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.|
|(99)||(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
January 30, 2006
|||Third-party radiological assessments established a clinical benefit of 85% following treatment with CoFactor and 5-FU, a higher outcome than the Company reported previously. The Company previously reported a clinical benefit of 65% as assessed by the clinical site investigators. Clinical benefit is defined as the percentage of patients on study drug whose tumors shrunk or stabilized.|
|||The primary endpoint for the study, objective response, as determined by blinded third-party radiology assessment, exceeded the 25% target originally established for the trial. The reviewers determined that 35% of patients achieved an objective response and 9% of patients exhibited a minor response with CoFactor and 5-FU. Objective response is defined as those patients having complete or partial tumor responses and minor response is defined as a tumor reduction of less than 50% of total tumor size. A complete response is a complete disappearance of the tumor and a partial response is at least a 50% reduction in total tumor size. These measurements were confirmed by a repeat MRI or CT scan performed no less than four weeks after the criteria for response are first met, as defined by World Health Organization (WHO) criteria.|
|||Forty-one percent of patients exhibited stable disease and 15% exhibited progressive disease. Stable disease is no evidence of response (CR, PR, or MR) or progression; and progressive disease is at least a 25% increase in tumor size at the end of the treatment cycle, as measured by CT or MRI scans.|
|||Time to tumor progression (TTP), a secondary endpoint of the study, was reported to have reached 163 days, or greater than 5.4 months, surpassing the Companys expectations. TTP is defined as the time from the start of treatment until objective tumor progression. The determination for TTP is given as a median value based on Kaplan-Meier estimates.|
|||Median survival, another secondary endpoint of the study, could not be reported at this time since more than 50% of the patients on the study are still alive.|
|||No grade 3 or 4 drug-related hematological toxicities were recorded for patients during the trial and there were no grade 3 or 4 gastrointestinal toxicity events related to the CoFactor/5-FU treatment regimen, demonstrating that the treatment was well tolerated. Toxicity grades were determined in accordance with the National Cancer Institutes Common Terminology Criteria for Adverse Events grading system.|
The Phase II clinical trial is an open label, single arm Simon two-stage study design to assess the safety and efficacy of CoFactor plus 5-FU as a first line treatment of metastatic colorectal cancer. Patients enrolled in the trial had performance status ECOG 0-2 and measurable metastatic colorectal cancer, with or without prior adjuvant chemotherapy including 5-FU/leucovorin but no prior chemotherapy for metastatic disease. Patients may receive more than two cycles each consisting of CoFactor 60 mg/m2 and 5-FU 450 mg/m2 (weekly IV bolus) for six consecutive weeks, followed by a 14 day rest period, which is defined as a cycle. The trial is being conducted in the U.S. and Europe under a U.S. investigational new drug application.
CoFactor (ANX-510) is a folate-based biomodulator drug being developed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic 5-fluorouracil (5-FU). In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU 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. A Phase IIb randomized controlled clinical trial is ongoing to evaluate CoFactor 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.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that surpass the performance and safety of existing drugs, by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. 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.