NicOx SA announced that a US $3.3 million grant has been awarded by the National Cancer Institute of the NIH to the University of Michigan to conduct a clinical trial of nitric oxide-donating aspirin (NCX 4016). This placebo-controlled study will assess the pharmacokinetics of two different doses of NCX 4016 in subjects at risk of colon cancer, both at baseline and after six months of continuous oral administration of this drug. In addition, it will determine the effect of NCX 4016 on the number and features of aberrant crypt foci in the colon. Aberrant crypt foci are considered the earliest recognizable premalignant lesion in the colon. The study outline calls for the recruitment of 240 subjects, divided into three groups, 80 in each of the active drug (low and higher dose) and placebo groups.
Dr. Basil Rigas, a Scientist at the Institute for Cancer Prevention and Professor of Medicine and Attending Gastroenterologist at New York Medical College, where a significant part of the investigation will be conducted, said: "We are all very excited about studying this highly promising compound, with colon cancer prevention and treatment being our ultimate goal. This study represents the culmination of three years of work by my group and other investigators on the role of nitric oxide-donating compounds in colon cancer.
"We first obtained impressive data in cell culture systems, and these were followed by equally successful efficacy studies in animal models of colon cancer. Now, we are ready to advance our work to humans. If this study proves successful, it will likely be an important milestone towards the development of an effective and safe strategy for colon cancer prevention. Colon cancer is a major health problem with significant morbidity and mortality and thus deserves our concerted efforts to discover new safe and effective drugs of prevention."
Michele Garufi, Chairman and CEO of NicOx commented: "This major NIH grant confirms the high level of scientific interest in NCX 4016 and its significant potential in cancer prevention. We expect the results to provide clinical support of efficacy and to help establish NCX 4016 as a major chemopreventive agent against colon cancer. There is a strong scientific rationale for the effectiveness of NCX 4016 in the prevention of colon cancer which has been further supported by recent reports published in the New England Journal of Medicine confirming the clinical efficacy of aspirin in colon cancer prevention. NCX 4016 is expected to retain the chemopreventive properties of aspirin but with a broader mechanism of action and significantly improved safety profile as shown in clinical endoscopy trials presented last year at the Digestive Disease Week."