ADVENTRX Receives CoFactor Pancreatic Cancer Clinical Design and Protocol Final Advice Letter from EMEA.SAN DIEGO -- ADVENTRX Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :ANX ANX Annex ANX Adventrx Pharmaceuticals (San Diego, CA) ANX Automotive Network Exchange (AIAG) ANX Advanced Network Exchange ANX Ascending Node Crossing (satellites) ) today announced receipt of a final advice letter from the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) for its proposed CoFactor cofactor An atom, organic molecule, or molecular group that is necessary for the catalytic activity (see catalysis) of many enzymes. A cofactor may be tightly bound to the protein portion of an enzyme and thus be an integral part of its functional structure, or it may (TM) trial protocol in pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. . Based on this information, the Company currently plans to file a Clinical Trial Application for a pivotal Phase III multinational study in patients with advanced pancreatic cancer in the second quarter of 2005 and will initiate the trial following regulatory clearance. CoFactor is a biomodulator designed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU). The final advice letter was received following a recent meeting between ADVENTRX and the EMEA in which the Company sought assistance on the trial design protocol. Protocol assistance with the EMEA was provided without additional cost to the Company under the Orphan drug act. CoFactor was granted orphan drug status for pancreatic cancer in both the European Union (EU) and US in October of last year. The primary endpoint of the proposed pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the is time to tumor progression with secondary endpoints of objective response, quality of life and overall survival. Approximately 480 patients will be randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive either CoFactor/5-FU/gemcitabine or gemcitabine alone. Gemcitabine is the current standard of care in the EU and US for advanced pancreatic cancer. The international trial is expected to be conducted at both EU and non-EU clinical sites. In a previous Phase I/II clinical trial in Europe, CoFactor in combination with 5-FU demonstrated clinical benefit, defined as stable disease or tumor response, in 40% of pancreatic patients. "Our progress with the EMEA marks an important milestone in our efforts to advance CoFactor through the clinical process," said Cellia Habita, M.D., Ph.D., senior vice president of clinical and medical affairs for ADVENTRX. "Our earlier clinical studies with CoFactor in combination with 5-FU as a cancer therapy indicates its potential to lower toxicities and increase survival compared with current therapies. Pancreatic cancer is among the most fatal cancers with less than 5 percent of patients surviving more than five-years following diagnosis." CoFactor in combination with 5-FU is currently being studied in a Phase II trial in metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer in the US and Europe. During the first quarter of 2005, ADVENTRX filed for clearance with the US Food and Drug Administration to launch a Phase III randomized, controlled trial in metastatic colorectal cancer. Also during the first quarter of 2005, the Company filed Clinical Trial Applications in the EU, including the United Kingdom and Germany, and in countries outside the EU, for clearance to evaluate CoFactor in a Phase IIb, international, multi-center, randomized, controlled trial for metastatic colorectal cancer. About ADVENTRX ADVENTRX Pharmaceuticals, Inc. 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 metabolism, bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. and drug 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 quarterly report on Form 10-QSB, 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. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion