FDA Grants Investigational New Drug Status to Critical Outcome Technologies for COTI-2

Critical Outcome Technologies Inc (TSXV:COT,OTCMKTS:COTQF) announced that the FDA has granted investigational new drug status (IND) for COTI-2, the company’s small molecule activator of misfolded mutant p53 protein, in gynecological cancers.

As quoted in the press release:

The Company plans to commence a Phase 1 clinical trial in the second half of calendar 2015 in partnership with the University of Texas, MD Anderson Cancer Center in Houston. The grant of this IND triggers the issuance of 715,720 common shares of the Company as final payment of contingent share consideration that arose on the acquisition of DDP Therapeutics in November 2007.

COTI-2 is a small molecule activator of misfolded mutant p53 protein approved for clinical development. Extensive studies have demonstrated COTI-2’s ability to restore mutant p53 function and thus induce cancer cell death in many common p53 mutations. Mutations of the p53 gene are the most common genetic alterations in human cancers, occurring in a wide range of cancers, including ovarian, lung, colorectal, breast, liver, bladder and other cancers. COTI-2’s specific protein target, low toxicity, combination effectiveness with standard agents, and potential for longer term outpatient therapy as an oral agent, supports a dramatic change in the treatment of susceptible cancers.

Wayne Danter, president and CEO of Critical Outcome Technologies, commented:

The grant of this IND marks the achievement of the second important milestone for COTI-2 in 2015 and builds on the Orphan Drug designation received for ovarian cancer from the FDA in June 2014. “During preclinical studies, COTI-2 with its novel mechanism of action demonstrated selective and potent anti-cancer p53-dependent activity in many cancers. We look forward to reproducing these encouraging results in a clinical setting and confirming that COTI-2 is a highly promising novel treatment option for women with gynecological cancers having p53 mutations.

Click here to read the full Critical Outcome Technologies Inc (TSXV:COT,OTCMKTS:COTQF) press release.