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FOR IMMEDIATE RELEASE
Therion Biologics and National Cancer
Institute
Initiate Human Clinical Trials of Next-Generation
Product for Colorectal Cancer
Begins Phase I Clinical
Trial of CEA-TRICOM Cancer
Vaccine
Cambridge, MA, February 20, 2001- Therion Biologics
and the National Cancer Institute (NCI) have
initiated a Phase I trial for a new generation of
colorectal cancer vaccines, CEA-TRICOM. This
next-generation product is a novel vaccine that
incorporates a triple dose of co-stimulatory
molecules as well as the CEA tumor antigen.
CEA-TRICOM is designed to stimulate and strengthen
the body's immune system to kill colorectal cancer
cells. In preclinical studies to date conducted by
the NCI and Therion, researchers have demonstrated
that this combination of three co-stimulatory
molecules dramatically boosts the immune response
to eradicate cancer in murine models.
"One of Therion's strengths is its ability to take
leading edge science and rapidly move it into
clinical studies," said Dennis Panicali, Ph.D.,
President and Chief Executive Officer of Therion
Biologics Corporation. "Preclinical studies of
CEA-TRICOM at NCI have shown the vaccine to be
several times more effective than antigen-based
vaccines alone. Based on these results, we believe
that this product has the potential to enhance our
current immunotherapy treatments for patients with
advanced-stage colorectal cancer."
Dr. Panicali noted that Therion is developing its
first-generation colorectal cancer vaccine,
ALVAC-CEA/B7.1, in collaboration with Aventis
Pasteur Limited. Currently in Phase II clinical
studies, Therion and Aventis expect ALVAC-CEA/B7.1
to enter Phase III trials within the next two
years. Unlike CEA-TRICOM, the ALVAC-CEA/B7.1
vaccine utilizes a single co-stimulatory
molecule.
The current clinical trial of CEA-TRICOM with NCI
is designed to demonstrate proof-of-principle for
using multiple co-stimulatory molecules in
conjunction with a tumor antigen to improve the
strength of cellular immune responses. The study
is being conducted as part of an existing
Cooperative Research and Development Agreement
(CRADA) between Therion and the NCI's Laboratory of
Tumor Immunology and Biology. Therion is
developing both CEA-TRICOM and ALVAC-CEA/B7.1
together with Aventis Pasteur as part of their
ongoing collaboration for the advancement of
therapeutic cancer vaccines.
"This trial will give us valuable additional
information about the prime-boost strategy with
poxviruses," said J. Mark Lievonen, President of
Aventis Pasteur in Canada, which is leading an
international research effort to find therapeutic
cancer vaccines. "As well, we expect to learn a
great deal about the use of TRICOM in humans," he
added. "These results will help guide the
evolution of our cancer vaccine program."
CEA-TRICOM is a recombinant, pox virus-based
vaccine that targets carcinoembryonic antigen
(CEA), a protein found on the surface of
colorectal, pancreatic, breast and lung cancer
cells. In the current trial, Therion's CEA-TRICOM
product is administered in a priming and boosting
protocol using two unique pox virus vectors,
rV-CEA-TRICOM and rF-CEA-TRICOM. The TRICOM
component of the vaccine consists of three
co-stimulatory molecules known to elicit strong
cellular immune responses necessary for complete
tumor destruction.
CEA-TRICOM Study Design
The Phase I trial is a multi-stage, dose
escalation study that will assess the safety and
immunologic effects of CEA-TRICOM in up to 42
patients who have advanced metastatic colorectal
cancer. Subjects will receive rF-CEA-TRICOM alone,
rV-CEA-TRICOM followed by booster vaccinations with
rF-CEA-TRICOM, or rV-CEA-TRICOM followed by
rF-CEA-TRICOM and GM-CSF adjuvant. The primary
measure of immune response will be the level of CEA
specific T-cells stimulated by vaccination, with
levels of CEA-expressing tumor cells in the blood
used as a potential secondary measure of treatment
effect. Principal investigator John Marshall,
M.D., of Georgetown University Medical Center will
lead the study at the Vincent T. Lombardi Cancer
Center.
Background on Colorectal Cancer
According to the American Cancer Society,
colorectal cancer is the third most common cause of
cancer death in the U.S., with an estimated 130,000
new cases and 60,000 deaths each year. Although 40
percent of colorectal cancer patients can be
effectively treated with surgery and radiation when
tumors are detected early, nearly 60 percent of
those afflicted will be diagnosed with or progress
to develop metastatic cancer. In patients with
colorectal cancers that have spread regionally to
involve adjacent organs or lymph nodes, the
five-year relative survival rate is around 65
percent. Current standard treatments for
colorectal cancer include surgery, chemotherapy and
radiation.
The limitations of current cancer treatments,
however, suggest the need for novel therapeutic
approaches that keep cancer in check while
maintaining a patient's quality of life. The lead
vaccine product for colorectal cancer emerging from
Therion's collaboration with Aventis,
ALVAC-CEA/B7.1, has demonstrated utility in
patients with metastatic colorectal cancer,
providing initial disease stabilization with
minimal side effects for improved treatment
outcomes.
Therion Biologics Corporation is engaged in the
development of therapeutic vaccines for cancer and
preventive vaccines for AIDS. Currently, Therion
has two lead products for colorectal and prostate
cancer, ALVAC-CEA/B7.1 and PROSTVAC-VF,
respectively, moving into pivotal clinical trials
in the next two years. The company also has a
broad pipeline of vaccines in early clinical
development for treatment of other major cancers,
including breast cancer, lung cancer, melanoma and
other solid tumors. Therion's collaborators
include Aventis Pasteur, the National Cancer
Institute and a network of leading clinical
institutions around the world. 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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Sharon Karlsberg or
Wendy Soutsos
Feinstein Kean Healthcare Inc
(617) 577-8110
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