ORLANDO, Fla. and CAMBRIDGE, Mass., May 15, 2005 � Therion Biologics Corporation announces the presentation of Phase I data from two PANVAC-VF studies for the targeted treatment of pancreatic cancer at the 2005 American Society of Clinical Oncology (ASCO) meeting, being held May 14-18, 2005. The presentation detailed follow-up clinical results from PANVAC-VF and related therapeutic cancer vaccines of study 1 (CEA/TRICOM�) and study 2 (PANVAC-VF). The preliminary data collectively suggest that treatment with PANVAC-VF is well tolerated and results in prolonged overall survival in patients with advanced pancreatic cancer.
The presentation of abstract number 2576 titled, �Extended survival in second-line pancreatic cancer after therapeutic vaccination� was given in an ASCO poster session on Sunday, May 15th by Thomas J. Schuetz, M.D., Ph.D., Chief Medical Officer of Therion.
�Pancreatic cancer is one of the most difficult cancers to treat and historical control data suggest a median overall survival in advanced-stage patients of approximately three months,� commented Thomas J. Schuetz, M.D., Ph.D., Chief Medical Officer of Therion. �Although these studies were small and uncontrolled, the median overall survival is more than double the expected value based on historical control data. Notably, patients in these studies were treated in the second- and third-line setting and one-year survival was 32%; this compares very favorably to studies in which patients are treated in the first-line setting and one year survival is in the range of 20%.�
Therion is currently conducting a randomized, controlled Phase III clinical trial for PANVAC-VF under the guidance of a Special Protocol Assessment (SPA) provided by the FDA. 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.
About PANVAC-VF
PANVAC-VF is a targeted cancer therapy designed to stimulate a patient�s immune system to seek out and destroy cancer cells expressing epitopes (antigenic peptide sequences) of CEA and MUC-1, two proteins found in many tumors, including over 90% of all pancreatic cancers. PANVAC-VF is designed to introduce the genes for CEA, MUC-1, and TRICOM� (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. PANVAC-VF is currently in a Phase III trial for the treatment of patients with advanced pancreatic cancer.
About the studies:
Twenty-two patients with Stage III or IV pancreatic cancer were enrolled into the two Phase I studies, both designed to evaluate the safety of PANVAC-VF and related therapeutic vaccines. All patients had received prior therapy. All patients continue to be followed for survival. No serious adverse events (AE) related to the vaccine occurred and the most commonly reported AE�s were grade one injection site reactions. Median overall survival (OS) in the two studies was 7.9 and 6.3 months, respectively. One year survival was 33% and 30%. Twenty five percent of the patients were alive at 18 months in the first study and one patient is alive at 2+ years.
In addition to Dr. Schuetz and K. Manson of Therion, authors on the abstract included H. L. Kaufman of Columbia University, New York; J. L. Marshall of Georgetown University, Washington, DC; and H. Safran of Brown University, Providence, RI.
Upcoming Presentations at ASCO
Therion�s PROSTVAC�-VF program for prostate cancer will be highlighted in the following upcoming oral presentation and poster session:
Oral Presentation:
Abstract 2405
J. Gulley (NCI)
Monday, May 16 (7:45 am � 10:45 am)
Developmental Therapeutics: Immunotherapy
Poster Session:
Abstract 2518
P. Arlen (NCI)
Tuesday, May 17 (8:00 am � 12:00 pm)
Developmental Therapeutics: Immunotherapy
Therion also has a booth (# 1413) at ASCO where company representatives are available to discuss investigator opportunities for late-stage studies on 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 is in a Phase III registration trial for the treatment of pancreatic cancer;
� PROSTVAC-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 www.therion.com.
Contacts:
Titus M.F.M. Plattel
Senior Director, Marketing
Therion Biologics Corporation
(617) 475.7312
www.therion.com
Kari Lampka
MacDougall BioCommunications
On site at ASCO: 617.470.8388
(508) 647.0209
[email protected]
