Clinical Results

Background

Sucanon™ is the first member of a new class of diabetic drugs that was discovered in the research laboratories of Biotech Holdings Ltd., in Vancouver, British Columbia. The pre-clinical and clinical work was done in China and Sucanon was approved following a submission of an NDA in China.  Supplementary clinical work was conducted in BraziI and this has shown that the same clinical activity can be reproduced in a non-Asian population.

Sucanon

Sucanon™ is a small, water soluble, stable compound that is synthesized and then formulated into tablets. Compared to other commercial hypoglycemic agents (i.e. low blood sugar), Sucanon™ is a very potent member of its class. It is several times more potent than insulin, and many hundred fold more potent than most commercialized hypoglycemic agents. The adult dose of Sucanon™ is around 2 mg per day.

Clinical Studies

The clinical benefits of Sucanon™ have been demonstrated in a double-blind, randomized, controlled, multi-center, efficacy and safety study in 370 adult patients with Type II diabetes conducted in China.  Sucanon™ tablets were administered – one in the morning and one in the evening. The duration of this study was 6 months – four months of treatment; one month evaluation, and one month post-treatment follow-up. Glibenclamide is a commonly prescribed sulfonylurea and its benefits and limitations have been well known to diabetologists for over a decade.

The parameters of response to this study included an evaluation of the changes in clinical signs and symptoms of diabetes, any alteration in the blood and urine measurements of glucose metabolism, and any alteration in blood lipid levels.

The results indicated that patients receiving either Glibenclamide or Sucanon™ responded in a relevant clinical manner and the differences from baseline measurements were statistically significant. The lack of response in patients who were randomized to receive placebo was also unequivocal. In this group the effect of administration was clinically small or non-existent, and the baseline to treatment difference was statistically insignificant.

Response to therapy was documented both by loss of or a reduction in symptoms (including polyuria, polvdipsia, polyphagia, and fatigue), but also by a reduction to normal or near normal levels in the elevated fasting blood glucose and urinary sugar, and a normalization of the glucose tolerance test.

The improvements associated with therapy for the Glibenclamide group of patients and the Sucanon™ group of patients were both better than placebo for all parameters measured, to a level that was statistically significant. Elevated cholesterol and trigylceride levels in the blood were reduced to normal or near normal levels on Sucanon™ therapy. The level of reduction in cholesterol and triglyceride was clinically and statistically significant. A response analysis was done by the study coordinator in China and it was stated to be highly significant for Sucanon™ therapy with an overall response rate of 87%. In addition, the toxicity profile after daily treatment for four months was difficult to distinguish from placebo.

 

Business Development

Biotech Holdings began marketing of Sucanon in China in 1997 through its subsidiary VoIque Pharmaceutical, but suspended distribution in 2000 due to contractual and a change of strategic direction, with the new emphasis on Latin American markets. In 2001 and 2003. Sucanon was granted regulatory approval in Peru and Mexico. Beginning in 2006, Sucanon™ was distributed in Mexico. Subsequently marketing was initiated in other countries.