Houston, TX, (November 4, 2004) Cytogenix, Inc. (CYGX: OTC: BB)
CytoGenix, Inc. (CYGX: OTC: BB) announces that it has submitted a pre-Investigational New Drug (IND) brief and has initiated discussions with the FDA Center for Drug Evaluation and Research Division of Antiviral Drug Products (DAVDP) for the Company's anti-herpes topical formulation CY301.
The pre-IND dialog helps drug sponsors to prepare IND submissions that contain all of the data that the Agency will require to permit human (clinical) trials. The FDA's primary concern at this stage is that the product is safe. The company must produce data from a series of laboratory and animal tests to demonstrate that the product is safe when used as prescribed. Safety and effectiveness data the Company has produced to date is included in the pre-IND brief.
Dr. Malcolm Skolnick, CytoGenix, Chairman and CEO commented, "This is a significant milestone in our company's history. It is the first product in our pipeline that is moving into this phase. There is a very large unmet medical need for an effective anti-herpes treatment. Genital herpes reduces the quality of life for tens of millions of Americans and worldwide, is a major cause of infant blindness and increases the risk of contracting HIV."
CytoGenix, Inc. is a biopharmaceutical company that develops and markets innovative products and services based on its proprietary DNA expression technology. CytoGenix has products in pre-clinical development including an antimicrobial compound and, anti-herpes, anti-psoriasis and anti-inflammatory topical creams. The company owns a US patent for its core DNA expression technology and has over 40 international or US pending patent applications.
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: Communications Director — Juan Ferreira, (407) 774-9949
