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NEWLY-PUBLISHED, FOURTH PEER-REVIEWED REPORT ON PHYTOSERM FEMARELLE™ OFFERS GOOD NEWS FOR POSTMENOPAUSAL WOMEN

12-Month Clinical Study Evaluating Efficacy and Safety of Dietary Supplement for Menopausal Symptoms Helps Distinguish DT56a as a Novel, Effective Approach to Relieving Menopausal Symptoms and Building Bone Density Dalton, Israel, July 22, 2004 - (HealthNewsDigest.com)A newly published clinical study, "Efficacy and safety of standard versus low-dose Femarelle (DT56a) for the treatment of menopausal symptoms"; I. Yoles et al, in the Journal of Clinical & Experimental Obstetrics & Gynecology (2004;31(2):123-126), the fourth peer-reviewed report on this phyto-SERM in 12 months, finds that Femarelle™ (DT56a), can safely and effectively relieve menopausal symptoms in menopausal women while building bone density (BMD), without any adverse side effects. This is good news for menopausal women looking for non-medical relief following on the heels of the recent JAMA report (July 7, 2004), which concluded that soy protein containing isoflavone was not effective in improving BMD, cognitive function or plasma lipids in healthy postmenopausal women.

"Unlike soy isoflavone products, Femarelle is a potent, non-estrogen phyto selective estrogen receptor modulator (SERM) that has been shown through numerous published studies and abstracts, including this most recent one, to safely and effectively relieve the hot flashes, sleep disturbances and headaches - symptoms that plague many menopausal women," says Israel Yoles, MD, Department of Obstetrics and Gynecology, Sheba Medical Center, Tel Hashomer, Israel, and an author of the article.

"DT56a, which is the active substance in Femarelle™, is a phytoSERM, and is unlike any soy product that uses extracted isoflavone. Femarelle is manufactured with a unique enzymatic process of isolation to ensure that the whole phytoestrogen family of compounds, as is found in the tofu, remains in their naturally intact form. Femarelle, unlike other supplements, is made from tofu, a derivative of the soybean, which is attributed with many beneficial properties. The unique manufacturing process of Femarelle increases the bio-availability to the body, providing high efficacy and selectivety in its affect. The combination of compounds found in Femarelle, such as the lignans and the coumestans, provide the beneficial impact of the soybean, rather than soy protein (which was reported on in the recent JAMA study). Other soy supplements sold in the U.S. are extracted isoflavones, and are not phytoSERMS," adds Dr. Yoles.

According to the study, hot flushes were the dominant symptom that effected menopausal women in both groups. The majority of women reported relief of the predominant menopausal symptoms, including hot flashes, sleep disturbances, and muscle and joint discomfort. "After 12 months of using Femarelle™, the treatment groups reported relief; vasomotor symptoms: 75%, headaches: 64%, and joint and muscle discomfort: 70%," adds Yoles.

The study also found that after using Femarelle™, 81% of the patients found relief from at least one menopausal symptom, which was sustained in 76% of the women after 12 months. "These results are considered extremely high by many in the medical community" says Dr. Yoles. In addition, while there was a significant reduction in the menopausal symptoms in both groups, there was no change in endometrial thickness and blood hormone levels (FSH, E2, or TSH levels) after 12 months.

The safety and efficacy of DT56a have been shown through four published, peer-reviewed studies, as well as four published abstracts and 11 presentations in scientific congresses around the world since 2001. These published clinical studies have shown not only that Femarelle™ alleviates menopausal symptoms, such as hot flashes, sleep disturbances, night sweats and joint and muscle discomfort for three out of four women within the first week of treatment, but that the recommended dose of 2 capsules per day (644 mg/day) will also increase bone mineral density by 3.6% in the lumbar spine and 2.0% in the femoral neck after 12 months.

DT56a has been sold in more than 12 countries since 1999 and will be available in the United States in drug stores, including CVS stores, in mid-August. It can presently be purchased online at CVS.com, at www.femarelle.com, or by calling 1-877-FEMAREL (or 1-877-336-2735).

Se-cure Pharmaceuticals Ltd., which manufactures and distributes Femarelle™ in the U.S. and abroad, is a research-driven pharmaceutical company headquartered in Israel, whose principal mission is the discovery, development and manufacturing of products that offer safe and innovative solutions to health needs. The company aligns its product development with basic research, including chemical and biochemical research, as well as pre-clinical and clinical studies. The company's vision centers on the development of therapeutic solutions with an emphasis on safety of use and the prevention of side effects following long-term use.

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