OXiGENE, Inc, recently announced that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the company's lead vascular-disrupting agent, combretastatin A4 phosphate (CA4P), for the treatment of ovarian cancer. CA4P is being evaluated in a phase II clinical trial in combination with the widely used chemotherapy regimen, carboplatin/paclitaxel, for the treatment of platinum-resistant ovarian cancer. Results previously reported from a phase Ib clinical trial showed a 67% response rate to the combined CA4P/chemotherapy treatment among women with advanced ovarian cancer who failed previous cancer therapy.
"US Orphan Drug designation for ovarian cancer is a significant achievement for OXiGENE; a milestone that we believe may provide a market advantage as we advance CA4P as a treatment under development in this key indication," commented Frederick Driscoll, president and CEO of OXiGENE. "We have been encouraged from the positive patient response data reported and are further encouraged by reports that the treatment was well tolerated by individuals. We believe that this designation further validates CA4P's clinical potential and we are optimistic about one day delivering a therapeutic treatment for an unmet medical need in ovarian cancer."