ORLANDO, Fla. and CAMBRIDGE, Mass., May 16, 2005 � Therion Biologics Corporation announces the presentation of Phase II data from its targeted cancer therapy PROSTVAC�-VF program for the treatment of patients with metastatic androgen-insensitive prostate cancer (AIPC) at the 2005 American Society of Clinical Oncology (ASCO) meeting, being held May 14-18, 2005. The presentation detailed clinical results from a trial conducted by the National Cancer Institute (NCI). The data confirmed the safety profile of Therion�s prime/boost vaccine strategy and treatment with PROSTVAC-VF was associated with declines in PSA in several patients and a clear decrease in tumor size for one patient.
The oral presentation of abstract number 2405 titled, �A Phase II study of a PSA-TRICOM vaccine, and the role of GM-CSF, in patients (pts) with metastatic androgen insensitive prostate cancer (AIPC)� was given on Monday, May 16 at 7:45 a.m. by James Gulley, M.D. of the NCI.
�This is the second oral presentation of important safety and preliminary efficacy data from clinical studies evaluating our prostate cancer vaccines,� commented Thomas J. Schuetz, M.D., Ph.D., Chief Medical Officer of Therion. �Overall, PROSTVAC-VF has been shown to have an effect on PSA and responses in a variety of stages of prostate cancer. What�s notable in this study is that PROSTVAC-VF used in a prime/boost regimen resulted in PSA declines in five patients after just three months of treatment and one patient at eight months of treatment had a clear partial response (50% size decrease in his tumor mass). These preliminary data suggest that PROSTVAC-VF can indeed direct the generation of cytotoxic T cell clones that are capable of destroying tumor cells.�
About the study:
The Phase II study has enrolled 30 patients to-date with metastatic AIPC without prior chemotherapy or progressive disease. Patients were randomized into four cohorts utilizing a prime/boost vaccine strategy with PROSTVAC-VF. Five of the 16 patients that have undergone restaging evaluation at three months have demonstrated PSA declines (4 patients with declines of greater than 30% and 1 patient with a decline of greater than 50%). Six patients continued on study beyond the initial three-month period. One patient at eight months experienced a greater than 50% decrease in the size of his tumor mass. Another patient who remains with stable disease at 10 months of treatment had a 29% decrease in his soft tissue disease. A third patient on study for 11 months continues to have stable disease.
Additional data on Therion�s PROSTVAC-VF program for prostate cancer is included in Abstract number 2518 titled, �Antiandrogen (AA), Vaccine (V), and Combination Therapy in D0.5 Prostate Cancer (CaP) Patients (Pts)�, which will be presented by Dr. Philip Arlen of the National Cancer Institute (NCI) in an ASCO poster session on Tuesday, May 17 from 8:00am � 12:00pm.
Therion also has a booth (# 1413) at ASCO where company representatives are available to discuss investigator opportunities for late-stage studies with 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]
