Clinical Study Gives New Hope to Patients with Age-Related Macular Degeneration

ROME (June 9, 2003) - There is new hope for patients in the early stages of Age-Related Macular Degeneration (AMD), the leading cause of blindness in older adults. A double-blind, placebo-controlled study has found that patients with early AMD showed a statistically significant improvement in visual function when treated with Phototrop, a compound that combines acetyl-L-carnitine, highly concentrated omega-3, and coenzyme Q10.

The findings were reported for the first time in the United States at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Fort Lauderdale.

Phototrop was developed by sigma-tau HealthScience, a wholly-owned subsidiary of the Italian pharmaceutical company sigma-tau S.p.A. It currently is only available in Italy, where it is being marketed to ophthalmologists, but sigma-tau HealthScience is evaluating several options for U.S. distribution.

“The combination of a good omega-3 product with the acetyl-L-carnitine proved to be effective in the controlled clinical research,” said Janos Feher, M.D., Department of Ophthalmology, University of Rome La Sapienza, the study’s lead researcher. “Based on the results of our research, we believe patients with early AMD will benefit from taking Phototrop.”

Currently, there are few treatments for older adults suffering from degeneration of the macula --- the center of the retina. Although the cause of AMD is still unknown, previous research has shown that the decline of mitochondrial function and the oxidation of the retina’s cellular membranes play a central role in the disease’s onset and progression. The recent study was aimed at testing the effectiveness of certain compounds that restore mitochondrial and retinal functions.

“A previous pilot study had shown that patients with early AMD showed an improvement when given this combination of acetyl-L-carnitine, omega-3 and coenzyme Q10,” Dr. Feher said. “We used a double-blind, placebo-controlled study --- an approach that is still quite rare in the field of dietary supplements ---- to confirm those findings. ”

Study Overview

The 12-month, double-blind, placebo-controlled, single-center study carried out in Hungary was titled “Mitotrop Compounds for the Treatment of Early Age-Related Macular Degeneration: The Metabolic Approach and a Clinical Trial.” The 106 patients enrolled in the study were aged 55 to 70 and had been diagnosed with early AMD. There was no significant difference between the treatment groups at screening.

After six months, the patients taking 2 capsules of Phototrop per day showed a statistically significant improvement. After 12 months, the improvement was even more pronounced. The primary response criterion for efficacy was a change of the central 10° visual field mean defect between screening and 12 months. These findings justify an assumption that an appropriate association of mitotrop compounds (those that influence mitochondrial metabolism) may improve visual functions in early AMD.

About Phototrop

In currently incurable neurodegenerative diseases such as macular degeneration, improvement, stabilization or a slower progression of the disease over time are considered a positive response to treatment. These types of responses were observed in patients treated with Phototrop in clinical trials for early AMD.

Phototrop contains a combination of acetyl-L-carnitine, highly concentrated
omege-3 fatty acids, and coenzyme Q10. Acetyl L-carnitine improves mitochondrial functions, particularly lipid metabolism. Omega-3 fatty acids play an important role as structural membrane lipids, particularly in nerve tissue and the retina. Coenzyme Q10, is a powerful antioxidant and a component of the mitochondrial electron transport chain.

About The Metabolic Approach

sigma-tau HealthScience is addressing the problems associated with a longer life by pioneering The Metabolic Approach to health and well-being. “This approach is unique because it focuses on the role that nutritional supplements can play in treating the cellular and molecular problems that lead to disease and aging even before symptoms are evident,” said Dr. Massimo Picari, M.D., director of strategic marketing and communications at sigma-tau HealthScience. The Metabolic Approach is based on the assumption that a proper combination of endogenous and other natural compounds (e.g. carnitines, Coenzyme Q10, omega-3, etc.) can provide metabolic support that removes or minimizes the cause of cell damage long before symptoms appear and well before they ultimately evolve into conditions that are detrimental to good health.

About sigma-tau

Founded in 1957, sigma-tau S.p.A. has focused the largest part of its research on the development of metabolic compounds, i.e. molecules that occur within the human body. The company has either sponsored or been involved in 70 percent of all the research ever done on L-carnitine, and holds more than 150 related patents. sigma-tau’s L-carnitine is approved by the U.S. Food and Drug Administration (FDA), as well as 31 other health ministries worldwide.

sigma-tau HealthScience was established in 1998 to pursue the development of these compounds in the nutritional supplement area. All of the company’s products, from raw materials to finished formulations, meet pharmaceutical grade quality standards and are produced according to GMP guidelines. The sigma-tau HealthScience company philosophy is that only pharmaceutical quality products supported by the strongest scientific research and testing should be made available to healthcare professionals and consumers. Product quality backed up by strong science, research and development and thorough testing are the foundation of the sigma-tau HealthScience product system.

For more information about the company, please visit www.st-hs.com

Janos Feher, M.D., Ph.D. is chief of the Ophthalmic Neuroscience Program at the Institute of Ophthalmology at the University of Rome "La Sapienza." Dr. Feher specializes in the study of age- and stress-related eye diseases and associated therapies. He has published 147 original papers in five languages, and has presented more than 80 papers at various national and international conferences.

Massimo Picari, M.D. is vice president of strategic marketing and communications at sigma-tau HealthScience S.p.A. Dr. Picari helped develop the company's Metabolic Approach, which focuses on the role that nutritional supplements can play in treating the cellular and molecular problems that lead to disease and aging even before symptoms are evident. The Metabolic Approach is based on the assumption that a proper combination of endogenous and other natural compounds (e.g. carnitines, Coenzyme Q10, omega-3, etc.) can provide metabolic support that removes or minimizes the cause of cell damage long before symptoms appear and well before they ultimately evolve into conditions that are detrimental to good health.

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