VBL Therapeutics (NASDAQ:VBLT) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Ofra-Vec (VB-111) in combination with Paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.
Ofra-vec is an investigational anti-cancer, gene-based agent from the company, in development to treat a wide range of solid tumors.
Prof. Dror Harats, M.D., chief executive officer, commented, "We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. This can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved”.
The biotechnology company expects primary endpoint data for ofra-vec from OVAL Phase 3 top-line progression free survival (PFS) in the second half of 2022.
Based on the positive results from the Phase 3 clinical trial, VBL anticipates submitting a Biologics License Application (BLA) to the regulatory authorities in the first half of 2023.
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
VBL Therapeutics is currently trading up 3.45 percent at $1.50 in the premarket trading.
