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Genaera Begins Dosing Second Phase 1 Trial Of Type 2 Diabetes And Obesity Compound Trodusquemine (MSI-1436)
Genaera
Corporation (Nasdaq: GENR) announced that dosing of subjects has
begun in study MSI-1436C-103, the ascending single dose Phase 1 study of
trodusquemine (MSI-1436), in overweight and obese type 2 diabetics.
MSI-1436 is a novel therapeutic for the treatment of type 2 diabetes and
obesity which works centrally and peripherally to regulate insulin and
leptin receptor signaling through inhibition of its novel target enzyme
PTP-1B.
Study 103 is similar in design to the previously completed Study 101
which was conducted in healthy obese and overweight volunteers. The current
study will continue to expand the safety database for MSI-1436 and
establish the pharmacokinetics of the drug in a population of type 2
diabetics who are poorly controlled on metformin. The study will also
evaluate a range of secondary endpoints including short-term
insulin/glucose control indices, glucose tolerance and evaluation of
insulin sensitivity.
"We have achieved another important milestone in the development of
MSI- 1436 and can now begin collecting data from obese type 2 diabetics,"
said Jack Armstrong, President and Chief Executive Officer of Genaera. "The
unique mechanism of action provides MSI-1436 with the potential to impact
two of the key pathologies of type 2 diabetes: insulin resistance and
obesity. We anticipate that this clinical study will provide a first step
in demonstrating the safety of MSI-1436 in obese and overweight type 2
diabetics and will help determine an optimal therapeutic dose for this
population."
This randomized, vehicle-controlled study, being conducted at dgd
Research, Inc., a leading diabetes clinical research center in San Antonio,
Texas, is enrolling otherwise healthy overweight and obese type 2 diabetic
volunteers to evaluate the safety, tolerability, and pharmacokinetics of
ascending single doses of intravenously administered MSI-1436 in this
special population. The ascending single dose protocol will initially
enroll approximately 28 subjects at four dose levels (3, 6, 10, and 15
mg/m2) and is expected to be completed late in the first half of 2008.
About Trodusquemine (MSI-1436)
Trodusquemine is a centrally and peripherally-acting appetite
suppressant and the first highly selective inhibitor of protein tyrosine
phosphatase 1B (PTP-1B). PTP-1B is central to controlling the function of
both the leptin and insulin pathways. By inhibiting PTP-1B, MSI-1436 is
expected to decrease appetite and normalize blood sugar. Trodusquemine has
produced consistent, sustainable weight loss in a variety of animal models
and appears to overcome metabolic readjustment, which often limits
sustained weight loss during caloric restriction. In addition,
trodusquemine has shown the ability to reverse co-morbidities associated
with obesity such as abnormal glucose metabolism and cholesterol elevation.
About Genaera
Genaera Corporation is focused on advancing the science and treatment
of metabolic diseases. The Company has significant market opportunities
with a first-in-class molecule, trodusquemine (MSI-1436), that has the
potential to redefine the treatment paradigm for obesity and type 2
diabetes and is presently in a Phase 1 trial in obesity. In addition,
Genaera has a value- driven, fully out-licensed partnership with MedImmune,
Inc. for a second core program that is presently undergoing Phase 2
clinical testing in asthma. Genaera is committed to directing resources to
its core program and the aggressive clinical development of its key assets
to build stockholder value. For further information, please see our website
at http://www.genaera.com.
This announcement contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks and uncertainties, known and unknown. Forward-looking
statements reflect management's current views and are based on certain
expectations and assumptions. Such statements include, among others,
statements regarding the preliminary results, clinical development plans
and prospects for Genaera's programs including trodusquemine (MSI-1436) and
the IL-9 antibody program. You may identify some of these forward-looking
statements by the use of words in the statements such as "anticipate,"
"believe," "continue," "develop," "expect," "plan" and "potential" or other
words of similar meaning. Genaera's actual results and performance could
differ materially from those currently anticipated and expressed in these
and other forward-looking statements as a result of a number of risk
factors, including, but not limited to: Genaera's history of operating
losses since inception and its need for additional funds to operate its
business; the costs, delays and uncertainties inherent in scientific
research, drug development, clinical trials and the regulatory approval
process; the risk that clinical trials for Genaera's product candidates
including trodusquemine (MSI-1436) and the IL-9 antibody program may be
delayed or may not be successful; the risk that Genaera may not obtain
regulatory approval for its products, whether due to adequacy of the
development program, the conduct of the clinical trials, changing
regulatory requirements, different methods of evaluating and interpreting
data, regulatory interpretations of clinical risk and benefit, or
otherwise; Genaera's reliance on its collaborators, in connection with the
development and commercialization of Genaera's product candidates; market
acceptance of Genaera's products, if regulatory approval is achieved;
competition; general financial, economic, regulatory and political
conditions affecting the biotechnology and pharmaceutical industry; and the
other risks and uncertainties discussed in this announcement and in
Genaera's filings with the U.S. Securities and Exchange Commission, all of
which are available from the Commission in its EDGAR database at
http://www.sec.gov as well as other sources. You are encouraged to read these
reports. Given the uncertainties affecting development stage pharmaceutical
companies, you are cautioned not to place undue reliance on any such
forward-looking statements, any of which may turn out to be wrong due to
inaccurate assumptions, unknown risks, uncertainties or other factors.
Genaera does not intend (and it is not obligated) to publicly update,
revise or correct these forward-looking statements or the risk factors that
may relate thereto.
Genaera Corporation
http://www.genaera.com
Dozarea Genaera Începe a doua etapã 1 proces al diabetului de tip 2 ºi obezitatea Compound Trodusquemine (MSI-1436) - Genaera Begins Dosing Second Phase 1 Trial Of Type 2 Diabetes And Obesity Compound Trodusquemine (MSI-1436) - articole medicale engleza - startsanatate