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Insmed Provides Update On IPLEX(TM) Expanded Access Program In Italy For The Treatment Of Amyotrophic Lateral Sclerosis
Insmed Inc. (Nasdaq:
INSM), a developer of follow-on biologics and biopharmaceuticals,
provided an update on the IPLEX(TM) Expanded Access Program (EAP) in Italy
for the treatment of Amyotrophic Lateral Sclerosis (ALS). Since early 2007,
the EAP has grown to include 15 physicians and approximately 70 subjects
have been enrolled into the program. Additional subjects continue to be
enrolled into the program. IPLEX(TM) appears to have been safe and well
tolerated in the subject population to date and no individuals have dropped
out of the study for reasons related to IPLEX(TM). The Company received
cost recovery of $5.2 million for drug supplies for the full-year 2007.
The study utilizes a Revised ALS Functional Rating Scale (ALSFRS) to
monitor the progress of the subjects. The ALSFRS is used to determine a
patient's capacity and independence in several functional activities
including speech, salivation, swallowing, handwriting, cutting foods and
handling utensils, dressing and hygiene, turning in bed, walking, climbing
stairs, and respiratory function. The purpose of collecting this
information is to help ensure safety and to gain an understanding as to
whether IPLEX(TM) provides any benefit to these subjects.
ALS, often referred to as Lou Gehrig's disease, is a progressive
neurodegenerative disorder that affects nerve cells in the brain and spinal
cord. Motor neurons reach from the brain to the spinal cord and from the
spinal cord to the muscles throughout the body. The progressive
degeneration of the motor neurons in ALS eventually leads to their death.
When the motor neurons die, the ability of the brain to initiate and
control muscle movement is lost. With voluntary muscle movement action
progressively negatively affected, those patients in the later stage of the
disease may become totally paralyzed. The ALS Association believes that
5,600 people in the U.S. are diagnosed with ALS annually, and an estimated
30,000 Americans suffer from the disease. Most ALS patients die within
three to five years after onset of symptoms, according to the National
Institute of Neurological Disorders and Stroke.
"We are pleased with the progress of the EAP for IPLEX(TM) in Italy,"
said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer.
"Because this disease has few treatment options, the patients participating
in this study are in desperate need of effective medicines. We look forward
to continuing to work with Italian health authorities and clinicians to
advance this important study and, in conjunction with them, will proceed
with a thorough analysis of the data from this study at an appropriate
point in the future."
About IPLEX(TM)
IPLEX(TM) was approved in the United States in December 2005 for the
treatment of children with growth failure due to severe primary IGF-I
deficiency (Primary IGFD). IPLEX(TM) rhIGF-I/rhIGFBP-3), is a complex of
recombinant human insulin-like growth factor-I (rhIGF-I) and its
predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being
investigated for various other indications with unmet medical needs.
About Insmed
Insmed Inc. is a biopharmaceutical company with unique protein process
development and manufacturing experience and a proprietary protein platform
aimed at niche markets with unmet medical needs. For more information,
please visit http://www.insmed.com.
Forward-Looking Statements
This release contains forward-looking statements which are made
pursuant to provisions of Section 21E of the Securities Exchange Act of
1934. Investors are cautioned that such statements in this release,
including statements relating to planned clinical study design, regulatory
and business strategies, plans and objectives of management and growth
opportunities for existing or proposed products, constitute forward-looking
statements which involve risks and uncertainties that could cause actual
results to differ materially from those anticipated by the forward-looking
statements. The risks and uncertainties include, without limitation, risks
that product candidates may fail in the clinic or may not be successfully
marketed or manufactured, we may lack financial resources to complete
development of product candidates, the FDA may interpret the results of
studies differently than us, competing products may be more successful,
demand for new pharmaceutical products may decrease, the biopharmaceutical
industry may experience negative market trends, our entrance into the
follow on biologics market may be unsuccessful, our common stock could be
delisted from the Nasdaq Global Market and other risks and challenges
detailed in our filings with the U.S. Securities and Exchange Commission,
including our Quarterly Report on Form 10-Q for the quarter ended September
30, 2007. Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this release.
We undertake no obligation to publicly release the results of any revisions
to these forward-looking statements that may be made to reflect events or
circumstances that occur after the date of this release or to reflect the
occurrence of unanticipated events.
Insmed Inc.
http://www.insmed.com
Insmed prevede actualizare pe IPLEX (tm) program de acces extins, în Italia, pentru tratamentul de sclerozã lateralã amiotroficã - Insmed Provides Update On IPLEX(TM) Expanded Access Program In Italy For The Treatment Of Amyotrophic Lateral Sclerosis - articole medicale engleza - startsanatate