-----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, O4qrQlqCfv3R5vdD2uLaD8VZlA20B1pzj/tQ4BdCwJfbhTwFbXmmOO7iKhj4s9vq wwtbSEMLNm19JWpnmeoCwA== 0001157523-08-009527.txt : 20081124 0001157523-08-009527.hdr.sgml : 20081124 20081124070912 ACCESSION NUMBER: 0001157523-08-009527 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081124 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081124 DATE AS OF CHANGE: 20081124 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: 081209088 BUSINESS ADDRESS: STREET 1: 162 FIFTH AVENUE SUITE 900 CITY: NEW YORK STATE: NY ZIP: 10010 BUSINESS PHONE: 212-994-8200 MAIL ADDRESS: STREET 1: 162 FIFTH AVENUE SUITE 900 CITY: NEW YORK STATE: NY ZIP: 10010 8-K 1 a5837870.htm 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

November 24, 2008
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 jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

3 Forbes Road

Lexington, MA

02421

(Address of principal executive offices)

(Zip Code)


781-674-4400
(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 November 24, 2008, Antigenics Inc. (the Company) announced an oral presentation of final data from a Phase 1 investigator-sponsored trial of the Company’s investigational cancer vaccine Oncophage® (vitespen) in recurrent, high-grade glioma at the Society of Neuro-Oncology’s 13th Annual Scientific Meeting in Las Vegas. Final results from the study, conducted at the Brain Tumor Research Center at the University of California, San Francisco, showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. All patients enrolled into the trial had at least one recurrence of brain cancer.      

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 November 24, 2008


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, 2008 By:

/s/ Garo H. Armen

Chief Executive Officer

EX-99.1 2 a5837870ex991.htm EXHIBIT 99.1

Exhibit 99.1

Final Data From Phase 1 Investigator-Sponsored Trial of Oncophage® Cancer Vaccine in Glioma Presented at the Society for Neuro-Oncology’s Annual Meeting

Overall Median Survival Extends to 10.5 months in Patients after Surgery with Multiple Recurrent Brain Cancer

LAS VEGAS & NEW YORK & MOSCOW--(BUSINESS WIRE)--November 24, 2008--Antigenics Inc. (NASDAQ: AGEN) today announced an oral presentation of final data from a Phase 1 investigator-sponsored trial of the company’s investigational cancer vaccine Oncophage® (vitespen) in recurrent, high-grade glioma at the Society for Neuro-Oncology’s 13th Annual Scientific Meeting in Las Vegas.

Final results from the study, conducted at the Brain Tumor Research Center at the University of California, San Francisco, showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. All patients enrolled into the trial had at least one recurrence of brain cancer.

“These are the most challenging patients to treat because their survival is typically three to six months,” said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at the University of California, San Francisco. “These preliminary results suggest a possible impact on survival as well as a very favorable safety profile.”

In addition to survival data, the study also observed a correlation between immune response and overall survival as a result of Oncophage vaccination (n=12; P < .001). These responses were validated by using three separate immune techniques and showed that Oncophage evoked a tumor-specific immune response by producing activated T-cells and natural killer cells that can destroy tumor cells.


“Gliomas develop built-in immunoresistant pathways which play an important role in tumor progression,” said Dr. Parsa. “This study demonstrated significant tumor-specific immune responses leading to a proliferation of T-cells which did not exist in these patients before vaccination with Oncophage. We look forward to completing the Phase 2 portion of this study and presenting results next year.”

Study Design and Findings

The investigator-sponsored Phase 1/2 study was designed to evaluate the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma. Patients were monitored for immune response before and after Oncophage treatment using three different techniques.

According to investigators, no adverse events or toxicities identified were considered attributable to the vaccine. A tumor-specific immune response was detected after vaccination in all 12 patients.

About Oncophage

In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. Derived from each individual’s tumor, Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer and 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 studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase 1/2 trial in recurrent glioma.

Oncophage has received fast track and orphan drug designations from the U.S. Food and Drug Administration for both kidney cancer and metastatic melanoma. Oncophage has orphan drug status for kidney cancer from the European Medicines Agency.

About Brain Tumors

Glioma is the most common type of brain tumor and is currently a fatal disease impairing areas such as thinking, personality and movement. The National Cancer Institute estimates that about 19,000 cases are diagnosed every year in the U.S. and according to historical estimates, the median survival of patients with previously treated glioma is typically three to six months.


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. The Brain Tumor Research Center at UCSF is internationally recognized as a major research and treatment center for adults and children with tumors of the brain and spinal cord. 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. For more information, please visit antigenics.com

This press release contains forward-looking information, including statements regarding the potential safety and activity of Oncophage in patients with glioma, future clinical trials and anticipated timing for results and presentation of data. These risks and uncertainties include, among others, the risk that future results will not support further Oncophage development or registration; decisions of patients and doctors, the ability to enroll patients within the desired clinical trial timelines; the ability of the Company to raise money, maintain an acceptable cash burn, and retain employees; 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’ Annual Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2008. 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
Cell: 917-443-3325
Work: 212-994-8206
suberoi@antigenics.com
or
Investor Relations:
Robert Anstey, 800-962-2436
ir@antigenics.com

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