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Genaera Announces Diabetes IND In Effect For Trodusquemine (MSI-1436)
Genaera
Corporation (Nasdaq: GENR) announced that the investigational new
drug (IND) application submitted to the US Food and Drug Administration
(FDA) for trodusquemine (MSI-1436) in type 2 diabetes is now in effect.
This application represents the second IND filed by the Company in 2007 for
MSI- 1436. A previous IND for the treatment of obesity, under which Genaera
is currently conducting phase 1 clinical trials, has been in effect since
April 2007. MSI-1436 is a novel therapeutic for the treatment of type 2
diabetes and obesity which acts by regulating insulin and leptin receptor
signaling through inhibition of the tyrosine phosphatase, PTP-1B.
"A growing body of data indicates that inhibition of PTP-1B is central
to controlling the key pathologies associated with type 2 diabetes; namely
insulin sensitivity and obesity," said Jack Armstrong, President and Chief
Executive Officer of Genaera. "Since MSI-1436 has demonstrated significant
potential to impact both the insulin and leptin pathways, we believe this
new IND provides us with the opportunity for additional indications and a
much broader potential market. Therefore, we are implementing a clinical
plan which evaluates the drug's potential in type 2 diabetes, in addition
to our ongoing obesity studies. With this dual strategy, we believe that we
are well-positioned to maximize the therapeutic potential of MSI-1436."
In October 2007, Genaera completed the first phase 1 study of MSI-1436
in healthy obese and overweight subjects. MSI-1436 is currently being
evaluated in a second phase 1 ascending single dose study in overweight and
obese type 2 diabetics (study MSI-1436C-103) under Genaera's obesity IND.
Additional phase 1 studies will explore the potential of MSI-1436 in type 2
diabetics and the Company plans to pursue type 2 diabetes as its lead
indication in phase 2.
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
Genaera anunta Diabet IND în vigoare pentru Trodusquemine (MSI-1436) - Genaera Announces Diabetes IND In Effect For Trodusquemine (MSI-1436) - articole medicale engleza - startsanatate