BioSante Pharmaceuticals, Inc. announced publication of results from a phase II clinical study that show BioSante’s Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 per cent. In addition, the vaccine demonstrated a 35 per cent increase in one year survival, from 63 per cent to 85 per cent. A new multi-centre clinical study is planned to begin this year.

In the study, titled, “A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumour Vaccine for Pancreatic Adenocarcinoma: A phase II trial of Safety, Efficacy, and Immune Activation,” published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses.

The median disease-free survival of patients was 17.3 months (95% CI, 14.6–22.8) with median survival of 24.8 months (95% CI, 21.2–31.6). The administration of immunotherapy was well tolerated. In addition, the post-immunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that “an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer.”

The 60 patient phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Centre in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante’s Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. BioSante already has received Orphan Drug designation from the US Food & Drug Administration for the pancreas cancer vaccine.

“We are very excited by the positive results of this study. This is encouraging news concerning potential treatment for a disease that can be so devastating for so many patients,” said Stephen M Simes, BioSante’s president & CEO. “Besides pancreatic cancer, Johns Hopkins researchers also are investigating the use of BioSante’s cancer vaccines for the treatment of several different forms of cancer, including leukaemia, breast cancer and multiple myeloma. We look forward to continuing our collaboration with this well-respected research institute as further studies are conducted.”

About 95 per cent of pancreatic cancer is adenocarcinomas. Patients with pancreatic cancer have one of the poorest five-year survival rates of any form of cancer with median survival around three to six months. Pancreatic cancer is sometimes called a “silent killer” because it does not always cause noticeable symptoms and most symptoms are non-specific and varied.

It is for this reason that pancreatic cancer often is not diagnosed until the disease is too advanced for current treatment options to be effective. Therefore, in view of the current poor patient prognosis, the need for novel and improved pancreatic cancer treatments is urgent.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology and its lead products include LibiGel (transdermal testosterone gel) for the treatment of Female Sexual Dysfunction (FSD) which is in phase III clinical development under a US Food and Drug Administration (FDA) Special Protocol Assessment.