Tikcro has reported that the US Department of Health and Human Services (HHS) has granted orphan drug status to BioCancell’s BC-819 drug. It is currently in phase I/IIa clinical trials for use in treating ovarian cancer.
The first patient in a phase I/IIa clinical trial for advanced ovarian cancer using BC-819 began treatment in the second quarter of 2009. The trial is expected to include a total of 12 patients, each receiving nine weekly treatments.
The phase I/IIa trial follows a compassionate use trial conducted in Israel with a patient suffering from ovarian cancer characterized by intra-peritoneal distribution of metastases and ascites, who failed conventional chemotherapy treatment.