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HYD Pharma Receives GMP Certification for Deuterium-Depleted Water (DDW) Production Facility

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Company will soon apply for ethical approval to start Phase 2 clinical trial in chronic lymphocytic leukemia Budapest, Hungary, September 2, 2015 / B3C newswire / -- 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 commercialise 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.

About HYD LLC HYD LLC was established in 1992 for the development and worlwide marketing of drugs and consumer products, that utilize the proprietary procedure, deuterium depletion. Since 1993, the company has been pioneering in research and drug development related to deuterium depletion, and was worldwide the first to investigate the biological role and physiological importance of naturally occurring deuterium. The company’s mission is to develop and register novel pharmaceutical and consumer products primarily for the treatment and prevention of tumorous diseases, and to open up new ways of application of the method in further ranges of indication. The world’s first deuterium-depleted antitumor medicine, Vetera-DDW-25® for veterinary application, was registered in Hungary, in 1999. In 2000, the company brought the  Preventa® deuterium-depleted drinking water products to the market. In 2012, Primus Capital closed a USD 2 Million investment in HYD Pharma Inc.. The investment is being used for validation of research results, and for set up the deuterium-depleted water (DDW) producing facility.

About Deuterium/Hydrogen Ratio The deuterium/hydrogen (D/H) mass ratio is the largest of stable isotopes of the same element, causing differences in physical and chemical behaviour of the two isotopes. Based on the research and development that has been conducted by HYD LLC since 1993, it is evident that deuterium has a key role in cell metabolism. It is suggested that cells are readily able to regulate their D/H ratios, while changes trigger distinct molecular phenotypes. Altered D/H ratios strongly regulate the expression of distinct genes and the activity of enzymes having key roles in cell cycle regulation and also regulate various molecular mechanisms with downstream effects on metabolism.

In May, 2015, the 3rd International Congress on Deuterium Depletion focused on the latest advances in the research and clinical application of deuterium depletion, its present and future role in anticancer research and oncotherapy, diabetes and neuroscience. All lectures are available at https://www.youtube.com/watch?v=7gAH9Dx2Xos&list=PL5uczjSxbC3E5DwCKEDWDBLm_01cDy63L, the interviews with key-note speakers of the conference at https://www.youtube.com/watch?v=JGBs9QEvPwY&list=PL5uczjSxbC3FT8-cCmfpUD14IVKm7I6p4.

Results presented at the meeting clearly show that the D/H ratio in cellular water pools and the transfer of their deuterium content to different structural and functional molecules via reductive synthesis are essential for maintaining normal cellular functions, DNA and protein integrity.  Pharmaceutical manufacturing of deuterium-depleted nutritional products, including deuterium-depleted water, the proprietary procedure established by HYD LLC for Cancer Research & Drug Development, has broad potentials to enhance the effectiveness of current oncotherapies, as well as to innovate new ones.

Contact

Gábor Somlyai PhD CEO HYD LLC for Cancer Research and Drug Development Phone: +36 1/ 365-1660 Fax: +36 1/365-1661 gsomlyai@hyd.hu www.hyd.hu www.deuteriumdepletion.com www.preventa.org www.vetera.hu

 

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