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) May 2, 2005

ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)


001-32157
(Commission File Number)
 
84-1318182
(IRS Employer Identification No.)


6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
(Address of principal executive offices) (Zip Code)


(858) 552-0866
(Company’s telephone number, including area code)

 
 


Item 8.01. Other Events.

On May 2, 2005, the Company announced that it would be announcing preliminary results for its CoFactor Phase II Trial, which will be published at the ASCO Annual Meeting, held May 13-17, in Orlando, Fla.
 
The press release issued by the Company on May 2, 2005 with respect to this matter is included with this report as an exhibit.

Item 9.01. Financial Statements and Exhibits
 
(99)  
©The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report.


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.

     
  ADVENTRX Pharmaceuticals, Inc.
 
 
 
 
 
 
By:   /s/ Carrie E. Carlander
 
Name: Carrie E. Carlander
  Title: Chief Financial Officer, Vice President, Finance, and Treasurer
   
 
 May 2, 2005

 



EXHIBIT INDEX

Exhibit
 
Description
 
99.1
 
Press Release of the Company dated May 2, 2005.
 
 
 

 
 
Exhibit 99.1

ADVENTRX’s Preliminary Results for CoFactor Phase II Trial Published at ASCO

SAN DIEGO - May 2, 2005 - ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that an abstract with preliminary safety and efficacy results from its Phase II trial using CoFactor with 5-fluorouracil (5-FU) for the treatment of metastatic colorectal cancer will be published in the American Society of Clinical Oncology (ASCO) 2005 Annual Meeting Proceedings. CoFactor is ADVENTRX’s biomodulator designed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU).

The ASCO Annual Meeting will be held May 13-17, in Orlando, Fla. The Company currently plans to announce an update of the Phase II results reported in abstract #3698 entitled, “A Simon 2 stage study of 5, 10 methylenetetrahydrofolic acid (CO) with 5-fluorouracil (FU) as first line treatment in metastatic colorectal cancer (mCRC),” following the commencement of the ASCO Annual Meeting.

“We are encouraged by our continued progress with CoFactor as we have, in a relatively short time, completed patient enrollment in our Phase II trial, met our primary clinical endpoint, and based on these results, received approval to initiate two late stage trials,” said Evan M. Levine, president and CEO for ADVENTRX. “We look forward to announcing additional Phase II results, which we believe will further support our efforts to bring CoFactor through the regulatory process.”

ADVENTRX recently received clearance to begin a US Phase III pivotal trial and clearance in the UK to begin an international Phase IIb trial using CoFactor with 5-FU in metastatic colorectal cancer and plans to initiate both trials this year. The Company currently plans to file in the first half of this year for clearance to initiate an EU-based Phase III CoFactor study in pancreatic cancer.

About CoFactor
CoFactor is a folate-based biomodulator drug developed to enhance the activity of the widely used cancer chemotherapeutic, 5-FU. Clinical data from previous clinical trials in Europe have demonstrated clinical benefit and improved overall median survival in patients with advanced tumors, including colorectal, pancreatic and breast. In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU, FdUMP, to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. This improves 5-FU performance and lowers toxicity. ADVENTRX is the exclusive licensee of this compound. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm.

About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance of existing drugs and address significant problems such as drug metabolism, bioavailability and resistance. More information can be found on the Company's Web site at www.adventrx.com.

Forward Looking Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s last annual report on Form 10-KSB, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
 

 
 
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
 
Investor Contact:
Lippert Heilshorn & Associates
Jody Cain (jcain@lhai.com)
Brandi Floberg (bfloberg@lhai.com)
310-691-7100
     
    Media Contact:
Lippert/Heilshorn & Associates
Mark Stuart (mstuart@lhai.com)
310-691-7116