Genaera
Corporation (Nasdaq: GENR) today announced that the first patient has been
enrolled in a multi-center, open-label, pharmacodynamic Phase II clinical
trial, MSI-1256F-212 (“Study 212”), to explore the efficacy and safety of
EVIZON(TM) (squalamine lactate) at higher doses. Study 212 is designed to
evaluate up to 140 patients with wet age-related macular degeneration
(“AMD”) treated with EVIZON(TM) at four dose levels (40 mg, 80 mg, 120 mg
and 160 mg) over a 20 week period.
“Genaera is pleased to announce the beginning of active enrollment in
Study 212,” commented Jack Armstrong, President and Chief Executive
Officer. “We have assembled an outstanding group of investigators and study
sites and are looking forward to obtaining additional information on the
most effective dose of EVIZON. This study will provide more detailed
information on EVIZON’s effects on visual acuity in both affected eyes of
patients with exudative AMD. There is a significant medical need for a drug
that treats wet AMD in both eyes simultaneously, while avoiding the
complications of intravitreal injections. EVIZON is differentiated from
other competitor drugs having demonstrated a positive effect in both study
and fellow affected eyes in previous clinical trials. We look forward to
confirming that EVIZON is the treatment to meet that medical need.”
For information about participation in EVIZON(TM) clinical trials,
patients and physicians may call Genaera’s Clinical Trial Hotline at (800)
299-9156.
Genaera Corporation is a biopharmaceutical company committed to
developing medicines to address substantial unmet medical needs in major
pharmaceutical markets. The Company has products in development for the
treatment of eye, cancer, respiratory disorders and metabolic syndrome.
EVIZON(TM) (squalamine lactate) is Genaera’s lead product in development
for ophthalmic indications, specifically wet age-related macular
degeneration (AMD). Genaera’s other programs include: squalamine for the
treatment of cancer; interleukin-9 antibody, a respiratory treatment based
on the discovery of a genetic cause of asthma; LOMUCIN(TM), a mucoregulator
to treat the overproduction of mucus and secretions involved in many forms
of chronic respiratory disease; and trodusquemine (MSI-1436) for the
treatment of obesity.
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 preliminary results, future clinical development plans
and prospects for Genaera’s programs, including EVIZON(TM) (squalamine
lactate), squalamine, LOMUCIN(TM), IL-9 antibody and trodusquemine
(MSI-1436). 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 EVIZON,
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; the risk that EVIZON ceases to meet the criteria for CMA2 Pilot
or Fast Track designation at some point in the future; 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 sec 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
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