Growing Companies are ViroMed Co., Ltd, Ionis Pharmaceuticals,...

Major skin cancer research study to begin at The Hormel Institute – Austin Daily Herald – Austin Herald

By adminJune 11, 2020Adult Stem Cells

Dr. Rebecca Morris, leader of the Stem Cells and Cancer lab at The Hormel Institute, received a multi-year grant to study stem cells originating in adult bone marrow and their possible effects on skin diseases, including cancer. The grant, from the Nation Institute of Healths National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), awarded Morris with $373,688 over two years for her research project Identification of Novel Epidermal Progenitors.

Morris said this research is significant because it will contribute new understanding of epithelial biology, and blood and bone marrow in general, provide possible new targets for epithelial cancer prevention and control, validate liquid biopsy of blood as a diagnostic tool, and help her and her team to achieve their goal of preventing and alleviating chronic skin diseases including cancer, psoriasis, and epidermolysis bullosa.

Many years ago, I contributed basic research on identification and isolation of adult tissue stem cells from skin epidermis, and demonstrated their role in skin cancer initiation and promotion, Morris said. Now, I am again thrilled to be on the edge of discovery of a new population of epithelial stem cells and have the opportunity to determine their roles in regeneration and cancer.

Cells in the body that cover surfaces (like the epidermis, or top layer of skin) or line spaces (like ducts in mammary gland or lining of the colon) are called epithelial cells. In adults, most cancers originate from these epithelial cells. However, new research has identified certain bone marrow derived epithelial cells (BMDECs) in normal, healthy human subjects.

Morris and her team do not believe anyone has yet described the features and nature of these cells, or analyzed their function.

The research team has hypothesized that the epithelial cells from the bone marrow are epithelial stem cells. They therefore hope to demonstrate that BMDECs include a novel population of adult tissue stem cells that can be gathered to chronically compromised epithelium, such as skin cancer or psoriasis, and regenerate it.

Skin cancer is by far the most common type of cancer in the United States, with millions of people diagnosed each year. As we enter summer, it is important to remember simple steps like staying out of the sun during the middle of the day, staying in the shade, and wearing sunscreen can help reduce your skin cancer risk.

Next steps for Morriss research include determining how these blood borne epithelial cells are recruited to the skin, the recruiting molecules, how the recruitment can be good or bad, and how to modulate their recruitment to alleviate disease.

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Major skin cancer research study to begin at The Hormel Institute - Austin Daily Herald - Austin Herald