TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
|(State or other jurisdiction of
|(Commission File Number)||(IRS Employer
San Diego, California 92121
|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|
|(d)||The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report.|
|By:||/s/ Evan M. Levine|
|Name:||Evan M. Levine|
|Title:||President & Chief Executive Officer
June 5, 2006
|Press Release of the Company dated June 5, 2006 re. Presentation of Positive Phase II CoFactor Results at ASCO Conference|
|||Preliminary median overall survival was reported as 459 days or approximately 15.1 months as estimated by Kaplan-Meier projections. Overall survival is defined as the time from the start of patient dosing until death. Median survival is the point at which 50% of patients in the study are still alive. Out of the 50 patients enrolled in this Phase II study, 28 are confirmed deceased.|
|||By historical comparison, median overall survival was determined to be 11.7 months for first line treatment of metastatic colorectal cancer using 5-fluorouracil (5-FU) plus leucovorin from the most recent meta-analysis of 19 previously published studies. (J Clin Oncol, 22:3766-3775, 2004. Erratum, J Clin Oncol, 23:1337-1338, 2005)|
|||The primary endpoint for the study, objective response, exceeded the 25% target originally established for the trial. Blinded third-party radiology reviewers determined that 35% of patients achieved an objective response with CoFactor plus 5-FU, based on 46 patients evaluable for response. Objective response is defined as those patients having complete or partial tumor responses, by World Health Organization (WHO) criteria.|
|||By historical comparison, tumor response rate was determined to be 21% for first line treatment of metastatic colorectal cancer using 5-FU plus leucovorin from the most recent meta-analysis of 19 previously published studies. (J Clin Oncol, 22:3766-3775, 2004. Erratum, J Clin Oncol, 23:1337-1338, 2005)|
|||Median time to tumor progression (TTP), previously reported by the Company as 163 days, has been amended to 162 days, or approximately 5.3 months. TTP is defined as the time from the start of patient dosing until objective tumor progression.|
|||There was no grade 3 or 4 drug-related hematological toxicity recorded for patients during the trial and there was no grade 3 or 4 gastrointestinal toxicity related to the CoFactor/5-FU treatment regimen, demonstrating that the treatment was well tolerated. A single case of grade 4 neutropenia was reported during the 30 day follow-up period after the last dose of CoFactor plus|
|5-FU study therapy and after the patient started treatment with FOLFOX plus Avastinâ. The overall incidence of grade 3 or 4 adverse events was 22%, including hip fracture, deep vein thrombosis, metastatic colon cancer, respiratory failure and pulmonary embolism, not related to study drug. 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 a multi-center, open label, single arm study to assess the safety and efficacy of CoFactor plus 5-FU administered as a weekly bolus in 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. 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 replace leucovorin to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapy 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. 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 Q2 2006.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease 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 annual report on Form 10-K and its Quarterly Reports 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.