Cotinga Pharmaceuticals Inc. (COTQF)

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Critical Outcome Technologies Files Investigational New Drug Application With the FDA for COTI-2

#COTQF / #COT.V

Novel p53-Dependent Cancer Therapy One Step Closer to the Clinic

http://www.marketwired.com/press-release/-2013503.htm

LONDON, ON--(Marketwired - April 27, 2015) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE: COT) (OTCQB: COTQF), announced today the filing of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration's Center for Drug Evaluation and Research ("FDA") for COTI-2, a potential breakthrough therapy intended for the treatment of women with gynecological cancers with p53 mutations. Advanced gynecological cancers have a particularly high prevalence rate (as high as 95%) of p53 mutations. The IND application is a complete description of the chemistry, non-clinical pharmacodynamics and pharmacokinetics, safety toxicology, manufacturing and other relevant information related to COTI-2 as a potential treatment for patients with p53 mutations.

Subject to the FDA granting the IND application, the Company intends to initiate a Phase 1 clinical trial of an oral formulation of COTI-2 in patients with gynecological cancers (cervical, endometrial and ovarian) at the University of Texas MD Anderson Cancer Center in Houston. Extensive preclinical studies have demonstrated COTI-2's ability to restore mutant p53 function and thus induce cancer cell death in cancers with many common p53 mutations. In the upcoming clinical trial, the Company intends to determine primarily the safety of COTI-2, as well as obtain some indications of efficacy, the maximum tolerated-dose and pharmacokinetics in treating gynecological cancers containing p53 mutations in patients who have failed the current first line therapies used in these types of cancers.

"The filing of this IND application is a critical step forward in moving our lead oncology asset into the clinic," said Dr. Wayne Danter, President and CEO. "With a novel mechanism of action, orphan drug status for ovarian cancer, and a strong clinical development partner in MD Anderson, we believe that COTI-2 is well positioned for a Phase 1 clinical trial in gynecological cancers. Most ovarian cancers have at least one p53 mutation and COTI-2 may represent a potential breakthrough therapy for patients with these mutations. We look forward to working with the FDA in anticipation of their granting the IND application in the near future and commencing our COTI-2 trial for the benefit of women with gynecological cancers who have failed standard therapies."

For additional information pertaining to gynecological cancers, please visit our blog at www.criticaloutcomeblog.com/blog-posts.