Sackville, N.B.-based Soricimed Biopharma Inc., a clinical-stage pharmaceutical company developing peptide-based cancer therapeutics, has won a key regulatory approval from the Food and Drug Administration in the U.S.
The company said in a statement the FDA has granted orphan-drug designation to Soricmed’s flagship compound SOR-C13 for the treatment of ovarian cancer. Orphan drug status qualifies Soricimed for various development incentives, including tax credits and reduced filing fees for clinical trials undertaken in the U.S. If approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the U.S.
In granting orphan drug status, the regulatory body reviews the rarity and severity of the medical condition, as well as the potential benefit of the product treating this condition.
Soricimed last month reported it had received positive initial readings from the Phase 1 trials of SOR-C13, including indications that it can stabilize some cancer tumours.
Sor-C13 is a peptide, or a naturally occurring biological molecule, that clings to the calcium in a cancer cell and deprives it of oxygen, thereby killing the tumour. Soricimed hopes to establish that it is an effective means of treating cancer with minimal suffering for the patient.
Soricimed cited the American Cancer Society as saying ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system, with an incidence rate of 11.9 per 100,000 and a death rate of 7.7 per 100,000. In some cases, orphan drugs can be made available to patients before marketing approval on a compassionate use basis.
“Receiving orphan drug status is significant,” said Soricimed President and CEO Paul Gunn in the statement. “It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13.”
Soricimed last year conducted trials with 22 patients with advanced solid-tumour cancer in Hamilton and London, Ont., and Houston, Texas. The goal was to gain Phase 1 approval from both Health Canada and the U.S. Food and Drug Administration.
Phase 1 trials are designed to establish that a drug is safe for use in humans. The next step in bringing the product to market will be Phase 2 trials, which are far more costly and aim to prove the drug’s efficacy.