Cell Genesys Searches for Prostate Cancer Cure

Those who believe investing is simply a matter of evaluating the bottom line have obviously not examined the fundamentals of too many biotech corporations. Many emerging biotech firms are years away from actual production, and have horrific balance sheets. That does not mean potential investors should shy away from them altogether, but they really need to understand the story and how likely it is that the company will deliver the goods.

Just like panning for gold or drilling for oil, what these companies do offer is hope. In the case of Cell Genesys (CEGE) it is the hope for a cure to prostate cancer, the second-deadliest form of cancer among men.

While CEGE focuses on a variety of different cancers and treatment options, it is the company's GVAX immunotherapy for prostate cancer that is invoking memories of Louis Pasteur.

GVAX immunotherapy for prostate cancer is, in essence, a vaccine designed to enlist the body's own immune system to ward off unhealthy, or cancerous, cells. And clinical trials seem to suggest that GVAX has at least landed some early punches in the fight.

In a recent Phase-II trial consisting of 80 Hormone Refractory Prostate Cancer [HRPC] patients, the survival time for the 22 who were administered the highest GVAX dosage is expected to exceed 29.1 months — significantly better than the 19.3 months achieved by Taxotere® (currently the best option for treating HRPC) in a similar, albeit larger, trial.

In fact, Cell Genesys is so optimistic about GVAX as a remedy for prostate cancer that the company asked for and was granted Fast Track status by the FDA in May of 2006. A Fast Track designation helps to expedite the review process and Biologics License Applications (BLAs) for potential life-saving drugs and procedures.

Cell Genesys is currently conducting two Phase-III trials of GVAX immunotherapy for prostate cancer.

The first (VITAL-1) began in July 2004 and compares GVAX to Taxotere® chemotherapy administered with prednisone (an immunosuppressant), while the second (VITAL-2) commenced in June 2005 and compares GVAX plus Taxotere® to Taxotere® plus prednisone.

If those trials go well, all that red ink may turn black — and lives could be saved or prolonged in the process.

Not such a bad investment, perhaps.

Disclosure: none