GTHA – GeneThera, Inc.
Stock Guru Profile GeneThera, Inc. (OTCBB:GTHA)
GeneThera and Leading Italian Research Institute to Begin Clinical Trials on Mad-Cow and Other Animal Diseases
Dr. Tony Milici – Chairman of the Board, President & CEO
Dr. Milici has a Ph.D. in Experimental Hematology and M.D. in Medicine and Surgery, receiving degrees from University of Rome (Italy) and Stanford University. His credentials are impeccable. His collaboration with THE leading Italian Research Institute on Mad Cow Disease is the ONLY game in town or in this country.
Let’s take a closer look at August 6, 2006, article in USA Today: Mad Cow Watch Goes Blind. What this story reveals is that the USDA refuses to let ANYONE test for Mad Cow Disease in this country.
This is significant to Dr. Milici’s company, GeneThera, because he has been working on Mad Cow Disease or (bovine spongiform encephalopathy). It is generally accepted that the test used by the U.S.D.A. in the miniscule percentage of animals tested is seriously flawed and not conducted by parties that are trained to perform the testing. Further, the USDA testing tests only one part of the brain and could miss the infection in a different section of the brain.
Here is the USA Today article. An explanation of the signficance to GeneThera, Inc. will follow.
Creekstone Farms, a Kansas beef producer, wants to reassure customers that its cattle are safe to eat by testing them all for mad cow disease. Sounds like a smart business move, but there’s one problem: The federal government won’t let the company do it.
The U.S. Department of Agriculture – invoking an obscure 1913 law intended to thwart con artists from peddling bogus hog cholera serum to pig farmers – is blocking companies from selling the testing kits to Creekstone.
USDA is doing the bidding of large cattle barons afraid that Creekstone’s marketing will force them to do the same tests to stay competitive. It’s true that the incidence of mad cow disease is quite low. But there’s little logic in stopping a company from exceeding regulations to meet the demands of its customers, or protecting its rivals from legitimate competition.
Not only is USDA blocking Creekstone, the department said last month that it’s reducing its mad cow testing program by 90%. The industry and its sympathetic regulators seem to believe that the problem isn’t mad cow disease. It’s tests that find mad cow.
The department tests only 1% of the roughly 100,000 cattle slaughtered daily. The new plan will test only 110 cows a day.
By cutting back on testing, USDA will save about $35 million a year. That’s a pittance compared with the devastation the cattle industry could face if just one human case of mad cow disease is linked to domestic beef.
The brain-wasting disease – known formally as bovine spongiform encephalopathy, or BSE – is extremely rare but extremely deadly. Since 1986, it has killed more than 150 people worldwide, mostly in Britain, who ate infected meat.
Scientists don’t know the exact cause of BSE but think it’s spread when cows are fed ground-up parts of cattle and other cud-chewing animals. The government has tightened cattle-feed rules, but loopholes still permit cattle blood as a milk substitute and chicken waste as a protein supplement.
Canada has found four cows with BSE this year, and at least one was born after similar cattle feed rules were imposed that should have prevented the animal from being infected. Acting out of an abundance of caution, U.S. plans to increase Canadian beef and cattle imports have been put on hold until the new cases are investigated. That makes sense, but it’s hard to justify cutbacks on U.S. testing at the same time we demand other nations provide greater assurances.
Sixty-five nations have full or partial restrictions on importing U.S. beef products because of fears that the testing isn’t rigorous enough. As a result, U.S. beef product exports declined from $3.8 billion in 2003, before the first mad cow was detected in the USA, to $1.4 billion last year. Foreign buyers are demanding that USDA do more.
“In a nation dedicated to free market competition,” says John Stewart, CEO of Creekstone, which is suing USDA, “a company that wants to do more than is required to ensure the quality of its product and to satisfy customer demand should be allowed to do so.”
When regulators disagree with reasoning like that, you know the game is rigged.
Dr. Milici is ready to proceed with clinical trials. In order to do this he has aligned his company with the national institute in Italy which test every slaughtered cow for Mad Cow Disease. GeneThera is performing assays in Italy on every slaughtered cow.
This is a two stage test. GeneThera set up the test at the Research and Development level in the United States. The next step is to go through the validation process using GeneThera’s molecular test and this will be done in Italy.
For this phase GeneThera will take the results of this test and match them with the test that the Institute in Italy is using. This will enable Dr. Milici to determine how his test stacks up agains the test currently being used. Italy’s leading applied research laboratory, Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna (IZSLER) to collaborate on scientific research related to the diagnosis of animal transmittable diseases, such as Mad-Cow and Scrapie diseases.
The goal of these clinical trials is to validate GeneThera’s proprietary technology by comparing 10,000 samples between GeneThera’s developed test and an approved Post Mortem test under ESFA guidelines for validation. Basically, GeneThera will be responsible for supervising all aspects of the testing under this Agreement, while the Institute will provide its facilities and assist in the accreditation and validation of the tests and technology of GeneThera.
GeneThera has complied with the scientific standards for clinical trials by agreeing:
(i) establishment of validation protocols to compare GeneThera’s live animal blood test technology for the detection of Transmissible Spongiform Encephalopathy (”TSE”) to current available methodologies for “post mortem detection” of TSE;
(ii) to establish a research protocol for a time course correlation study between the TSE-specific gene marker expression levels in blood and the presence of TSE in live experimentally infected animals, and
(iii) to establish a Bovine Spongiform Encephalopathy (”BSE”) screening program using GeneThera’s live animal blood test system for large scale cattle testing in feedlots and slaughter houses.
IZSLER (The Italian Institute) has begun collecting the first samples from the Institutes’s experimentally infected cattle herd with GeneThera’s Field Collection System(TM) for review by GeneThera’s staff.
This is a brave move by Dr. Milici and he is very excited. We will review the Newsweek Article and GeneThera’s Clinical Trials in our next article. Feel free to link and read ahead!
SOURCE: GeneThera, Inc.
CONTACT: GeneThera, Inc.
Dr. Tony Milici, 303-463-6371
http://www.genethera.net
About GeneThera, Inc. GeneThera, Inc. is a molecular biotechnology company located in Wheat Ridge, CO. The Company provides genetic diagnostic solutions for the veterinary and agricultural industries with future plans to include the health-care industry. The Company’s proprietary diagnostic solution is based on a genetic expression assay, GEA(TM), a protocol designed to function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GEA is designed for a host of individual diseases, the current priority being Mad Cow disease, Chronic Wasting Disease, a disease affecting elk and deer in North America; E.Coli 0157:H7 and Johnne’s Disease, diseases affecting cattle worldwide.
About IZSLER Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna (IZSLER),(www.bs.izs.it), offers a broad range of services in the Public Veterinary sectors in particular, Food Safety to the Veterinary Services, Breeders and Consumers. Its functions today can be described as those of a Technical-Scientific Body providing services as required of it by national and regional law. At the present, IZSLER employs over 600 persons, 90 of them are graduated scientists (veterinarians, biologists and chemists). On a regional basis (Lombardia and Emilia Romagna), IZSLER performs diagnosis for a variety of viral infectious diseases of ruminants, pigs, horses, poultry and other species of economic interest (rabbits, fishes, bees….), and microbiological and chemical analysis on foodstuffs of animal origin destined for human consumption and on food resources for animals.
“Safe Harbor” Statement: Certain statements in this release are “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. Such statements are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the Company’s ability to meet the terms and conditions required to obtain its project financing, risks and delays associated with product development, risk of market acceptance of new products, risk of technology or product obsolescence, competitive risks, reliance on development partners and the need for additional capital.
Forward Loooking Statement: A number of statements contained in this report are forward-looking statements, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, competitive market conditions, successful integration of acquisitions, the ability to secure additional sources of financing, the ability to reduce operating expenses and other factors not set forth herein. The actual results that the Company may achieve may differ materially from any forward-looking statements due to such risks and uncertainties.
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