CAMBRIDGE, Mass., Feb. 10 /PRNewswire/ -- Therion Biologics today announced that the Phase III clinical trial for PANVAC-VF to treat metastatic pancreatic cancer patients has completed enrollment. In addition, PANVAC-VF received Orphan Drug Designation from the Food and Drug Administration (FDA).
“The pace of enrollment for our pivotal Phase III study exceeded our expectations, which both underscores the overall promise of this candidate and moves us potentially through and beyond proof-of-concept towards a BLA filing this year. This study was designed to address the key, unmet medical need of patients with pancreatic cancer in the second-line setting for which there is currently no approved therapy,” said Thomas J. Schuetz, Chief Medical Officer. “We anticipate that this novel therapeutic cancer vaccine could be on the way to approval by 2007.”
The randomized, controlled Phase III clinical trial for PANVAC-VF, being conducted under the guidance of a Special Protocol Assessment (SPA) provided by the FDA, has enrolled 250 patients with pancreatic cancer who had received prior treatment with gemcitabine. The SPA indicates that, if the trial successfully meets its primary endpoint of overall survival, the data will provide the basis for an efficacy claim in a marketing application for PANVAC- VF. Therion plans to submit a Biological License Application (BLA) to the FDA later this year.
Therion’s novel therapeutic cancer vaccine PANVAC-VF, has received Orphan Drug Designation by the FDA for the treatment of patients with pancreatic cancer. In the United States, 32,000 patients annually are diagnosed with pancreatic cancer, while over 31,000 patients annually die from the disease.
The Orphan Drug Designation, which is intended to provide incentives for drug development in diseases involving a small number of patients, provides Therion with substantial benefits, including grants and tax credits for research and development, reduced filing fees for marketing applications, and up to seven years of market exclusivity for PANVAC-VF upon regulatory approval.
Therion is also developing a novel therapeutic cancer vaccine, PROSTVAC- VF, for the treatment of patients with prostate cancer. Today Therion announced the completion of the randomized, double-blind Phase II study in 125 men with advanced prostate cancer. Final clinical data are expected by early Q2 2006. Later this year, Therion expects to start a randomized, double- blind, controlled Phase III PROSTVAC(R)-VF trial in cooperation with the Eastern Cooperative Oncology Group (ECOG) and National Cancer Institute (NCI). The trial, titled PARADIGM, would support a BLA filing for PROSTVAC-VF for the treatment of patients with advanced prostate cancer.
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 is in a Phase III registration trial for the treatment of pancreatic cancer; * PROSTVAC(R)-VF is in Phase II trials for the treatment of prostate cancer.
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 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
Therion Biologics
CONTACT: Titus M.F.M. Plattel, MBA, Vice President, Marketing of TherionBiologics Corporation, +1-617-475-7312, tplattel@therionbio.com; or KariWatson of MacDougall Biomedical Communications, +1-508-647-0209,kwatson@macbiocom.com
Web site: http://www.therion.com//
