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news.Critical Outcome Technologies has announced that the US Food and Drug Administration (FDA) has granted COTI-2 an Orphan Drug Designation for the treatment of ovarian cancer.
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Critical Outcome Technologies president and CEO Dr Wayne Danter said that receiving the Orphan Drug Designation for COTI-2 speaks to the need for new treatment options for patients with ovarian cancer.
"When current first line treatments fail, oncologists have limited treatment options to offer these patients. 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," Dr Danter added.
Critical Outcome Technologies board chairman John Drake said that this is an important milestone for COTI-2 and brings the company 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," Drake added.