Biocancell Therapeutics Ltd. (TASE:BICL) has received authorization from the US Food and Drug Administration (FDA) to begin a Phase I/IIa clinical trial of its BC-819 treatment for ovarian cancer.
Biocancell develops targeted cancer treatments, focusing on the H19 gene, which is found at high levels cancer tissue, but at almost undetectable levels in healthy tissue. Biocancell develops cancer treatments which destroy tumors but leave healthy tissue undamaged.
The goal of the study is check the safety of the treatment, at increasing dosage levels.
The trial is expected to study 12 women in the US and Israel. The company hopes to launch the trial in Israel as soon as it receives authorization from the Helsinki Committees of the medical centers and of the Ministry of Health, and in the US pending local regulatory authorizations.
The treatment was given in a compassionate use case to a patient with ovarian cancer, who responded well and has remained stable for the 14 months since the treatment began.
According to the company, the H19 gene is present in 70-85% of bladder, ovarian, pancreatic, breast, colorectal and hepatocellular cancer patients, and in significant percentages in a large number of other cancer types.
Biocancell shares jumped 48% today, and have gained 285% so far in 2009. Its shares ended 2008 at NIS 40.50.
Published by Globes [online], Israel business news - www.globes-online.com - on January 13, 2009
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