The company said it has sought scientific advice on final aspects of the trial design from regulatory authorities in Europe and the US and expects to initiate patient enrollment during the summer of 2007.
The trial is designed to expand evidence for the safety and efficacy of Genasense combined with dacarbazine for patients who have not previously been treated with chemotherapy. Genasense in melanoma has been designated an orphan drug in Australia and the US, and the drug has fast track designation in the US.
“As the lead investigative site in the prior trial, we were highly gratified by seeing results that exceeded those from any other randomized study in patients with advanced melanoma,” commented Dr Agop Bedikian, professor of Medicine, MD Anderson Cancer Center.
Genasense is a targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.