TORONTO, Canada, March 8, 2016 – Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to peptide SOR-C13 for the treatment of ovarian cancer.
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.
According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system, with an incidence rate of 11.9 per 100,000 and a death rate of 7.7 per 100,000. In some cases, orphan drugs can be made available to patients before marketing approval on a compassionate use basis.
“Receiving orphan drug status is significant”, stated Paul Gunn, President and CEO at Soricimed. “It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13.”
Soricimed announced that it had reached its target enrollment and treatment duration in its Phase 1 trial of SOR-C13 in patients with solid tumor cancers who had failed other treatments. Topline results were released last month.
About SOR-C13: SOR-C13 is a first-in-class peptide in development for the treatment of cancer. SOR-C13 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. TRPV6-mediated Ca2+ entry is responsible for maintaining a high tumour proliferation rate, as well as increasing tumour cell survival and fortifying mechanisms that withstand cell destruction. By binding to this channel, SOR-C13 starves cancer cells of calcium that is needed for cell growth and division. As demonstrated in animal models, the result is an inhibition of tumor growth. Due to the high specificity of SOR-C13 for its target and its unique mechanism of action this drug candidate may result in fewer and less severe side effects compared to standard cancer chemotherapy. SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.
About Soricimed Biopharma: Soricimed Biopharma Inc., a private Canadian clinical stage company developing novel cancer therapeutics and diagnostics, was created in 2005 by Professor Jack Stewart and Paul Gunn following the discovery and development of a proprietary peptide, soricidin. Soricidin derivatives, including SOR-C13, are the basis for Soricimed Biopharma Inc.’s targeted cancer management program. Using focused, innovative strategies in collaboration with major world-class cancer research institutions, Soricimed’s drugs have demonstrated a capability to reduce cancer cell viability, induce apoptosis and to reduce human tumour volume while minimizing side-effects in various classic animal and in vitro tumour models. Soricmed recently announced positive top-line results indicating safety, tolerability and potential activity in a Phase I trial of first-in-class peptide 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 Centre. Privately held, Soricimed is funded through private investors and various programs from the Governments of Canada and New Brunswick. For more information please visit, www.soricimed.com.
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Julie Fotheringham - Partner, Hageman Communications