First Patient Enrolled In Investigator-Sponsored Phase 1/2 Trial Of Antigenics Inc. (New York)' Oncophage Cancer Vaccine In Glioma
NEW YORK, Nov. 21 /PRNewswire-FirstCall/ -- Antigenics Inc. 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.
Antigenics Inc.CONTACT: Sunny Uberoi, Corporate Communications, +1-212-994-8206,suberoi@antigenics.com, or Shalini Sharp, Investor Relations,1-800-962-2436, ir@antigenics.com, both of Antigenics Inc.