ORLANDO, Fla. and CAMBRIDGE, Mass., May 14, 2005 � Therion Biologics Corporation announces the presentation of Phase II data from its PROSTVAC�-VF program for the targeted treatment of patients with prostate cancer at the 2005 American Society of Clinical Oncology (ASCO) meeting, being held May 14-18, 2005. The presentation detailed follow-up clinical results at 50 months from ECOG 7897, a trial conducted by the Eastern Cooperative Oncology Group (ECOG). The data favored Therion�s prime/boost regimen using vaccinia expressing PSA (rV-PSA) followed by fowlpox expressing PSA (rF-PSA) and collectively suggest that men with hormone-dependent prostate cancer and rising PSA may derive long-term clinical benefit from vaccinations with poxviruses expressing PSA.
The oral presentation of abstract number 4501 titled, �Phase II prime/boost vaccination using poxviruses expressing PSA in hormone-dependent prostate cancer: Follow-up clinical results from the ECOG 7897� was given on Saturday, May 14th at 11:15AM by Howard L. Kaufman, M.D. of Columbia University, New York.
�These follow-up results are extremely promising with the majority of subjects in all treatment arms remaining free of disease progression and exhibiting stable PSA scores at 50 months,� commented Dr. Kaufman on behalf of the Eastern Cooperative Oncology Group. �Collectively, these results establish the feasibility of a therapeutic cancer vaccine strategy for men with early hormone-dependent prostate cancer recurrences, and we believe that they support the advancement of Therion�s PROSTVAC-VF program into Phase III studies.�
�The persistent trend at 50 months with PSA and clinical response favoring patients receiving a prime/boost regimen represents the third confirmation of our dosing strategy for our targeted cancer therapies,� commented Thomas J. Schuetz, M.D., Ph.D., Chief Medical Officer of Therion. �These data not only suggest the superiority of our favored prime/boost regimen over the other vaccine strategies used in this study, but they also continue to support the safety profile of our targeted cancer therapy platform.�
About the study:
ECOG 7897 is an ongoing Phase II clinical trial for the evaluation of a prime/boost vaccine strategy using vaccinia virus and fowlpox virus expressing human PSA in patients with hormone-dependent prostate cancer. Sixty-four eligible patients with biochemical (PSA) progression after local therapy were randomly assigned to three treatment arms: (A) rF-PSA by intramuscular injection every six weeks for four doses, (B) rF-PSA for three doses followed by rV-PSA given by intradermal injection, or (C) rV-PSA followed by three rF-PSA vaccines. The patients enrolled in this trial have been followed for PSA response and clinical outcome for a period of 50 months to date. Vaccination was well tolerated. The median time to PSA progression is 9.2 and 9.1 months for arms A and B respectively, compared to 18.2 months for arm C. The median time to clinical progression has still not been reached for any treatment group with 80% of men in arms A and B free of disease progression compared to 90% of men in arm C free of clinical progression.
In addition to the study detailed in today�s announcement, data on Therion�s PANVAC-VF and PROSTVAC-VF programs for pancreatic and prostate cancer respectively will be highlighted in the following upcoming oral presentations and poster sessions:
Oral Presentations:
Abstract 2405
J. Gulley (NCI) Monday
May 16 (7:45 am � 10:45 am)
Developmental Therapeutics: Immunotherapy
Poster Sessions:
Abstract 2576
T. Schuetz (Therion)
Sunday, May 15 (8:00 am � 12:00 pm)
Developmental Therapeutics: Immunotherapy
Abstract 2518
P. Arlen (NCI)
Tuesday, May 17 (8:00am � 12:00 pm)
Developmental Therapeutics: Immunotherapy
Therion will also have a booth (# 1413) at ASCO to educate and recruit oncologists for late-stage studies on the Company�s product candidates.
About PROSTVAC�-VF
PROSTVAC-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-VF is designed to introduce the genes for PSA 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. PROSTVAC-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-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
(508) 647.0209
Onsite at ASCO: 617.470.8388
[email protected]
