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FOR IMMEDIATE RELEASE
Promising Therapeutic Vaccine for
Prostate Cancer
Enters Expanded Clinical Studies
--National Cancer Institute Sponsors
Additional Phase II
trials for Therion Biologics' PROSTVAC VF--
Cambridge, MA, September 7, 2000 - To advance
ongoing clinical studies of a promising new
prostate cancer treatment, Therion Biologics
Corporation and the National Cancer Institute (NCI)
have initiated two additional Phase II trials for
PROSTVAC VF. PROSTVAC VF, a novel vaccine designed
to stimulate and strengthen the body's natural
immune response against prostate tumor cells, has
demonstrated strong Phase I clinical results and
may also have potential utility as a complement to
standard radiotherapy and anti-androgen hormone
therapies. Through the new studies, over one
hundred patients with localized prostate cancer
will receive Therion's PROSTVAC VF product.
Prostate cancer is the second leading cause of
cancer death in men, with an estimated 180,000 new
cases and 37,000 deaths in the U.S. annually. The
trials are part of a broader Collaborative Research
and Development Agreement (CRADA) between Therion
and the NCI's Laboratory of Tumor Immunology and
Biology under the direction of Dr. Jeffrey
Schlom.
"Through our successful partnership with NCI,
Therion continues to build on promising early
clinical data supporting the safety and potential
utility of our lead product, PROSTVAC VF," said
Dennis Panicali, Ph.D., President and Chief
Executive Officer of Therion Biologics Corporation.
"In addition to other ongoing Phase II trials,
these new studies will provide human clinical data
in a broader range of patients, including those
with early-stage disease and those receiving
complementary therapies. Positive Phase II clinical
data will form the foundation for moving our
PROSTVAC VF product into Phase III trials." Dr.
Panicali noted that Therion and its collaborators,
NCI and Dana Farber Cancer Institute, recently
published results from a Phase I study of PROSTVAC
in the May issue of Clinical Cancer Research.
PROSTVAC VF is a recombinant vaccine that targets
prostate-specific antigen (PSA), a protein produced
by prostate tumor cells. Circulating PSA levels
serve as a marker of disease progression. Therion's
PROSTVAC VF product consists of two components,
rV-PSA, which is designed to "prime" or generate an
initial immune response against cells displaying
PSA, and rF-PSA, which is administered subsequently
as a booster to enhance and sustain the immune
response. Additionally, initial dosings in the NCI
Phase II trials will include vaccination with
rV-B7.1 which acts to further strengthen cellular
immune responses against cancer cells.
Study Designs
The first Phase II study will assess the safety
and immunologic effects of PROSTVAC VF in 30
patients who have localized prostate cancer and are
receiving standard radiotherapy. Patients will be
randomized to receive PROSTVAC VF before, during
and after primary radiotherapy with an initial dose
of rV-PSA + rV-B7.1 followed by subsequent rF-PSA
vaccinations. The primary measure of immune
response will be the level of PSA specific T-cells
stimulated by vaccination, with serum PSA levels
used as secondary measures of treatment effects.
Principal investigator Bill Dahut, M.D., of the
National Naval Medical Center will lead this
study.
The second Phase II study will also test the safety
and immunologic effects of PROSTVAC VF, and will
additionally compare the efficacy of PROSTVAC VF to
anti-androgen hormone therapy with Nilutamide.
Anti-androgen therapy is a standard first course of
treatment for patients diagnosed with localized
prostate cancer. Nilutamide is an established
second line treatment for patients with cancer that
has progressed. The study will involve 78 patients
with localized hormone refractory prostate cancer,
and will evaluate comparative evidence of disease
progression as measured by serum PSA levels as well
as effect on immune response. Principal
investigator Philip M. Arlen, M.D., of the National
Institutes of Health (NIH) will lead this
study.
Therion Biologics Corporation is engaged in the
development of therapeutic vaccines for cancer and
preventive vaccines for AIDS. Currently, Therion
has nine products in Phase I and Phase II clinical
development for the treatment of major cancers,
including prostate, colorectal and breast cancer
and melanoma. The Company also has a major
corporate alliance with Aventis Pasteur for the
development of therapeutic vaccines for colorectal
and lung cancers and melanoma. 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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Wendy Soutsos or
Sharon Karlsberg
Feinstein Kean Healthcare Inc
(617) 577-8110
http://www.fkhealth.com
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