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BioCancell's ovarian cancer drug wins orphan drug status

Posted on: Wed, 26 Aug 2009 09:50:00 EDT

Symbols: TIKRF

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Aug 26, 2009 (Datamonitor via COMTEX) --
TIKRF | Quote | Chart | News | PowerRating -- Tikcro Technologies, a development-stage company, has reported that the US Department of Health and Human Services has granted orphan drug status to BioCancell Therapeutics's BC-819 drug, currently in Phase I/IIa clinical trials, for its 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 addresses patients suffering from advanced ovarian cancer characterized by ascites, peritoneal cavity fluid containing cancerous cells that did not previously respond to standard treatment for the disease. The trial is expected to include a total of 12 patients, each receiving nine weekly treatments.

This 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. The results of the compassionate trial showed that the drug caused no serious adverse events at any dosage, Tikcro said.

Additionally, the patient's blood showed a 50% decrease of the ovarian cancer marker protein CA-125, and a significant decrease in the number of cancerous cells in the ascites was measured. Clinical improvement was reported in the patient's condition.

Tikcro holds 36% of Biocancell (after conversion of notes and exercise of warrants), and 27% on a fully diluted basis. BioCancell Therapeutics is a biotechnology company engaged in the development of patient oriented targeted therapy for the treatment of a range of cancers.

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