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Cancer Treatment -
NEWS RELEASENovember 20, 1998
HYDROS MEETS FDA
An innovative treatment for cancer using deuterium-depleted water (DDW) may soon be entering clinical trials in the United States. Developed by Gabor Somlyai, Ph.D. of HYD Ltd., a Hungarian biotechnology company, DDW is being developed for use in North America by HYDROS, Inc., a company in Los Angeles, California. Officials from HYDROS, Inc. met in early November with the FDA for a PRE-IND (Investigational New Drug) Review, and the company is now preparing to submit an IND to the FDA. The company recently received a favorable safety and efficacy Interim Evaluation on their DDW treatment for patients with prostate cancer in the Phase II clinical trials that are now going on in Budapest, Hungary. Previously, in pre-clinical studies with mice transplanted with human breast cancer, administration of deuterium-depleted water inhibited tumor growth and caused tumors to shrink and disappear, with no toxic side effects.
"The FDA was very encouraging and supportive of our project", says Robert Sobel, Chief Executive Officer of HYDROS, Inc. "They urged us to submit the IND application as soon as possible and suggested a few locations in Southern California that are capable of performing the clinical trials." Due to the successful Phase II clinical trials in Hungary, the company plans to begin Phase III clinical trials in the United States for prostate cancer; clinical trials for breast cancer will begin with Phase II/III. No decision has been made as to where the clinical trials will be held.
Hydrogen exists naturally in three isotopic forms; (1) Hydrogen with a mass number of one, (2) Deuterium with a mass number of two and (3) Tritium with a mass number of three. Deuterium is the only stable and non-radiating isotope of Hydrogen. Due to their mass difference, Hydrogen and Deuterium behave differently in chemical reactions. In other words, Deuterium can be considered as an "independent element". In high concentrations, Deuterium exerts a major impact on various biological systems (viruses, algae, plants, mice, etc.) which is the consequence of the so-called isotopic effect.
The water content in living organisms and the D2O concentration of natural water, which is 150 ppm (parts per million), the Deuterium (D) concentration in the living organisms is more than 10 mmol/L. Just to put this figure in perspective it should be noted that the Ca2+ (calcium) concentration in the body is approximately 2 mmol/L. This demonstrates that science has overlooked an element, which is present in the body at a five time's greater concentration than calcium.
Experimental work by Dr. Gabor Somlyai, President and Chief Medical Officer of HYDROS, Inc., showed that cell proliferation in cultured fibroblasts were a function of the deuterium concentration of the media. While normal cells can tolerate a lower-than-physiological deuterium concentration (20 – 130 ppm D), cancer cells with chromosome mutations that produce uncontrolled growth are extremely sensitive to deuterium depletion. In mice transplanted with human breast cancer, 70% inhibition of tumor growth was achieved in 80 days of oral administration of DDW, and in 59% of the mice; the tumors shrunk completely and disappeared. The DDW was completely nontoxic when substituted for normal drinking water for several months.
HYD, Ltd. (parent company of HYDROS, Inc.) was formed to develop DDW for the treatment of neoplastic diseases. HYDROS, Inc. was formed to develop and to market the treatment in North America. The company has obtained patents in 12 countries, including the United States, and patents are pending in 11 other countries. HYDROS has access to all the proprietary pre-clinical, clinical, and toxicological results obtained by HYD, Ltd. in Hungary.
Other products using DDW as the active ingredient are also in development. These preparations can be used for preventing and treating tumorous diseases; for retarding the aging process in the skin and for treating other skin-diseases, i.e. psoriasis. It is currently used in skin care products in seven countries. In dermatological tests, DDW has demonstrated a curative effect on many skin diseases. It promotes regeneration of the skin by reducing the deuterium concentration in upper skin layers, and it helps to restore optimal metabolic activity. It can be used as a preventative medicine in precancerous skin conditions. Used as a sunscreen ingredient, it protects against harmful UV-A and UV-B radiation and can reduce the risk of skin cancer. It can also be very beneficial in veterinary products and as a food ingredient.
The safety and efficacy in pre-clinical and clinical studies indicate that, the potential of this innovative approach to cancer treatment looks promising. "The marketing potential of DDW, as an anticancer drug, is estimated at several billion dollars a year for the pharmaceutical product alone, assuming that only 30% of new cancer patients each year were using our product", says Mr. Sobel. "The other products in development – the cosmetics, sunscreens, and veterinary products – have a similar potential", he says. HYDROS, Inc. is looking for either an alliance with a major pharmaceutical company or additional funding in order to begin clinical trials in the United States. More information can be obtained at the company’s web site, at http://www.hydros.com or by mail at: Hydros, Inc.; 23679 Calabasas Road, #331; Calabasas, California 91302-1502 USA.
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