-----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, Tg8NqF7t7BuV8IMXHNFiwzCIhAbFM7MX1MjBm3SkjJDqtNKnOydjh45pQKoC93Mr 4Q9F2BEB+a+oXEv9lalTaw== 0001144204-08-003565.txt : 20080123 0001144204-08-003565.hdr.sgml : 20080123 20080123163356 ACCESSION NUMBER: 0001144204-08-003565 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080122 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080123 DATE AS OF CHANGE: 20080123 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RESPONSE GENETICS INC CENTRAL INDEX KEY: 0001124608 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33509 FILM NUMBER: 08545107 BUSINESS ADDRESS: STREET 1: 1640 MARENGO ST., STREET 2: 6TH FLOOR CITY: LOS ANGELES, STATE: CA ZIP: 90033 BUSINESS PHONE: (323) 224-3900 MAIL ADDRESS: STREET 1: 1640 MARENGO ST., STREET 2: 6TH FLOOR CITY: LOS ANGELES, STATE: CA ZIP: 90033 8-K 1 v100568_8k.htm
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):
January 22, 2008

 
RESPONSE GENETICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
000-1124608
 
11-3525548
(State or other jurisdiction of
incorporation or organization)
 
(Commission
File Number)
 
(IRS employer
identification no.)
 
1640 Marengo St., 6th Floor
Los Angeles, California 90033
(323) 224-3900
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 
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):
 
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o 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 January 22, 2008, Response Genetics, Inc. (NASDAQ: RGDX) announced that it has begun performing the MAGE-A3 gene expression screening assay for GlaxoSmithKline’s (GSK) Phase III clinical trial of the investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in MAGE-A3 positive patients with stage IB, II or IIIA Non-Small Cell Lung Cancer (NSCLC). These assays will be performed in formalin-fixed paraffin-embedded tissue.

GSK has begun recruiting for a Phase III trial evaluating MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. With a target of about 2,270 patients, the randomized, double-blind, and placebo-controlled MAGRIT trial will enroll patients with stage IB, II or IIIA resected NSCLC. This would be the largest clinical trial ever conducted in lung cancer treatment. All patients participating in the trial have cancers expressing a tumor-specific antigen, MAGE-A3, which is present in approximately 35 to 50 percent of early NSCLC. The primary endpoint of the trial is disease-free survival.

The Company issued a press release announcing the commencement of the MAGE-A3 trials on January 22, 2008. The press release is incorporated herein by reference and a copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:
 
  Exhibit Number Description
     
99.1
Press Release of Response Genetics, Inc. dated January 22, 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.
 
     
 
RESPONSE GENETICS, INC.
 
 
 
 
 
 
Dated: January 23, 2008
By:  
/s/ Kathleen Danenberg
 
Kathleen Danenberg
  President & Chief Executive Officer
 
 
 

 
 
EX-99.1 2 v100568_ex99-1.htm
EXHIBIT 99.1

 
FOR IMMEDIATE RELEASE

Investor Relations Contact:
Media Relations Contact:
Christine Yang
Camille Payne
Trout Group
Kaleidoscope Marketing Group
646-378-2929
212-479-1028

Response Genetics, Inc. to Perform the MAGE-A3 Screening Assay for the Current GlaxoSmithKline Phase III Novel MAGE-A3 Cancer Immunotherapeutic in
Non-Small Cell Lung Cancer


LOS ANGELES, January 22, 2008—Response Genetics, Inc. (NASDAQ: RGDX) today announced that it has begun performing the MAGE-A3 gene expression screening assay for GlaxoSmithKline’s (GSK) Phase III clinical trial of the investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in MAGE-A3 positive patients with stage IB, II or IIIA Non-Small Cell Lung Cancer (NSCLC). These assays will be performed in formalin-fixed paraffin-embedded tissue.

“We are pleased to be working with GlaxoSmithKline in support of this important clinical trial,” said Kathleen Danenberg, President and CEO of Response Genetics. “This would be the largest clinical trial ever conducted in lung cancer treatment and, with approximately 35 to 50 percent of early NSCLC expressing the MAGE-A3 tumor-specific antigen, we are excited to be involved and to be providing our biomarker analysis.”

GSK has begun recruiting for a Phase III trial evaluating MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. With a target of about 2,270 patients, the randomized, double-blind, and placebo-controlled MAGRIT trial will enroll patients with stage IB, II or IIIA resected NSCLC. This would be the largest clinical trial ever conducted in lung cancer treatment. All patients participating in the trial have cancers expressing a tumor-specific antigen, MAGE-A3, which is present in approximately 35 to 50 percent of early NSCLC. The primary endpoint of the trial is disease-free survival.

About Response Genetics, Inc.
Response Genetics, Inc. (“RGI”) (NASDAQ: RGDX) is engaged in the research and development of pharmacogenomic cancer diagnostic tests based on its proprietary and patented technologies. RGI’s technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin embedded specimens. RGI currently generates revenue primarily from the sales of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. The company was founded in 1999 and its principal headquarters are located in Los Angeles, California. For more information, please visit www.responsegenetics.com.

-more-
 
 
 

 

Forward Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of Response Genetics, Inc. (the “Company”) related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as "projects", "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward- looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update forward- looking statements, whether because of new information, future events or otherwise, except as required by law.

###
 
 
 

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