CAMBRIDGE, Mass., June 28 /PRNewswire/ -- Therion Biologics today
announced the results of its Phase 3 randomized, controlled clinical trial
of PANVAC-VF for the treatment of patients with advanced pancreatic cancer.
The trial did not meet its primary efficacy endpoint of improving overall
survival compared with palliative chemotherapy or best supportive care, and
the company no longer plans to file a Biologics License Application (BLA)
with the FDA.
The Phase 3 trial enrolled 255 patients with advanced pancreatic
cancer, and was conducted under a Special Protocol Assessment (SPA) from
the FDA. Based on the median overall survival of over six months in two
Phase 1 studies, the Phase 3 study was powered to detect a two-month
improvement over control chemotherapy. The study was conducted at
approximately 60 centers in the United States and accrued patients from
June 2004 through January 2006.
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
cancers. Preliminary results of a Phase 2 study of patients with advanced
ovarian cancer treated with PANVAC-VF were presented by Dr. James Gulley
from the NCI at the American Society of Clinical Oncology (ASCO) Annual
Meeting in Atlanta, Georgia.
Therion Biologics previously announced the results of its Phase 2
randomized, double-blind, placebo-controlled clinical trial of PROSTVAC-VF
for the treatment of men with advanced prostate cancer also at the ASCO
Annual Meeting. The trial did not meet its primary efficacy endpoint of
improving progression-free survival with PROSTVAC-VF treatment. However,
preliminary data suggest that PROSTVAC-VF is associated with a potential
reduction in mortality compared to placebo.
Therion also announced that its investors have identified an investment
bank to manage the sale of the company. The sales process will commence
immediately and is expected to conclude in several months.
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. 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:
Mark Leuchtenberger
President and CEO
Therion Biologics Corporation
(617).475.7209
http://www.therionbio.com
Kari Watson
MacDougall Biomedical Communications
(508).647.0209
kwatson@macbiocom.com
SOURCE Therion Biologics
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Related links:
http://www.therion.com
CONTACT:
Mark Leuchtenberger, President and CEO of
Therion Biologics Corporation, +1-617-475-7209; or Kari Watson of
MacDougall Biomedical Communications, +1-508-647-0209,
kwatson@macbiocom.com
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