White Papers, CSE^® Naturally hGH

PRODUCT INFORMATION:
Homeopathic Recombinant
Human Growth Hormone (HrhGH)Naturally hGH- Oral
90 Chewable Tablets
USP 6C + 100C +200C
For chewable oral administration
U.S. Patents # 5,629,286 and # 6,239,105B B1, other patents pending

GENERAL INFORMATION:

CSE^® Naturally hGH is a healthy aging medicine. Biomed Comm’s^® randomized, double-blind, placebo controlled clinical studies demonstrate that CSE^® Naturally hGH, Jenúv™ and injectable rhGH are biochemically and structurally unique. These different formulas hence provide similar, as well as, different benefits. In the following paragraphs we help you understand more about the benefits of CSE^® Naturally- hGH.

Growth Hormone In The Body

Growth hormone (GH) enhances cell-to-cell communication, slowing the aging process¹. Cell communication maintains inner harmony in the nervous, hormonal and immune systems. Growth hormone functions as a growth factor by regulating broad effects ranging from nutrient uptake and enzyme activity to gene expression and cell repair. GH changes cell behavior related to life, division, repair and renewal.

Our sense of well being and our survival depend upon adaptive and memory-specific learned skills based on each person’s set of experiences. Growth hormone increases our ability to problem-solve, be graceful, feel safe and control health. Growth hormone signals the body physically and electro-magnetically via a specific cell receptor² (which acts like a radio antenna).

Organs vulnerable to early aging provide easy-to-self-diagnose symptoms such as those shown in Table 1.

Description:

CSE^® Naturally hGH is Biomed Comm,^® Inc’s registered trademark for homeopathic recombinant human growth hormone (HrhGH).

SECRETION FROM MANY CELLS AND FEEDBACK LOOPS

HGH is produced largely from the anterior pituitary, however is also produced by macrophages, T and B lymphocytes, osteoblasts and preadipocytes. It is secreted in pulses controlled by complex feedback loops that include hGH and insulin-like growth factor –1 (IGF-1) as well as emotions, perceptions, diet and health status.

RECOMBINANT DNA TECHNOLOGY

Recombinant human GH (rhGH) is produced using a special, non toxic strain of E-coli bacteria that has been modified to carry the hGH gene. Recombinant hGH is identical in amino acid sequence and structure as human pituitary growth hormone. Recombinant material is natural material that has been grown in a laboratory from all pure sources. This process ensures purity and safety.

The word recombinant comes from the root words “re” and “combined” and refers to the process of combining and recombining materials in a controlled safe GMP laboratory. Scientists are now able to create ‘blue prints’ for building GH from earth-derived substances. These ‘blue print’ recipes combine natural sugars, natural phosphate groups and natural, DNA-specialized proteins called purines and pyrimidines in a nucleotide sequence that consequentially builds a DNA chain resulting in the human protein growth hormone.

The ‘blue print’ or DNA code for hGH is combined (inserted) into the DNA of simple, single cell ‘parent organisms’, such as cell culture controlled-E-coli. As the parent organisms multiply they also produce hGH recognized by body as itself, just as if the body made it. The new rhGH protein is separated from any impure material by a filter leaving only highly purified recombinant protein.

This technology produces hGH naturally generally free of contamination. It is grown in a laboratory following GMP guidelines. This product is USP grade containing no human or animal sources.

DESCRIPTION:
Homeopathic recombinant human growth hormone is contained in an almost white chewable lactose tablet for oral administration and absorption anywhere on the tongue. CSE^® Naturally hGH is the only patented oral medicine containing actual rhGH.

ACTIVE INGREDIENTS:
Recombinant human growth hormone, USP 6C + 100C + 200C.

CLINICAL STUDIES ON HOMEOPATHIC RHGH:

Randomized, double-blinded, placebo-controlled clinical studies on HrhGH demonstrated positive and replicated benefits without toxic or adverse side effects.³ The three differently designed studies showed that oral chewable tablets of HrhGH were clinically effective, safe, non-toxic and economically practical with benefits including physical, physiological and psychological ones.

Summary -The clinical studies found that common self-reported symptoms of aging were safely improved without side effects. HrhGH improved self-reported quality of life measures compared to ‘the placebo effect’. 162 healthy people ages 18-72 years of age participated in studies lasting four to eight weeks in three different cities chewing one tablet three times daily: 1) upon rising, 2) 3-5 pm and 3) after dinner 7-9pm. Clinical effectiveness was determined by statistical differences between chewable tablets of HrhGH and placebo (looked and tasted the same, however contained no active substance) after 21 days.

Lean Body Mass - Lean body mass maintenance is critical for longevity and quality of life functions because lean mass below 65% of ideal weight no longer supports life⁴. Lean mass deteriorates during aging and directly correlates to death. Lean mass includes muscle, bone, organ-density, and everything else in the body except water and fat. Chewable tablets of CSE^®-Naturally hGH increased lean mass compared to no increase on placebo (P=0.05, Figure 1) and increases in arm and leg strength, endurance, appearance, psychological state and attitude about life (Table 2). Weight loss also occurred compared to placebo (P<0.05). Hips, where fat mass is commonly observable, decreased –2.1 inches/month ("0.50 SEM) on treatment compared to placebo (P<0.001). Neither age nor gender affected these outcomes, only CSE^®-Naturally-hGH treatment made the difference.

Overall Improvements - Participants using CSE^®-Naturally hGH chewable tablets showed significant improvements in target organs most responsive to hGH in the body compared to placebo. For example, there were statistically significant improvements in skin softness and skin moisture, relief from intestinal pain and/or bloating, fewer urinary-genital discharges and easier breathing with less coughing and phlegm build-up. People were relieved of bleeding gums, phlegm build-up, coughing, anger, apathy, and abnormal urinary-genital discharges on CSE^® Naturally hGH compared to placebo. People reported statistically significant relief from apathy, anxiety, anger, headaches, joint pain and/or water retention and swelling. Participants reported greater energy, stamina, increased libido, visual improvement, better sleep quality (length and depth significantly improved) compared to placebo. HrhGH benefits and worsening effects are given by percentage of people in Table 2 below⁵.

While longer studies are necessary, the implications of these studies are that affordable and non-toxic options are available to people as preventative medicines.

NO TOXICITY

No toxic effects were reported including no abnormal liver enzyme measurements in the studies.

SAFETY AND QUESTIONS ABOUT CANCER

There is no evidence that HGH increases one’s risk of getting cancer, however there is some controversy among scientists regarding the effects of injectable rhGH on existing cancers. Homeopathic rhGH may be one way of safely taking rhGH, however longer term studies are needed across all sex, age, health and ethnicity identities to prudently know the answer to this important question. There is not conclusive data in the medical literature indicating that high concentrations of hGH increase the risk of new or recurring cancers⁶. There are no conclusive animal models that indicate cancer can be caused in the prostate, breast or colon from increased concentrations of hGH in the blood⁷. The scientific literature generally indicates that growth hormone itself does not lead to cancer⁸.

Healthy people have relatively normal circadian rhythms of hGH secretions. In contrast, in one study selected cancer patients had highly abnormal circadian secretions of hGH⁹. Thus, altered feedback loops and abnormal signaling between hGH and IGF-1 are found in cancer patients¹⁰

hGH powerfully effects the body, psyche and mind by regulating complex positive and negative feedback mechanisms. Thus, it is easy to appreciate that hGH plays an important role for biological activities in the body through hGH cell signaling. In order to maintain healthy balance within the body, the processes of building up (anabolic) and tearing down (catabolic processes) need to occur in a balanced manner, which is called homeostasis. Homeostasis prevents disease in the body, optimizing health naturally.

Warnings:

• As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare
• Consult a physician before use if you have Diabetes, Stroke or Cancer.
• If new symptoms occur, discontinue use and consult a healthcare professional.
• Professional before using this product.
• Use of oral contraceptives may interfere with hGH/IGF-1 balance.
• Lactose in tablets may impact lactose intolerant people.

Directions:

Chew one tablet three times per day at these times: 1) upon rising, 2) 3-5pm in the afternoon, 3) dinner 7-9pm. Do this regime for 4 months. Take the next month off (30 days or less). Start cycle again. Clear mouth of food or drink for 20 minutes before and after chewing the tablet. Drink plenty of clean water to rid body of released toxins.

Other Information:
Store at 50·- 95· F (10·-35· C)

Inactive Ingredient:
USP Lactose

Tamper Seal:
Biomed Comm ^® products have a white tamper evident seal printed with “Sealed For Your Protection”. Do not use if seal is broken or missing.

For information contact:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.

Biomed Comm,^® Inc.
2 Nickerson Street Suite 102
Seattle, WA. 98109
888-637-3516
www.biomedcomm.com

Made in the U.S.A. according to Good Manufacturing Practices (GMP)

¹ Semsei I. On the nature of aging. Mech. Aging Dev. 2000; 117:93-108

² Liboff AR. Geomagnetic cyclotron resonance in living cells. J Biol Phys 1985; 13:99-102

³ Brewitt B, Hughes J, Welsh EA, Jackson R Homeopathic human growth hormone for physiologic and psychologic health. Altern.& Complemen. Therap. 1999; 5:373-385

⁴ Griffin GE, Paton NI, Cofranscesco Jr J. et al. Nutrition and quality of life in HIV infection: the roles of growth hormone in HIV-associated wasting, update on AIDS wasting and lipodystropby: one day seminar. Twelfth World AIDS Conference, Geneva, June 28, 1998

⁵ Based upon people who reported the symptom and it went away or the symptom appeared new

⁶ de Pinieux G, Legrier ME, Poirson-Bichat F, Courty Y, Bras-Goncalves R, Dutrillaux AM, Nemati F, Oudard S, Lidereau R, Broqua P, Junien JL, Dutrillaux B, Poupon MF Clinical and experimental progression of a new model of human prostate cancer and therapeutic approach. Am J Pathol 2001;159:753-64

⁷ Cohen P, Clemmons DR, Rosenfeld RG. Does the GH-IGF axis play a role in cancer pathogenesis? Growth Horm IGF Res 2000 Dec;10(6):297-305

⁸ Juul A. Determination of insulin-like growth factor-I in the monitoring of growth hormone treatment with respect to efficacy of treatment and side effects: should potential risks of cardiovascular disease and cancer be considered? Horm Res 1999; 51 Suppl 3:141-8

⁹ Pincus SM, Hartman ML, Roelfsema F, Thorner MO, Veldhuis JD. Hormone pulsatility discrimination via coarse and short time sampling. Am J Physiol 1999 Nov;277(5 Pt 1):E948-57

¹⁰ Urdl W. Polycystic ovarian disease: endocrinological parameters with specific reference to growth hormone and somatomedin-C. Arch Gynecol Obstet 1988; 243:13-36

Patent information: Biomed Comm,^® Inc. Intellectual Property