Breakthrough Science

1. Breakthrough Science In Chronic Degenerative Disease & Aging
www.SelectiveProteinDeficiency.com
George A. Scheele, M.D.
December 15, 2015

 

Factor4 Health represents a breakthrough in Evolutionary Medicine which utilizes evolutionary theory to explain the rise in chronic degenerative diseases associated with the Metabolic Syndrome and how to beneficially treat these diseases with Accelerated Amino Acid Delivery Technologies (AAADT).

BACKGROUND SCIENCE

  • In 1975 Dr. Scheele invented 2D gel electrophoresis that allowed the first detailed analysis of protein synthesis in individual tissues according to the size and charge of each protein (1).
  • Detailed nutritional studies in rats in the 80s and 90s, analyzed by 2D gel electrophoresis, showed that decreased levels of dietary protein (15% to 0% of daily calories) resulted in progressive losses in the synthesis of positive-charged proteins throughout the body (2).
  • These studies identified, for the first time, a considerable vulnerability in the synthesis of positive-charged proteins, rich in Lysine [K] and Arginine [R] residues, due to poor nutrition.
  • This unique observation has been called Selective Protein Deficiency Syndrome by Dr. Scheele in his 2011 book, entitled The Obesity Cure (3).
  • Scheele’s complete bibliography may be viewed on his career website (4).

EVOLUTIONARY THEORY EXPLAINS THE NUTRITIONAL RESULTS & POINTS TO SATIETY AND HUNGER SIGNALS THAT CONTROL METABOLIC DISEASE

In answer to the question, “Why do higher animals not make the 9 essential amino acids (EAA) and the 6 semi-essential amino acids,“ Dr. Scheele has provided the following insights:

  • Plants, bacteria and yeast can make all 20 amino acids that are required for protein synthesis. Vertebrates, mammals and humans can only make 5 of these amino acids, which are called non-essential amino acids (NEAA) because they are not required in the diet. Depending upon dietary conditions higher animals cannot make the other 15 amino acids, called essential amino acids (EAA), and therefore they must be acquired in the diet.
  • Unlike plants, bacteria and yeast, highly mobile forms of life on planet earth, containing well developed muscular structures, need strong hunger and satiety signals to survive and reproduce. Because of this insight, Dr. Scheele made the following conclusions:
  • The relative presence of EAAs in the blood stream represent the signal for satiety in the appetite center of the brain, the Arcuate Nucleus.
  • The relative absence of EAAs in the blood stream represents the signal for hunger in the appetite center.
  • Proteins enriched in Lysine [K] and Arginine [R] residues are most susceptible to amino acid deficiencies in the food chain because Lysine [K] is essential and Arginine [R] is conditionally essential. We have interrogated the human proteome and identified proteins with high KR values that could easily explain the diverse loss of metabolic functions in a number of metabolic diseases that comprise the Metabolic Syndrome. These include obesity, type-2 diabetes, lipid disorders and cardiovascular disease. Other KR-rich proteins may explain Alzheimer’s Disease, dementia and aging.
  • The isoelectric points of individual proteins, denoted by pI, is an index of the balance of positive-charged (K + R) and negative-charged (D + E) amino acid residues in that protein.
  • Treatment of the deficiency in EAAs that lead to Selective Protein Deficiency Syndrome would effectively prevent and treat most, if not all, non-genetic forms of metabolic disease(s).

For more information on the dietary restrictions of amino acids in protein synthesis, see “Primer on Amino Acids and Protein Synthesis in Humans.”

ACCELERATED AMINO ACID DELIVERY TECHNOLOGY (AAADT)

  • Scheele therefore created an AAADT formulation that contains EAA and backup protein together with vitamins, minerals and micronutrients.
  • EAAs act synergistically to accelerate the digestion and absorption of amino acids in the backup protein by stimulating cholecystokinin, secretin and the digestive process.
  • The technology is protected by 3 issued patents and forms the basis for Factor4 Health products, including Factor4 Weight Control®.
  • Recent analysis of AAADT indicates that Factor4 Weight Control® accelerates amino acid delivery to the body by more than 10-fold, increasing both the efficiency and the timeline for delivery of amino acids to the body.
  • The Modern American Diet (MAD) and the Standard American Diet (SAD) are both deficient in essential amino acids, including Lysine [K] and Arginine [R].

2005 HYPOTHESIS FOR TREATMENT OF OVERWEIGHT DISORDERS AND OBESITY

Factor4 Weight Control®, providing EAAs with backup protein, has been shown to provide the following beneficial effects:

  • Appetite levels are reduced leading to significant reductions in caloric intake to 800-1200 Calories per day
  • Energy levels are increased, usually doubled
  • Muscle tone is increased improving body definition
  • Body weight decreases as fat stores are metabolized

2007 CLINICAL TRIAL ON WEIGHT LOSS

An open-label clinical trial was conducted in 2007 on 25 subjects over three months. Twelve subjects volunteered to continue the study through 6 and 12 months.

Endpoints 3 mos.
(n = 25)		 6 mos.
(n = 12)		 12 mos.
(n = 12)
Weight Loss 8.4 lbs 16.2 lbs 33.4 lbs
% Body Weight Loss 4.5% 8.2% 16.2%

The FDA looks for a 5% decrease in percent body weight over 12 months.

Recent improvements in the regimen that utilizes Factor4 Weight Control® have now shown up to a 33% loss in percent body weight over 8 to 12 months. To date we have treated more than 5,000 subjects with overweight disorders and obesity with profound results.

2011: “THE OBESITY CURE” PUBLISHED (3)

  • First description of “Selective Protein Deficiency.”

2014: PROGRESS TOWARD FDA CLINICAL TRIALS

  • A relationship has been established with Dr. Lawrence Cheskin, Director of the Obesity Clinic at the Johns Hopkins Bloomberg School of Public Health, to conduct placebo-controlled clinical trials on Factor4 Weight Control for FDA approval.
  • Relationships are being established with the University of Hawaii Medical Center, the Scripps Medical Center in La Jolla, CA, the State University of Ohio Medical Center to participate in a definitive clinical trial for weight loss health.

2009-2015: ADDITIONAL BENEFITS IN METABOLIC HEALTH

With a cohort of over 5,000 individuals on long-term use of Factor4, patients began calling in to describe additional benefits in their metabolic health:

  • Individuals with type-2 diabetes saw a reduction in elevated fasting blood sugar by about 80% within 3 to 4 weeks allowing similar reductions in oral drugs and insulin.
  • Individuals with lipid disorders reported a significant increase in HDL (good cholesterol) resulting in a doubling of HDL levels, thus decreasing LDL/HDL ratios within 3 to 6 months.
  • Patients with cardiovascular disease reported significant improvements in these conditions that were associated with a decrease in arterial plaque over several months.
  • Dramatic improvements were seen in individuals who suffer from autoimmune disorders like Migraine headaches, Chronic Fatigue Syndrome, Multiple Sclerosis and Crohn’s Disease.

FUNDING THE NON-PROFIT ORG: FOUNDATION & INSTITUTE TO IMPROVE WORLD HEALTH

Our 501c3, foundation to Improve World Health, will raise $50 to $100 million to accomplish the following:

  • Pay for the multiple FDA clinical trials as described above for individual chronic degenerative diseases.

The La Jolla Project

  • Conduct basic science efforts to convert the entire human genome and proteome into a “Nutritional Pathosome” indicating the rank-file order in which we anticipate human proteins will become vulnerable (disappear) during poor nutritional health, defined as a diet deficient in essential and positive-charged amino acids.
  • Link the disappearance of positive-charged proteins with the pathogenesis of individual human metabolic diseases (chronic degenerative diseases and aging).
  • Define all the metabolic pathways in the human body and highlight those enzymes that are vulnerable to a poor nutritious diet, as defined above.
  • Develop an Annual Meeting for Evolution Theory and the Biology of Chronic Degenerative Disease and Aging to be held in La Jolla, CA.

The Vision Statement, the Strategy Statement and the Operational Plan are available for review upon signing a Confidentiality Agreement.

PLANS FOR FUNDING OF NOVALIFE

  • Up until the present time, NovaLife has been primarily funded by Dr. Scheele, who owns in excess of 95% of the Company.
  • Private Placement Offerings have now been planned to raise $5 million from High Net-Worth Individuals, followed in two years by raising $50 million from Venture Capital funding to prepare for a Initial Public Offering.

MARKET SIZE OF METABOLIC DISEASES IN US

Market Size
Overweight disorders 150 million
Obesity 75 million
High blood pressure 34 million
High cholesterol & TGL 30 million
High blood sugar (prediabetes) 90 million
Type-2 Diabetes 30 million
Cardiovascular Disease 57 million
Autoimmune disease 50 million
Cancer 18 million
Osteoarthritis 20 million
Gallstones 19 million

Healthcare costs in the US, which exceed 18% of GDP, are slated to further increase with time. We estimate that Factor4 health products could reduce health care costs to less than 10% of GDP within 10 years.

THE NEED FOR CLINICAL RESEARCH TO PROVIDE CURES FOR METABOLIC DISEASE

Francis Collins, Director of the NIH commented in April, 2015 that among 7,000 known diseases there are only approximately 500 cures. That means only 7% of diseases have a known cure, while the other 93% have no known cure.

DR. SCHEELE ARTICLES:

Dr. Scheele has posted a series of articles on the medical benefits and scientific principles underlying Factor4 Health™ Products, including Factor4 Weight Control® on http://blog.factor4health.com/articles/. These articles summarize the numerous medical and scientific breakthroughs in Factor4 Health based on Dr. Scheele’s innovative research over the past 45 years. These include:

  • Twelve medical articles on the benefits of Factor4 in specific metabolic diseases, including Obesity, Type 2 Diabetes, Lipid Disorders, Cardiovascular Disease, Aging, Loss of Hormones, Sleep Deprivation, Depression, Memory/Focus, Chronic Stress, Anxiety/Mood Disorders, and Autoimmune Diseases.
  • Six articles on the scientific principles that underlie the therapeutic benefits of Factor4, including an article showing how Factor4 accelerates delivery of essential amino acids by more than 10-fold.
  • One paper, which chronicles the clinical success of Factor4 Weight Control® in weight loss health through a clinical trial conducted in 2007
  • Two media articles, including (i) The Obesity Cure and (ii) The Perfect Storm in Health Care Encircling the Globe

 

DR SCHEELE CONTACT INFORMATION AND WEBSITES

T: 858-456-0666

E: gscheele@san.rr.com

Websites and Blogsites:

 

REFERENCES

  1. Scheele, G. (1975) Two dimensional gel analysis of soluble proteins – Characterization of guinea pig exocrine pancreatic proteins. J. Biol. Chem. 250: 5375-85.
  1. Schick, J., Verspohl, R., Kern, H. and Scheele, G. (1984) Two distinct genetic patterns of response in the exocrine pancreas to inverse changes in protein and carbohydrate in the diet, Am. J. Physiol. 248: G611-616.
  1. “The Obesity Cure” (2011) Published by Bookmasters, Ashland, OH.
  1. A discussion of Dr. Scheele’s research projects may be viewed on his career website at http://www.drgeorgescheele.com/HTML/Scientist.htm.

Confidential Document: All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any other information storage and retrieval system, without the written permission of the publisher.

Disclaimer: This product is not meant to diagnose, treat, cure, or prevent any disease by the use of pharmaceutical drugs. As a dietary supplement, with all natural ingredients, considered to be “generally regarded as safe” (GRAS), Factor4 is intended only to improve health and wellness in the organs and tissues throughout the body. Comments and notations, derived from testimonials and limited human studies, have not been evaluated by the FDA. All results stated in this white paper and on our website(s) are actual results from real customers or individuals included in our clinical trials. Individual results may vary depending on personal goals and use.