HYD Receives Approval for Phase 2 Clinical Trial
News Jul 19, 2016
HYD Pharma Inc. has been granted ethical approval by the State Institute for Drug Control (SIDC) in Slovakia for Phase 2 as one-of-the-first clinical trials to prove the anticancer effect of deuterium-depleted water (DDW) in chronic lymphocytic leukemia (CLL). HYD Pharma will apply for ethics approval for additional 5 clinical study sites in 2 other countries by the end of 2016. Scientific results clearly show that the deuterium/hydrogen ratio in cellular water pools and the transfer of their deuterium content to different structural and functional molecules are essential for maintaining normal cell functions, DNA and protein integrity.
CLL was chosen upon the consideration, that it is one of the few tumor types, where - according to the treatment protocol - even if the diagnosis is clear, the patients will not receive immediate treatment if the stage of the illness allows it. Patients with asymptomatic chronic lymphocytic leukemia (CLL) in early stage (Binet A) who are at high risk of progression and are treatment naive are to be enrolled into the study allowing the investigators to study the effect of deuterium depletion without being influenced by any ongoing conventional therapy.
In contrast to the inability to cure CLL with current therapeutic regimens, there are very rare examples of the spontaneous regression of the disease. In 2015, Trigon Biotechnology Inc., strategic partner of HYD Pharma received new GMP compliance certificates for the deuterium-depleted water (DDW) producing facility, and DDW as Active Pharmaceutical Ingredient was registered at the European Medicine Agency (EMA) and the protocol in the EudraCT system.
László G. Boros, MD, (University of California) and Gábor Somlyai, chief scientist of HYD Pharma, recently published an article in Medical Hypotheses, titled “Submolecular regulation of cell transformation by deuterium depleting water exchange reactions in the tricarboxylic acid substrate cycle”, co-authored by prominent collaborators from Johns Hopkins University; Morsani College of Medicine (University of South Florida) and the University of Arizona Comprehensive Cancer Center.
The article identifies deuterium as an oncoisotope, and the new research clarifies how normal cells discriminate against deuterium and how tumor cells lack this process. In June, 2016, Cell Metabolism paper, Comment to the Editor, has been accepted and posted as an Open Access article.
Gábor Somlyai, president of HYD Pharma Inc. commented: “Achieving the GMP certification and receiving ethical approval are essential elements for the pending phase 2 clinical study, and reflects our continued focus towards deuterium depletion as an additional new tool in oncotherapy. Our proprietary procedure has broad potentials to enhance the efficacy of current oncotherapies, as well as to innovate new ones.”