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Abeona Therapeutics® and Children's Hospital Colorado Announce Newest Treatment Center for ZEVASKYN® Gene Therapy
Globenewswire· 2025-10-08 11:30
Core Insights - Abeona Therapeutics has activated Children's Hospital Colorado as a Qualified Treatment Center for ZEVASKYN, a gene-modified therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][2] - ZEVASKYN is the first FDA-approved therapy for treating wounds in RDEB patients, offering a long-lasting treatment option and improved quality of life [2][5] - The collaboration aims to broaden access to ZEVASKYN across a network of established epidermolysis bullosa centers [2] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product [11] - The company operates a cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [11] Product Details - ZEVASKYN (prademagene zamikeracel) is an autologous cell sheet-based gene therapy designed to treat wounds in both adult and pediatric patients with RDEB [6][5] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is essential for skin integrity [5][6] - Clinical results have shown meaningful wound healing and pain reduction with a single application of ZEVASKYN [5] Clinical and Research Context - Children's Hospital Colorado is recognized as a center of excellence for epidermolysis bullosa and is part of the EB Clinical Research Consortium, contributing to advanced research and treatment options [2][10] - The hospital's Precision Medicine Institute supports innovative treatments by utilizing patients' unique genetic information [2] Patient Support Services - Abeona offers a comprehensive patient support program called Abeona Assist, which helps patients navigate insurance benefits, financial assistance, and logistical support for treatment [3]
UPDATE -- Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYN™ Gene Therapy to Treat Wounds in Painful Skin Disorder
Globenewswire· 2025-05-14 12:07
Core Points - ZEVASKYN is the first and only cell-based gene therapy approved for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [2][8] - Ann & Robert H. Lurie Children's Hospital of Chicago is the first Qualified Treatment Center (QTC) for ZEVASKYN, with treatments expected to begin in Q3 2025 [1][3] - Abeona Therapeutics has launched the Abeona Assist™ program to provide personalized support for patients and families throughout the treatment journey [1][5] Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being a key product in its portfolio [15] - The company operates a cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [15] Treatment Details - ZEVASKYN incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is essential for skin integrity [8] - The therapy has shown clinically meaningful results in wound healing and pain reduction with a single application [8] Hospital and Research Center - Lurie Children's Hospital has been a center of excellence for genetic skin diseases for over 30 years and is recognized for its expertise in treating epidermolysis bullosa [3][12] - The hospital has been providing FDA-approved gene therapies since 2019 and is expanding its offerings, with ZEVASKYN being the tenth gene therapy available [4]
Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder
Globenewswire· 2025-05-14 11:30
Core Insights - ZEVASKYN is the first and only cell-based gene therapy approved for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [2][8] - Ann & Robert H. Lurie Children's Hospital of Chicago is the first Qualified Treatment Center (QTC) for ZEVASKYN, ready to begin patient evaluations [1][3] - Abeona Therapeutics has established the Abeona Assist™ program to provide personalized support for patients and families throughout the treatment process [5] Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being a key product [15] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [15] - Abeona is committed to enabling access to ZEVASKYN for eligible patients in the U.S. through comprehensive support services [5] Treatment Details - ZEVASKYN is indicated for the treatment of wounds in both adult and pediatric patients with RDEB, utilizing gene-modified cellular sheets to promote healing [9][8] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is essential for skin integrity [8][7] - Clinical data has shown that ZEVASKYN can lead to meaningful wound healing and pain reduction with a single application [8] Hospital Collaboration - Lurie Children's Hospital has been recognized for its expertise in treating epidermolysis bullosa and has been a center for excellence in genetic skin diseases for over 30 years [3][12] - The hospital has been providing FDA-approved gene therapies since 2019 and is expanding its offerings, with ZEVASKYN being the tenth gene therapy available [4] - The first patient is expected to receive ZEVASKYN treatment in August 2025, following biopsies in July 2025 [4]