FDA Puts RV001 on Fast Track for Treating Prostate Cancer

FDA Puts RV001 on Fast Track for Treating Prostate Cancer
The U.S. Food and Drug Administration (FDA) has granted fast track status to RV001, RhoVac's investigational therapy for prostate cancer, the company announced. Fast track designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants RhoVac greater access to FDA input throughout the regulatory process and makes RV001 eligible for accelerated approval and priority review, if it meets certain criteria. With the fast track designation, RhoVac also may apply for a "rolling review," in which the company submits sections of its biologic license application for review as they are completed, rather than all together after clinical testing finishes. "We are extremely pleased and proud that our drug candidate, RV001, has earned fast track designation by the FDA," Anders Månsson, RhoVac's CEO, said in a press release. "The fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority ... sends a clear signal of recognition of the drug's potential to all our would-be partners, which is something of great importance to us," Månsson said. RV001 is a peptide-based medicine meant to prevent cancer recurrence and spread. The treatment mimics the Ras homolog gene family member C (RhoC), a protein that helps cancer cells migrate and take hold in other tissues, and stimulates the immune system to recognize and target cells producing this protein. While these treatments historically have shown poor effectiveness against solid tumors, the goal of RV001 is to target the metastatic cancer cells, rather than the solid primary tumor. In this manner, the treatment is expected to eliminate spreading cells before they establish hard-to-treat tumors outside
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