-----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, T5HjFvW3fzHOLGnEkmHLFpJOrEQC7plll/5PJvt+CuDqoTXRcU0rlmLFmBwwN9/D 2AMiLtg0Tc233rG0rbn5vg== 0001193125-09-173848.txt : 20090813 0001193125-09-173848.hdr.sgml : 20090813 20090813093321 ACCESSION NUMBER: 0001193125-09-173848 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090811 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090813 DATE AS OF CHANGE: 20090813 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: 091008615 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 d8k.htm FORM 8-K Form 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

August 12, 2009

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 7.01 Regulation FD Disclosure

On August 12, 2009, Antigenics Inc. announced that the Brain Tumor Research Center at the University of California, San Francisco, has begun enrolling patients into a Phase 2 clinical trial of Oncophage (vitespen) in combination with the standard of care—radiation therapy plus Temodar (temozolomide)—for newly diagnosed glioma patients.

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 August 12, 2009


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: August 13, 2009

    By:  

/s/ Shalini Sharp

      Shalini Sharp
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit No.

 

Description of Exhibit

99.1   Press Release dated August 12, 2009
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

    Sunny Uberoi
    Corporate Communications
   

212 994 8206

suberoi@antigenics.com

    Shalini Sharp
    Investor Relations
   

800.962.2436

ir@antigenics.com

Patients Begin Enrolling into Investigator-Sponsored Phase 2 Trial of Antigenics’ Oncophage® Cancer Vaccine in Newly Diagnosed Glioma

Lexington (MA) and San Francisco — August 12, 2009 — Antigenics Inc. (NASDAQ: AGEN) today announced that the Brain Tumor Research Center at the University of California, San Francisco, has begun enrolling patients into a Phase 2 clinical trial of Oncophage (vitespen) in combination with the standard of care —radiation therapy plus Temodar (temozolomide)—for newly diagnosed glioma patients. The overall goals of the investigator-sponsored study are to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment.

“To date, improvements in overall survival for newly diagnosed glioma patients have been negligible,” said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at the University of California, San Francisco, and principal investigator of the trial. “The rationale for moving Oncophage into this patient population and combining it with radiation and Temodar was underscored by the encouraging results from the ongoing Phase 2 study in recurrent glioma, a more challenging patient population where the results showed overall survival increasing to approximately 10.5 months.”

Study Details

The Phase 2 single-arm trial is designed to enroll about 60 patients with newly diagnosed glioma. Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. According to the protocol, patients will receive Oncophage once weekly for 4 consecutive weeks and monthly until vaccine depletion with concurrent Temodar.


The trial is supported through a grant from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence.

About Oncophage

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 2 trial in recurrent glioma.

In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities are ongoing. In October 2008, Antigenics submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma.

Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.

In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.

About Brain and Spinal Cord Tumors

The American Cancer Society estimates that 22,070 malignant tumors of the brain or spinal cord will be diagnosed during 2009 in the United States, and that about 12,920 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 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 www.antigenics.com.

This press release contains forward-looking statements, including statements regarding the potential of Oncophage to improve overall survival and the potential advantage of Oncophage in effectively generating an immune response. 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 2 trial of Oncophage in glioma may indicate that it causes significant or unacceptable 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; and the factors described under the Risk Factors section of Antigenics’ Form 10-Q as filed with the Securities and Exchange Commission for the quarter ended June 30, 2009. 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.

-----END PRIVACY-ENHANCED MESSAGE-----