SECURITIES AND EXCHANGE COMMISSION
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(Companys telephone number, including area code)
|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.|
|Item 9.01. Financial Statements and Exhibits.|
|(c) The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report.|
|ADVENTRX Pharmaceuticals, Inc.
|By:||/s/ Carrie E. Carlander|
|Name:||Carrie E. Carlander|
|Title:||Chief Financial Officer, Vice President|
|Finance, and Treasurer|
|December 7, 2005|
ANX-530 has demonstrated the ability to markedly reduce injection-site irritation in preclinical testing, compared to NavelbineÒ, GlaxoSmithKlines approved form of vinorelbine tartrate. NavelbineÒ prescribing information includes a black box warning for necrosis and thrombophlebitis. Pre-clinical studies with ANX-530 showed equivalent pharmacokinetic and pharmacodynamic profiles when compared to Navelbine. Vinorelbine tartrate is currently used as a monotherapy or in combination with other chemotherapeutic agents for the treatment of non-small cell lung, breast, ovarian and other cancers.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. The Companys lead compound, CoFactor, is a biomodulator of 5-fluorouracil (5-FU), a widely used cancer chemotherapy. Phase II and Phase IIb clinical trials are ongoing to evaluate CoFactor use with 5-FU as a first line treatment of metastatic colorectal cancer. The Company has received clearance under a special protocol assessment from the US Food and Drug Administration (FDA) to begin a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer, which is currently planned to begin patient dosing in Q1 2006. More information can be found on the Companys Web site at www.adventrx.com.
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on managements 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 regarding ADVENTRX, see the section titled Risk Factors in ADVENTRXs last quarterly report on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.