Canada-based bioinformatics and accelerated drug discovery firm Critical Outcome Technologies (COTI) has submitted an orphan drug application to the US Food and Drug Administration (FDA) for its lead cancer drug candidate, COTI-2, to treat patients with ovarian cancer.
The company said that COTI-2, with its p53 dependent mechanism of action, represents a significant therapeutic advantage over treatments currently available for ovarian and other gynecological cancers.
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COTI president and CEO Wayne Danter said the fact that more than 95% of ovarian cancers have a p53 gene mutation, combined with the extent of unmet medical need in ovarian cancer patients, makes a treatment for this indication one of the company’s top priorities.
"If COTI-2 is granted orphan drug status, the financial benefits in the future could be substantial and COTI-2 would be directed down a unique development pathway within the FDA, including the possibility of an expedited regulatory process and the potential for fewer patients to be required in clinical trials," Danter said.
With the FDA orphan drug status, the company will qualify several benefits under the US Orphan Drug Act of 1983 (ODA) as amended.
The benefits might include a seven-year period of orphan drug exclusivity upon product approval, fee reductions, assistance in study design from the FDA, potential for expedited drug development and eligibility for drug grants.
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By GlobalDataCOTI specialises in accelerating the discovery and development of small molecules, by reducing the time and cost to bring new drugs to market.
The company’s artificial intelligence system, CHEMSAS, uses a series of predictive computer models to discover compounds with a high-probability of being successfully developed from disease specific drug discovery through chemical optimisation and preclinical testing.
According to the company, the new compounds are targeted for a variety of diseases, particularly those for that current treatments are either lacking or ineffective.
Image: Micrograph of a low malignant potential mucinous ovarian tumour. Photo: courtesy of Nephron.
