BioGenCell Receives FDA Fast Track Designation with Expanded Access for BGC101

NETANYA, Israel, Dec. 19, 2024 /PRNewswire/ -- BioGenCell, a biotechnology leader in regenerative medicine, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead candidate, BGC101, for treating severe Critical Limb Threatening Ischemia (CLTI). BGC101 aims to prevent amputations, hinder disease progression and relieve pain for  severe CLTI patients - offering hope to no-option patients.

Fast Track Designation enables accelerated clinical development of therapies that address serious conditions with unmet needs. In selected cases, such as BioGenCell's, it also already enables compassionate-use access for eligible patients.

"Achieving Fast Track Designation is a significant milestone for BioGenCell and for patients in critical need" said Dr. David Raab, Chairman of BioGenCell. Dr. Porat, BioGenCell's Founder and CEO, added, "This recognition underscores the promise of our personalized cell therapy, supported by preliminary clinical results and a clear mechanism of action."

Addressing an Unmet Need in CLTI
CLTI is the most severe stage of peripheral artery disease, associated with high amputation and mortality rates, which results from diabetes and atherosclerosis. Many patients are ineligible for revascularization, underscoring the need for alternative treatments.

BGC101 leverages BioGenCell's proprietary TRACT platform to develop personalized therapies using immune and stem cells from the patient's own blood. This rapid, scalable process generates the cell therapy in just one day. It promotes tissue regeneration to restore blood flow and function to the damaged limb. Patients have seen benefits lasting over seven years after just a single treatment.

Multinational Phase 2 Trial Completes Enrollment
BioGenCell's Phase 2 clinical trial, a randomized, double-blind study evaluating the safety and efficacy of BGC101, has completed patient recruitment. The trial conducted at leading institutions in the United States, Europe, and Israel, focused on amputation-free survival and symptom relief.

About BioGenCell
BioGenCell advances regenerative medicine with personalized cell-based therapies for degenerative microvascular diseases. By combining immune and stem cell technologies, BioGenCell's platform offers patient-centered solutions, with BGC101 aiming to prevent amputations in CLTI patients and demonstrating promising clinical outcomes.

For more information, visit www.biogencell.net.
Or Contact: 
Hamutal Shapira
Email: [email protected]
Tel: +972-9-8609248

Safe Harbor Statement
This release contains forward-looking statements subject to risks and uncertainties. Actual outcomes may differ materially. BioGenCell assumes no obligation to update statements unless required by law.

SOURCE BioGenCell