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FOR IMMEDIATE RELEASE
Therion Biologics and National Cancer
Institute Initiate
Phase II Trial of Novel Melanoma Vaccines
-Newest vaccines join Therion's cancer
portfolio with
additional prostate, colorectal and lung cancer
products in efficacy studies-
Cambridge, MA, October 18, 1999 - Therion
Biologics Corporation announced today that it has
initiated a Phase II clinical trial in
collaboration with the National Cancer Institute
(NCI) to evaluate two novel therapeutic vaccines
for treating melanoma. The trial is designed to
evaluate the efficacy of recombinant viral vectors
that express tyrosinase, a melanoma-associated
antigen that has exhibited promising immunogenic
properties in preclinical studies. Like Therion's
other therapeutic products, the new tyrosinase
vaccines are designed to stimulate potent,
tumor-specific immune responses that result in the
destruction of cancer cells.
"Recent clinical research has shown that tyrosinase
is a particularly promising melanoma antigen due to
its ability to stimulate a comprehensive cellular
immune response," said Dennis L. Panicali, Ph.D.,
President and Chief Executive Officer of Therion.
"Because this potentially offers an improved
therapeutic approach for specifically attacking
melanoma cells, we look forward to evaluating these
tyrosinase vaccines in their first human clinical
study."
Dr. Panicali continued, "This new trial is part of
our strategy to rapidly develop and carefully
evaluate in patients a number of promising product
candidates for treatment of major cancers.
Including our recent work in melanoma, Therion and
NCI have successfully advanced seven therapeutic
vaccines from preclinical research to Phase I and
Phase II trials. We look forward to continued
clinical growth through this collaboration."
The latest Phase II study, which will be conducted
in adult patients with metastatic melanoma, is
designed to evaluate clinical responses to multiple
immunizations with two potential products,
recombinant fowlpox and vaccinia viral vectors
encoding tyrosinase. Tyrosinase has been shown to
be commonly expressed in metastatic melanoma
tumors. Therion's tyrosinase vaccines will be
tested alone and in conjunction with interleukin-2
(IL-2), a known immunostimulatory molecule, to
evaluate IL-2's potential to enhance the immune
response. The study is expected to enroll up to 73
patients.
The trial is being conducted as part of an
existing, five-year Cooperative Research and
Development Agreement (CRADA) with the NCI to
advance the development of immunotherapeutic
vaccines for cancer. Suzanne L. Topalian, M.D.,
Senior Investigator, Surgery Branch of the NCI,
will serve as principal investigator for the study;
Steven A. Rosenberg, M.D., Chief of the NCI Surgery
Branch, will serve as associate investigator.
According to the American Cancer Society, the
overall incidence rate for melanoma is increasing
faster than that of any other cancer. Melanoma is
also the most serious form of skin cancer with
41,600 new cases and 7,300 deaths in the United
States in 1998. By the year 2000, an American's
lifetime risk of developing melanoma will be one in
75.
Therion Biologics Corporation is engaged in the
development of therapeutic vaccines for cancer and
preventive vaccines for AIDS. Currently, Therion
has seven products in Phase I and Phase II clinical
development for the treatment of major cancers,
including prostate and colorectal cancers and
melanoma. The Company also has a major corporate
alliance with Pasteur Mérieux Connaught for
the development of therapeutic colorectal cancer
and melanoma vaccines. Therion is headquartered in
Cambridge, Massachusetts.
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Contacts:
Dennis L. Panicali, Ph.D.
President and CEO
Therion Biologics Corporation
(617) 876-7779
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Robert Gottlieb or
Sharon Karlsberg
Feinstein Kean Healthcare Inc
(617) 577-8110
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