-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, A26JiD71jV444ndM2FHkYFm6QebTvJQ99Vju8rOBWJi1aXV4XlTFuWl375JRlw5P pB66b9DOz5idvtRgM3k/xg== 0001157523-07-009707.txt : 20071010 0001157523-07-009707.hdr.sgml : 20071010 20071010082018 ACCESSION NUMBER: 0001157523-07-009707 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071010 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071010 DATE AS OF CHANGE: 20071010 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANTIGENICS INC /DE/ CENTRAL INDEX KEY: 0001098972 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061562417 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29089 FILM NUMBER: 071164112 BUSINESS ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 BUSINESS PHONE: 212-994-8200 MAIL ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2100 CITY: NEW YORK STATE: NY ZIP: 10111 8-K 1 a5513962.txt ANTIGENICS INC. 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 October 10, 2007 Date of Report (Date of earliest event reported) - -------------------------------------------------------------------------------- ANTIGENICS INC. (Exact name of registrant as specified in its charter) - -------------------------------------------------------------------------------- DELAWARE 000-29089 06-1562417 (State or other (Commission (IRS Employer jurisdiction File Number) Identification No.) of incorporation) 162 Fifth Avenue, Suite 900 New York, NY 10010 (Address of principal executive offices) (Zip Code) 212-994-8200 (Registrant's telephone number, including area code) - -------------------------------------------------------------------------------- Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01 Other Events On October 10, 2007, Antigenics Inc. announced that the Brain Tumor Research Center at the University of California, San Francisco, has initiated a Phase 2 clinical trial of Oncophage(R) (vitespen), Antigenics' investigational patient-specific cancer vaccine, for the treatment of recurrent glioma. The primary objective of the investigator-sponsored study is to evaluate overall survival in glioma patients receiving Oncophage vaccination. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this current report on Form 8-K. Item 9.01 Financial Statements and Exhibits (d) Exhibits The following exhibit is furnished herewith: 99.1 Press Release dated October 10, 2007 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ANTIGENICS INC. Date: October 10, 2007 By: /s/ Garo H. Armen ----------------------- Garo H. Armen, Ph.D. Chairman and Chief Executive Officer EXHIBIT INDEX Exhibit No. Description of Exhibit - ----------- ---------------------- 99.1 Press Release dated October 10, 2007 EX-99.1 2 a5513962ex99-1.txt EXHIBIT 99.1 Exhibit 99.1 First Patient Registered in Investigator-Sponsored Phase 2 Trial of Antigenics' Oncophage Cancer Vaccine in Glioma Trial being supported by grants from American Brain Tumor Association and the National Cancer Institute NEW YORK--(BUSINESS WIRE)--Oct. 10, 2007--Antigenics Inc. (NASDAQ: AGEN) today announced that the Brain Tumor Research Center at the University of California, San Francisco (UCSF), has initiated a Phase 2 clinical trial of Oncophage(R) (vitespen), Antigenics' investigational patient-specific cancer vaccine, for the treatment of recurrent glioma. The primary objective of the investigator-sponsored study is to evaluate overall survival in glioma patients receiving Oncophage vaccination. "We are highly encouraged by the preliminary Phase 1 results in which we observed prolonged overall survival when compared with historical controls, as well as a tumor-specific immune response in all treated patients," 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. "Commencement of this Phase 2 trial with Oncophage is an important milestone in the advancement of this novel therapy and represents a potentially important next step in the treatment of this devastating disease." Preliminary Phase 1 results were presented at the 75th annual meeting of the American Association of Neurological Surgeons in April and showed that Oncophage vaccination was associated with significant tumor-specific immune response in all 12 treated patients from baseline (P < .001). Updated results from Phase 1 of this study will be presented at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer conference on October 25, 2007. Derived from each individual's tumor, Oncophage is designed to program the body's immune system to target cancer cells of that patient. Similar to most cancer vaccines, Oncophage has indicated a good safety profile. 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. Antigenics recently filed an application for marketing authorization with the Russian Ministry of Public Health for Oncophage as a adjuvant treatment for patients with intermediate-risk kidney cancer. Study Details The Phase 2 trial is designed to enroll approximately 30 patients with recurrent high-grade glioma. Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. Eligible patients will be treated after surgery with Oncophage once weekly for four weeks, followed by biweekly injections until vaccine depletion. The objectives of the study are to evaluate overall survival and immune response to therapy. The trial will be supported through grants from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence. About Brain and Spinal Cord Tumors Glioma is a cancer affecting the central nervous system that begins in glial cells (connective tissue cells that surround and support nerve cells). Malignant glioma is currently a fatal disease. The American Cancer Society estimates that 20,500 malignant tumors of the brain or spinal cord will be diagnosed during 2007 in the United States, and that about 12,740 people will die from these tumors. 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 www.ucsf.edu. About Antigenics Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. The company's investigational product portfolio includes Oncophage(R) (vitespen), a patient-specific therapeutic cancer vaccine being evaluated in several indications; Aroplatin(TM) (L-NDDP), a liposomal, third-generation platinum chemotherapeutic; AG-707, a therapeutic vaccine for the treatment of genital herpes; and QS-21, an adjuvant being evaluated by Antigenics' corporate partners in several late-stage clinical trials. For more information, please visit www.antigenics.com. This press release contains forward-looking information, including, without limitation, statements regarding the potential results of a Phase 1 clinical trial of Oncophage in patients with glioma; future plans to present and publish trial data and results; future clinical trial plans, including anticipated funding, enrollment and participation in a Phase 2 trial of Oncophage in patients with glioma; and the demographics for disease indications. These risks and uncertainties include, among others, the risk that a small investigator-sponsored study in 12 patients is not representative of what will be shown in larger trials that could support registration; the ability of clinical investigators participating in Antigenics' trials to raise funds and enroll patients; timing and results of studies involving Oncophage; and the factors described in the Risk Factors section of Antigenics' Form 10-Q as filed with the Securities and Exchange Commission on August 9, 2007. 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. CONTACT: Antigenics Inc. Media Relations: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com or Investor Relations: Robert Anstey, 800-962-2436 ir@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----