Cancer Treatment -
NEWS RELEASE
October 13, 1997
Deuterium Depletion as a New Tool in Cancer Therapy
Based on research and development that has been conducted by HYD Ltd.
since 1990, it is now evident that the heavy isotope of hydrogen, "Deuterium"
has a key role in cell metabolism (Somlyai et al., FEBS Letter, Vol. 317, number 1,2, 1-4 February 1993, Acta medica empirica
7/1997). There is conclusive evidence that the application of deuterium depleted water
(DDW) causes a delay of cell growth in tissue culture. In animal experiments, deuterium
depleted water (DDW) slowed down, halted or reversed the growth of tumors originating from
malignant (neoplastic) cell lines of human origin, in immunosuppressed mice, and
spontaneous tumors of cats and dogs.
HYD Ltd., following preclinical safety and efficacy studies, initiated
a Phase II double blind randomized clinical trial to evaluate the potential usefulness of
therapeutic deuterium depletion. Approximately 10 tons of water (50% deuterium depleted
water (DDW), 50% placebo with normal deuterium-content) had been prepared and used for the
purpose of the clinical trial. The 35 patients involved in the trial were diagnosed with
prostate tumors. This study was in effect from August of 1995 until May of 1997. Interim
evaluation of the collected results was carried out this summer. The transrectal
ultrasonic examination showed an average of 23.9% decrease in total prostate volume in 15
patients in the treated group compared to the 7.7% decrease in the 11 patients in the
control group. After two months 50 % of the patients in the treated group became free of
urinary complaints, while no changes were found in the control group.
Based on the toxicology and efficacy studies plus the report of the
interim evaluation of the Phase II clinical study, the Hungarian Institute of Pharmacology
(FDA in Hungary) agreed to allow patients who have not responded to conventional cancer
treatment expanded access to deuterium depleted water (DDW). This continuation of the
Phase II clinical trial involving additional cancer patients is currently being conducted
in Hungary and is scheduled to be completed by mid 1998. HYDROS Inc. (California, USA)
(http://www.hydros.com), an affiliated company of HYD, Ltd. (Budapest, Hungary)
(http://www.hyd.hu), is in the process of filing the PRE-IND review with the
FDA.
