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Therion Biologics Corporation Completes Enrollment in Phase II Clinical Trial of PROSTVAC(R)-VF in Androgen Independent Prostate Cancer

Posted on: Thursday, 7 July 2005, 09:00 CDT

CAMBRIDGE, Mass., July 7 /PRNewswire/ -- Therion Biologics Corporation announced that the Company has completed enrollment in its Phase II clinical trial for PROSTVAC-VF in patients with androgen-independent prostate cancer. PROSTVAC-VF is Therion's investigational targeted cancer therapy designed to stimulate a patient's own immune system to seek out and destroy malignant cells expressing PSA.

"Thanks to the enthusiasm for PROSTVAC-VF among the physician and patient community we have been able to enroll this Phase II rapidly," said Mark Leuchtenberger, President and Chief Executive Officer of Therion Biologics Corporation. "We anticipate completing the analysis of the Phase II PROSTVAC- VF trial during the first quarter of 2006 and by the second half of next year Therion should have PROSTVAC-VF in pivotal Phase III studies as our second product to reach such achievement."

"We are currently reviewing a proposal from National Cancer Institute (NCI) for conducting a Phase III PROSTVAC-VF trial with the Eastern Cooperative Oncology Group (ECOG) next year," said Thomas Schuetz, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Therion Biologics Corporation. "The proposed trial, titled PARADIGM, would be a double-blind, controlled study to support a BLA filing for PROSTVAC-VF, and we are gratified that the NCI and ECOG share our conviction in the great potential this drug may have for prostate cancer patients."

About the Phase II Study

The Phase II clinical trial is a randomized, double-blind, controlled study to evaluate the safety and efficacy of PROSTVAC-VF in combination with GM-CSF in patients with androgen-independent prostate cancer. The study has enrolled 120 patients with metastatic disease at over 50 treatment centers across the United States. Patients randomized into the treatment group received an initial "priming" dose of PROSTVAC-VF in combination with GM-CSF, followed by six monthly "booster" vaccinations. Patients randomized into the control arm received inactive vaccine, without the specificity for PSA and the co-stimulatory TRICOM(TM) molecules. The primary endpoint of the study is progression-free survival, defined as the proportion of patients who remain alive and progression-free at the end of the 24-week study. The principal investigator is Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology and Chief, Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute.

In addition to Therion's Phase II trial, PROSTVAC-VF is being studied in several Phase I/II and Phase II studies sponsored by the NCI. Data from three of these studies were presented in May at the 2005 American Society of Clinical Oncology (ASCO) meeting. Four year follow-up safety and preliminary efficacy data from the ECOG prostate cancer study of patients receiving PSA based-vaccines showed promising results with the majority of subjects in the treatment arms remaining free of disease progression and exhibiting stable PSA values at 50 months. Safety and preliminary efficacy data from the NCI Phase I/II study demonstrated that treatment with PROSTVAC-VF was associated with declines in PSA in several patients and a clear decrease in tumor size for two patients. NCI data from a Phase I/II trial in patients with prostate cancer receiving concomitant hormone therapy suggested that patients may respond better to hormone therapy after being treated with PSA-based vaccines.

About PROSTVAC(R)-VF

PROSTVAC(R)-VF is a targeted cancer therapy designed to stimulate a patient's own immune system to seek out and destroy cancer cells expressing epitopes (antigenic peptide sequences) of PSA found in prostate cancer. PROSTVAC(R)-VF is designed to introduce the genes for PSA, and TRICOM(TM) (B7.1, ICAM-1 and LFA-3) -- a proprietary triad of costimulatory molecules essential for maximizing the antitumor cellular immune response -- into a patient's existing antigen-presenting cells. This stimulates the activation and proliferation of an array of cytotoxic T cells, which seek out and destroy cancer cells bearing any of the targeted epitopes. PROSTVAC(R)-VF is currently in a Phase II trial for the treatment of patients with asymptomatic androgen independent 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 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: Titus M.F.M. Plattel Senior Director, Marketing Therion Biologics Corporation (617).475.7312 http://www.therion.com/ Kari Lampka MacDougall Biomedical Communications (508).647.0209 klampka@macbiocom.com

Therion Biologics Corporation

CONTACT: Titus M.F.M. Plattel, Senior Director, Marketing of TherionBiologics Corporation, +1-617-475-7312; or Kari Lampka of MacDougallBiomedical Communications, +1-508-647-0209, klampka@macbiocom.com

Web site: http://www.therion.com/

Source: PRNewswire

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