SOUTH SAN FRANCISCO, Calif. In both
cases, the difference between groups was not statistically
significant.
Lucentis is being developed by Genentech and the Novartis Ophthalmics
Business
Unit. Genentech retains commercial rights for Lucentis in North
America (United States, Canada and
Mexico)., and a team of scientists at Genentech conducted
seminal work in the field, which resulted
in the identification and cloning of
a gene termed Vascular Endothelial Growth Factor (VEGF), now
known as VEGF-A. Forward-looking statements
reflect management's current views and are based on
certain expectations and
assumptions.
lutein photodynamic
Genentech and Novartis Pharma AG recently announced
top-line positive
results from the Phase III MARINA study. Approximately 25
to 30 million people
are affected globally and this number is expected to
triple over the next 25 years.gov as well as
other
sources.
devastating degeneration
After uveitis, endophthalmitis was the second most common ocular
serious
adverse event occurring in patients treated with Lucentis.
Ongoing Phase III Studies
The MARINA (Minimally classic/ occult trial of the Anti-VEGF antibody
RhuFab V2 In the treatment
of Neovascular AMD) study is a randomized,
multi-center, double-masked, sham-injection controlled
study evaluating the
safety and efficacy of two different doses of Lucentis in 716 patients with
minimally classic or occult subfoveal wet AMD. For additional information about
the company, please
visit http://www.com. PLYMOUTH MEETING, Pa. Depending on their response, patients may then participate
in a
separate study (MSI-1256F-211) in which they can continue to receive EVIZON
for up to a year
. 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. Dry AMD results in varying forms of sight loss
and may or may not develop
into the wet form.
About Genaera
Genaera Corporation is a biopharmaceutical company
committed to developing
medicines to address substantial unmet medical needs in major pharmaceutical
markets. 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.progression retinal
, Genentech's senior vice president,
development and chief medical
officer. In October 2004, the FDA granted EVIZON Fast Track
designation. 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. Approximately 500,000 new cases of wet AMD are diagnosed annually
worldwide.jolts confrontation
A preliminary
analysis of the data showed there was an increased risk of
the serious ocular adverse event uveitis
in patients treated with Lucentis in
combination with PDT compared to patients treated with PDT alone
. Novartis has exclusive
commercialization rights for the rest of the world.
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. Enrollment
in this trial is closed
. Enrollment in this trial is ongoing. 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
.membranes degenerative
The wet form is caused by growth of abnormal blood vessels also known as
choroidal neovascularization
(CNV) or ocular angiogenesis under the macula.
About Genentech
Genentech is a leading
biotechnology company that discovers, develops,
manufactures and commercializes biotherapeutics for
significant unmet medical
needs. Recently, the FDA
selected EVIZON for participation in the Continuous
Marketing Application
(CMA) Pilot 2 program.
MSI-1256F-209, the cornerstone and largest of
Genaera's Phase II studies,
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. Securities and Exchange Commission, all of which are available from
the
Commission in its EDGAR database at http://www.macular explored
0003). An amendment
to the study protocol was made
after data safety monitoring identified this
imbalance. The process of angiogenesis is
normally
regulated throughout development and adult life, and the uncontrolled
growth of new blood vessels
is an important contributor to a number of
pathologic conditions, including wet AMD. 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. The Company has four products
in development for the treatment of
eye, cancer and respiratory disorders.
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.degeneration explored
Preliminary Phase I/II
Data Show Lucentis(TM) in Combination With Visudyne(R) Maintained or Improved Vision in Approximately
90 Percent of Patients With Wet Ag
A preliminary analysis of the MARINA
data showed that adverse
events were similar to those seen in earlier trials
of Lucentis. The FOCUS study was conducted at
25 sites
in the United States.
About Lucentis
Lucentis (ranibizumab) is a humanized
therapeutic antibody fragment
developed at Genentech and designed to bind and inhibit VEGF-A, a protein
that
plays a critical role in angiogenesis (the formation of new blood vessels). In 1989,
Napoleone
Ferrara, M. Specifically, this study will evaluate the safety and effects of
systemically administered
EVIZON before and after photodynamic therapy with
Visudyne.
For information about participation
in EVIZON clinical trials, patients
and physicians may call Genaera's Clinical Trial Hotline at
(800) 299-9156. Dry AMD,
or the avascular form, is the more common and milder form of AMD, accounting
for 85% to 90% of all cases. You are encouraged to read these reports.macula degenerative
Results from all
patients
treated with 40 mg of EVIZON, each of whom suffered from wet AMD in
both eyes, demonstrated that
of 100% of eyes (n=12) had preserved or improved
vision during evaluation in both affected eyes through
month four. The condition affects the eyes Macula, in some cases causing it to stop working entirely
which causes blindness.
progression retinal
, Genentech,
Inc. Patients treated with Lucentis plus PDT at 12 months had
, on
average, a significant improvement in visual acuity compared to visual acuity
at study entry
, an important secondary endpoint, while the PDT-alone group
demonstrated a decrease in mean visual
acuity from baseline to 12 months.
"We are excited to see a statistically significant improvement
in vision
for patients with wet AMD in a second trial in which patients were treated
with Lucentis
," said Hal Barron, M. There appeared to be no
imbalance in serious non-ocular adverse events in the
MARINA study.
About the Study
The FOCUS (RhuFab V2 Ocular Treatment Combining the
Use of Visudyne(TM) to
Evaluate Safety) trial is a Phase I/II randomized, single-masked study
evaluating
the safety, tolerability and efficacy of Lucentis in combination
with PDT in 162 patients with predominantly
classic subfoveal wet AMD. This is a
randomized, multi-center, double-masked, active treatment controlled
study
comparing two different doses of Lucentis to PDT in 423 patients. In this multi-
center
, open-label, parallel group study, EVIZON is administered intravenously
once weekly for four weeks
with no further treatment through the four month
evaluation.progression pills
Among
non-ocular serious adverse
events, the frequency of cerebral vascular events
was slightly higher in those treated with Lucentis
, while the frequency of
myocardial infarctions was slightly higher in the PDT-alone arm. Results
from this study are expected in the fourth quarter of 2005.D.
Wet AMD is caused by the growth of
abnormal blood vessels, or choroidal
neovascularization, under the central part of the retina, the
macula.macula degeneration
Among other
things, the timing could be affected by additional time requirements for data
analysis or discussions with the FDA.S.
Avinash Desai, MD, Executive Director, Medical Affairs
at Genaera will present
these clinical results at the 2nd Annual IBC Ocular Angiogenesis Meeting
being
held in Cambridge, Massachusetts, from March 24-25, 2005.epiretinal cedars
Approximately 90 percent of patients
maintained or improved vision (defined as a loss of less than 15 letters in
visual acuity) when
treated with the combination of Lucentis and PDT compared
to approximately 68 percent of those treated
in the control arm of PDT alone
(p = 0. In this
study, patients were randomized 2:1 to receive
PDT followed by either 0. In this trial, Lucentis is
administered once per month for the first three
doses followed thereafter by
doses once every three months for two years.
Media Contact:
Megan Pace 650-467-7334
Investor Contact: Kathee Littrell 650-225-1034
Dr. 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.confrontation retina
The National Eye Institute
estimates that there are 1., Vancouver, Canada
) treatment in 45 patients
with AMD. At the end of 48 weeks of therapy, each patient will
be followed
for a further 12 months. 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, in certain cases, apoptosis. Although the wet form of AMD
accounts
for only 10% to 15% of all AMD, the chance for severe sight loss is
much greater. In North America
alone, approximately 200,000 new cases of wet AMD
are diagnosed each year.epiretinal halloran
One-year data from
the trial will be presented at the 23rd Annual Meeting of
the American Society of Retina Specialists
(ASRS), July 16 to 20 in Montreal,
Canada. Genentech manufactures
and commercializes multiple
biotechnology products directly in the United
States and licenses several additional products to
other companies.sec.lutein healthlink
(NYSE: DNA) announced today that a single-masked Phase I/II clinical
study of
the investigational drug Lucentis(TM) (ranibizumab) met its primary
efficacy endpoint of maintaining
vision in patients with wet age-related
macular degeneration (AMD) when used in combination with
verteporfin
(Visudyne(R)) photodynamic therapy (PDT). Serious ocular
adverse events occurring
more frequently in Lucentis-treated patients were
rare (<1%) and included uveitis and endophthalmitis
. The trial is
ongoing in the United States, Europe and Australia with predominantly classic
wet
AMD. This results in a deterioration of sight over a period of
months to years.Genaera to Present
EVIZON(TM) Age-Related Macular Degeneration Data At Ophthalmology Conference
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.blindness halloran
These vessels leak fluid and blood and cause scar
tissue that destroys the
central retina. Based on its mechanism of action, the EVIZON pretreatment
has the
potential to improve the effect of Visudyne, and EVIZON follow up treatment
may inhibit
the detrimental effects of the VEGF 'burst' that commonly occurs
after Visudyne treatment.S.photodynamic confrontation
AMD
occurs in two forms: dry and wet.
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; 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 EVIZON(TM) ceases to meet the criteria for CMA2
Pilot
or Fast Track designation at some point in the future; 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.lutein vitrectomy
The dry form is associated with
atrophic cell death of the central
retina or macula, which is required for
fine vision used for activities such as reading, driving
or recognizing faces.
The VEGF protein plays a critical role in angiogenesis, and serves as one of
the key contributors to physiological or pathological conditions that can
stimulate the formation
of new blood vessels. Phase II
clinical trial (MSI-1256F-207) with EVIZON(TM) (squalamine lactate
) for the
treatment of choroidal neovascularization associated with age-related macular
degeneration
(AMD), also known as "wet" AMD. EVIZON is the leading
systemically delivered anti-angiogenic drug
being developed to treat AMD. These results suggest EVIZON may have a role in the
treatment of human
choroidal neovascular membrane formation that underlies the
pathology of wet AMD.Macular Degeneration
is a condition that mainly affects those over 60 years old (age related) but can also affect children
and teenagers (juvenile).
blindness pills
5 mg
injections of Lucentis or sham injections for 23 months.
Genentech
and Novartis Pharma AG are conducting an additional Phase III
study of Lucentis, ANCHOR (ANti-VEGF
Antibody for the Treatment of
Predominantly Classic CHORoidal Neovascularization in AMD).
Lucentis
is designed to block new blood vessel growth and leakiness, which
lead to wet AMD disease progression
and vision loss. A considerable number of the currently approved biotechnology products
originated
from, or are based on, Genentech science., and is traded on the
New York Stock Exchange under the
symbol DNA.
Other Ongoing Clinical Trials
Genaera is currently conducting two additional
Phase II trials of EVIZON
in wet AMD at multiple sites throughout the United States.
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.macula lutein
Genentech
is conducting an additional Phase IIIb study, PIER (A Phase
IIIb, Multicenter, Randomized, Double
-Masked, Sham Injection-Controlled Study
of the Efficacy and Safety of Ranibizumab in Subjects with
Subfoveal Choroidal
Neovascularization with or without Classic CNV Secondary to Age-Related
Macular
Degeneration), a randomized, double-masked, sham injection-controlled
study comparing one of two
doses of Lucentis to sham injections in 184
patients in the United States with wet AMD. The
company
has headquarters in South San Francisco, Calif.membranes macular
D.
About Angiogenesis
Genentech is
a leader in research and product development in the area of
angiogenesis, the process by which new
blood vessels are formed. Results
from six patients 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.photodynamic cedars
Lucentis is a humanized therapeutic antibody
fragment developed at
Genentech and designed to bind and inhibit Vascular Endothelial Growth Factor
A (VEGF-A), a protein that plays a critical role in angiogenesis (the
formation of new blood vessels
). To perform a sham
injection, the treating physician prepares and anesthetizes the patient's eye
but does not perform an injection. Results from this study are
expected in the first half of 2006
.gene. Desai will report interim results from subjects who had received
either 10 mg or 40 mg of EVIZON
as a part of the trial.
AMD occurs in two types: the "dry" form and the more severe "wet" form
.
jolts affects
Common side effects occurring in the Lucentis arms more
frequently than in the control group were
mild to moderate and included
conjunctival hemorrhage, eye pain and vitreous floaters.
About AMD
AMD is a major cause of painless central visual loss and is the leading
cause of
blindness for people over the age of 60.6 million people with AMD in the United States
alone., Genaera
Corporation (Nasdaq: GENR) today announced a presentation of clinical results,
previously reported
in February 2005, including pharmacokinetic data and
updated visual acuity outcomes, from a multi
-center open-label U.
About AMD
Wet AMD resulting from angiogenesis is the leading
cause of legal
blindness among adults age 50 or older in the Western world. It is responsible for
90% of severe vision loss associated with
AMD. EVIZON(TM) (squalamine lactate) is
Genaera's lead
product in development for ophthalmic indications, specifically
"wet" age-related macular degeneration
(AMD).degenerative lutein
The statements made in this press release relating to the expected time
frame for
results from the Phase III ANCHOR and PIER trials are
forward-looking and actual results could differ
materially.healthlink halloran
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