By Estel Grace Masangkay
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Critical Outcome Technologies Inc.’ (COTI) investigational drug COTI-2 for the treatment of ovarian cancer.
John Drake, Chairman of the Board at Critical Outcome Technologies, said, “This is an important milestone for COTI-2 and brings us one step closer to bringing this exciting compound to ovarian cancer patients. We are looking forward to moving COTI-2 into the clinic in early 2015 and the Orphan Drug Designation should prove helpful in our ongoing dialogue with potential licensees as this drug candidate's development progresses.”
The FDA grants Orphan Drug Designation to drug candidates aimed at addressing serious or life-threatening conditions affecting less than 200,000 in the U.S. every year. The status confers a range of benefits to the sponsor company which include assistance in clinical study design, potential faster drug development, and eligibility for orphan disease development grants. The designation also entitles recipient drug makers to fee reductions, tax credits for clinical trial costs, and a period of seven-year marketing exclusivity upon approval.
Dr. Wayne Danter, President and CEO of Critical Outcome Technologies, said, “Receiving the Orphan Drug Designation for COTI-2 speaks to the need for new treatment options for patients with ovarian cancer… With its p53 dependent mechanism of action, COTI-2 is a novel compound with the potential to benefit these patients, as more than 95% of serious ovarian cancers have a p53 gene mutation. We continue to believe that COTI-2 could represent a significant therapeutic advantage over treatments currently available for ovarian and other gynecological cancers.”
COTI is a bioinformatics company focused on accelerating discovery and development of small molecules for the treatment of various diseases. The company uses its proprietary artificial intelligence system CHEMSAS(R) to identify which lead candidates have a high likelihood of successful development. The company specializes in compounds that address diseases which have either lacking or ineffective current treatments.