Houston, TX, (January 25, 2005) Cytogenix, Inc. (CYGX: OTC: BB)
CytoGenix, Inc. (CYGX: OTC: BB) announced that on January 18, 2005, company representatives participated in a teleconference with members of the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) concerning the company's CY301 anti-herpes topical agent Investigational New Drug application (IND).
In preparation for the IND filing later this year, experts from the CBER Division of Cellular and Gene Therapies provided comments, guidance and clarification about the Agency's pre-clinical requirements for CY301 anti-herpes topical treatment. The FDA team included specialists in toxicology, pharmacology, virology and clinical research.
Dr. Malcolm Skolnick, CytoGenix President and CEO commented, "This event is a very important milestone in the history of the company. It is our first conference with the FDA about marketing a product that uses the company's proprietary single stranded DNA expression technology. The interchange was useful and, the FDA officials were very helpful in reviewing the requirements for filing an IND for the CY301 anti-herpes treatment. We will comply with the letter and spirit of the regulations, as we gain valuable experience while establishing credibility with the group that will review many of our new product submissions in the future."
CytoGenix, Inc. is a Houston-based biopharmaceutical company that develops and markets innovative products and services based on its proprietary ssDNA expression technology. The company has developed a breakthrough synthetic process for large-scale production of high purity DNA at fraction of the cost of traditional fermentation methods. CytoGenix currently has one issued US patent and over 48 international or US pending patent applications claiming methods and materials in connection with this platform technology.
SAFE HARBOR: Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, risks associated with the acceptance of new products, competition, and other factors more fully detailed in the company's filings with the Securities and Exchange Commission. Additional information about CytoGenix and its technology can be found on the website at www.cytogenix.com.
Contact: CytoGenix, Inc., Communications Director - Juan Ferreira, (407) 774-9949
