“We’re actually in the curious situation that we already have the clinical trials done, and now we’re working on the pre-clinical studies,” Dr. White told us. But this surgical procedure has not yet gotten FDA approval. “The critical issue is we’re going to have to demonstrate reversal of diabetes in monkeys,” White explained. “The question is how long the FDA will require us to reverse diabetes.” FDA guidelines state 90 days, but Dr. White believes they may require between 6 months to a year of proven diabetic reversal on monkeys before the U.S. government agency will permit human clinical trials.

White presented a recent research breakthrough at the World Transplant Congress in Boston last month. “Along with everybody else, we had been using Sertoli cells taken from neonatal pigs,” White told us. “We have discovered neonatal Sertoli cells are not nearly as effective as Sertoli cells taken from sexually mature adult pigs. We can demonstrate these are much better developed to fulfill their function of preventing rejection, and we have gotten good results with the adult Sertoli cells.” He continues to use the islet cells from neonatal pigs in his innovative research, as did the University of Minnesota with their significant advance in reversing diabetics in monkeys.

While rodent trials are ongoing as a prelude to primate experiments, Dr. White has turned to the financial markets to complete his research and commercialize this treatment option for Type 1 diabetics. On May 25th, the Toronto Venture Exchange approved the Pheromone Sciences (TSX: PHS) joint venture with Sertonex Inc. of London (Ontario) and Sertoli Technologies (Arizona) to develop a commercially viable treatment for Type 1 diabetes. Dr. White serves on the board of Pheromone, has been engaged as the principal researcher on this project and accepted the Chair of the company’s scientific advisory board.

Since then, the company has begun adding scientific and business advisors to bring the project forward to commercialization. Formerly the Assistant Dean of Medicine at the University of Calgary, Dr. Norman Wong joined the Pheromone scientific advisory board in mid July to assist in product development of the diabetes treatment. Wong has published numerous articles on diabetic research and has researched the pathogenesis of diabetes mellitus. Two weeks later, Dr. Jannette Dufour joined the scientific board. She had previously worked at the University of Alberta’s Clinical Islet Transplant Program (originators of the Edmonton Protocol for Type 1 diabetes). Dr. Dufour is presently also assistant professor at Texas Tech University.

It may be possible, after the company’s commercialization process advances, that the much larger universe of Type 2 diabetics – especially those who are insulin-dependent – could benefit from this xenotransplantation technique. This number, in the United States alone, could exceed 12 million diabetics. According to the U.S. Center for Disease Control about 800,000 new cases of diabetes are diagnosed each year.

About $10 million dollars are spent on health care for diabetics every hour of the day. “We are looking at three to four million recipients initially with the number growing,” said Dr. White of the xenotransplantation technique he is currently developing. As with many pioneering developments, further research, such as the work being conducted by Dr. White, builds upon the initial success of the Edmonton Protocol. In the near future, we may see a widely available treatment which can benefit a greater number of diabetics.

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