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Life Extension Magazine

LE Magazine April 2003

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Biotechnology & The Future of Medicine

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We are on the threshold of a new era in medicine. Cell therapy, the manipulation of immature stem cells to combat disease, is the latest revolutionary breakthrough in biological research. Not since Robert Hooke first peered through a piece of glass and called what he found a "cell" has science made such a giant leap in its understanding of this most basic-and eloquent-of structures.

One company at the forefront of this compelling and burgeoning field is Celmed Biotechnologies.

Celmed Biotechnologies was created in June 2001 to pursue work in the realm of autologous stem cell therapy for neurological diseases, including Alzheimer's, Parkinson's and Huntington's. In autologous stem cell therapy, stem cells drawn from the patient are later implanted back into the patient's body. This type of therapy has distinct advantages over heterologous stem cell therapy, where cells from matched donors are used.

Additional programs are focused towards the application of photodynamic therapy to restore bone marrow function in patients who have undergone chemotherapy for chronic myeloid leukemia (CML) and non-Hodgkins' lymphoma (NHL). This therapy also reduces the risk of life-threatening complications common with traditional bone marrow transplant procedures.

Peptide research

Peptides are short chains of 20 or fewer amino acids-shorter than proteins, which range from 50 to over 300 amino acids in length. Natural processes of cellular and tissue regeneration involve peptide chains; they can either induce or inhibit biological effects, acting as agonists or antagonists in physiological systems. When used therapeutically, peptides are highly specific in their activity and effective at low doses. Unfortunately, there is one significant problem with the use of peptides as medicine: they are unstable and quickly lose activity once introduced into the body. The solution has been to develop long acting peptides, or LAP1, which are biochemically altered in a manner that stabilizes and preserves the peptide's unique sequence of amino acids.

A novel peptide that increases growth hormone activity

One of the most important therapeutic developments is a peptide that duplicates the activity of growth hormone releasing hormone (GHRH)-also known as growth hormone releasing factor (GRF)-in the body. In youth, a part of the brain called the hypothalamus makes plenty of GHRH, which stimulates the pituitary gland to release growth hormone (GH). Growth hormone, in turn, stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver. The majority of growth hormone's youth-preserving, disease-preventative effects spring from the effects of IGF-1, which is also known as anabolic tissue growth factor. IGF-1 enhances immune function and preserves muscle tissue both structurally and functionally. Growth hormone acts directly to decrease the amount of fat stored in fat cells, helping to maintain youthful body composition.

Growth hormone and IGF-1 production decline by about 14% every 10 years. Muscle loss, fat gain, skin thinning, immune dysfunction and bone demineralization increase as GH and IGF-1 production declines. To date, growth hormone replacement is one of the most potent known therapies for slowing the onset of physical signs of aging. Unfortunately, it's prohibitively expensive, and its safety has not been conclusively proven. The therapeutic peptide ThGRF (TH 9507) is a growth hormone releasing factor analogue: it behaves like GRF in the body, leading to an increase in levels of both growth hormone and IGF-1.

ThGRF research: selected studies

Research is bearing out the clinical value of ThGRF.2 It has been shown to have a longer duration of activity when compared with endogenous (made in the body) GRF. It reliably raises GH levels, and closely mimics the body's natural GH secretion pattern.

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Many hormones and neurotransmitters are released in pulses, with levels rising and falling slightly in a regular pattern. It's difficult to mimic this natural pulsatility with growth hormone replacement therapy, and with the lack of natural ups and downs come adverse effects, including fluid retention, carpal tunnel syndrome and insulin resistance. While some clinicians have managed to achieve some level of pulsatility by giving frequent subcutaneous injections of growth hormone, the use of ThGRF has thus far proven to be safer, more convenient and more conducive to a pulsatile pattern resembling the natural physiological release of GH and IGF-1. To date, some of the applications include: ThGRF, growth hormone and IGF-1 levels. In a study of men aged 50 to 60 years, ThGRF administration caused IGF-1 levels to rise by 90% to 106% in a matter of only a few days-to levels comparable to those of a young adult.3 The 39 men involved all had similar IGF-1 levels when the study began. Other hormones were not adversely affected, which implies that ThGRF had highly specific effects on the body. Side effects were comparable to those seen with placebo. All told, this study found that ThGRF therapy could successfully and safely restore growth hormone secretion to youthful levels.

Sleep. In aging people, insomnia is a common complaint. Current treatments for insomnia are effective for those who have trouble falling asleep, but do little to help decrease frequent wakeful episodes during the night. Sleep-inducing medications have some drawbacks: they can be addicting, and they usually impair rather than improve daytime alertness and increase the risk of accidents. ThGRF has been assessed as a therapy for sleep maintenance insomnia in a Phase II trial involving 12 healthy subjects between 50 and 65 years of age. The peptide slightly increased restful slow wave sleep and increased alertness during the day, especially during the hours of late afternoon and early evening.

Continued on Page 2 of 2

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