PCOS Messages for June, 2000: FYI - Press release on INS-1 successful clinical trial for pcos

FYI - Press release on INS-1 successful clinical trial for pcos

From: Michele (anonymous@obgyn.net)
Fri, 30 Jun 2000 11:25:18 -0500 (CDT)

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Study Confirms Effectiveness of INS-1 in Improving ovulation, Aiding Heart Health in Lean Women With PCOS Updated 6:59 AM ET June 26, 2000

TORONTO, June 26 /PRNewswire/ -- Researchers studying a promising new drug for Polycystic Ovary Syndrome (PCOS) reported that treatment with INS-1, a novel oral insulin sensitizer, enhanced ovulation, lowered systolic and diastolic blood pressure and improved lipid profiles in lean women with PCOS, according to a paper presented at ENDO 2000, the annual meeting of The Endocrine Society. Insmed Incorporated (NASDAQ:INSM) is developing INS-1 for the treatment of PCOS and Type 2 diabetes.

A team of researchers at Virginia Commonwealth University in Richmond, Virginia and the Hospital de Clinicas Caracus in Caracas, Venezuela reported the results of a randomized, double-blind, placebo-controlled study to determine the effect of administering INS-1 in lean women with PCOS. Of the 20 subjects, half were given two 300 mg capsules of INS-1 once daily for 6-8 weeks; the other 10 received placebo.

Women treated with INS-1 experienced a reduction in serum insulin and androgen levels, as well as decreases in serum triglycerides and blood pressure. Six of the 10 women (60%) in the INS-1 group ovulated, compared with only two of 10 women (20%) in the placebo group. John E. Nestler, M.D., Chairman, Division of Endocrinology and Metabolism at Virginia Commonwealth University said, "This study strongly suggests that INS-1 is effective treating lean women with PCOS, just as it had been shown previously to be effective in obese women with PCOS. Considering the dearth of treatment options for this disorder, these results are very promising."

PCOS is the most common female endocrine disorder, affecting up to 10% of premenopausal women. It is the major cause of anovulatory infertility. Insulin resistance is often implicated as a major cause of PCOS and a number of cardiovascular disease risk factors, collectively described as the insulin resistance syndrome (Syndrome X). Insulin resistance and hyperinsulinemia contribute to PCOS by increasing ovarian androgen (male hormonal) production and impeding ovulation.

Insmed Incorporated is a biopharmaceutical company focused on the development of products to treat metabolic and endocrine-related conditions. In addition to INS-1 Insmed is developing SomatoKine(r), a complex of IGF-I and its primary binding protein, IGFBP3, for Type 1 and 2 diabetes and osteoporotic hip fracture. Insmed underwrote this study.

Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding expected financial position, results of operations, cash flows, dividends, financing plans, business strategies, operating efficiencies or synergies, budgets, capital and other expenditures, competitive positions, growth opportunities for existing or proposed products or services, plans and objectives of management, demand for new pharmaceutical products, market trends in the pharmaceutical business, inflation and various economic and business trends. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed, the Company may lack financial resources to complete development of product candidates, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release.

Contact: Sophia Twaddell of Fleishman Hillard, 312-751-3738, for Insmed

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michele

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