Genta Inc.'s phase 3 clinical; trial of chemotherapy with or without Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) met its goal of increasing the proportion of patients who achieved a complete or nodular partial remission.

In this trial, 241 patients were treated with fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense. The study prospectively defined disease-related symptoms that included fever, night sweats, fatigue, abdominal discomfort or early satiety due to enlargement of liver or spleen, and impaired cosmesis or mobility due to enlarged lymph nodes, states the company release.

"The analysis from this large, prospective, randomised trial reconfirms what has been intuitively understood by oncologists and haematologists, namely that the achievement of complete remission is highly beneficial for patients with leukaemia," said Dr. Loretta M. Itri, chief medical officer and president, pharmaceutical development, Genta.

"We look forward to improving on these results when we extend the use of Genasense into studies of patients with less advanced disease," he added.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development programme with Genasense evaluating its potential to treat various forms of cancer.

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.