Present Status

Kenilin LTD met with the Food and Drug Administration on January 23, 2007, for a pre-investigator new drug meeting. The Agency was especially supportive of Kenilin for our willingness to test our innovative wound medicine on the worst-case scenario patients – diabetic patients who are on dialysis. No other wound medications on the market have ever been tested on dialysis patients, let alone diabetic patients on dialysis.

Dialysis patients are widely known to be difficult to heal due to their very poor circulation, and are prone to limb loss. Diabetics on dialysis are even more challenging and vulnerable to amputation. Even drugs that are presently FDA approved for use on dialysis patients have, in fact, never been tested on these patients since no company wants to risk the outcome of their study statistics. The developers of Kenilin, however, petitioned the FDA to do an approved study of Kenilin on diabetic patients on dialysis, taking on the most challenging wound patients that we could. In so doing, the Agency expressed their wish for Kenilin's success and guided us on the steps required for human trials.

Our company will be collaborating with the State University of New York (Downstate Medical Center, Brooklyn, NY) in finishing up the testing prior to these trials. The human efficacy Phase 2 trials are set to commence at several sites: Rose Medical wound center, under the direction of Jeff Jensen DPM, who has been the principal investigator for 21 wound trials; the State University of New York (Downstate Medical Center, Brooklyn, NY) under the direction of Felix Ray Ortega MD. Kenilin is also presently in dialogue with Memorial Hermann Texas Medical Center as a potential third site.

Proof of Concept

Kenilin has been legally used on 30 patients with over 50 wounds in the medical practices of Dr. Burton and Jack W. Moncrief MD.

Patents

A favorable recent notice has been issued from the Patent Office. We are patent pending and should be awarded our patents within 8 to 16 months. Foreign patents for Europe and other countries have been filed as of May, 2007.