Oncolix gets key FDA backing for ovarian cancer drug - Prolanta - media

media

An ovarian cancer drug developed by Houston-based Oncolix Inc. has been granted orphan drug designation by the U.S. Food and Drug Administration and is ready to begin Phase I clinical trials later this year.
Orphan drug designation is granted to promising drugs geared to treat a population of fewer than 200,000 people who live with the disease in the U.S. Currently, about 170,000 women are living with ovarian cancer.
For Oncolix, this means the $1.9 million registration fee will be waived once the company submits its drug, known as Prolanta, for approval. Also, if Prolanta receives approval, the drug will be given seven years of market exclusivity.
Currently, the only treatment option available for patients with ovarian cancer is chemotherapy, Michael Redman, CEO of Oncolix, told HBJ.
The orphan drug designation was granted on April 18. Redman said the company applied for the status about 70 days before it received notification from the FDA.
The company is applying for the same status in Europe and Japan. If granted, the designation would guarantee 10 years of exclusivity.
The Phase I trial, slated to begin later this year, would involve between 12 to 18 patients and be performed in connection with The University of Texas M.D. Anderson Cancer Center.
Redman was a co-founder of The Woodlands-based Opexa Therapeutics Inc. (NASDAQ: OPXA). He sold the company in 2004.