Genaera Announces Positive EVIZON(TM) Phase II (MSI-1256F-207) AMD Data at Annual ARVO Meeting

Phase II clinical trial
(MSI-1256F-207). Preliminary
pharmacokinetic results from six patients treated with 40 mg of EVIZON weekly
for four weeks suggest that EVIZON undergoes biphasic elimination from the
circulation with a terminal half-life of approximately seven hours.

Additional Ongoing AMD Clinical Trials
MSI-1256F-208 is a Phase II trial designed to evaluate the effects of
three different doses of EVIZON (10 mg, 20 mg or 40 mg) with initial
concomitant Visudyne(R) (QLT Inc. This Phase II multi-center,
randomized, double masked, controlled study will evaluate two dose levels of
EVIZON (20 mg or 40 mg) given once weekly for four weeks, followed by
maintenance doses once every four weeks until week 48. Planned secondary analyses include evaluation of changes in visual
acuity from baseline in the study eye at year two, change in visual acuity in
fellow eyes affected with wet AMD, and quality of life. In North America alone, approximately 200 ,000 new cases of
wet AMD are diagnosed each year.

membranes epiretinal

"EVIZON has consistently demonstrated an excellent safety profile and the
20mg and 40 mg doses continue to offer promise to treat this debilitating eye
disease and may provide a number of advantages over other therapies in AMD,"
commented Dr . In October 2004, the FDA granted EVIZON Fast Track
designation. The multi-center, randomized, controlled , masked study also includes
monthly EVIZON maintenance therapy through six months, along with an
additional twelve months follow-up for each patient. 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 to address substantial unmet medical needs in major pharmaceutical
markets.gov as well as other sources.
Ultimately, as the leading systemic anti-angiogenic investigative new drug in
development for the treatment of wet AMD, we hope to reveal the great
potential EVIZON has to be a leading therapy in the rapidly growing AMD
market . Working within activated endothelial cells, EVIZON
inhibits growth factor signaling including VEGF , integrin expression, and
reverses cytoskeletal formation, thereby resulting in endothelial cell
inactivation and apoptosis. It is responsible for 90% of severe vision loss
associated with AMD .sec.

confrontation retinal

All subjects receiving the 40 mg dose had preserved or improved
vision during evaluation in both affected eyes through month 4 after weekly
therapy with EVIZON during the first month of the study. Each study will be a multi-center, randomized, double-masked, controlled
trial and will evaluate two systemically-administered doses of EVIZON (40 mg
and 20 mg) versus placebo, dosed weekly for four weeks followed by maintenance
doses every four weeks until week 104. At the end
of 48 weeks of therapy, each patient will be followed for a further 12 months.

About EVIZON(TM )
EVIZON is a unique first in class synthetic small molecule administered
systemically that directly interrupts and reverses multiple facets of the
angiogenic process.
Additional preclinical studies have demonstrated that systemic EVIZON
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.

About AMD
Wet AMD resulting from angiogenesis is the leading cause of legal
blindness among adults age 50 or older in the Western world. EVIZON(TM) (squalamine lactate ) is
Genaera's lead product in development for ophthalmic indications, specifically
"wet" age-related macular degeneration (AMD).S.
You are encouraged to read these reports. 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.

halloran retinal

Dr. Preliminary results from six subjects treated with 10 mg of
EVIZON, each diagnosed with bilateral wet AMD, demonstrated 90% of eyes (n=10)
had preserved or improved vision during evaluation at four months after
initiation of therapy.
Wet AMD is caused by the growth of abnormal blood vessels, or choroidal
neovascularization, under the central part of the retina, the macula. 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; and
LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and
secretions involved in many forms of chronic respiratory disease. Food and Drug Administration
(FDA) for the design of two global registration Phase III clinical trials
evaluating EVIZON(TM) (squalamine lactate ) for the treatment of choroidal
neovascularization associated with age-related macular degeneration (AMD),
also known as "wet" AMD. Enrollment in this trial
is closed. Approximately 25
to 30 million people are affected globally and this number is expected to
triple over the next 25 years . 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.

retinal blindness

S.6 lines), while the greatest degree of loss was 2 letters on the
ETDRS chart. Phase II trial results corroborate the visual acuity results
from our previously reported Phase I/II clinical trial results in which all
subjects had stable or improved vision at a similar dose and provide
additional evidence of the tremendous potential for EVIZON as the leading
systemic anti-angiogenic therapy for this bilateral blinding eye disease,"
said Roy C. EVIZON(TM) (squalamine lactate) is
Genaera's lead product in development for ophthalmic indications, specifically
"wet " age-related macular degeneration (AMD). 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.

Levitt,
MD, President and Chief Executive Officer of Genaera.
Additionally , we intend to demonstrate in these studies the numerous
advantages of systemic delivery of EVIZON , which is noninvasive to the eye,
including the potential to treat the commonly affected fellow eye .
AMD occurs in two types: the "dry" form and the more severe "wet" form.

blindness affects

Enrollment in this trial
is closed.

About EVIZON(TM)
EVIZON is a unique first in class synthetic small molecule administered
systemically that directly interrupts and reverses multiple facets of the
angiogenic process.
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 . "We look forward to
confirming these results by demonstrating a statistically significant clinical
benefit in these upcoming large scale registration trials of EVIZON.

blindness progression

AMD occurs in two types: the "dry" form and the more severe "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. Approximately 500,000 new cases of wet AMD are diagnosed
annually worldwide.
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 EVIZON(TM) 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 EVIZON(TM) 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.
You are encouraged to read these reports. In this multi-center , open-label, parallel group
study, EVIZON is administered intravenously once weekly for four weeks , and
then all subjects were followed out to month 4 with no further treatment after
week four . Depending on their response, patients may continue to receive
EVIZON as needed for up to one additional year in a separate study (MSI-1256F-
211).
Enrollment in this trial is closed.

About Genaera
Genaera Corporation is a biopharmaceutical company committed to developing
medicines to address substantial unmet medical needs in major pharmaceutical
markets. Securities and Exchange Commission, all of which are available from
the Commission in its EDGAR database at http://www.

explored macular

All but one subject were diagnosed as having wet AMD in both eyes,
including early and advanced lesions . To date, 14 of the 16 eligible subjects from study 207 have
elected to enroll in this trial, which permits monthly infusions of EVIZON on
an "as needed" basis. No change
in kinetics or drug accumulation was observed through week 5. Garcia. It is responsible for 90% of severe vision loss
associated with AMD. Securities and Exchange Commission, all of which are available from
the Commission in its EDGAR database at http://www.
"We are very pleased to have sought and reached agreement with the FDA on
the design of our Phase III trials of EVIZON in wet AMD," said Roy C.
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 EVIZON in 100
patients with AMD over a two-year period. Systemically administered EVIZON inhibits abnormal
angiogenesis in rodent models of retinopathy of prematurity, and the
development of choroidal neovascular membranes in rat models of AMD.

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.

fractures vitrectomy

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.
An update of preliminary data first reported in February 2005 was also
presented. 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; and
LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and
secretions involved in many forms of chronic respiratory disease.

healthlink explored

Subjects in the trial were evaluated at
various intervals including: week three (after two doses of EVIZON ), week five
(one week after the fourth dose, termed end-of-therapy), and two and four
months after initiation of therapy with EVIZON. Dry AMD,
or the avascular form is the more common and milder form of AMD, accounting
for 85% to 90% of all cases.S. This SPA is a binding written agreement between
Genaera and the FDA that the clinical protocols for the planned Phase III
trials are adequate to meet scientific and regulatory requirements to form the
primary basis for efficacy claims in a new drug application (NDA) for EVIZON. Dry AMD,
or the avascular form is the more common and milder form of AMD, accounting
for 85% to 90% of all cases.

vitrectomy membranes

In the fellow eye, visual acuity change at month 2 ranged from a gain
of 15 letters to a loss of 2.6 lines), while the greatest degree of
loss was 12 letters on the ETDRS chart.S."
AMD Clinical Trial Program
Genaera is currently conducting three Phase II trials of EVIZON in wet AMD
at multiple sites throughout the United States .
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 EVIZON in 100
patients with AMD over a two-year period. Approximately 25
to 30 million people are affected globally and this number is expected to
triple over the next 25 years. Levitt.
MSI-1256F-207 is a Phase II pharmacokinetic and safety trial that will
evaluate 18 subjects with AMD at three different doses of EVIZON (10 mg, 20 mg
or 40 mg) over four months .

lutein macula

Garcia reported interim results from 18 subjects who had received
either 10, 20 or 40 mg doses of EVIZON as a part of the trial. No drug-related systemic adverse events, no drug-related
ocular adverse events and no drug-related serious adverse events occurred in
subjects involved in the trial. These include evidence for a preliminary dose response, which is
helpful in choosing the doses for our Phase III studies that will be starting
soon and characterization of pharmacokinetic profiles for this drug in AMD
patients at these clinical doses. Moreover, the results announced today are
particularly important because we were able to conveniently and safely treat
both of the subjects' affected eyes with 20 mg and 40 mg of EVIZON regardless
of the stage of the lesion.

progression affects

Of the six subjects receiving 20 mg infusions of EVIZON in study 207, five
maintained stable vision in their study eye through the month 2 evaluation,
while all six fellow eyes were stable or improved. In the study eye , the
greatest degree of improvement at two months was a gain relative to baseline
of 6 letters , while the greatest degree of loss was 17 letters on the ETDRS
chart. The Company has four products in development for the treatment of
eye, cancer and respiratory disorders.sec.

macula degenerative

The greatest degree
of improvement in study eyes at four months in these subjects was a gain
relative to baseline of 18 letters (3. Similar positive results were obtained
in the fellow eyes of this cohort, with a gain relative to baseline of 18
letters (3. For
these patients, the less-invasive method of delivery of EVIZON avoids the
risks of bilateral ocular injections. Working within activated endothelial cells, EVIZON
inhibits growth factor signaling including VEGF, integrin expression, and
reverses cytoskeletal formation, thereby resulting in endothelial cell
inactivation and apoptosis.

About AMD
Wet AMD resulting from angiogenesis is the leading cause of legal
blindness among adults age 50 or older in the Western world. With this SPA in hand
we are ready to begin our registration trials in the very near future., Vancouver, Canada)
treatment in 45 patients with wet AMD. Specifically , this study will evaluate
the safety and effects of systemically administered EVIZON before and after
PDT with Visudyne. These results support that EVIZON may have a role in the
treatment of human choroidal neovascular membrane formation that underlies the
pathology of wet AMD.
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 EVIZON(TM) 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 EVIZON(TM) 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.

pdt macula

, Genaera Corporation
(Nasdaq: GENR) and study investigators today announced positive interim
clinical trial results, including pharmacokinetic data and visual acuity
outcomes, from a multi-center open-label U. Levitt, MD, President and Chief Executive Officer of Genaera
Corporation. At the end of 48 weeks
of therapy, each patient will be followed for a further 12 months.
For information about participation in EVIZON clinical trials, patients
and physicians may call Genaera's Clinical Trial Hotline at (800) 299-9156., Genaera
Corporation (Nasdaq: GENR) today announced that it has reached agreement on a
Special Protocol Assessment (SPA) with the U."

Other Ongoing Clinical Trials
Genaera is currently conducting three Phase II trials of EVIZON in wet AMD
at multiple sites throughout the United States.

healthlink translocation

One subject on the 10 mg dose withdrew from therapy
after month 2, with visual loss of 26 ETDRS letters."
"These U.
For information about participation in EVIZON clinical trials, patients
and physicians may call Genaera's Clinical Trial Hotline at (800) 299-9156. Forward-looking statements
reflect management's current views and are based on certain expectations and
assumptions.

The condition affects the eyes Macula, in some cases causing it to stop working entirely which causes blindness.

retina healthlink

Garcia, MD , Bernice Weingarten Distinguished
Professor of Ophthalmology and Visual Science, University of Texas Health
Science Center at Houston. "In addition, we accomplished other important goals in this small
study. Since current approved or investigational anti-
angiogenic agents require administration by intravitreal injection, the
results announced today are especially significant for the approximately one-
third or more of wet AMD patients with both eyes affected simultaneously. These results support that EVIZON may have a role in the
treatment of human choroidal neovascular membrane formation that underlies the
pathology of wet AMD. Forward-looking statements
reflect management's current views and are based on certain expectations and
assumptions.S.
MSI-1256F-208 is a Phase II trial designed to evaluate the safety and
clinical effects of three different doses of EVIZON (10 mg, 20 mg or 40 mg)
with initial concomitant PDT with Visudyne(R) (QLT Inc. The multi-center, randomized , controlled, masked study also
includes monthly EVIZON maintenance therapy through six months, along with an
additional twelve months follow-up for each patient. 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.

photodynamic vitrectomy

The study is one of a continuing series evaluating EVIZON (TM)
(squalamine lactate) for the treatment of choroidal neovascularization
associated with age -related macular degeneration (AMD), also known as "wet"
AMD.

Genaera Completes Special Protocol Assessment with FDA for EVIZON(TM) in Age-Related Macular Degeneration

-Phase III to Begin in June 2005-

PLYMOUTH MEETING, Pa. "The SPA is an important
milestone in our aggressive clinical development plans for EVIZON and
solidifies our regulatory pathway towards FDA approval .
"In our early Phase I and II trials EVIZON has stabilized or improved
vision in most everyone we have treated, including patients with two affected
eyes, with a good safety profile", commented Dr. This Phase II multi-center,
randomized, double masked, controlled study will evaluate two dose levels of
EVIZON (20 mg or 40 mg) versus placebo, dosed once weekly for four weeks,
followed by maintenance doses once every four weeks until week 48. Although the wet form
of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight
loss is much greater.

halloran confrontation

PLYMOUTH MEETING , Pa. 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.gov as well as other sources .

epiretinal vitrectomy

Specifically, this study will evaluate the safety and effects of
systemically administered EVIZON before and after photodynamic therapy with
Visudyne. Approximately 500,000 new cases of wet AMD are diagnosed
annually worldwide.

jolts blindness

After concluding their participation in this
trial, subjects from study 207 were permitted to continue in a twelve-month
follow-up study of infusion interval and long -term safety of EVIZON (MSI-
1256F-211). The total
number of patients enrolled into each Phase III study will be based upon
analyses of data from the Company's existing and ongoing Phase II clinical
trials, as agreed upon with the FDA. In October 2004, the FDA
granted EVIZON Fast Track designation .
Wet AMD is caused by the growth of abnormal blood vessels, or choroidal
neovascularization, under the central part of the retina, the macula.

lutein epiretinal

Additional preclinical studies have demonstrated that systemic EVIZON
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. Dry AMD results in varying forms of sight loss
and may or may not eventually develop into the wet form. Photodynamic therapy (PDT) will be
allowed for all patients if deemed necessary by the study physician.

pdt macular

The data were presented at the Association for Research in Vision and
Ophthalmology (ARVO) Annual Meeting on May 1, 2005 by retinal specialist and
study advisor Charles A. All subjects
received four weekly doses of intravenous EVIZON with no further maintenance
therapy. "Data from this unmasked study showed that the 20 mg
dose stabilized or improved visual acuity in most patients out to two months
in both affected eyes including advanced lesions that generally go untreated. In early 2005, the FDA
selected EVIZON for participation in the Continuous Marketing Application
(CMA) Pilot 2 program. Enrollment
in this trial is ongoing.
The primary objectives of these studies are to demonstrate safety and
significant clinical benefit of EVIZON therapy on visual acuity at one year in
the study eye (assessed by Early Treatment Diabetic Retinopathy scoring system
or ETDRS).

Macular Degeneration is a condition that mainly affects those over 60 years old (age related) but can also affect children and teenagers (juvenile).

macular retinal

The drug was well tolerated
in all subjects., Vancouver, Canada) treatment in 45 patients
with AMD. Systemically administered EVIZON inhibits abnormal
angiogenesis in rodent models of retinopathy of prematurity, and the
development of choroidal neovascular membranes in rat models of AMD."
The two identical international Phase III studies are designed to enroll
patients with predominantly classic, minimally classic and occult forms of wet
AMD. Dry AMD results in varying forms of sight loss
and may or may not eventually develop into the wet form.

translocation confrontation

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 . In January 2005, the FDA selected
EVIZON for participation in the Continuous Marketing Application (CMA) Pilot 2
program. The Company has four products in development for the treatment of
eye, cancer and respiratory disorders.