Sackville, N.B.-based biotech Soricimed Biopharma Inc. said this week that the Food and Drug Administration in the U.S. and Health Canada have given it the green light to proceed with Phase 1 trials for its main drug candidate, an anti-cancer agent called SOR-C13.
“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,” Jack Stewart, Chairman and Chief Scientific Officer of the company, said in a press release. “The data generated from our Phase I trial will educate us about the safety of SOR-C13, setting us up for future studies."
SOR-C13 is a targeted peptide, or a small protein. This particular peptide can stop growth in cervical, bone and lung cancer cells. Pre-clinical studies have shown that SOR-C13 induces apoptosis (cell death), inhibits cell proliferation and reduces tumor volume while minimizing side effects associated with typical chemotherapy.
Soricimed plans to conduct its Phase I trial, which assesses human safety of new drugs, in several cancer centres in Canada and the U.S. The trial will also assess pharmacokinetics, biomarkers and initial evidence for efficacy.
Soricimed, which has raised $10.5 million in funding, has said previously it plans to find a large drug company to partner with for the second and third phases. Phase II and III trials together can cost hundreds of millions of dollars.
As of last autumn, Soricimed had raised almost $6 million from private investors in New Brunswick, aided by the province’s Investor Tax Credit program, and almost $5 million through the programs of Atlantic Canada Opportunities Agency and the National Research Council.