CAMBRIDGE, Mass., June 28 /PRNewswire/ -- Therion Biologics today announced the results of its Phase 3 randomized, controlled clinical trial of PANVAC-VF for the treatment of patients with advanced pancreatic cancer. The trial did not meet its primary efficacy endpoint of improving overall survival compared with palliative chemotherapy or best supportive care, and the company no longer plans to file a Biologics License Application (BLA) with the FDA.
The Phase 3 trial enrolled 255 patients with advanced pancreatic cancer, and was conducted under a Special Protocol Assessment (SPA) from the FDA. Based on the median overall survival of over six months in two Phase 1 studies, the Phase 3 study was powered to detect a two-month improvement over control chemotherapy. The study was conducted at approximately 60 centers in the United States and accrued patients from June 2004 through January 2006.
In addition to advanced pancreatic cancer, PANVAC-VF is being investigated in studies sponsored by the National Cancer Institute (NCI) for the treatment of advanced ovarian, colorectal, and non-small cell lung cancers. Preliminary results of a Phase 2 study of patients with advanced ovarian cancer treated with PANVAC-VF were presented by Dr. James Gulley from the NCI at the American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta, Georgia.
Therion Biologics previously 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 also at the ASCO Annual Meeting. 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.
Therion also announced that its investors have identified an investment bank to manage the sale of the company. The sales process will commence immediately and is expected to conclude in several months.
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. Therion’s strategic partners are the NCI and a network of renowned clinical institutions. Therion’s technology platform has been evaluated over a 13-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.therion.com.
Contacts: Mark Leuchtenberger President and CEO Therion Biologics Corporation (617).475.7209 http://www.therionbio.com Kari Watson MacDougall Biomedical Communications (508).647.0209 kwatson@macbiocom.com
Therion Biologics
CONTACT: Mark Leuchtenberger, President and CEO of Therion BiologicsCorporation, +1-617-475-7209; or Kari Watson of MacDougall BiomedicalCommunications, +1-508-647-0209, kwatson@macbiocom.com
Web site: http://www.therion.com/
