FDA grants orphan drug designation to Soricimed’s SOR-C13 to treat ovarian cancer

The company is now eligible for several development incentives, including tax credits and reduced filing fees for clinical trials carried out in the US.

If FDA approves SOR-C13 for commercialization, it could qualify for seven years of marketing exclusivity in the US.

Soricimed Biopharma president and CEO Paul Gunn said: "Receiving orphan drug status is significant.

"It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13."

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 maintains a high tumour proliferation rate, increases tumour cell survival and consolidates mechanisms that combat cell destruction.

By binding to TRPV6, SOR-C13 ceases cancer cells of calcium that is required for cell growth and division.

Soricimed claims that SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.

Last month, Soricimed unveiled positive top-line results in phase 1 trial of SOR-C13 in subjects with advanced solid tumour cancers.

Preliminary data indicated safety and tolerability in phase I subjects and potential activity was demonstrated with 54% of subjects achieving stable disease.

Image: Ovarian cancer results in abnormal cells that have the ability to invade or spread to other parts of the body. Photo: courtesy of Nephron.