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). 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.
List of
Templeton Audios follows. on Thursday, March 31, President of Jewish Life
Network/Steinhardt Foundation
, Irving "Yitz" Greenberg, will continue
public discussion about changes in Judaism in recent decades
.
abnormal rivas
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. 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
. In North America alone, approximately 200,000 new cases of
wet AMD are diagnosed each year.sec. 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., who serves as president
of Templeton Foundation Press and the
John Templeton Foundation. Koenig, M.
Greenberg is President
Emeritus and Cofounder of The National Center
for Learning and Leadership (CLAL).abnormal hypothesis
"We look forward
to
confirming these results by demonstrating a statistically significant clinical
benefit in these
upcoming large scale registration trials of EVIZON. 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.95, 6 CDs)
Running time:
approximately 6 hours, 59 minutes
ISBN: 1-932031-87-1
Read by: John Mucci and Len Stea
Category:
Spirituality and Health
A practical and inspiring self-help manual that creates a purpose-filled
life.
Wisdom from World Religions: Pathways toward Heaven on Earth by Sir John
Templeton
($29.synchronicities reincarnation
Although the wet form
of AMD accounts for only 10% to 15% of all AMD, the chance for severe
sight
loss is much greater., M. Emmons and Joanna
Hill, Introduction by Brother David Steindl
-Rast ($12.
One of the leading U. pulpit rabbis, Schulweis has a legacy of
scholarship, creativity
, community development and spiritual
expression that has enriched the lives of Jews and non-Jews
alike. Hartman is a leading thinker among philosophers of
contemporary Judaism and an internationally
renowned Jewish author.godhood yitzchak
Levitt,
MD, President and Chief Executive Officer of Genaera. 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. and
Canada).S.theosophy spiritualist
"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. Levitt.
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.
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. Approximately 25
to 30 million people are affected globally and
this number is expected to
triple over the next 25 years. Templeton,
Jr.
Purpose and Power
in Retirement: New Opportunities for Meaning and
Significance by
Harold G.
($14. The Institute
's inaugural
symposium begins Wednesday, March 30 at 7:30 p.
featuring Rabbi David Ellenson, President
of Hebrew Union
College-Jewish Institute of Religion.synchronicities obvious
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 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. "Formatting our books as CDs brings their
messages
to an even wider audience. Opening the series
is renowned author, philosopher and lecturer, Harold
S.m.Reincarnation category deals with the belief in a soul that survives death of a body and is reborn
in another.
godhood overal
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."
The two identical international Phase III studies are designed to enroll
patients with predominantly
classic, minimally classic and occult forms of wet
AMD. 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.95, 2 CDs)
Running time: approximately
1 hour, 16 minutes
ISBN: 1-932031-80-4
Read by: Frank Jacoby
Category: Inspirational
Seventeen
investment principles that guided Sir John Templeton's legendary
business career, each coupled with
a related spiritual principle that
reflects the interplay between the two. Koenig,
M.
pierrakos abnormal
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.95, 1 CD
)
Running time: approximately 1 hour, 7 minutes
ISBN: 1-932031-79-0
Read by: John Matthew
and Lisa Friedman
Category: Inspirational
Time-tested words of wisdom about gratitude from
various religious
traditions and authors, combined with narrative off the authors'
observations
, including Dr.
Spirituality in Patient Care: Why, How, When, and What by Harold G.95)
Running
time: TBD
ISBN: 1-932031-84-7
Read by: TBD
Category: Spirituality and Philosophy
Sir
John issues a challenge to apply the same energy that has been devoted
to scientific inquiry to the
pursuit of spiritual information, noting that
the benefits of extending spiritual knowledge might
exceed the benefits we
have realized thus far from scientific and medical advances. To
recognize
the potential for goodness in the face of the Holocaust, he
established the Jewish Foundation for
the Righteous.cayce broch
Enrollment in this trial is closed. 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.
AMD occurs in two types: the "dry" form and the more severe "wet" form. Now, wherever
and whenever people
listen to audio books, they'll have the option of listening to, as well as
reading
, our books that extend the dialogue between science and religion,
promote ethical values and the
development of character, and encourage a
humble approach in all of life's endeavors.
Please see contact information at end of release.95, 2 CDs)
Running time: approximately 1
hour, 20 minutes
ISBN: 1-932031-78-2
Read by: George Saris and Bea Brannon
Category: Inspirational
A guide on how to discover your calling, finding fulfillment that comes
from dedicating your
life to something beyond the narrow interests of self,
and why it is so important to do so. Koenig
with Gregg Lewis ($14. Harold Koenig, showing how his
personal trials became the catalyst for his
pioneering research.D.
overal parapsychology
Wet AMD is caused by the growth of abnormal blood vessels, or choroidal
neovascularization, under the central part of the retina, the macula. Forward-looking statements
reflect management's current views and are based on certain expectations and
assumptions.
Templeton Audios are available to the media for review upon request.
The inspirational titles
available in February 2005 as Templeton Audios
are:
Golden Nuggets by Sir John Templeton
($12.pierrakos disseminates
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.m.rivas synchronicities
, Genaera
Corporation (Nasdaq: GENR) today announced that it has reached agreement
on a
Special Protocol Assessment (SPA) with the U. 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. 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).
For information
about participation in EVIZON clinical trials, patients
and physicians may call Genaera's Clinical
Trial Hotline at (800) 299-9156.
You are encouraged to read these reports.
Words of Gratitude
for Mind, Body, and Soul by Robert A. Emmons' clinical research on the subject.D. Ellenson is a distinguished
rabbi, scholar, and leader of the Reform Movement, internationally
recognized for his publications
and research in the areas of Jewish
religious thought, ethics, and modern Jewish history.rebirth pierrakos
, Vancouver
, Canada)
treatment in 45 patients with wet AMD. Enrollment in this trial
is closed.
Templeton
Audio, an audio imprint of
Templeton Foundation Press, will be launched February 14, 2005 with ten
titles in the categories of inspiration, spirituality and health, and works
by Sir John Templeton
.S.95, 6
CDs)
Running time: approximately 6 hours, 13 minutes
ISBN: 1-932031-85-5
Read
by: John Matthew and Lisa Friedman
Category: Spirituality and Health
This is a remarkable
personal story of Dr.
Religion Writers/Assignment Desks
REMINDER.
LOS ANGELES----To
honor and
celebrate the achievements of Rabbi Harold M. The celebration will culminate with a Gala
Dinner on
Sunday, April 3, 2005.m.cayce rebirth
About AMD
Wet AMD resulting from angiogenesis
is the leading cause of legal
blindness among adults age 50 or older in the Western world.
"Our mission at Templeton Foundation Press is to publish and promote books
that increase the awareness
of the role of spirituality in our daily
lives," explains Joanna Hill, director of Templeton Foundation
Press and
manager of Templeton Audio.S.
Noble Purpose: The Joy of Living a Meaningful Life
by William Damon,
Introduction by David G.abnormal yitzchak
Genaera Completes Special Protocol Assessment with FDA
for EVIZON(TM) in Age-Related Macular Degeneration
"The SPA is an important
milestone in our
aggressive clinical development plans for EVIZON and
solidifies our regulatory pathway towards FDA
approval. EVIZON(TM) (squalamine lactate) is
Genaera's lead product in development for ophthalmic
indications, specifically
"wet" age-related macular degeneration (AMD). 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. They
will be on
sale in bookstores; through the Templeton Foundation Press website,
www.REMINDER/Institute
Established to Honor Rabbi Harold M. Schulweis; Eminent Rabbis to Assemble at Inaugural Symposium to
Celebrate Schulweis Accomplishments and
spiritualist numeric
Specifically, this study will evaluate
the safety and effects
of systemically administered EVIZON before and after
PDT with Visudyne. At the end
of 48 weeks
of therapy, each patient will be followed for a further 12 months.PRESS RELEASE Templeton Foundation
Press Announces Audio Versions of Its Books
templetonpress.
The Sir John Templeton audio books
available in April 2005 are:
Possibilities for Over One Hundredfold More Spiritual Information:
The
Humble Approach in Theology and Science by Sir John Templeton ($14.95)
Running time: TBD
ISBN: 1-932031-83-9
Read by: TBD
Category: Religion
Two hundred weekly sessions of study
that include teachings from Judaism,
Christianity, Buddhism, Hinduism, Islam, Jainism, Confucianism
, Taoism,
Sikhism, Zen, and Zoroastrianism, selected for their ability to uplift the
mind and contribute
to the growth of wisdom and a peaceful heart. His
influence in the last half century continues to
be seen in counseling
and support innovations, welcoming gay and lesbians into the
synagogue,
and moving the Jewish community to action on critical
global social issues.transmigration rivas
With this SPA in hand
we are ready to begin our registration trials in the very near future. Dry AMD,
or the avascular
form is the more common and milder form of AMD, accounting
for 85% to 90% of all cases.
The audio books are read by a variety of professionals. Schulweis and mark the
establishment
of the Harold M. Most recently, via the Jewish World Watch
program, numerous congregations all over
the world have joined VBS in
responding to the Darfur crisis.
numeric karmic
-Phase
III to Begin in June 2005-
PLYMOUTH MEETING, Pa."
Other Ongoing Clinical Trials
Genaera is currently conducting three Phase II trials of EVIZON in wet AMD
at multiple sites
throughout the United States. In January 2005, the FDA selected
EVIZON for participation in the Continuous
Marketing Application (CMA) Pilot 2
program.
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. Securities and Exchange Commission, all of which are available
from
the Commission in its EDGAR database at http://www. 773-702-7000 and fax 773-702-7212 (outside
U. Myers ($12. Rabbi
Laureate of Temple Israel in Natick, Massachusetts, his books include
the
best-seller "When Bad Things Happen to Good People," "How Good Do
We Have to Be?" and "Who Needs
God.pierrakos godhood
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.
About Genaera
Genaera Corporation is a biopharmaceutical company committed
to developing
medicines to address substantial unmet medical needs in major pharmaceutical
markets
. His commentary includes a brief description of
the content of the particular book, along with pertinent
anecdotes about
his father, Sir John Templeton, now in his 90s and still deeply interested
in
and involved with these books.org; and by calling 800-621-2736 or faxing 800-621-8476
(U. and Canada
); tel. ($14. It includes an overview of current social trends, debunks retirement
myths, and contents
that successful retirement results from identifying a
higher purpose in life that leads to emotional
fulfillment.
Rabbis Harold Kushner, David Hartman, Irving "Yitz" Greenberg and
David Ellenson
are slated to participate in lectures and public
conversations.hypothesis numeric
Photodynamic therapy (PDT) will be
allowed for all patients if deemed necessary by the study physician.
"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."
Templeton Foundation Press
Each Templeton
Audio book has a special introduction by John M.
Spiritual Investments: Wall Street Wisdom from
the Career of Sir John
Templeton by Gary Moore; read by Gary Moore ($12..."
At 7:30 p.yitzchak spiritualist
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. Dry AMD results in varying forms
of sight loss
and may or may not eventually develop into the wet form. It is responsible for 90%
of severe vision loss
associated with 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.S.D.95, 1 CD)
Running time: approximately 45
minutes
ISBN: 1-932031-81-2
Read by: Len Stea
Category: Inspirational
A collection of
sayings and practical, uplifting advice based on a lifetime
of experience, designed to inspire and
motivate those seeking deeper
meaning in life.
Spirituality and Health audios available in
March 2005 include:
The Healing Connection: The Story of a Physician's Search for the Link
between
Faith and Health by Harold G.
Friday, April 1, evening services at VBS will begin at 8:15 p. This
belief is common to many cultures and listings engage the reader in exploring and studying these beliefs
.
hypothesis alphabets
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.gov as well as other sources.
Why Are We Created? Increasing
Our Understanding of Humanity's Purpose on
Earth by Sir John Templeton and Rebekah Alezander Dunlap
($14.95)
Running time: TBD
ISBN: 1-932031-82-0
Read by: Bea Brannon
Category: Personal
growth
Thought-provocative questions designed to help people live happier and more
useful
lives by becoming more aware of the spiritual principles that
operate in the universe and putting
them into daily practice."
Beginning March 30, 2005, this gathering of great modern Jewish
rabbinic
leaders will be moderated by VBS Rabbi Edward Feinstein.
Serving as a library and as a source of
scholarship, education and
creative arts, the newly created Institute will preserve, expand and
share
Schulweis' remarkable legacy.numeric rivas
The Company has four products in development for the treatment of
eye
, cancer and respiratory disorders. 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.
Included
are Koenig's findings on the impact of faith on mental and physical health
and the realization
that religious faith and practice are connected to
mental and physical health.95, 4 CDs)
Running
time: approximately 3 hours, 30 minutes
ISBN: 1-932031-86-3
Read by: George Saris
Category:
Spirituality and Health
A guide for healthcare professionals, helping them identify and address
the
spiritual needs of their patients so they can treat the whole person; it
includes clear definitions
of religious coping, spiritual assessments,
transference and counter-transference, and boundaries
to care. His egalitarian
efforts to include women in Jewish religious services, his pioneering
NAACP
membership, and his work in the mid-60's in the Haight-Ashbury
district of San Francisco marked the
beginning of his efforts to evoke
social, religious and cultural change throughout the world. Kushner
. Remarks will also be heard from
Professor Rabbi David Hartman, Founder and Director of the Shalom
Hartman Institute.ginsburgh yitzchak
S. Schulweis Institute, Temple Valley Beth
Shalom (VBS) of Encino is hosting
"A Conversation of the Learned.godhood obvious
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