With the risk of sounding like a broken record, all the positive indications coming from GVAX are far from being concrete evidence. Showing efficacy and good safety profile in numerous small clinical trials is never a substitution for large phase III trials, which often have contradicting results to earlier clinical trials. Bearing this in mind, there seems to be a great deal of consistency in GVAX’s case.
First, the same platform was used to create cancer vaccines against 3 different kinds of cancer and demonstrated favorable results when compared to historical data for the current standard therapies. Second, a systemic immune response was observed in all the trials, mainly in patients who responded to the treatment. This is an indication for GVAX’s ability to stimulate the immune system in multiple cancer types. Third, there were almost no severe side effects throughout the trials, making GVAX’s safety profile superior to that of standard treatments like chemotherapy and bone marrow transplantation. As a result, it may become an ideal treatment especially for people who cannot cope with standard therapy. Furthermore, it opens the way for combining GVAX with conventional treatments. Fourth, in GVAX for prostate cancer, not only did the results from 2 different clinical trials compare favorably to available treatments, survival figures were almost identical. Fifth, the Sidney Kimmel Cancer Center at Johns Hopkins, one of the leading oncology centers in the US, chose to conduct and finance follow-on trials for both GVAX for pancreatic cancer and GVAX for Leukemia. The center is entitled to milestone payments and royalties derived from future sales of the drug, if successful, which makes this move an even bigger reinforcement. The medical center professionals would have never have agreed to finance these trials if they hadn’t regarded GVAX as a promising treatment.
Even after reviewing Cell Genesys’ promising prospects, it must be clear that any company in clinical stages is a speculative high-risk play by definition. Bearing in mind that in drug development there are many more failures than successes, it would be foolish to expect Cell Genesys to be different from any other company in this frustrating field. However, the impressive consistency demonstrated by GVAX in multiple clinical trials for multiple types of cancer combined with ongoing clinical evaluations for more than 10 different conditions and regimens make GVAX very compelling in terms of risk/reward ratio, even if most trials fail.