Business
Abeona Therapeutics Initiates Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa
Study open for enrollment and patient screening underway at Stanford University Company expects first patient to be treated in the first quarter of 2020
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Study open for enrollment and patient screening underway at Stanford University\n Company expects first patient to be treated in the first quarter of 2020 EB-101 manufactured at Abeona facility in Cleveland NEW YORK and CLEVELAND, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it has received Institutional Review Board (IRB) approval from Stanford University to commence the VIITAL™ study, the Company’s pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The majority of patients targeted for enrollment have completed the pre-screening process at Stanford, and the Company expects the first patient in the VIITAL™ study to be treated in the first quarter of 2020. “We expect 2020 to be a transformational year at Abeona, and we are proud to start it with the initiation of our pivotal Phase 3 study evaluating EB-101 in RDEB,” said João Siffert, M.D., Chief Executive Officer. “We look forward to the first patient receiving EB-101 this quarter, setting in motion the final stages of this important program. We have devoted significant effort to establish and validate our independent, fully-functional GMP facility that will produce EB-101 for the VIITAL™ study and has capacity to support commercial launch. EB-101 has the potential to be the first approved therapy for RDEB and the only durable treatment to address large chronic wounds, which are the most painful and debilitating.” The VIITAL™ Phase 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. The primary study endpoint is the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change from baseline in pain as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function. Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL™ study, with additional study sites expected to be added in the coming months. Additional information about the trial is available at abeon...