Genitope Maintains Positive View On MyVax Despite DSMB Interim Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Data safety monitoring board recommends Genitope continue a Phase III trial of the cancer vaccine, suggesting more data is needed.
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Genitope's cash position is strong enough to carry the company through 2007 when the final results of a critical Phase III trial evaluating the company's MyVax therapeutic cancer vaccine will be complete. "We believe that our current cash position is adequate to cover us through 2007 and that would carry us through the final results," Chief Financial Officer John Vuko stated during an Aug. 17 conference call addressing interim results of the pivotal trial. The final results of the Phase III study are expected in December 2007. MyVax is the company's lead drug candidate, which it is studying for the treatment of follicular non-Hodgkin's lymphoma. Genitope announced in July that an independent data safety monitoring board recommended that the Phase III trial continue following a planned interim analysis of efficacy data. The recommendation suggests that more data are needed to determine the efficacy of the cancer vaccine. "They did a very exhaustive review...and after the review their recommendation was that we continue the trial as planned," CEO Dan Denney said during the Aug. 17 call. "We were hoping that the curve would separate early, that we would see a lower median in the control group than we had designed the trial against," he admitted. Nonetheless, the exec said the trial appears to be replicating results seen in Phase II and that progression is dramatically slowing among patients further out in time. "These data are suggesting that we're fighting the disease post immunization," he said. "It's further out in time then we would have imagined, that we've lost the race on more of the patients early on, [but] once you start winning the race, you really start winning it. You win it for the vast, vast majority of patients." The Phase III trial is comparing the safety and efficacy of MyVax to a non-specific immunotherapy control, with the primary endpoint being progression-free survival. The study included 287 patients with previously untreated follicular non-Hodgkin's lymphoma randomized to treatment following a chemotherapy treatment period and a six-month rest period. The interim analysis included a Kaplan-Meier estimate of the probability of progression-free survival generated using the blinded data for all 287 randomized patients. However, the Kaplan-Meier estimate did not show a significant separation between patients treated with MyVax and the control group, the company reported. As of June 15, 2006, 158 patients had shown progression dates, while 129 patients, including those lost to follow up, had no documented progression, the company said in an Aug. 16 8-K filing with the Securities & Exchange Commission. Of the 129 patients, 83 had no signs of progression after 18 months had elapsed between randomization and the last documented clinical follow-up. "Of the 158 patients with documented progression dates, 28 had progression dates at least 18 months post the randomization dates with the remaining 130 patients having progression dates less than 18 months post the randomization dates," the company said. Genitope used the proceeds from an initial public offering in 2003 to fund the trial. However, at the time, the company said it expected to be in a position to file a BLA for MyVax by the end of 2005. Several companies investigating cancer vaccines have had difficulty demonstrating a significant survival benefit following treatment with the therapies. Therion announced it is seeking a buyer in June after its advanced pancreatic cancer therapy PANVAC-VF failed to meet its primary efficacy endpoint in a Phase III trial (1 (Also see "Cancer Vaccine Maker Therion Is Up For Sale After Disappointing Phase III Results" - Pink Sheet, 28 Jun, 2006.)). CancerVax dropped its Canvaxin , studied in melanoma, due to a lack of survival data, and Corixa terminated its melanoma vaccine Melacine after FDA requested additional studies. On a more positive front, Antigenics recently said a full analysis of Phase III data on its kidney cancer vaccine Oncophage supports continued development of the product after a clinically significant improvement in recurrence-free survival was seen in a subgroup of patients with a better prognosis (2 (Also see "Antigenics Will Collect Survival Data Before Taking Next Steps With Oncophage Vaccine" - Pink Sheet, 7 Jun, 2006.)). |