New Treatment Reverses Symptoms Of Menopause Without Hormone Therapy

A promising medical advancement that has been years in the making in Russia is now making its way to the United States. Scientists at the Institute of Theoretical and Experimental Biophysics of the Russian Academy of Sciences (ITEB RAS) have developed a breakthrough treatment that effectively alleviates symptoms of menopause by reversing age-related changes in the hypothalamic-pituitary-ovarian axis, which is the backbone of the neuroendocrine system. Lunada Biomedical, a newly established U.S. firm specializing in mitochondrial medicine has acquired worldwide rights to commercialize this research. Lunada Biomedical will be launching the compound in the U.S. under the commercial name "Amberen" in mid-September, 2007.

Instead of risking hormonal therapy or hoping for results with herbal treatment, Amberen consistently and safely rejuvenates the brain's communication with the hormonal system to create a more youthful pre-menopausal state without any known side effects. Since Viagra came on the scene, physicians have recognized signaling compounds as a powerful means to improve youthful function. Amberen contains a natural signaling molecule that restores youthful brain sensitivity so that it safely improves function in a way that no drug can. Better yet, its active ingredient is identical to a compound found in every cell of the body.

Dr. James Mahoney has been chosen to introduce Amberen in the United States at the Center for Hope and Healing in Southlake, Texas. "Recent results from the Women's Health Initiative have created a panic in menopausal women and their physicians throughout the United States", says Mahoney, a board-certified specialist whose veteran career is defined by cutting edge treatment of women with difficult menopausal challenges. He says the study demonstrated that hormone replacement therapy (HRT) did much more harm than good. At the same time, doctors claim that evidence is insufficient to recommend herbal therapy to treat hot flashes, mood problems, insomnia and sexual problems that are a common part of menopause.

"My research into a healthy menopause treatment led me to Amberen, a complete, clinically proven solution for my patients," he says. "Amberen is a safe, cost-effective, breakthrough discovery in the field of aging that is likely to change the way we look at menopause for generations."

The combined results of animal and human studies on the product will be published in "Advances in Gerontology," the journal of the Russian Gerontological Society, and will also be reported in Medline.ru, Russia's primary online biomedical journal. "In our studies, a hormone replacement therapy (HRT)-like effect was achieved by administering a natural, non-hormonal compound based on succinates, natural mitochondrial metabolites that essentially mimic the effects of hormones," says Professor E.I. Maevsky, M.D., Ph.D., deputy director of ITEB RAS. "The menopausal process was largely reversed in women who were in its early stages, while women who were in the late stages of menopause reported vast improvements in quality of life due to the disappearance of accompanying symptoms. These are truly revolutionary results that can change the lives of millions of aging women."

In studies, the compound restored the estral cycle in old mice and reversed other menopausal symptoms, including loss of bone tissue weight and calcium content. It also had a favorable effect on the appearance and behavior of animals-they became more active, their lackluster eyes acquired brightness, and their pale, yellowish coat regained white color and shine, resembling the coat of young animals. Spots of bald skin also grew new hair.

Furthermore, in the randomized, placebo-controlled clinical study in menopausal women, succinate-based monotherapy significantly lowered most subjectively evaluated characteristics of menopausal syndrome and increased blood serum levels of estrogen fourfold. This monotherapy also alleviated symptoms of some neurovegetative and psychoemotional disorders, such as hot flashes, headache, and anxiety.

"Our approach, which focuses on correcting metabolism and neuroendocrine control by using a signal energy intermediate, SBC (or succinate-based compound), instead of exogenous hormones, is the first of its kind and represents a step forward in metabolic mitochondrial medicine," says Professor Maria Kondrashova, a leading Russian scientist. "It offers hope in the development of safer treatments for a wide range of diseases, particularly those associated with aging. This platform puts the neuroendocrine theory of aging to work for the first time."

RESEARCH HISTORY - "Prof. Kondrashova discovered over 30 years ago that the substrate succinic acid has hormone-like effects and can be used, among other things, to slow aging," says Prof. Mayevsky. In 1976, Prof. Kondrashova carried out landmark animal trials on the anti-aging effects of succinates-derivatives of succinic acid-together with Prof. Vladimir Anisimov and Prof. Vladimir Dilman, the founder of the neuroendocrine theory of aging. In those trials, scientists were able to restore youthful hormonal balance in old rats. In follow-up experiments using the succinate-based compound, Prof. Anisimov significantly extended the lifespan of laboratory animals while also achieving a decrease in spontaneously occurring tumors.

Originally, Prof. Kondrashova and her team weren't trying to develop a treatment for menopause. Rather, they were conducting studies on human aging to determine whether it was possible to reverse biological age by stimulating the neuroendocrine system. They chose to study these effects on menopausal animals and humans because menopause is a classic example of aging, with very distinct age-related symptoms that are caused by the loss of hypothalamic regulation. Researchers literally stumbled onto the effects of succinates, which turned out to be a seminal moment in establishing a therapy for menopause in the context of the neuroendocrine theory of aging.

Prof. Maevsky emphasizes, however, that succinic acid and its derivatives that are currently available in commerce will not have similar effects. "In these trials," he says, "we used signal-level doses of highly biological active forms of succinate that were produced using a very complex process invented and patented by ITEB scientists. Very high biological activity of these succinates is determined by a specific molecular shape (conformation), and that gives "our" succinates vastly different therapeutic properties. ITEB technology has no other analogs in the world. Molecules of succinic acid are very fragile, and until now it was not even possible to study their shape without altering them. In addition to this process of synthesizing active conformers of succinates, at ITEB RAS, we have also invented new methods of studying the molecular conformation of highly sensitive substances."

ABOUT ITEB RAS - The Institute of Theoretical and Experimental Biophysics is one of Russia's premier scientific research institutions. ITEB is a division of the Russian Academy of Sciences, which is the Russian equivalent of the National Institutes of Health in the U.S. Composed of 26 laboratories and science centers, ITEB RAS makes important discoveries that save and improve human lives. The scientific staff of ITEB RAS comprises 330 researchers, including one academician, two corresponding members of the Russian Academy of Sciences, 45 doctors of science, and 166 Ph.Ds.

ITEB RAS is the successor to the Institute of Biophysics, which was founded in 1952. ITEB RAS traces its roots to 1919, with the creation of People's Commissariat of Health. It was the nation's first scientific organization to study biological processes, and it remains the national leader in this field. Many scientific research institutes populating the science town of Pushino are offshoots of ITEB RAS.