Critical Outcome Technologies Inc. (TSX-V: COT), a biopharmaceutical company, has submitted an orphan drug application intended for the treatment of Li-Fraumeni syndrome (LFS) to the US Food and Drug Administration for its lead cancer drug candidate, COTI-2.
Orphan Drug Designation would yield a number of benefits for the company, including:
- Possibly resulting in COTI-2 being directed down a unique development pathway within the FDA.
- Provide the possibility of an expedited regulatory process and the potential of fewer patients being required for clinical trials.
- Qualify the Company for several financial benefits under the US Orphan Drug Act of 1983 (ODA), as amended.
- 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 development grants.
"We believe that COTI-2's impact on cancer treatment will be far-reaching," said Dr. Wayne Danter, President and CEO of Critical Outcome Technologies. "As we have noted in the past, we are pursuing multiple cancer indications with our lead asset, COTI-2. The prevalence of p53 gene mutations among people with LFS makes this a highly relevant target for COTI-2 and its unique mechanism of action. Obtaining an Orphan Drug Designation for COTI-2 in the treatment of LFS is therefore very attractive to us as the strong scientific rationale, limited competition in a niche market, and significant unmet medical need offers substantial motivation and incentive."
The Ontario-based company’s mission is to advance the treatment of cancer through targeted therapeutics. Their lead compound, COTI-2, has a novel p53-dependent mechanism of action with selective and potent anti-cancer activity.
This announcement follows a number of recent milestones for Critical Outcome Technologies. This past September, the company announced that for one-year, Outreach 99 LLC will manage and direct Critical Outcome’s investor relations program. Also, the company completed a private placement to provide additional funding for operations and strengthened the Board and management support with the addition of a US based independent director with substantial experience in drug development operations and orphan drug strategy.
Critical Outcome Technologies’ continued progress moves the world of medicine one step closer to saving thousands of lives by enabling accelerated development of new effective treatment options. “During this review process, we have pursued a number of indications and combination treatment opportunities for COTI-2 with a variety of potential development partners,” said Dr. Wayne Danter. “The application for Orphan Drug Designation for LFS is an important step in broadening the therapeutic scope of COTI-2."
For more information about Critical Outcome Technologies, visit www.criticaloutcome.com.
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