"We are delighted to begin this pivotal trial with the goal of
demonstrating the
great potential of LOMUCIN as an innovative way to reduce
the overproduction of mucus and thereby
open the airways of CF subjects
positively impacting lung functions and the quality of life for people
with
cystic fibrosis" commented Roy C.sec.5
million people nationwide may be carriers. ZLB Behring
is a subsidiary of
CSL Limited, a biopharmaceutical company, which operates worldwide
from its
headquarters in Melbourne, Australia.
aunt genevieve
Genaera Forward-Looking Statements
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." The Act would waive
the current 24-month waiting
period for Medicare benefits immediately for people with life-threatening
diseases such as IPF. Funds raised can help advance
the CPF's patient programs and services
, continue awareness and education
programs around the country, and provide resources for research
to find a cure
for IPF. Harris Memorial Foundation,
the National Coalition of Autoimmune Patient
Groups, the National Organization
for Rare Disorders, The Pulmonary Paper, the Second Wind Lung Transplant
Association, and more than 30 leading medical and research centers nationwide.tildonk yourman
Based on the role
of the hCLCA1 chloride
channel in respiratory diseases, such as cystic fibrosis, the Company has
developed LOMUCIN(TM). LOMUCIN(TM) is intended to block the hCLCA1-dependent
mucus overproduction
present in respiratory and sinus disorders, and thereby
provide a new strategy for opening the airways
and easing breathing in
patients with these diseases. The Company has four products in development
for the treatment of
eye, cancer and respiratory disorders.
For more information please visit
http://www. have severe Alpha-1, and 2.
Additionally, ZLB Behring operates one of the world's largest
,
fully-owned plasma collection networks.lung antibiotics
Securities and Exchange Commission, all of which are available
from
the Commission in its EDGAR database at http://www.Coalition for Pulmonary Fibrosis Announces
2005 National IPF Awareness Week Activities
1, 2005
SAN JOSE, Calif., The Coalition
for Pulmonary
Fibrosis (CPF) today announced plans for the third annual National IPF
Awareness
Week, to be held Sept. Alpha-1 can also cause liver
impairment and failure in both children and adults;
in fact, Alpha-1
is the leading cause of childhood liver transplants.S.transplant waiting
PLYMOUTH MEETING, Pa.
Cystic Fibrosis Foundation Therapeutics, Inc.
You are encouraged to read these reports.
About Idiopathic Pulmonary Fibrosis
IPF is a lung disorder characterized by a progressive scarring
-- known as
fibrosis -- and deterioration of the lungs, which slowly robs its victims of
their
ability to breathe. One Test, Once a Lifetime,"
is intended to educate physicians on the need for
testing for Alpha-1,
including how to test and how to treat people who test positive for
the deficiency
.kloppenburg battled
org.S.C. The CPF is also supporting two major stem cell bills
that have captured the attention of
Congress -- one bill allows federal
funding for embryonic stem cell research and another establishes
a network for
optimizing umbilical cord stem cell research.
May is Alpha-1 Awareness Month in
many states across the country.cf niece
This study, which will be initiated in Ireland, will evaluate
the use of
LOMUCIN in two hundred individuals with cystic fibrosis (CF) through a
multi-center
, randomized, double-blind, placebo-controlled trial. Placebo tablets will be
administered to an additional
one hundred people with the disease. Talniflumate has been approved and marketed for almost 20 years
in Argentina, and selected other countries excluding the United States,
Europe, and Japan., is
a donor-supported,
nonprofit organization committed to finding therapies-and eventually a
cure
-for CF, and to improving the lives of those with the disease.
About the Coalition
for Pulmonary Fibrosis
The Coalition for Pulmonary Fibrosis (CPF) is a 501(c)(3) nonprofit
organization
, founded in 2001 to further education, patient support and
research efforts for interstitial lung
disease, and specifically pulmonary
fibrosis.crista triplets
Charlie Norwood (R-GA), who, weeks before,
announced
he had IPF, Rep.lung genevieve
, Genaera
Corporation (Nasdaq: GENR) today announced the start of its pivotal Phase
II
clinical trial for the mucoregulator drug, LOMUCIN(TM), in people with cystic
fibrosis (CF
). In patients with the illness, a defective gene causes the
body to produce abnormally thick, sticky
mucus that can lead to chronic lung
infections and impairs digestion. 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, including
cystic
fibrosis. 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.gov as well as other sources."
Last year during
the 2004 National IPF Awareness Week, CPF representatives
and IPF patients met with more than 60
Members of Congress, including
successful meetings with Rep. Joe Barton (R-TX), Chair of the Energy
and Commerce
Committee, and Rep.
ZLB Behring, a global leader in the plasma therapeutics industry
,
encourages all individuals with Chronic Obstructive Pulmonary Disease
(COPD), emphysema or asthma;
individuals with a family history of
Alpha-1; and individuals with unexplained or chronic liver disease
to
contact their doctors to discuss getting tested for Alpha-1.cf lungs
Genaera Initiates Pivotal Phase II
Clinical Trial of LOMUCIN(TM) for Cystic Fibrosis
D. Total support of
CFFT is provided by the
CF Foundation. For more information about CF, the CF
Foundation or CFFT, call (800) FIGHT CF or visit
http://www.
While only 3,000 to 4,000 people in the United States have been
diagnosed with Alpha
-1 to date, researchers estimate that up to
100,000 adults and children in the U.lint lung
IPF is difficult
to diagnose and an estimated two-thirds
of patients die within five years of diagnosis. The Detection
Program, themed "Making a Clear Diagnosis. The company's broad portfolio of
life-saving therapeutics
are used in the treatment of individuals with
hemophilia and other bleeding disorders, immune deficiency
disorders
and inherited emphysema; the prevention of hemolytic diseases for the
newborn; cardiac
surgery patients; and shock and burn victims.triplets celine
During IPF Week, for the
third consecutive year, a
delegation of CPF representatives will travel to
Washington, D.
cystic celine
LOMUCIN(TM) is
a known compound, talniflumate, which was discovered,
developed and marketed as an anti-inflammatory
drug by Laboratorios Bago of
Buenos Aires, Argentina, the leading independent pharmaceutical company
in
South America. CF is a
life-threatening, genetic disease that affects approximately 30,000
people in
the United States.cff. EVIZON(TM) (squalamine lactate) is
Genaera's lead product in
development for ophthalmic indications, specifically
"wet" age-related macular degeneration (AMD
). 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. That means that up to 95%
of people
with Alpha1-Antitrypsin deficiency may remain undiagnosed.lint genevieve
"By evaluating a potential mucus-regulating
drug, these researchers are
pursuing a unique approach to CF therapy that could enhance the length
and
quality of life for those battling this disease," said Robert J. "We
believe that this larger
, longer-term trial is the logical next step to
further advance the clinical development of LOMUCIN
for CF and look forward to
working with CFFT.yance aunt
The study
will assess the safety and efficacy of
LOMUCIN oral tablets on pulmonary
function and related symptoms.
This study will administer
LOMUCIN oral tablets three times per day for
52 weeks to one hundred individuals with CF."
Background on LOMUCIN(TM) and the Mucoregulator Program
The mucoregulator program is Genaera
's second product development program
based on its genomics discoveries. The effects of talniflumate
in blocking hCLCA1 and mucus
overproduction were discovered by Genaera scientists who have submitted
patent
applications protecting the novel uses of talniflumate as a mucoregulator. 25 - Oct.
IPF patients and CPF representatives will meet with Members of Congress in
Washington, D. Ted Strickland
(D-OH). With more than 8,500 members nationwide, the CPF is
the largest nonprofit organization in
the country dedicated to helping those
with pulmonary fibrosis.Alpha-1 Awareness Month: Awareness
is Key for Underdiagnosed Genetic Disorder; ``Making a Clear Diagnosis. One Test Once a Lifetime''
cystic lint
(CFFT) the
nonprofit drug discovery and development affiliate of the Cystic Fibrosis
Foundation
, is supporting this pivotal trial with study-specific funding of up
to $2. Beall, Ph. 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. 27-29 to improve awareness of IPF in the Congressional
community, to discuss the importance of increased funding of IPF-related
research, and to encourage
Members to advance IPF-related legislation
currently before Congress, including the "Ending the Medicare
Disability
Waiting Period Act of 2005.
The CPF is also publishing its first Fundraising Tool
Kit during National
IPF Awareness Week to encourage community-based fundraising activities all
year
round. Symptoms of the lung disorder include shortness of breath,
chronic cough, and reduced lung
function.tildonk fibrosis
The CPF is governed by the nation's leading pulmonologists,
individuals affected by pulmonary
fibrosis, medical research professionals and
advocacy organizations.----Do you know
someone with
a chronic breathing problem that isn't responding to
treatment? They could have Alpha1-Antitrypsin
Deficiency, or Alpha-1,
an underdiagnosed genetic disorder that can affect the lungs and
liver
.celine niece
,
president and CEO of the Cystic Fibrosis Foundation.
CFFT is the nonprofit drug development
affiliate of the CF Foundation that
operates drug discovery, development and evaluation efforts.
Sept.
"IPF patients and CPF representatives are really making a difference on
Capitol Hill
by raising awareness of the importance of legislation in Congress
that has the potential of impacting
IPF patients and families, and the health
care professionals who treat them," said Mark Shreve, chief
executive officer
of the CPF. "This advocacy effort is a crucial part of our campaign and
provides
a great source of hope to our members, and assurance that their
viewpoints are being represented
at a national level.org .org .battled niece
Genaera has an exclusive agreement with Laboratorios Bago to develop
and
commercialize LOMUCIN(TM) as a new chemical entity and mucoregulator drug in
all major pharmaceutical
markets including the United States, Europe, and
Japan. 25 - Oct. 1, 2005. to meet with lawmakers
and raise awareness of idiopathic
pulmonary fibrosis (IPF) on Capitol Hill. The Fundraising Tool
Kit will serve as a guide for those
interested in organizing events and activities to help support
those affected
by IPF, and advance IPF-related research.
As part of its continuing long-term commitment
to the Alpha-1
community, ZLB Behring is pleased to roll out a comprehensive
Detection Program
during Alpha-1 Awareness Month.crista yance
Results of
the study are anticipated to be available by the second
half of 2007. The CPF's nonprofit partners include the Caring
Voice Coalition, the Genetic Alliance
, the Mary D.
Business Editors/Health Editors
KING OF PRUSSIA, Pa. For more
information
on this program and ZLB Behring's other patient and
physician support programs, contact 1-866-ZEMAIRA
(1-866-936-2472) or
visit www.zemaira.crista niece
35 million in milestone-driven, matching funds through a Therapeutics
Development Award.org.
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 clinical trials for Genaera
's product candidates, including
LOMUCIN(TM) may be delayed or may not be successful; the risk that
subsequent
clinical trial results differ from the results previously announced; 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 LOMUCIN 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.
The CPF will also be offering commemorative pins in support
of IPF Week.
The pins will be available on the CPF web site beginning in July.
The Detection Program
is a new component of the educational
support ZLB Behring provides to the Alpha-1 community.sprinkle genevieve
A previous
exploratory Phase II study
demonstrated a trend toward better lung function in people with CF who
took
LOMUCIN compared to those receiving placebo tablets and found that LOMUCIN was
well tolerated
in the study. Levitt, MD, Chief Executive Officer. The CPF will also be introducing
its new Fundraising
Tool Kit for patients, families and friends who want to
help raise much-needed funds for IPF research
, patient support and education. The kit will provide organizations
and individuals the opportunity
to make a difference in the lives of IPF
patients by offering ideas and guiding them through the
process of organizing
their own fundraising events and initiatives, while at the same time raising
awareness of IPF in their local communities. Approximately 83,000 Americans suffer from IPF, and
there is currently no known cause or cure. For more information,
please visit www.yourman antibiotics
cff.
About Genaera Corporation
Genaera Corporation is a biopharmaceutical company committed to
developing
medicines to address substantial unmet medical needs in major pharmaceutical
markets
.com
About ZLB Behring
ZLB Behring is a global leader in the plasma protein
biotherapeutics
industry.battled waiting
Third Annual National IPF Awareness Week To Be Held Sept.C.
For additional information
about National IPF Awareness Week 2005
activities, or to contribute to CPF-sponsored fundraising
events, visit
http://www. Dedicated to improving the quality of life
for patients throughout the
world, ZLB Behring provides safe and
effective plasma-derived and recombinant products and offers
patients
a wide range of related services.triplets transplant
About the Cystic Fibrosis Foundation and CFFT
The Cystic Fibrosis Foundation, in Bethesda, Md. For more information, visit http://www.coalitionforpf
. An estimated 31,000 new cases are
diagnosed each year.coalitionforpf. The
deficiency can be
detected by a relatively simple blood test, with the
diagnosis confirmed by a physician.ZLBBehring
.com
lungs crista
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