Soricimed Biopharma has received FDA clearance for the investigational new drug (IND) application of SOR-C13 as an anti-cancer agent and Health Canada approval for Phase I trial of SOR-C13.
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The targeted peptide inhibits the non-voltage gated calcium channel found in epithelial cancers such as ovarian, breast, prostate and others.
SOR-C13 has shown to induce apoptosis, inhibit cell proliferation and reduce tumor volume, with reduced side effects, in the pre-clinical studies.
Soricimed chairman and chief scientific officer Jack Stewart said, "Acceptance by the FDA and Health Canada of this application, along with the advancement of SOR-C13 to clinical testing are two major milestones for Soricimed and key steps along the path to the drug’s development and commercialization."
The multicenter, open-label trial is designed to assess safety and tolerability in patients with advanced cancer tumors, with a weighting on ovarian cancers.
The dose escalation study will also assess pharmacokinetics, biomarkers and initial evidence for efficacy.
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