good news in their 8 k
Item 8.01. Other Events.
Recent Developments
Genitope Corporation previously announced that its independent Data Safety Monitoring Board, or DSMB, met on November 15, 2004 to review preliminary data from the company’s pivotal Phase 3 (2000-03) clinical trial to evaluate the safety and efficacy of the company’s lead product candidate, MyVax ® personalized immunotherapy, in patients with previously untreated follicular non-Hodgkin’s lymphoma. After reviewing safety data for the entire Phase 3 clinical trial and blinded, preliminary immune response data for more than 100 of the initial patients immunized in the Phase 3 clinical trial, the DSMB noted no concerns and recommended that the trial continue as planned.
Testing of patient serum samples from our blinded Phase 3 clinical trial (2000-03) was conducted to determine the presence of an immune response directed against the tumor idiotype portion of MyVax Ò personalized immunotherapy. This testing looked for the presence of anti-idiotype antibodies. We have tested Phase 3 clinical trial samples from 122 treated patients.
Our testing looked for an increase in the level of anti-idiotype antibodies present in a patient’s sera at any time over the course of immunization. Anti-idiotype antibody responses were observed. In order to assess how the rate of response compared to that observed in our Phase 2 (9901) clinical trial, serum samples from the 21 patients treated in the Phase 2 clinical trial and serum samples from 122 patients treated in the Phase 3 clinical trial were retested using the same reagents. Patients treated in the Phase 2 clinical trial received five doses of MyVax Ò personalized immunotherapy over a 24 week period, while patients treated in the Phase 3 clinical trial received seven doses of either MyVax Ò personalized immunotherapy or the control non-specific immunotherapy over a 24 week period. Assuming that all anti-idiotype antibody responses seen in the Phase 3 clinical trial samples were from patients assigned to the experimental arm (patients who received MyVax Ò personalized immunotherapy), the anti-idiotype antibody response rate seen to date in the Phase 3 clinical trial is meaningfully higher than that observed in the Phase 2 clinical trial.
To date, no correlation between the presence of an anti-idiotype immune response and clinical benefit has been demonstrated in a controlled clinical trial. The final immune response rate obtained when all patients treated in the Phase 3 clinical trial are tested may differ from the results observed in the 122 patients tested to date. In addition, our testing was not designed to examine whether anti-idiotype immune responses were restricted to the patient-specific portion of MyVax Ò personalized immunotherapy. Further, there is a significant difference in the number of patients evaluated in the Phase 2 clinical trial and the Phase 3 clinical trial to date. Therefore, undue reliance should not be placed on this information. |
