ROCKVILLE, Md., June 12, 2008 (PRIME NEWSWIRE) -- Cytomedix, Inc. (AMEX:GTF) today announced plans for entering the multi-billion dollar anti-inflammatory market with patent protected peptides derived from Platelet Factor 4 (PF4), a growth factor released when blood platelets are activated. The Company's initial peptide, designated CT-112, was discovered early in the research of platelet derived growth factors.
Pre-clinical animal studies have indicated that the CT-112 peptide may be active for the treatment of inflammatory diseases such as Rheumatoid Arthritis, Crohn's Disease, Tissue Reperfusion Injury and other related medical conditions. The studies further indicated that CT-112 may be administered orally, unlike other anti-inflammatory drugs currently on the market which are administered via injection.
"The animal studies done in the past suggest that CT-112 is well tolerated over a wide range of doses from low to high. This leads us to believe that it may not result in the type of serious side effects that have plagued other therapies in the field, including increased rates of heart attack and infection," stated Martin Rosendale, Chief Operating Officer of Cytomedix, Inc.
"The encouraging pre-clinical results and animal safety studies which support the expectation of a safe and efficacious drug, have convinced us that this new drug candidate may be ready for clinical evaluation," Mr. Rosendale said. "We are enthusiastic about the potential for CT-112 and look forward to the clinical development and FDA review process required for a new drug. We have initiated contact with the FDA Office of Drug Evaluation II, and we are currently assembling the necessary data in preparation for an Investigational New Drug (IND) application," he added.
"The discovery of CT-112 in the mid 1990s, resulted during the development of the Company's AutoloGel System(tm) and investigation of platelet derived growth factors. Since then, there have been further advances in peptide manufacturing technology and the understanding of the science underpinning such compounds. In addition, there is an increasing demand for new pharmaceutical products, particularly for anti-inflammatory compounds. This has created conditions which encourage a fresh exploration of the development and commercialization opportunities for CT-112," said Kshitij Mohan, Ph.D. Chairman and Chief Executive Officer of Cytomedix, Inc. "The market for anti-inflammatory therapeutics exceeds $12 billion per year for Rheumatoid Arthritis alone."
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for use on wounds and other applications. The current offering is the AutoloGel(tm) System, a process that utilizes an autologous platelet gel composed of multiple growth factors, other platelet releasates, and fibrin matrix. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.
SAFE HARBOR STATEMENT
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix's actual results may differ materially due to a number of factors, many of which are beyond Cytomedix's ability to predict or control, including among others, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, and competitive responses. CT-112 was introduced as a therapeutic candidate with an FDA Pre-IND meeting in 1995. It is uncertain whether the company will obtain the funds necessary for development, or whether current market conditions will support a renewed effort to develop CT-112. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.