? We have developed a new dialdehyde based cold high-level disinfection/sterilization product for treatment of medical instruments specially heat sensitive fiberoptic endoscopes and have demonstrated that it is 100% effective against Mycobacterium tuberculosis in less than 30 minutes at 20 degree Celcius at a concentration of as low as 0.5%. Our formulations at 2%, 1% and 0.5% dilutions, also exhibited sporicidal activity against B. subtilis & C. sporogenes at 20 degree Celcius. The formulations were stable enough at the pH of activity. This Phase-II proposal aims to elevate our product from the level of feasibility demonstration to that of marketable high level disinfection product that has acceptable use life and storage stability, will not damage or alter the functionality of medical equipment, is sporicidal & rapidly tuberculocidal at 20 degree Celcius to assure fast turn around time, and will meet the safety and efficacy requirements for federal (510k) approval. It is proposed that a large scale and cheaper synthesis of active ingredient of our product and its analyses will be optimized into a set for standard operating procedure under GMP and GLP licenses from FDA. An optimized formulation will be designed for stability, materials compatibility, user friendliness, and disinfection/ sterilization capabilities to fulfill the federal efficacy and safety requirements for 510(k) notification for marketability. This will be achieved through a research done in 5 specific aims, proposed here. Based on the promising data exhibited by the active ingredient of our product in Phase I study, a US patent application has been filed. The same data also indicate that the success our product through this proposed Phase-ll study, which leads to the FDA approval against 510(k) notification, is clearly foreseen, too. This product can help contain many nosocomial infections, which affect as many as 2 million citizens and cost more than $ 4.5 millions to economy annually. Our product has a potential to eradicate the problems associated with HLD agents of today, and to capture their almost entire market. ? ? ?
