Nutra Pharma reports third-party validation of Mycobacteria test

Nutra Pharma Corp announced that its majority-owned subsidiary, Infectech Inc. received third-party verification of its technology by Dr. Paul Hyman of Ohio State University. Dr. Hyman has achieved the identification and bacterial genetic amplification of an important strain of Mycobacteria faster than what is presently in the medical literature...

BOYNTON BEACH, FL, Sept. 7, 2004 (BUSINESS WIRE) -- Nutra Pharma Corp announced that its majority-owned subsidiary, Infectech Inc. received third-party verification of its technology by Dr. Paul Hyman of Ohio State University. Dr. Hyman has achieved the identification and bacterial genetic amplification of an important strain of Mycobacteria faster than what is presently in the medical literature.

"Mycobacterium avium paratuberculosis could be detected significantly sooner than expected for normal culture techniques," stated Professor Hyman. "The bacterium are slow-growing and can take longer than fourteen weeks to culture using the current accepted media. With Infectech's technology, sufficient DNA for PCR gene amplification could be extracted from paraffin that had no visible colonies on it, sometimes in as little as one week," he concluded.

Mycobacterium paratuberculosis is a hardy bacteria related to the agents of leprosy and tuberculosis. It is the causative agent of Johne's disease (pronounced "yo-knees"), a contagious, chronic and usually fatal infection that affects ruminants (cattle, goats and sheep). All ruminants are susceptible to the disease and it is worldwide in distribution. A national study of US dairies, Dairy NAHMS 96, found that approximately 22 percent of US dairy farms have at least 10% of the herd infected with Johne's disease. The study determined that infected herds experience an average loss of $75 per cow inventory annually. Small herds (fewer than 50 cows) lost an average of $178 per cow, while large herds (greater than 500 cows) lost $181 per cow. This loss was due to reduced milk production, early culling, and poor conditioning at culling.

The major problem associated with the successful control of Johne's disease is that there are no rapid, reliable, inexpensive tests for identifying subclinical carrier animals. The current diagnostic method of choice is the bacterial culture of feces on specialized media. Unfortunately, the causative agent, Mycobacterium paratuberculosis is a finicky organism, is hard to grow on artificial media, culturing takes about 14 weeks but can take as long as twenty weeks for colonies to appear. This makes the process of identifying and removing infected animals from the herd a painfully slow task. In addition, the number of organisms shed in the feces of infected animals may vary with time, meaning that several attempts at fecal culture may be necessary before an infected individual is finally identified as a shedder.

Infectech owns 29 issued patents related to the rapid isolation, growth, identification and antibiotic sensitivity of disease-causing bacteria that includes Mycobacterium paratuberculosis. Infectech's researchers discovered that certain grades of paraffin wax, when used in conjunction with a microscope slide, and combined with a nutrient broth, provides for the rapid isolation, growth and identification of various disease-causing bacteria. Infectech has developed a diagnostic test kit based on this technology. The basic test kit consists of a glass slide coated with paraffin, which is used as a carbon (food) source by certain pathogenic bacterial species such as TB. The slides are incubated in a sample of almost any bodily fluid (a non-invasive sample of saliva is preferred) within a nutrient broth. This creates a semi-solid growth medium for the bacteria, which imitates its natural environment within a human or animal host. The bacteria collect on the paraffin slide in 4-8 days. Testing can then be done to identify the species of bacteria. This testing can be done via acid-fast staining or through PCR gene amplification. Additionally, the bacteria can be cultured with antibiotics to test for specific sensitivities. Through the choice of different nutrient broths, each kit can be tailored to encourage the growth of a specific bacterium. The test kits are being designed to work on a class of bacteria that includes TB, MAI, Para-tuberculosis, Pseudomonas and Nocardia.

"Dr. Hyman's validation of Infectech's patented technology clearly shows that we can identify a costly disease in a fraction of the time," commented Dr. Mitchell Felder, Chief Executive Officer for Infectech. "By identifying Mycobacterium paratuberculosis in as little as one week instead of fourteen weeks or more, this technology could save the agricultural community millions of dollars annually," he continued.

"We are very excited about the progress that has been made by Dr. Hyman and Ohio State University," said Rik Deitsch, Nutra Pharma's Chief Executive Officer. "They have already validated Infectech's Identikit with a very important strain of mycobacterium. After completing the work in two other strains (MAI and Tuberculosis), Infectech will seek to gain regulatory approval from the FDA, bringing the Company to revenues in the near future," he added.

About Nutra Pharma Corp.
Nutra Pharma Corp. (www.nutrapharma.com) is a biotechnology holding company that owns rights to patents and intellectual property related to the development of drugs for HIV and multiple sclerosis ("MS"). The Company's minority-owned holding, ReceptoPharm, Inc., is developing these technologies. The Company's majority owned subsidiary Infectech, Inc., is engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious diseases such as Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma will continue to identify and acquire intellectual property and companies in the biotechnology arena.

About Infectech Inc.
Infectech Inc. (www.infetech.com) is a biotechnology/genomics company that specializes in the research, development and production of laboratory kits used in the rapid identification and antibiotic sensitivity testing of disease-causing pathogens. The company's patents span the identification and antibiotic sensitivity testing of a family of disease-causing bacteria that includes: Tuberculosis, Para-tuberculosis, Pseudomonas, M. avium and Nocardia. These bacteria are cited as a prominent cause of death in patients with cancer, cystic fibrosis, and AIDS, as well as in patients undergoing surgery. Infectech's other patents include technology designed for use in the bioremediation of contaminated soil and water. Additionally, Infectech also owns a patent for the nontoxic induction of apoptosis in cancer cells utilizing hydrophobic hydrocarbons. Apoptosis is a method for inducing a genetically based induction of "cell suicide" in cells. It therefore serves as the foundation for cancer therapy.

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