MONCTON, New Brunswick, December 15, 2015 – Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, today announced that it has reached its target enrollment and treatment duration in its Phase 1 trial. The Phase 1 is designed to evaluate the safety and tolerability of SOR-C13 in patients with solid tumor cancers who have failed other treatments. The Phase 1 was conducted at two sites in Canada and at the University of Texas MD Anderson Cancer Center under regulatory submissions filed by Soricimed with both the US Food and Drug Administration and Health Canada. The Company has initiated the compilation of the formal Clinical Study Report and expects to have top-line results from the trial early in Q1 of 2016.
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 over-represented in solid-tumor cancers. 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.
"We are extremely pleased to have completed this first-in-man clinical trial of SOR-C13” said Paul Gunn, President and CEO of Soricimed. “This clinical study was primarily designed to evaluate the safety and tolerability of SOR-C13. With 23 patients enrolled and 22 treated for the targeted duration, we have met our enrollment objectives. We thank all of the patients and their families and the investigators who participated in this trial. I look forward to reporting the top-line results of the trial in Q1 of 2016."
The Phase 1 trial is a multicenter, open-label, dose escalation study designed to assess safety and tolerability of SOR-C13 in up to 30 subjects with advanced solid tumor cancers, with a weighting on ovarian cancer. In addition to assessing the safety, tolerability and pharmacokinetics of SOR-C13 the trial is also designed to look at additional secondary endpoints including efficacy (clinically meaningful response) and to collect data on biomarkers that may be used in the future as indicators of potential efficacy. Study subjects who achieved a clinically meaningful response to 2 cycles of treatment in the trial, including disease stabilization, were offered additional SOR-C13 cycles after cycle 2 at the same dose level. Subjects were enrolled into the trial at 2 sites in Canada and at the University of Texas MD Anderson Cancer Treatment Center.
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 are the basis for Soricimed Biopharma Inc.’s targeted cancer management program focused on cancer therapeutics and diagnostics. 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. Privately held, Soricimed is funded through private investors and various programs from the Governments of Canada and New Brunswick.
Julie Fotheringham - Partner, Hageman Communications