Closely-held Soricimed Biopharma has reached its target enrollment and treatment duration in a Phase 1 trial to evaluate the safety and tolerability of SOR-C13 in patients with solid tumor cancers who have failed other treatments.
The first-in-man study 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 FDA and Health Canada.
The company has initiated compilation of the formal Clinical Study Report and expects to have top-line results from the trial early in the first quarter of 2016.
“With 23 patients enrolled and 22 treated for the targeted duration, we have met our enrollment objectives,” president and CEO, Paul Gunn, said in a statement.
The Phase 1 open-label, dose escalation study is designed to assess the safety and tolerability of SOR-C13 in up to 30 subjects with advanced solid tumor cancers, with a weighting on ovarian cancer.
The study is also looking at additional secondary endpoints, including efficacy, and data collection on biomarkers that may be used in the future as indicators of potential efficacy.
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 is designed to starve cancer cells of calcium that is needed for cell growth and division. Animal studies demonstrated an inhibition of tumor growth.
Due to the high specificity of SOR-C13 for its target and its mechanism of action, SOR-C13 may result in fewer and less severe side effects, compared with standard cancer chemotherapy. SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.