NEW YORK (AP) - BioSante Pharmaceuticals Inc. has announced that its pancreatic cancer therapy improved survival in an early clinical trial.
The Lincolnshire, Ill., company said patients who were treated with the pancreatic cancer version of its GVAX therapy had median survival of 5.5 months from the start of treatment, and eight of the patients lived for at least one year. Patients who did not receive GVAX Pancreas had median survival of 3.3 months and two of them lived for one year or more.
The drug was tested on 30 patients in an early-stage clinical trial. All patients had advanced or metastatic pancreatic adenocarcinoma, which is the most common type of pancreatic cancer. All patients in the study were treated with Bristol-Myers Squibb Co.'s drug Yervoy, which was approved in 2011 as a treatment for skin cancer.
BioSante said the study was not designed to compare GVAX Pancreas and Yervoy. It said the side effects of its drug were "manageable."
GVAX Pancreas is made from the patient's cancer cells. The cells are genetically modified to produce a protein that stimulates the immune system, and they are irradiated to prevent cancer cell growth. The Food and Drug Administration has awarded the therapy orphan drug status, which means BioSante may be able to conduct faster studies of the drug and if it is approved, the company will have years of marketing exclusivity.
The company acquired GVAX in 2009, when it bought Cell Genesys Inc. BioSante is also studying GVAX treatments for prostate cancer, leukemia, breast cancer, and myeloma.
BioSante developed the hot flash treatment Elestrin, and earlier this month regulators approved Bio-T-Gel, a testosterone gel it licensed to Teva Pharmaceutical Industries Ltd. Its most advanced drug candidate is LibiGel, a testosterone gel that is intended to treat sexual dysfunction in women. However in 2011 BioSante said the drug failed in two late-stage clinical trials.
Date: February 27, 2012
Source: Associated Press