Healthcare Industry News: Leucovorin
News Release - June 26, 2006
Data Safety Monitoring Board Recommends Continuation of ADVENTRX Phase IIb Clinical Trial for CoFactorSAN DIEGO, June 26 (HSMN NewsFeed) -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ) announced today that the independent Data Safety Monitoring Board (DSMB) has completed a planned interim analysis of safety and efficacy data from the Company's CoFactor® Phase IIb clinical trial and has recommended that the trial continue without any modifications. Since the data are masked, results from the interim safety and efficacy analysis will not be made available to the Company until the study is completed. The interim evaluation was based on data from 150 patients, which represents half of the planned total enrollment of 300 patients.
"We are pleased to have received a positive recommendation from the DSMB which supports the continuation of this trial," said James A. Merritt, chief medical advisor for ADVENTRX. "We are enthusiastic about comparing CoFactor against Leucovorin as a 5-FU biomodulator in first line treatment of metastatic colorectal cancer. The trial is progressing as planned and has recruited over 80 percent of the total patient number expected."
The Phase IIb clinical trial is a multi-center, randomized study to evaluate the safety and efficacy of infusional CoFactor and 5-FU versus infusional Leucovorin and 5-FU in subjects with metastatic colorectal cancer. Currently there are approximately 250 patients enrolled in the clinical trial.
The Data Safety Monitoring Board (DSMB) is comprised of medical, surgical and statistical experts in colorectal cancer and in clinical trials who were selected by the Company to serve as an independent monitoring board. The board operates under a written charter which is established in compliance with good clinical practice guidelines. The DSMB is responsible for monitoring patient safety in the Phase IIb clinical trial and for conducting periodic analyses of trial safety and efficacy results. Company representatives organized the meeting and provided information regarding accrual and patient demographics and disposition, but did not otherwise participate in the meeting and discussion.
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS), improving 5-FU performance. The Company reported Phase II results from an independent radiological assessment that found an objective response of 35% in first line treatment of metastatic colorectal cancer with CoFactor and 5-FU. The Company also reported median time to tumor progression (TTP) of 162 days, preliminary median overall survival of 459 days with no study drug-related grade 3 or grade 4 gastrointestinal or hematological toxicity. The Company has received clearance under a special protocol assessment (SPA) 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 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 Company's 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 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 regarding ADVENTRX, see the section titled "Risk Factors" in ADVENTRX's 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. ADVENTRX undertakes no obligation to release publicly any revisions to forward-looking statements to reflect events or circumstances which occur after the date hereof.
Source: ADVENTRX Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.