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Genaera Reports Positive Preliminary Two-Month Data from Phase II Study for Squalamine... [DTZHYMG]

Genaera Reports Positive Preliminary Two-Month Data from Phase II Study for
Squalamine in Age-Related Macular Degeneration

PLYMOUTH MEETING, Pa., Jan. 10 /PRNewswire-FirstCall/ -- Genaera
Corporation (Nasdaq: GENR) today announced positive preliminary clinical
results, including improved vision, from a multicenter open-label U.S. Phase
II clinical trial (MSI-1256F-207) with squalamine for the treatment of
choroidal neovascularization associated with age-related macular degeneration
(AMD), also known as "wet" AMD. Squalamine is the leading systemically
delivered anti-angiogenic drug being developed to treat AMD. Data from this
study are scheduled to be presented by Carl Regillo, MD, FACS, Professor of
Ophthalmology, Thomas Jefferson University, School of Medicine and Wills Eye
Hospital, Philadelphia, at the 28th Annual Meeting of the Macula Society in
Key Biscayne Florida on February 25, 2005.
Preliminary results from six patients treated with 40 mg of squalamine,
each of whom suffered from wet AMD in both eyes, demonstrated that of 100% of
eyes (n=12) had preserved or improved vision at week three (after two doses of
squalamine), week five (end of therapy) and two months after initiation of
therapy. The greatest degree of improvement at two months was a gain relative
to baseline of 28 letters (5.6 lines), while the greatest degree of loss was
11 letters on the ETDRS chart. In clinical trials of therapies for wet AMD,
gain or loss of less than 15 letters (three lines) on the ETDRS chart
constitutes stable vision, while gain equal to or greater than 15 letters
constitutes improved vision. All patients received four weekly doses of
squalamine, with no further maintenance therapy. There have been no
withdrawals from therapy or drug-related serious adverse events in the trial
thus far. Data discussed in this press release are included in the Overview
Presentation, under Investor Relations at http://www.genaera.com
"These preliminary results appear promising," said Professor Regillo. "I
very much look forward to taking part in the next steps of squalamine clinical
development through participation in the MSI-1256F-208 and -209 studies, as
well as assisting Genaera in the preparation of its Phase III studies starting
later this year."
"These U.S. Phase II trial results are comparable to our previously
reported Phase I/II clinical results in which 100% of wet AMD patients had
stable or improved vision, and provide additional evidence of squalamine's
tremendous potential as a less invasive systemic anti-angiogenic therapy for
this blinding eye disease," said Roy C. Levitt, MD, President and Chief
Executive Officer of Genaera Corporation. "The results announced today are
particularly important because all of these patients had both eyes affected
with wet AMD and we were able to treat both eyes with squalamine, conveniently
and safely. In contrast, other anti-angiogenic agents approved or in
development would have required a needle injection into both eyes in these
patients. About one third of wet AMD patients have both eyes affected at the
same time."
Dr. Levitt added, "This is one of three Phase II studies enrolling in the
U.S. to evaluate squalamine in wet AMD. While these are preliminary results
in a small number of patients, thus far our data suggest a dose response
indicating that a 40 mg dose may provide clinical benefit beyond that provided
by the lowest dose tested, 10 mg. Studies are ongoing to further evaluate
whether there is a role for the10 mg dose. We look forward to presenting
these data in greater detail at upcoming medical meetings and continuing to
assess the potential for squalamine as a treatment for this debilitating
condition."
Clinical Trial Program
Genaera is currently conducting three Phase II trials of squalamine in AMD
at multiple sites throughout the United States. Recently, the FDA selected
squalamine for participation in the Continuous Marketing Application (CMA)
Pilot 2 program. In October 2004, the FDA granted squalamine Fast Track
designation.
MSI-1256F-207 is a Phase II pharmacokinetic and safety trial that will
evaluate 18 patients with AMD at three different doses of squalamine (10 mg,
20 mg or 40 mg) over four months. In this multi-center, open-label, parallel
group study, squalamine is administered intravenously at three doses, once
weekly for four weeks. Depending on their response, patients may continue to
receive squalamine for up to a year in a separate study (MSI-1256F-211).
MSI-1256F-208 is a Phase II trial designed to evaluate the effects of
three different doses of squalamine in combination with an initial Visudyne(R)
treatment in 45 patients with AMD. Specifically, this study will evaluate the
safety and effects of systemically administered squalamine before and after
photodynamic therapy with Visudyne(R). Based on its mechanism of action, this
squalamine pretreatment has the potential to improve the effect of
Visudyne(R), and squalamine follow up treatment may inhibit the detrimental
effects of the VEGF 'burst' that commonly occurs after Visudyne(R) treatment.
The multi-center, randomized, controlled, masked study also includes monthly
squalamine maintenance therapy through six months, along with an additional
twelve months follow-up for each patient.
MSI-1256F-209 is the cornerstone and largest of Genaera's three Phase II
studies and is designed to evaluate the safety and efficacy of squalamine in
100 patients with AMD over a two-year period. This Phase II multi-center,
randomized, double masked, controlled study will evaluate two dose levels of
squalamine (20 mg or 40 mg) given once weekly for four weeks, followed by
maintenance doses once every four weeks until week 48. At the end of 48 weeks
of therapy, each patient will be followed for a further 12 months. Genaera
anticipates using data analyses from this study in coordinating Phase III
activities.
For information about participation in squalamine clinical trials,
patients and physicians may call Genaera's Clinical Trial Hotline at (800)
299-9156.
About Squalamine
Squalamine is a unique first in class synthetic small molecule
administered systemically that directly interrupts and reverses multiple
facets of the angiogenic process. Working within activated endothelial cells,
squalamine inhibits growth factor signaling including VEGF, integrin
expression, and reverses cytoskeletal formation, thereby resulting in
endothelial cell inactivation and apoptosis. Systemically administered
squalamine inhibits abnormal angiogenesis in rodent models of retinopathy of
prematurity, and the development of choroidal neovascular membranes in rat
models of AMD. Additional preclinical studies have demonstrated that systemic
squalamine administration is effective in reaching abnormal ocular blood
vessels in primates, and leads to partial regression and inhibition of new
abnormal vessels in the eye. These results support that squalamine may have a
role in the treatment of human choroidal neovascular membrane formation that
underlies the pathology of wet AMD.
About AMD
Wet AMD resulting from angiogenesis is the leading cause of legal
blindness among adults age 50 or older in the Western world. Approximately 25
to 30 million people are affected globally and this number is expected to
triple over the next 25 years.
AMD occurs in two types: the "dry" form and the more severe "wet" form.
Wet AMD is caused by the growth of abnormal blood vessels, or choroidal
neovascularization, under the central part of the retina, the macula. Dry AMD,
or the avascular form is the more common and milder form of AMD, accounting
for 85% to 90% of all cases. Dry AMD results in varying forms of sight loss
and may or may not eventually develop into the wet form. Although the wet form
of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight
loss is much greater. It is responsible for 90% of severe vision loss
associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed
annually worldwide. In North America alone, approximately 200,000 new cases of
wet AMD are diagnosed each year.
About Genaera
Genaera Corporation is a biopharmaceutical company committed to developing
medicines for serious diseases from genomics and natural products. Research
and development efforts are focused on anti-angiogenesis and respiratory
diseases. Genaera has three products in development addressing substantial
unmet medical needs in major pharmaceutical markets. These include
squalamine, an anti-angiogenesis treatment for cancer and eye disease;
interleukin-9 antibody, a respiratory treatment based on the discovery of a
genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the
overproduction of mucus and secretions involved in many forms of chronic
respiratory disease. For more information on Genaera, visit the company's
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. 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: the risk that subsequent clinical trial results differ from the results
announced today; the risk that squalamine ceases to meet the criteria for CMA2
Pilot or Fast Track designation at some point in the future; 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 squalamine 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 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.
SOURCE Genaera Corporation
10Jan05 13:30 GMT
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