Healthcare Industry News: PROSTVAC
News Release - June 3, 2006
Therion Reports Results of Phase 2 PROSTVAC(R)-VF Trial at ASCO Annual Meeting and Formalizes Plan for an NCI-Sponsored Phase 3 StudyPotential Survival Difference Identified in Phase 2 Study
CAMBRIDGE, Mass., June 3 (HSMN NewsFeed) -- Therion Biologics today announced the results of its Phase 2 randomized, double-blind, placebo-controlled clinical trial of PROSTVAC-VF for the treatment of men with advanced prostate cancer at the annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. The trial did not meet its primary efficacy endpoint of improving progression-free survival with PROSTVAC-VF treatment. However, preliminary data suggest that PROSTVAC-VF is associated with a potential reduction in mortality compared to placebo.
Mark Leuchtenberger, CEO of Therion commented, "Even though this study did not meet the primary endpoint, we believe that there are indications that point to a survival benefit in less advanced patient populations and as a result we have formalized plans with the Eastern Cooperative Oncology Group to move into a Phase 3 trial."
PROSTVAC-VF Phase 2 Study Profile
The randomized, controlled Phase 2 clinical trial for PROSTVAC-VF enrolled 125 patients with metastatic, androgen independent, asymptomatic prostate cancer. On average, patients were approximately 73 years old and had had prostate cancer for 8.5 years. The mean baseline PSA in the study, consistent with the presence of metastatic disease, was 149 (normal range < 4.) The primary endpoint of the study was progression-free survival, defined as the proportion of patients who remained alive and progression-free at the end of the 24-week study. Secondary endpoints included time to onset of pain, time to onset of opiate use, and overall survival. The randomization of patients in the study was stratified based on whether or not patients were taking bisphosphonates at baseline. Forty-two percent of the patients in the study were using bisphosphonates at baseline.
PROSTVAC-VF Phase 2 Study Preliminary Results
There was no significant difference between PROSTVAC-VF and Control in the primary endpoint of progression-free survival. However, while the pre-specified statistical analysis on survival is not scheduled to occur until Q4 2006, there is a difference, although not statistically significant, in overall survival favoring PROSTVAC-VF at this time. The suggestion of a survival difference is seen most clearly in the predefined subgroup of patients who were not taking bisphosphonates at baseline. Among this group of patients, 37.5 % of patients who received placebo have died and 22 % of patients who received PROSTVAC-VF have died (p=0.28).
"This controlled study was designed to explore the potential efficacy of PROSTVAC-VF and to inform the design of future registration studies," said Thomas J. Schuetz, Chief Medical Officer. "The survival difference observed in the non-bisphosphonate PROSTVAC-VF patient group, if confirmed through our scheduled follow-up later this year, would certainly clarify the design of a PROSTVAC-VF registration study in this patient population."
PROSTVAC-VF Phase 3 Study
Therion also announced the formalization of plans with the National Cancer Institute (NCI) and Eastern Cooperative Oncology Group (ECOG) for the design of a randomized, double-blind, controlled Phase 3 PROSTVAC-VF trial, which will be called the 'PARADIGM' study. ECOG is primarily funded by the National Cancer Institute and is one of the largest clinical cancer research organizations in the U.S. The PARADIGM study is a randomized, double-blind, controlled Phase 3 study in men with androgen-independent prostate cancer, but no measurable metastatic disease. This is a patient population with less advanced disease compared to the Phase 2 patient population, and they would generally not be taking bisphosphonates. The primary efficacy endpoint will be time-to-overt metastatic disease. PROSTVAC-VF recently was awarded Fast Track designation by FDA in conjunction with the design of the PARADIGM study. The Company intends to submit a request for a Special Protocol Assessment for this study during the summer and begin recruitment for the Phase 3 PARADIGM study under the aegis of ECOG by the end of 2006.
About Therion Biologics Corporation
Therion Biologics Corporation is a leader in the development of novel targeted cancer therapeutics designed to selectively seek out and destroy malignant cells without the serious side effects associated with cytotoxic chemotherapy. The Company has two lead product candidates:
* PANVAC-VF has finalized accrual to a Phase 3 registration trial for the treatment of pancreatic cancer; results will be available in mid 2006.
* PROSTVAC®-VF recently completed a Phase 2 trial for the treatment of prostate cancer; a National Cancer Institute (NCI) Phase 3 study, conducted by the Eastern Cooperative Oncology Group, ECOG, is planned to open by the end of 2006
In addition to these lead product candidates, clinical trials evaluating Therion's innovative targeted therapeutics in colorectal, ovarian, breast and lung cancers are also ongoing or planned. Therion's strategic partners are the National Cancer Institute (NCI) and a network of renowned clinical institutions.
Therion's technology platform has been evaluated over a 14-year period in more than 30 clinical trials comprising close to 1000 patients, chiefly through the Company's longstanding partnership with the NCI. This extensive research has enabled Therion to clinically optimize its technology and maximize the probability for downstream success. Therion's two lead product candidates, PANVAC-VF and PROSTVAC-VF, are a direct result of these efforts.
For more information, please visit http://www.therionbio.com.
Source: Therion Biologics
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