Preventive Nutrient Company (PNC) Inc. is a Commercial Product Research and Development (R&D) organization that obtains patents and licenses for various pharmaceutical and nutraceutical agents. PNC, Inc. was founded in 1997 to explore the potentiality of over-the-counter nutraceuticals for the control of glucose metabolism. It currently offers clinical trials with Cyclo-Z (Cyclo- [his-pro] plus zinc), a drug that treats diabetes without any known adverse side effects, for purposes of FDA approval. The company also plans to offer clinical trials with Cyclo-Z for the treatment of other medical conditions such as obesity, Alzheimer's disease, and related metabolic diseases. PNC completed the Phase 1 Clinical Trial successfully with Cyclo-Z in the year 2006 at the VA Greater Los Angeles Medical Center (VA GLAMC). The Phase II Clinical Trial (CT) for diabetes has been initiated (2009) at the VA GLAMC in cooperation with previous colleagues who have no financial interest in PNC. After completion of the phase II CT, PNC plans to enter into a partnership agreement with a major pharmaceutical company. This study was funded by the VA Merit Review program after fierce competition with other scientists in the field. All three patent rights for the treatment of diabetes, obesity and Alzheimer’s disease belong to the Department of Veterans Affairs on behalf of the US government. Thus, the profits obtained from the commercialization of these products will be used for research activities in adult onset metabolic diseases. Ultimately, the products must be sold to the patients through their healthcare professionals. The PNC has applied for grants, including the SBIR grant from the National Institutes of Health from the VA to complete Phase II clinical trials for obesity, Alzheimer’s Disease, and other metabolic diseases. PNC has commenced raising private funds to further the required research and testing toward meeting FDA requirements. We also receive donations to the VA research service. These drugs will be potentially the best drugs for the prevention and treatment of these adult onset metabolic diseases such as diabetes, obesity and Alzheimer’s disease.

It was estimated that the cost for the treatment of diabetes in the year 2007 exceed $174 billion or as high as $218 billion (www.diabetesincontrol.com). According to publications, the drug market for diabetes treatment is estimated to be over $20 billion per year in the USA in 2000 and $25 billion in 2007. Time magazine previously reported (September 4, 2000) that type 2 diabetic patients jumped from 4.9% of the total U.S. population in 1990 to 6.5% in 1998, and this percentage is now increased to 8%. It was estimated about 21 millions were diabetic in the year 2005 and 24 millions were diabetic and 57 millions are pre-diabetic in the year 2007 in the US (ADA News 2006 and 2008). It was also predicted that the risk for developing diabetes for individuals born in the year 2000 is 32.8 % for males and 38.5% for females in their lifetime (CDC report ). Of the 1.6 million people that are yearly diagnosed with diabetes, 12,000 to 24,000 develop a new onset of blindness each year, 46,739 are treated for end-stage kidney disease, and 71, 000 received lower-limb amputation from diabetes-related complications in the US (ADA report 2008).

The most important anti-diabetes agent is one that improves insulin sensitivity. Several years ago, FDA approved pioglitazone and rosiglitazone for marketing as diabetes treatment drugs, which increase insulin sensitivity. Both pioglitazone and rosiglitazone activate PPAR which stimulate gene expression of GLUT-4. These drugs also stimulate other gene expression and aggravate some vital complications such as hypercardia and liver diseases. More recently, Glucogon-like protein-1 (GLP-1) and Dipetidyl peptidase-4 (DDP-4) inhibitor have been approved for maintaining stable blood glucose by FDA. However, a high number of patients (40%) experienced nausea or vomiting with GLP-1 treatment . Although DPP-4 inhibitor exhibits minimum side effects, the reduction of HbA1c was only between 0.39-0.56 % in 12 week trial period Based on our background studies and observation, we expect that Cyclo-Z treatment will reduce HbA1c level between 1.0 to 3.0%, fasting blood glucose between 10-30 mg/dL and postprandial blood glucose 20-80 mg/dL, and very significantly improve OGT in a 24 week clinical trial period. These estimations are very modest and Cyclo-Z is expected to be comparable to or better than any other existing anti-diabetes agents. Cyclo-Z is believed to correct the cause of diabetes by stimulating IDE synthesis, which improves insulin sensitivity and diabetes. If we prove that Cyclo-Z is indeed safe and effective for the treatment of human diabetes from the phase 2 clinical trial, the impact of this study on both global diabetes healthcare benefits and the economic advantage to diabetic patients and to the US drug industry will be enormous.

PNC has obtained patent approvals approvals for the prevention and treatment of obesity and Alzheimer’s disease.

Approximately 4 different drugs are now available for the treatment of AD patients. They are Aricept (donepezil), Excelon (rivastigmine), Namenda (memantine HCL), and Razadyne (galantamine). These drugs are mostly acetyl- and butyryl-cholinesterase inhibitors and have been shown to be effective and well tolerated in the symptomatic treatment of Alzheimer’s disease and against progressive degeneration of brain neuronal cells in AD. However, scientists do not fully understand how cholinesterase inhibitors work to treat AD. Interestingly, plasma butyrylcholinesterase and acetylcholinesterase levels are elevated in patients with AD and in type 2 diabetic patients. These enzymes and related proteins are commonly found in both Alzheimer’s disease and diabetes. Based on our background studies and observation, we expect that treatment with Cyclo-Z which ameliorated diabetes in several animal models, will have a great impact on the treatment and prevention of AD better than any of the existing drugs. If this treatment is translatable to humans, many individuals will be greatly helped with Cyclo-Z in the treatment of the cause of AD by stimulating IDE synthesis, which decreases Aβ levels. If we prove that Cyclo-Z is indeed safe and effective for the treatment of AD in the phase 2 clinical trial, the impact of this study on global AD healthcare benefits and the economic advantage to AD patients and on the US AD healthcare system will be immeasurable.