IPLEX(TM) Demonstrates Significant, Dose-Dependent Increases in Growth Rate
01 Mai 2006 - 9:00PM
PR Newswire (US)
Data Presented in Oral Presentation at Pediatric Academic
Societies' 2006 Annual Meeting SAN FRANCISCO, May 1
/PRNewswire-FirstCall/ -- Insmed Incorporated (NASDAQ:INSM) today
announced results from a prospective, multicenter clinical trial of
rhIGF-I/rhIGFBP-3, or IPLEX(TM) (mecasermin rinfabate [rDNA origin]
injection) administered once daily to children with severe primary
insulin-like growth factor-I (IGF-I) deficiency. The study showed
that treatment resulted in statistically significant,
dose-dependent increases in height velocity (growth rate) with a
favorable safety profile. The first-year results from the 24-month
study were presented in an oral presentation at the Pediatric
Academic Societies' (PAS) 2006 Annual Meeting at the Moscone Center
in San Francisco, CA. In the scientific abstract presenting the
safety and efficacy data for IPLEX in children with severe primary
IGF-I deficiency (primary growth hormone insensitivity), the
investigators reported that the mean height velocity for the dose
group titrated with up to 2 mg/kg/day increased from 2.0 cm/year
pre- treatment to 8.3 cm/year during treatment. Children with
genetic and acquired forms of growth hormone (GH) insensitivity
appeared to respond equally well to treatment. IPLEX is the only
once daily IGF-I replacement therapy available for the treatment of
severe primary IGFD. The once-daily dosing regimen used in the
study was associated with a high compliance rate of 95% of
injections taken. "We are very pleased with the growth rates and
safety profile achieved with IPLEX in this patient population,"
remarked Dr. Kenneth Attie, Vice President, Medical Affairs at
Insmed. "Once-daily administration of the complex provided
physiologic replacement of IGF-I and was well-accepted by patients
and their families in the study," he added. The safety profile of
IPLEX proved favorable as instances of low blood sugar
(hypoglycemia) were mostly mild and asymptomatic, with no
hypoglycemic seizures reported. Patients with severe GH
insensitivity have a predisposition to hypoglycemia without
treatment. Of the subjects enrolled in the study, 28% reported a
history of hypoglycemia prior to treatment. This was similar to the
proportion of subjects (31%) who experienced at least one incidence
of hypoglycemia during the first year of treatment with IPLEX,
usually described as mild and asymptomatic. In the study, no
patients discontinued IPLEX due to a related adverse event. Two
patients had papilledema (one with a blocked pre-existing
ventriculo-peritoneal shunt and one asymptomatic). No instances of
facial nerve paralysis were reported. As is common with protein
therapeutics, antibodies to the protein complex were detected in
most patients, but were not associated with growth attenuation or
adverse effects. IPLEX was approved as an orphan drug by the United
States Food and Drug Administration in December 2005 for the
treatment of growth failure in children with severe primary IGF-I
deficiency (Primary IGFD) or with growth hormone (GH) gene deletion
who have developed neutralizing antibodies to GH. About IPLEX
IPLEX, a complex of recombinant human IGF-I and its binding protein
IGFBP- 3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I
replacement therapy. It is also the only FDA-approved therapy that
provides both IGF-I and IGFBP-3 to treat children with severe
primary IGFD. The drug, to be launched during the second quarter of
2006, is also being investigated for various other indications with
unmet medical needs, including extreme insulin resistance, myotonic
muscular dystrophy and HIV Associated Adipose Redistribution
Syndrome (HARS). For more information about IPLEX please go to
http://www.go-iplex.com/. About the Condition Severe primary IGFD
is a genetic or acquired condition in which patients do not
generate sufficient quantities of insulin-like growth factor-I
(IGF-I) due to defect in the growth hormone (GH) receptor/IGF-I
pathway. Gene mutations leading to growth failure due to IGF-I
deficiency have been identified in the growth hormone receptor, in
the GH receptor signalling pathway, and in the IGF-I gene itself.
Patients with severe primary IGFD present with marked short stature
and a poor prognosis for adult stature. About Insmed Incorporated
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 http://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 of 1995. Forward-looking statements in this press
release include, but are not limited to, statements regarding
planned clinical trial design, our regulatory and business
strategies, plans and objectives of management 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 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.
DATASOURCE: Insmed Incorporated CONTACT: Media: Mark Undercoffler,
+1-415-984-6172, , or Investor Relations: Tim Ryan, +1-212-477-9007
x24, , both for Insmed Incorporated Web site:
http://www.insmed.com/ http://www.go-iplex.com/
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