Sponsored by
NEW YORK, Nov. 21 /PRNewswire-FirstCall/ -- Antigenics Inc. (Nasdaq: AGEN)
today announced that the Brain Tumor Research Center at the University of
California, San Francisco, has initiated a Phase 1/2 clinical trial of
Oncophage(R) (vitespen; formerly HSPPC-96), Antigenics' investigational
patient-specific cancer vaccine, as a treatment for patients with recurrent
glioma. The primary goal of the investigator-sponsored study is to establish
the feasibility, safety and preliminary efficacy of Oncophage vaccination in
glioma patients. Glioma is a cancer affecting the central nervous system
(brain and spinal cord) that begins in the connective tissue that surrounds
and supports nerve cells. Malignant glioma is currently a fatal disease.
"Once patients with malignant glioma fail conventional therapy, such as
radiation and chemotherapy, there are limited treatment options. Therapeutic
vaccine approaches such as Oncophage offer the potential to specifically
target tumor cells without injury to normal, healthy cells," said Andrew T.
Parsa, MD, PhD, assistant professor in the department of neurological surgery
at the University of California, San Francisco, and principal investigator of
the trial. "Our trial builds on excellent work done by many investigators
demonstrating the feasibility and potential efficacy of immunotherapy for the
treatment of brain tumors. Other investigators have shown promising results
with single-peptide or dendritic cell vaccines. Oncophage has the potential
advantage of effectively generating an immune response against multiple tumor
peptides, without requiring dendritic cell isolation."
Derived from each individual's tumor, Oncophage, which is an
investigational therapy, contains the 'antigenic fingerprint' of the patient's
particular cancer, and in theory is designed to reprogram the body's immune
system to target only cancer cells bearing this fingerprint. Oncophage is
intended to leave healthy tissue unaffected and limit the debilitating side
effects typically associated with traditional cancer treatments such as
chemotherapy and radiation therapy. Oncophage has been granted fast track and
orphan drug designations from the US Food and Drug Administration (FDA) in
both metastatic melanoma and renal cell carcinoma.
Study Details
The Phase 1/2 trial is designed to enroll about 60 patients with primary
or recurrent high-grade glioma. Patients will undergo surgery to remove their
tumors, which are then used to manufacture their patient-specific vaccines.
According to the protocol, primary patients will receive vaccine upon
recurrence, whereas patients with recurrent disease will be treated after
surgery.
The trial is designed to sequentially evaluate the safety of three dosing
regimens of Oncophage. The objectives of the two-phase trial are to determine
the safety of Oncophage in this patient population; clinical response to
therapy, including time to disease progression and overall survival rate; and
immune response to therapy. The trial will be supported through a grant from
the American Brain Tumor Association and the National Cancer Institute Special
Programs of Research Excellence.
About Brain and Spinal Cord Tumors
The American Cancer Society estimates that 18,500 malignant tumors of the
brain or spinal cord will be diagnosed during 2005 in the United States, and
that about 12,760 people will die from these tumors. Primary malignant brain
tumors are uniformly fatal, and the five-year survival rate for the highest
grade of malignant glial neoplasm, glioblastoma multiforme, is less than 2
percent. Brain and spinal cord tumors account for about 1 percent of all
cancers and 2 percent of all cancer-related deaths.
About UCSF
UCSF is a leading university that consistently defines health care
worldwide by conducting advanced biomedical research, educating graduate
students in the life sciences, and providing complex patient care. For more
information, please visit http://www.ucsf.edu.
About Antigenics
Antigenics is working to develop patient-specific immunotherapeutics and
revolutionary treatments for cancers, infectious diseases and autoimmune
disorders. The company's lead product candidate is Oncophage(R) (vitespen;
formerly HSPPC-96), a late-stage, patient-specific cancer vaccine being
evaluated in several indications, including renal cell carcinoma and
metastatic melanoma. Antigenics' portfolio of investigational products also
includes AG-858 (HSPPC-70), a patient-specific cancer vaccine in Phase 2
development; two liposomal cancer treatments, Aroplatin(TM) and ATRA-IV; and
AG-707, a Phase 1 genital herpes vaccine. For more information, please visit
http://www.antigenics.com.
This press release contains forward-looking statements, including
statements regarding the potential of Oncophage to specifically target tumor
cells without injury to normal, healthy cells, and the potential advantage of
Oncophage in effectively generating an immune response against multiple tumor
peptides without requiring dendritic cell isolation. These statements are
subject to risks and uncertainties that could cause actual results to differ
materially from those projected in these forward-looking statements. These
risks and uncertainties include, among others, that the Phase 1/2 trial of
Oncophage in glioma may indicate that it causes side effects or that it has
limited clinical utility; even if the results from this trial are positive,
significant additional trials, the outcome of which are uncertain, would be
required before submitting an application for marketing approval; decisions by
regulatory agencies; timing and results of preclinical studies; and the
factors described under Factors That May Impact Future Results in the
Management's Discussion and Analysis of Financial Condition and Results of
Operations section of Antigenics' Form 10-Q as filed with the Securities and
Exchange Commission on November 4, 2005. Antigenics cautions investors not to
place considerable reliance on the forward-looking statements contained in
this press release. These statements speak only as of the date of this
document, and Antigenics undertakes no obligation to update or revise the
statements. All forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Antigenics' business is subject to
substantial risks and uncertainties, including those identified above. When
evaluating Antigenics' business and securities, investors should give careful
consideration to these risks and uncertainties.
SOURCE Antigenics Inc.
Web Site: http://www.antigenics.com http://www.ucsf.edu