The CEGE CEO stated that the interim for the Vital 1 GVAX Ph 3 trial in asymptomatic AIPC interim occurred as modeled and not earlier. With an extremely low allocated alpha for the interim per the O'Brien Fleming method, the chances of Vital 1 making it then were minimal. Actually, the fact that GVAX can hold its own during its ramp up period against a relatively fast acting cytotoxic such as Taxotere dosing in the control arm is a somewhat postive factor for the final look. Vital 1 allows monthly boosters without limitations if a patient and his doc wish unless and until a patient elects alternate treatment, such as subsequent Taxotere, after the initial 6 month GVAX biweekly dosing. This would seem to be an equal or better choice for patients than the limited three Provenge doses allowed in the 9902b trial. 9902b also allows experimental arm patients to take subsequent Taxotere. Dr. Petrylak's analysis, of course, that immunotherapy in AIPC followed by Taxotere might be very effective. In any event, we should all remember that the 3 year survival rate of Provenge in 9901 was 33%, meaning that 67% of patients in the Provenge experimental arm died within three years. The multi institution rapid autopsy program in AIPC found that most men died of undetected tumors and PAP was not among the 5 antigens that pathologists found predominantly expressed in these occult tumors. Wishing, of course, does not make GVAX or any cancer immunotherapy successful. However, Dr. Small and others have written about the critical need for other antigen taqrgets for immunotherapy in AIPC. The GVAX technology approach is to use a patient's own immune system to destroy and use antigens from irradiated metastatic cell lines genetically modified to express GM-CSF. This approach has proven surprising efficacy in a wide variety of different cancers in both preclinical and Ph 1 and Ph2 clinical trials. I doubt whether the many top docs at Harvard and John Hopkins using GVAX in these clinical trials of various cancers chose to do so because of lack of alternative experimental therapies. There are obviously risks in the Ph3 trials of any oncology product. IMHO, however, the FDA will eventually approve both Provenge and GVAX in AIPC. As an investment, CEGE has the advantage of having a much lower market cap, a more advanced and diverse pipeline and a much better reputation among top docs than DNDN. If GVAX in AIPC is successful in either or both Vital 1 and/or Vital 2, CEGE has the potential of being an enormously successful company. All JMHO.
