Scioderm

Abeona Therapeutics Activates Second Clinical Trial Site in EB-101 Pivotal Phase 3 VIITAL™ Study for Recessive Dystrophic Epidermolysis Bullosa

Retrieved on: 
Friday, July 23, 2021
Genodermatoses, Health sciences, Life sciences, Health, Epidermolysis bullosa dystrophica, Epidermolysis bullosa, Scioderm, Therapy, Chronic wound, EB

The EB-101 pivotal VIITAL study is currently ongoing at Stanford University Medical Center in Palo Alto, CA.

Key Points: 
  • The EB-101 pivotal VIITAL study is currently ongoing at Stanford University Medical Center in Palo Alto, CA.
  • EB-101 is an autologous, gene-corrected cell therapy currently being investigated in Abeonas pivotal Phase 3 VIITAL study for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy.
  • The EB-101 VIITAL study is a randomized clinical trial enrolling 10 to 15 RDEB patients with approximately 35 large, chronic wound sites treated in total.
  • Abeona produces EB-101 for the VIITAL study at its fully integrated gene and cell therapy manufacturing facility in Cleveland, OH.

Global Epidermolysis Bullosa Clinical Trial Pipeline Research Report 2021: Phase 3, Phase 2, Phase 1, Preclinical Research, and Discovery Stage - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 21, 2021
Health, Clinical trials, Health sciences, Genodermatoses, Health, Rare diseases, Life sciences, Epidermolysis bullosa, Food and Drug Administration, Clinical research, Pharmaceutical industry, Clinical trial, Scioderm, Genodermatosis

The "Global Epidermolysis Bullosa Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Epidermolysis Bullosa Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.
  • Epidermolysis Bullosa Pipeline Highlights - 2021, provides the most up-to-date information on key pipeline products in the global Epidermolysis Bullosa market.
  • It covers emerging therapies for Epidermolysis Bullosa in active clinical development stages including early and late stage clinical trials.
  • The report provides Epidermolysis Bullosa pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.

Abeona Therapeutics Announces Successful Type B Meeting with FDA for Pivotal Phase 3 VIITAL™ Study of EB-101 in Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Retrieved on: 
Monday, January 25, 2021
Genodermatoses, Health sciences, Life sciences, Branches of biology, Rare diseases, Collagen disease, Epidermolysis bullosa dystrophica, Epidermolysis bullosa, Scioderm, Therapy, Cell therapy

Following the successful completion of the FDA meeting,we continue with all necessary steps to enroll our next patient in the VIITAL study and aim to complete enrollment in 2021.

Key Points: 
  • Following the successful completion of the FDA meeting,we continue with all necessary steps to enroll our next patient in the VIITAL study and aim to complete enrollment in 2021.
  • Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL study.
  • EB-101 is an autologous, gene-corrected cell therapy currently being investigated in the pivotal Phase 3 VIITAL study for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy.
  • Abeona produces EB-101 for the VIITAL study at its fully-functional gene and cell therapy manufacturing facility in Cleveland, OH.

Rob Rayl named Chief Development Officer and Chief Operating Officer of debra of America

Retrieved on: 
Tuesday, November 17, 2020
Genodermatoses, Rare diseases, Debra, Epidermolysis bullosa, Health, Debra, Deb, Medical specialties, EB, Scioderm

NEW YORK, Nov. 17, 2020 /PRNewswire/ -- The Dystrophic Epidermolysis Bullosa Research Association of America ( debra of America ) today announced the appointment of Robert Rayl II as the organization's Chief Development Officer and Chief Operating Officer.

Key Points: 
  • NEW YORK, Nov. 17, 2020 /PRNewswire/ -- The Dystrophic Epidermolysis Bullosa Research Association of America ( debra of America ) today announced the appointment of Robert Rayl II as the organization's Chief Development Officer and Chief Operating Officer.
  • In this role, Rob will be responsible for the strategic direction, development, and assessment of all philanthropic avenues to increase revenue, financial support and organizational awareness for debra of America.
  • Rob has been an active board member at debra since 2014 and was elected Vice Chair in 2017.
  • debra of America is dedicated to finding a cure for EB, which affects 1 out of every 20,000 live births in the United States.

Recessive Dystrophic Epidermolysis (RDEB) Pipeline Insight, 2020 - Therapeutic Assessment, Unmet Needs, Products, Drugs, Companies - ResearchAndMarkets.com

Retrieved on: 
Friday, May 1, 2020
Health, Other Health, Other Science, Managed care, Research, Science, Pharmaceutical, Genodermatoses, Rally of the Ecologists of Burkina, Rare diseases, Health, Scioderm

This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Recessive Dystrophic Epidermolysis (RDEB) market.

Key Points: 
  • This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Recessive Dystrophic Epidermolysis (RDEB) market.
  • A detailed picture of the Recessive Dystrophic Epidermolysis (RDEB) pipeline landscape is provided, which includes the disease overview and Recessive Dystrophic Epidermolysis (RDEB) treatment guidelines.
  • The assessment part of the report embraces in-depth Recessive Dystrophic Epidermolysis (RDEB) commercial assessment and clinical assessment of the Recessive Dystrophic Epidermolysis (RDEB) pipeline products from the pre-clinical developmental phase to the marketed phase.
  • Different therapeutic candidates segmented into early-stage, mid-stage and late stage of development for the Recessive Dystrophic Epidermolysis (RDEB) treatment.

Abeona Therapeutics Announces First Patient Treated in Pivotal Phase III Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

Retrieved on: 
Tuesday, March 17, 2020
Branches of biology, Genodermatoses, Articles, Health sciences, Rare diseases, Epidermolysis bullosa, RTT, Gene therapy, Therapy, Scioderm, EB

Treating the first patient in our pivotal Phase III VIITAL study is an important achievement for the EB-101 program, now the most advanced gene therapy program in RDEB, said Joo Siffert, M.D., Chief Executive Officer.

Key Points: 
  • Treating the first patient in our pivotal Phase III VIITAL study is an important achievement for the EB-101 program, now the most advanced gene therapy program in RDEB, said Joo Siffert, M.D., Chief Executive Officer.
  • We remain confident that VIITALTM will replicate results from the Phase I/II trial demonstrating that EB-101 treatment resulted in sustained and durable wound healing with a favorable safety profile.
  • The VIITALPhase III study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total.
  • EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy.

Abeona Therapeutics Announces Participation in Inaugural World Congress on Epidermolysis Bullosa

Retrieved on: 
Tuesday, January 21, 2020
Genodermatoses, Rare diseases, Epidermolysis bullosa, RTT, Health, Branches of biology, EB, Clinical medicine, Scioderm, Epidermolysis bullosa simplex

NEW YORK and CLEVELAND, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced its participation in the first World Congress on Epidermolysis Bullosa (EB2020), which is convening the worlds leading experts on epidermolysis bullosa (EB) research and clinical management in London, January 19-23, 2020.

Key Points: 
  • NEW YORK and CLEVELAND, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced its participation in the first World Congress on Epidermolysis Bullosa (EB2020), which is convening the worlds leading experts on epidermolysis bullosa (EB) research and clinical management in London, January 19-23, 2020.
  • The presentation is part of the Clinical Trials and Research Program track at the congress.
  • Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases.
  • These statements include statements regarding our pipeline including the potential use of investigational product EB-101 in the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

Abeona Therapeutics Initiates Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

Retrieved on: 
Monday, January 13, 2020
Genodermatoses, Health sciences, Health, Rare diseases, Articles, Collagen disease, Epidermolysis bullosa dystrophica, Epidermolysis bullosa, Therapy, EB, Scioderm, Network of Excellence for Functional Biomaterials

The VIITALPhase 3 study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total.

Key Points: 
  • The VIITALPhase 3 study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total.
  • Abeona will produce EB-101 for the pivotal VIITALstudy at the Elisa Linton Center for Rare Disease Therapies, its fully-functional gene and cell therapy manufacturing facility, centrally-located in Cleveland, OH.
  • EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy.
  • Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases.

 DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Abeona Therapeutics, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, December 27, 2019
Legal, Professional services, Genodermatoses, Rare diseases, Collagen disease, Epidermolysis bullosa dystrophica, Epidermolysis bullosa, Health, EB, Rally of the Ecologists of Burkina, Branches of biology, Clinical medicine, Scioderm

Investors have until January 2, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until January 2, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) is one of Abeonas lead programs.
  • Abeona expected to initiate a pivotal clinical trial evaluating the potential of EB-101 for the treatment of RDEB in the middle of 2019.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Abeona Therapeutics Cleared to Initiate Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

Retrieved on: 
Monday, December 9, 2019
Health sciences, Articles, Health, Genodermatoses, Rare diseases, Collagen disease, Epidermolysis bullosa dystrophica, Epidermolysis bullosa, Biotechnology, Therapy, Biopharmaceutical, Scioderm

The FDA removed the clinical hold following the Companys submission of additional data points on transport stability of EB-101 to clinical sites.

Key Points: 
  • The FDA removed the clinical hold following the Companys submission of additional data points on transport stability of EB-101 to clinical sites.
  • The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101, said Joo Siffert, M.D., Chief Executive Officer of Abeona.
  • EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy.
  • Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases.