Agenus Announces Initiation of Enrollment in NCI-Sponsored Randomized Trial of
Prophage G-200 Vaccine With Avastin in Treatment of Brain Tumors
Study Seeking to Enroll 222 Patients; Largest Vaccine Trial Ever Funded by NCI
in Brain Tumors and the Largest Cancer Vaccine Study Ever Conducted in
Combination With Avastin
LEXINGTON, Mass., May 22, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN)
today announced enrollment has started for a large, randomized Phase 2 study
of Prophage G-200 (Heat Shock Protein Peptide Complex-96 or HSPPC-96) vaccine
in combination with bevacizumab (Avastin^®) for treatment of recurrent
glioblastoma multiforme (GBM) in adult patients. The study is being sponsored
by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative
group of the National Cancer Institute (NCI). The trial is expected to enroll
222 patients in treatment centers across the United States, and is the largest
brain tumor vaccine trial ever funded by NCI and the largest vaccine study
ever conducted with Avastin.
"The initiation of enrollment in this groundbreaking trial to evaluate the
efficacy of treatment with HSPPC-96 in conjunction with bevacizumab in
recurrent GBM represents a major milestone in efforts to develop effective
vaccines for people living with brain tumors.The significant commitment to
this trial from the NCI is also a reflection of the rapidly emerging promise
of vaccines as potential treatment options for millions of people with
different forms of cancer," said Andrew T. Parsa, MD, Ph.D., study chair for
the trial and newly appointed chair of the Department of Neurological Surgery
at Northwestern University.
At the American Society for Clinical Oncology meeting in 2011, Dr. Parsa
presented data indicating that the Prophage G-200 vaccine may help recurrent
GBM patients live longer and suggesting a possible clinical benefit. These
research findings, along with other preclinical and clinical data, were used
to support further testing of Prophage G-200 and were key considerations in
the decision by the NCI to sponsor a clinical trial involving Prophage G-200
combined with Avastin in the treatment of recurrent GBM.
"Our research shows that Prophage Series vaccines have the potential to play
an important role in the treatment of gliomas and other forms of cancer," said
Garo Armen, Ph.D., CEO and chairman of Agenus. "We are very pleased to be
collaborating with the Alliance and NCI on this landmark research effort."
About the ALLIANCE Trial
The ALLIANCE trial will investigate the benefits of treatment with a
combination of HSPPC-96 and bevacizumab in a three-arm design of 222 patients
with surgically resectable recurrent GBM using a primary endpoint of overall
survival.The study will compare efficacy of the HSPPC-96 vaccine administered
with bevacizumab either concomitantly or at progression, versus treatment with
bevacizumab alone. This study design is supported in part by previous research
indicating a potential synergistic effect between the mechanisms of action
behind both HSPPC-96 and bevacizumab.
For additional information about the Alliance Trial visit
About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central nervous system
(CNS) cancers have increased by 25 percent over the last three
decades.^The American Cancer Society estimates that approximately 23,000
malignant tumors of the brain or spinal cord will be diagnosed during 2013 in
the U.S. and approximately 14,000 people will die from these
tumors.Glioblastoma is the most common primary malignant brain tumor and has
been associated with a particularly poor prognosis, with survival rates at one
and five years equaling 33.7% and 4.5%, respectively.^ The current standard
of care for patients with newly diagnosed glioblastoma is surgical resection
followed by fractionated external beam radiotherapy and systemic
temozolomide^ resulting in a median overall survival (OS) of 14.6
months^ based on data from a randomized Phase III trial.Although this
treatment can prolong survival, it is not curative and the vast majority of
patients with glioblastoma experience recurrent disease, with a median time to
recurrence of seven months.^ Currently, there is no standard treatment for
patients with recurrent glioblastoma, although additional surgery,
chemotherapy (i.e., CCNU, temozolomide), bevacizumab, and radiotherapy are
About the Prophage Series Cancer Vaccines
Prophage series cancer vaccines are autologous therapies derived from cells
extracted from the patient's tumor.As a result, Prophage Series vaccines
contain a precise antigenic 'fingerprint' of the patient's particular cancer
and are designed to reprogram the body's immune system to target only cells
bearing this fingerprint, reducing the risk that powerful anti-cancer agents
will target healthy tissue and cause debilitating side effects often
associated with chemotherapy and radiation therapy.The Prophage Series G
vaccines are currently being studied in two different settings of glioma:
newly diagnosed and recurrent disease.
In addition to the recurrent GBM study in G-200, a Phase 2 trial testing
Prophage Series G-100 in patients with newly diagnosed glioma is ongoing. In
this trial, G-100 is being used with the standard of care, which includes
Temodar (Merck; temozolomide) and radiation.
Dr. Parsa has not received any financial support or travel expense
reimbursement for this work or for consulting activities on behalf of
Agenus.Dr. Parsa does not have an equity interest in Agenus or a financial
relationship with the company.
About the Alliance for Clinical Trials in Oncology at NCI
The Alliance for Clinical Trials in Oncology is an NCI cooperative group
formed by the merger of the American College of Surgeons Oncology Group
(ACOSOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer
Treatment Group (NCCTG).
Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on immunotherapeutic
products based on strong platform technologies with multiple product
candidates advancing through the clinic, including several product candidates
that have advanced into late-stage clinical trials through corporate partners.
Between Agenus and its partners, 19 programs are in clinical development. For
more information, please visit www.agenusbio.com.
This press release contains forward-looking statements, including statements
regarding potential clinical trial activities, outcome benefits, and funding
sources. These forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially. These
risks and uncertainties include, among others, the factors described under the
Risk Factors section of our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission for the period ended March 31, 2013. Agenus
cautions investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only as of the
date of this document, and Agenus undertakes no obligation to update or revise
the statements. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement. Agenus' business is subject to
substantial risks and uncertainties, including those identified above. When
evaluating Agenus' business and securities, investors should give careful
consideration to these risks and uncertainties.
1.Cancer Statistics Registrations, England (Series MB1), No. 41 2010
2.Central Brain Tumor Registry of the United States (CBTRUS) 2010 CBTRUS
statistical report: primary brain and central nervous system tumors
diagnosed in the United States in 2004-2006.
3.National Comprehensive Cancer Network clinical practice guidelines in
oncology-central nervous system cancers. v.1.2010.
4.Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.
5.Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging
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Avastin is a registered trademark of Genentech.
CONTACT: Media and Investors:
Jonae R. Barnes
Investor Relations &
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