-----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, CWCBkP9YiHUwXTCJNom237QMja6JK4HmBHhAsifCDtTte53rCZhluLTPotaGWGGn 5cFSX0iQV+ttCH8LH9N8lw== 0001157523-03-006979.txt : 20031125 0001157523-03-006979.hdr.sgml : 20031125 20031125122458 ACCESSION NUMBER: 0001157523-03-006979 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031124 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031125 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: 031022494 BUSINESS ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2170 CITY: NEW YORK STATE: NY ZIP: 10111 BUSINESS PHONE: 2123324774 MAIL ADDRESS: STREET 1: 630 FIFTH AVENUE SUITE 2170 CITY: NEW YORK STATE: NY ZIP: 10111 8-K 1 a4523451.txt ANTIGENICS 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 Date of Report (Date of earliest event reported): November 24, 2003 ANTIGENICS INC. (Exact name of registrant as specified in its charter) DELAWARE 000-29089 06-1562417 (State or other jurisdiction of (Commission file number) (I.R.S. Employer incorporation of organization) Identification No.) 630 FIFTH AVENUE, SUITE 2100 NEW YORK, NEW YORK 10111 (Address of principal executive offices and zip code) (212) 994-8200 (Registrant's telephone number, including area code) Item 5. Other Events On November 24, 2003, the Company announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the two Phase III clinical trials of the company's personalized cancer vaccine Oncophage(R) (HSPPC-96). The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this current report on Form 8-K. Item 7. Financial Statements and Exhibits. (c) Exhibits: 99.1 Press Release dated November 24, 2003 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: November 24, 2003 By: /s/ Garo H. Armen ----------------- Garo H. Armen, Ph.D. Chairman and Chief Executive Officer EXHIBIT INDEX The following designated exhibits are filed herewith: Exhibits: 99.1 Press Release dated November 24, 2003 EX-99 3 a4523451ex99.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 FDA Lifts Clinical Hold on Antigenics' Phase III Trials Of Oncophage; Patient Enrollment Allowed to Resume Immediately NEW YORK--(BUSINESS WIRE)--Nov. 24, 2003--Antigenics Inc. (NASDAQ: AGEN) announced today that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the two Phase III clinical trials of the company's personalized cancer vaccine Oncophage(R) (HSPPC-96). The agency's decision to lift the hold comes 13 weeks after its request for product characterization information in September 2003. Antigenics will immediately resume patient enrollment in its Phase III trials of Oncophage. "Our team worked hard to provide the information within our targeted timelines," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "We are grateful for the FDA's rapid and thorough review of our submission." The FDA had placed two Antigenics studies on partial clinical hold to review product characterization data. All other Oncophage trials, including Phase I and II studies, were unaffected by the hold. Antigenics is working to develop personalized immunotherapeutics and revolutionary treatments for cancers, infectious diseases and autoimmune disorders. This press release contains forward-looking statements, including statements regarding resuming patient enrollment for Antigenics' Phase III trials of Oncophage. These statements are subject to risks and uncertainties that could cause actual results to differ materially to those projected in these forward-looking statements. These risks and uncertainties include, among other factors, any negative impact the partial clinical hold may have had on the willingness of physicians and patients to participate in the trials, any further regulatory actions that delay the trials, and the factors related to the regulatory approval process described in the company's periodic filings with the Securities and Exchange Commission. Please see the "Factors That May Impact Future Results" section of the Management's Discussion and Analysis of Financial Condition and Results of Operations in the Antigenics Quarterly Report on Form 10-Q for the quarter ended September 30, 2003, for a full discussion of these and other risk factors. Antigenics cautions investors not to place significant 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. CONTACT: Antigenics Inc., New York Corporate Communications: Sunny Uberoi, 212-994-8206 suberoi@antigenics.com or Investor Relations: Tanya Sripanich, 212-994-8244 tsripanich@antigenics.com -----END PRIVACY-ENHANCED MESSAGE-----