Following a successful audition by the Hungarian National Institute of Pharmacy and Nutrition in May, 2015, Trigon Biotechnology Inc., strategic partner of HYD Pharma Inc., has received new GMP compliance certificates for the deuterium-depleted water (DDW) producing facility of HYD Pharma.
This GMP approval now certifies that HYD Pharma can produce DDW for its phase 2 clinical trial with chronic lymphocytic leukemia (CLL) as one-of-the-first clinical trials to prove the anticancer effect of deuterium depletion. HYD LLC having the completed protocol in hand will apply for ethical approval to start this Phase 2 clinical trial. In 2015 the first patients may be recruited.
Gábor Somlyai, president of HYD Pharma Inc. commented: “Achieving the successful GMP certification of our production site at Trigon Biotechnology Inc. is an essential element for the pending phase 2 clinical study, our ongoing business and reflects our continued focus towards deuterium depletion as an additional new tool in oncotherapy.”
HYD Pharma Inc. and its sister company, HYD LLC. develop pharmaceutical and consumer products based on the recognition that deuterium (D), the heavy isotope of hydrogen (H), has a central role in cell physiology and metabolism. Altered D/H ratios strongly regulate the expression of distinct genes as well as the activity of enzymes having key roles in cell cycle regulation.
Strategic replacement of hydrogen atoms in therapeutics with deuterium could positively influence efficacy and side effect profiles of drugs. A few years ago GSK announced that they will collaborate to develop and commercialize deuterium-containing medicines with Concert Pharmaceuticals and allocated an upfront $35 million payment to replace H for D on a given registered drug candidate.
DDW as Active Pharmaceutical Ingredient is registered at the European Medicine Agency (EMA). EudraCT number 2015-003820-30 has been issued for the Protocol Code Number HYD-HD85/45-CLL-02, which is now in effect.