Therion Biologics Announces Conclusion Of PANVAC-VF Phase 3 Trial

Main Category: Pancreatic Cancer
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 02 Jun 2006 - 0:00 PDT

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Therion Biologics today announced the conclusion of the Phase 3 trial of its novel therapeutic cancer vaccine, PANVAC-VF, in advanced pancreatic cancer, triggering analysis of the study results.

"The conclusion of our first pivotal study is a major milestone for Therion. We look forward to reporting the study results this summer, and if they are positive, we anticipate that the Biologics License Application (BLA) for PANVAC-VF will be submitted later this year," noted Mark Leuchtenberger, CEO of Therion.

The Phase 3 trial enrolled 255 patients with advanced pancreatic cancer, and was conducted under a Special Protocol Assessment (SPA) from the FDA. The SPA indicates that, if the trial meets its primary endpoint of overall survival, the results will provide the basis for an efficacy claim in a marketing application. PANVAC-VF has also 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 and over 31,000 patients annually die from the disease.

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 cancer. Preliminary results of a Phase 2 study of patients with advanced ovarian cancer treated with PANVAC-VF will be presented by Dr. James Gulley from the NCI at the American Society of Clinical Oncologists (ASCO) Meeting in Atlanta, Georgia.

Upcoming Presentations at ASCO

Therion's targeted immunotherapeutics, PANVAC-VF and PROSTVAC(R)-VF, will be highlighted in the following upcoming oral presentations and poster sessions:

Oral Presentations:

Abstract 2501

Randomized, double-blind, vector-controlled study of targeted immunotherapy in patients (pts) with hormone-refractory prostate cancer (HRPC) Saturday, June 3 (8:30 - 8:45 am); Presenter: Philip Wayne Kantoff, MD; Session: Immunotherapy in Prostate Cancer: Progress and Trials

Abstract 2512

A pilot study of a PANVAC-V and PANVAC-F in patients (pts) with metastatic carcinoma Sunday, June 4 (10:30 - 10:45 am); Presenter: James Gulley, MD, PhD, FACP; Session: Developmental Therapeutics: Immunotherapy

Poster Sessions:

Abstract 2567

A novel non-HLA-restricted cellular immune assay for monitoring patient (pt) response to targeted immunotherapeutics Sunday, June 4 (2:00 - 6:00 pm); Presenter: Kelledy Manson, MS; Session: Developmental Therapeutics: Immunotherapy

Abstract 2531

A randomized pilot study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen independent prostate cancer Tuesday, June 6 (8:00 am - 12:00 pm); Presenter: Philip M Arlen; Session: Developmental Therapeutics: Immunotherapy

Therion also has a booth (#3261) at ASCO where Company representatives will be available to discuss investigator opportunities for late-stage studies of the Company's product candidates.

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(R)-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.

Therion Biologics
http://www.therionbio.com/

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