1.) “MYOGENCE”

It is a specific combination of biologically active amino acids clinically developed to improve power, intensity and endurance of human physiological activity. Myogence is the only amino acid formula granted U.S. Patent for "enhanced physical performance" as measured by strength, power and stamina. The Myogence formula is expected to be the basis for numerous over-the-counter and clinically developed product line derivatives.

Though originally intended as an alternative for athletes seeking a nutritional alternative to anabolic steroids, it is anticipated that Myogence will work well in the context of boosting nutritional performance and stamina in various disease treatment contexts, including but not limited to African anti-retroviral regimens. The ability to not only enhance nutrition but also reduce the metabolic load on liver function needs further confirmation but is seen as a promising attribute in supplementing a variety of proprietary and generic treatment regimens.

Studies have postulated that “enriching” the blood with the Myogence formula of amino acids aids the exercising body in at least three ways.

1. Substrates made readily available by the blood to the bodily muscle mass decrease the workload on the liver, which would otherwise produce them, thus reducing energy utilized by the liver during exercise resulting in more energy available for activity.

2. Ready supply of amino acids and polypeptides as delivered by Myogence appear to facilitate skeletal muscle recovery and repair. More rapid skeletal muscle repair is thought to provide greater skeletal muscle availability for strength and stamina related to activity as well as recycling muscle as energy supply.

3. Substrates presented to the body cell mass by Myogence appear to have a positive impact on cardiovascular performance. Studies have indicated numerous relationships between amino acids and cardiovascular performance. Some have cited improved stroke volume and vascularization. Myogence may work in hypothesized scenarios indicating a positive impact on the “nitrogen puff” exchange and on the symbiotic relationship between nutrient substrate availability and muscle metabolism.

Study

A study was undertaken to evaluate Myogence by monitoring power output generated by peak conditioned athletes using a knee extension/flexion exercise machine in a randomized controlled crossover model. Plasma and urine amino acid concentrations were determined and based on amino acid disappearance profiles (reflecting utilization), an enriched protein supplement (Myogence) was formulated that resulted in significantly improved power and endurance for these athletes.

The enriched supplement resulted in higher power in each block. The increased power achieved was sustained throughout this phase of testing (p 0.05). The non-enriched supplement resulted in less power per block, and the power output steadily tapered off over time, demonstrating decreased endurance. Because of different numbers of cycles achieved by the different athletes prior to exhaustion, a paired t-test for each athlete using the two different supplements was then performed on the basis of total power generated as well as the number of cycles completed.

For each athlete, use of the enriched supplement resulted in significantly (p<0.05) more total power (a 91% increase compared with the basic supplement). Endurance was also prolonged with the enriched supplement as 6 of 7 subjects completed more cycles (for an average increase of 69%). The average power generated per cycle was calculated for all athletes as a group. As time (cycles) elapsed, successive averages reflected the power of those athletes continuing to exercise.

The two phases of this experimental model suggest that improved power and endurance are possible with a specifically enriched supplement. When tested for a set number of knee extension and flexions (Phase I), the athletes taking the enriched formulation always generated more net power during each block for testing. Furthermore, they were able to sustain a consistent and high level of power.

When the same athletes were not taking the enriched supplement, they displayed a steady decline in power generation demonstrating less endurance. During the second phase of the testing when the athletes exercised to the point of exhaustion, the power generation was consistently higher with the enriched formula and their endurance was significantly prolonged before exhaustion forced them to stop.

With each athlete serving as his own control, it appears that the enriched protein supplement provided a significant improvement in energy generation when it was taken for three days prior to testing as well as one-half hour before beginning the warm up and exercise testing. The concept of protein as an energy source is not new.

What is novel is the documentation of a specific blend of amino acids serving as a performance enhancer. Consistent anecdotal data also indicate positive change in disposition including, stronger hair, stronger finger and toe nails, improved vision, improved skin color, improved muscle tone and improved wound healing.

2.) ATHEROMINE is a second generation, safe Total Parenteral Nutrition (TPN) technology designed to induce the reduction of total and “bad” cholesterol and the regression of atherosclerosis (U.S. Patent #5,032,608). Developed by Dr. Dudrick, a leader in clinical nutritional intervention for over 40 years and recognized worldwide as “the father of” TPN, Atheromine features a specific amino acid profile delivered via central venous catheter. The IV delivery required extensive pre-clinical and FDA mandated Clinical Trials as they existed when carried out twenty years ago.

Atheromine is a viable treatment for at least 10% of the estimated $50 Billion per year U.S. CVD population who can not be helped by, or have not responded favorably to, conventional therapies. Atheromine has exhibited no indigenous adverse reactions other than those associated with TPN administration. Furthermore, it is complementary to the current “standard of care” pharmaceutical and technical endovascular or surgical interventions. As an over-the-counter consumer treatment, oral forms of Atheromine are potential “Blockbuster” healthcare products worldwide.

The effective medical action involves modifying cholesterol metabolism. This results in lower LDL (bad cholesterol) and higher HDL (good cholesterol) blood levels. Improved myocardial perfusion has also been demonstrated with Atheromine administration, resulting in improved oxygenation of the heart muscle, stroke volume and coronary vascularization. Because it can be applied to the treatment of over 70% of the U.S. CVD population, oral Atheromine will be promptly marketed GHPC. Additionally, we will advance the claim that, due to its added value, IV Atheromine should be administered as the amino acid formulation of choice for the vast majority of TPN solutions currently used worldwide. Furthermore, the base formula of Atheromine can be customized or “tailored” to the individual requirements of patients with a wide variety of co-morbidities or collateral conditions.

Atheromine is mainly indicated for people in “Western” Countries whose diet contains fat-rich foods and who subsequently exhibit the effects of “excess fat consumption” on their arteries. It is recognized that the two market areas with the highest per capita incidence of atherosclerosis are North America and Europe. Traditional diets that contain too much saturated fat overwhelm the body’s natural ability to cope, leading to high levels of LDL (bad cholesterol), secondary inflammation, and the subsequent build-up of plaque within the arteries.

The dangerous cardiovascular consequences that follow are well known. Atheromine provides low cost, non-pharmacologic, natural and wholesome alternative cardiovascular therapy that does not manifest the discomforts and risks associated with conventional care. In summary, Atheromine can be used either as a “stand alone” treatment or as an adjunct therapy for the management of atherosclerosis.

3.) An Electrolyte/Fluid Rehydration Formula - Developed during the course of studies by Stanley J. Dudrick, MD, FACS, the     formula can be marketed immediately in pill or capsule form administered with water or juice to both clinical and over the counter markets. Intravenous products would also be available to the clinical market.

Development of an OTC rehydration drink is also feasiblebased on the electrolyte formula alone and/or augmented by Myogence. Effective fluid replacement involves the transport of electrolytes across the intestinal lining and into the blood stream. Because it is now a clinically accepted fact that amino acids cross the intestinal mucosa at a greater rate than simple (glucose) or complex (fructose) carbohydrates, an amino acid mediated electrolyte transport would be superior to carbohydrate mediated rates.

The development of an electrolyte/fluid replacement drink that also provides the body with optimal amino acid profiles could revolutionize the fluid supplement industry.  A variety of intravenous purpose specific products would also be made available as a result of user demands and research validation of efficacy and safety.