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Insmed Reports Results from Nine Months of SomatoKine Therapy for a Patient with Extreme Insulin Resistance at the 43rd Meeting of the European Society of Pediatric Endocrinology.


RICHMOND, Va. -- Results Show Lowered HbA1c From 7.6% to 6.1%

Insmed Incorporated (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: INSM INSM Initiative Neue Soziale Marktwirtschaft (German)
INSM Integrated Network and Systems Management
) today reported on results from a nine-month analysis of therapy with SomatoKine(R) (rhIGF-I/rhIGFBP-3 (mecasermin rinfibate) for a patient with Leprechaunism, the most extreme form of insulin resistance. The nine-month analysis demonstrated substantial improvements in growth, metabolic control, and neurological development. Of significant importance, the patient has surpassed the average expected life-span for Leprechaunism, and continues to receive therapy to date. No adverse effects related to SomatoKine treatment were observed.

The results from the nine-month analysis were presented at the 43rd Annual Meeting of the European Society of Pediatric Endocrinology (ESPE) by Marc De Kerdanet, M.D. of the University Center Hospital, Rennes, France and Andreas Sommer, Ph.D., Insmed's Chief Scientific Officer.

The patient, referred to as Rennes-1, was a 4-month old female diagnosed with Leprechaunism. The diagnosis was confirmed by identification of two mutations in the insulin receptor gene. Prior to treatment, the patient had extremely high insulin levels (5490uU/mL), severe growth retardation (-3.3 SDS 1. (company) SDS - Scientific Data Systems.
2. (tool) SDS - Schema Definition Set.
 in height; -3.4 SDS in BMI BMI body mass index.

BMI
abbr.
body mass index


Body mass index (BMI)
A measurement that has replaced weight as the preferred determinant of obesity.
), and poor blood sugar control.

After nine-months of treatment with SomatoKine(R), the following observations were made:

1. IGF-I IGF-I

see somatomedin C.

IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with
 levels were restored within normal range,

2. HbA1c, a primary measure of blood sugar control, was reduced from 7.6% to 6.1%,

3. Circulating mean insulin levels were reduced 742% from 5490uU/mL to 652uU/mL,

4. Standard height deviation improved from -3.3 to -2.2 SDS, Body Mass Index (BMI) improved from -3.4 SDS to -1.7 SDS,

5. No adverse effects related to SomatoKine treatment were observed.

The abstract is available on Insmed's corporate website, www.insmed.com.

About Leprechaunism

Leprechaunism is characterized by extreme insulin resistance associated with a genetically defective insulin receptor resulting in hyperinsulinemia, uncontrolled glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 variation, failure to thrive Failure to Thrive Definition

Failure to thrive (FTT) is used to describe a delay in a child's growth or development. It is usually applied to infants and children up to two years of age who do not gain or maintain weight as they should.
 and short life expectancy. Leprechaunism is the most severe form of insulin resistance amongst a group of extreme insulin resistance syndromes that include Type A syndrome, Rabson-Mendenhall syndrome and type B syndrome.

More on SomatoKine(R) (rhIGF-I/rhIGFBP-3)

Insmed's rhIGF-I/rhIGFBP-3 is a proprietary delivery composition of insulin-like growth factor-I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF (Internet Governance Forum) An international organization of governments and U.N. agencies that was founded to discuss Internet issues such as security and spam. It was created at the United Nations Summit in 2005 after the U.S.  levels to physiological relevant levels. In diabetic subjects, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of rhIGF-I/rhIGFBP-3 demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of rhIGF-I/rhIGFBP-3 has demonstrated a significant improvement in functional recovery and bone mineral density bone mineral density
n.
See bone density.


bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry.
. rhIGF-I/rhIGFBP-3 is currently in a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  for the treatment of Growth Hormone Insensitivity Syndrome growth hormone insensitivity syndrome Laron dwarfism, pituitary dwarfism II An AR condition characterized by severe growth retardation, delayed bone age, occasionally blue sclerae, and physical manifestations of GH deficiency, due to a defect in the GH receptor  (GHIS).

About Insmed

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding clinical trials and goals, our regulatory and business strategies and growth opportunities for existing or proposed products. 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 or manufactured, the company may lack financial resources to complete development of product candidates, the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 may interpret the results of our studies differently than we have, 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. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 13, 2004
Words:762
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