TORONTO, ON – The U.S. Food and Drug Administration (FDA) has given an orphan drug designation to SOR-C13, a peptide being developed by Soricimed Biopharma as a treatment for pancreatic cancer.
SOR-C13 is a first-in-class peptide in development for the treatment of cancer. It binds with high selectivity and affinity to TRPV6, a calcium channel that is highly elevated in prostate, breast, lung and ovarian cancer and is correlated with poor outcomes. By binding to this channel, SOR-C13 starves cancer cells of calcium that is needed for cell growth and division. The peptide was previous granted the same designation for ovarian cancer.
“Receiving orphan drug status in both ovarian and pancreatic cancer highlights the unmet medical need and the potential of SOR-C13 to address these devastating cancers”, stated Paul Gunn, president and CEO at Soricimed. “We look forward to meeting with the FDA to discuss our development plans for SOR-C13 and to initiating additional clinical trials in 2017.”
Orphan drug status is granted following review of the rarity and severity of the medical condition, as well as the potential benefit of the product treating this condition. Orphan drug status qualifies Soricimed for various development incentives, including tax credits and reduced filing fees for clinical trials undertaken in the U.S. If approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the United States for this indication. In some cases, orphan drugs can be made available to patients before marketing approval on a compassionate use basis.
At the recent American Association of Cancer Researchers annual meeting, Soricimed released positive results indicating safety, tolerability and potential activity in a Phase I trial of SOR-C13 in subjects with advanced solid tumour cancers. Subjects were enrolled at Juravinski Cancer Centre, London Health Sciences Centre and the University of Texas MD Anderson Cancer Center.