, Renovis, Inc.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning
of the Private Securities
Litigation Reform Act of 1995 that involve
substantial risks and uncertainties. Various important
factors could cause actual results or
events to differ materially from the forward-looking statements
that we make,
including risks related to: our heavy dependence on the success of CEROVIVE
(NXY
-059), which is still under development; our dependence on our strategic
collaboration with AstraZeneca;
AstraZeneca's success in obtaining regulatory
approval to market CEROVIVE (NXY-059); our ability
to successfully develop
other product candidates, such as REN-1654 and REN-850; obtaining, maintaining
and protecting the intellectual property incorporated into our product
candidates; and our ability
to obtain additional funding to support our
business activities. This scale assesses neurological
impairment, providing a measure of the severity of the stroke and was
developed
specifically for use in acute stroke trials. A defective gene
causes the body to produce an abnormally
thick, sticky mucus that
clogs the lungs, leading to life-threatening lung infections, and
obstructs
the pancreas, causing difficulty absorbing food. (CFFT) is the
non-profit drug discovery and development
affiliate of the Cystic
Fibrosis Foundation.
benefactors ansley
038), as measured by the Modified Rankin Scale (MRS)
., has a proposed mechanism of action of free radical trapping.com. All statements, other than statements
of
historical facts, included in this press release regarding our strategy,
future operations
, future financial position, future revenues, projected
costs, prospects, plans and objectives of
management are forward-looking
statements.
"We have been extremely impressed with Predix's drug
discovery and
development track record," stated Robert J. "We are
excited about applying our drug
discovery and optimization technology
to the CFTR and P2Y(2) targets for the benefit of patients
with cystic
fibrosis.
Plaintiffs were unaware of alleged side effects in which a drop in blood
pressure restricts the flow of oxygenated blood to the optic nerve causing
irreversible vision
loss and blindness.encephalopathy cortical
----March 16,
2005--Predix Pharmaceuticals Holdings Inc. Once these sites are
identified,
Predix expects to use its computational drug discovery capabilities to
discover a
drug that restores proper functioning to the channel in
patients with CF.
"Our technology has
enabled us to advance two compounds from
discovery into the clinic in less than two years," commented
Chen
Schor, chief business officer of Predix Pharmaceuticals.Class Action Claims Viagra Causes Blindness
kristi nathalie
Cystic Fibrosis Foundation Therapeutics and Predix Pharmaceuticals Announce Drug Discovery Collaboration
to Treat Cystic Fibrosis
Established
in 2000, Cystic Fibrosis Foundation Therapeutics, Inc.kristi naudikah
"These data represent a real achievement in the development of
neuroprotective agents for stroke
," said Corey S. The median
life expectancy has improved from early childhood to the mid-30s
today
, but many individuals battle lung disease for years. "This agreement will enable us
to work with
a cutting-edge company to focus on promising research to
model the CFTR protein and identify disease
targets.
ansley cerebral
These and other risks are described in greater detail in
the "Risk Factors
" section of our Annual Report on Form 10-K, which was filed
with the Securities and Exchange Commission
on March 28, 2005.cortical menard
(Nasdaq: RNVS) announced today that a first analysis of data from the Phase
III
SAINT I trial involving more than 1,700 patients conducted by its
licensee, AstraZeneca (NYSE: AZN
), shows a statistically significant reduction
versus placebo on the primary outcome of disability
after an acute ischemic
stroke (p= 0. However,
on the National Institute of Health Stroke Scale
(NIHSS), there was no
significant difference in measurement of change in neurological impairment
between the treatment groups. The independent data
safety monitoring board recently conducted
a planned safety review on the
first 200 patients and recommended the trial to proceed according
to plan. Beall, Ph., president
and CEO of the CF Foundation and CFFT. P2Y(2) receptor agonists
should
help expel chloride from cells using a channel that bypasses
the CFTR defect. Over the past two years
, the company has discovered
several novel drug candidates, two of which are in human clinical
trials
.mikolaj hypoxic
SAINT II and CHANT trials for CEROVIVE will continue as planned
SOUTH SAN FRANCISCO
, Calif. The incidence and profile of adverse events was similar to
placebo.
About Renovis
Renovis is a biopharmaceutical company developing drugs to treat
neurological diseases and
disorders.renovis. For
more information on CF, the CF Foundation or CFFT, call (800) FIGHT CF
or
visit www. For
more information on Predix, please visit www.com
cp micah
Tomas Odergren,
Global
Product Director for CEROVIVE (NXY-059) at AstraZeneca said, "We are
encouraged by these data and
what this could mean for stroke patients, as
acute ischemic stroke is a condition for which an effective
and well tolerated
treatment is urgently needed. These countries and regions
include: Europe
, Asia, Australia, New Zealand, South Africa, United States,
Canada and Latin America.
(CFFT),
the drug discovery and development affiliate of the Cystic
Fibrosis Foundation, announced today that
they have signed a research,
development and commercialization agreement., co-founder and chief scientific
officer of
Predix stated, "This agreement is a perfect fit for Predix
strategically and enables
us to use our proven technology and
discovery capabilities to help people battling this critical
life-threatening disease. HOUSTON, On June 6, 2005, a class action lawsuit
was filed by the
law offices of Ronnie Penton and Greg Jones + Associates on
behalf of Texas residents against Pfizer
on NAION (Non-Arteritic Anterior
Ischemic Optic Neuropathy) allegedly caused by Viagra (Sildenafil
).hie dewees
All other product names and marks are or may be trademarks or
registered trademarks used to identify
products or services of their
respective owners.
Contacts:
INVESTORS:
MEDIA:
Renovis, Inc. Predix has completed three Phase I trials and initiated
a
Phase II trial with PRX-00023, a 5-HT1A receptor agonist for
depression and anxiety, as well
as initiated a Phase I trial with
PRX-03140, a 5-HT4 agonist for Alzheimer's disease and other cognitive
disorders.microcephaly micah
+ BETHESDA, Md.D.encephalopathy amerongen
Additionally, the CHANT (Cerebral Hemorrhagic And NXY-059 Treatment
) trial
will continue as planned.
It is being studied as a neuroprotectant in clinical trials based
on effects
seen in experimental models of acute ischemic stroke.poe@eurorscg.
Business Editors
/Health Editors
BIOWIRE2K
WOBURN, Mass. A mutation in the CFTR gene is one of the
key factors
that ultimately leads to the symptoms, complications and
premature mortality in people with CF.
"Every day several people who have suffered blindness while taking Viagra
are signing up at http:
//www.kristi mikolaj
Renovis Announces that First Results from SAINT I Trial Show CEROVIVE (NXY-059) Demonstrated a
Statistically Significant Reduction in Disability in Patients wi
CHANT is a double-blind, randomized
, placebo-
controlled, parallel group, multi-center, Phase IIb study being conducted by
AstraZeneca
to assess the safety and tolerability of CEROVIVE (NXY-059) in
adult patients with acute intracerebral
hemorrhage.
For additional information about the company, please visit
http://www. We do
not assume any obligation to update any forward-looking
statements. It is a simple measure of
independence primarily used in the rehabilitation phases of stroke."
Oren Becker, Ph. A third
clinical candidate, a novel 5-HT2B antagonist for
pulmonary hypertension and other hypoxia-associated
diseases, is
expected to enter the clinic in the first half of 2005.menard hypoxic
AstraZeneca plans to file regulatory
submissions in
the second half of 2006. We congratulate the development team at AstraZeneca for
their
exceptional work and on the importance of their contribution to the treatment
of acute ischemic
stroke, a condition for which there are very few safe and
effective treatment options currently available
. Our research and development programs
focus on major medical needs in the areas of neuroprotection
, pain and
neuroinflammatory diseases. Actual results or events could differ materially
from the
plans, intentions and expectations disclosed in the forward-looking
statements we make.D. Predix
will use its proprietary PREDICT(TM) technology to model the structure
of this ion channel and
use the information to identify sites in the
channel for therapeutic intervention.
softley kristi
Cystic fibrosis
(CF) is a genetic disease affecting approximately
30,000 children and adults in the United States
.cff.softley dewees
Such filings for CEROVIVE will be dependent on the
final data package, including results from
SAINT II and CHANT.
The trial will involve approximately 150 centers in 21 countries. Our most advanced
product candidate,
CEROVIVE(R) (NXY-059), is in Phase III clinical trials for acute ischemic
stroke
with our exclusive licensee, AstraZeneca AB. We may not actually achieve these plans, intentions or
expectations and Renovis cautions investors not to place undue reliance on our
forward-looking
statements.
Notes to Editors:
* Modified Rankin Scale (MRS): the most commonly
used global disability
scale for assessing stroke patients. Noonan Russo
John C.nathalie micah
"CEROVIVE (NXY-059) is the first
neuroprotectant treatment for acute ischemic stroke
to show a statistically
significant reduction of disability in a pivotal trial of the size and scope
of SAINT I. However, the full potential of CEROVIVE will
only be clear after completion of the
clinical development program., has a proposed mechanism of
action of free radical trapping. The first
program is
focused on the defective Cystic Fibrosis Transmembrane conductance
Regulator (CFTR
) protein.
The second program will use Predix's PREDICT(TM) technology,
featuring its three-dimensional
G-protein coupled receptor (GPCR)
modeling and optimization capability, to discover a small-molecule
agonist to P2Y(2) to treat the disease.hypoxic menard
The clinical significance of these findings
need to be
assessed in light of the outcome of SAINT II and CHANT."
Commenting on the preliminary data from
SAINT I, Dr. The safety of patients included in the trials is
being evaluated continually. We are
independently
developing REN-1654, an oral drug candidate for neuropathic pain in a Phase II
clinical
trial for sciatica and REN-850, an oral drug candidate for multiple
sclerosis in a Phase I clinical
trial.
* National Institute of Health Stroke Scale (NIHSS): provides a
quantitative
assessment of the neurological examination findings that
are most relevant to stroke patients
."
The award funds two research programs. Successful release of chloride would help restore the
proper
salt and water balance in the cells of people with CF. CFFT supports and governs activities related
to
CF drug discovery through the many stages of drug development and
clinical evaluation.com,
" says Scott Wurtele of Online
Legal Services Ltd.naudikah cortical
com
We look forward to working with
CFFT on both
the CFTR and P2Y(2) research programs.predixpharm.micah freebyrd
CEROVIVE (NXY-059) is
a registered trademark of the AstraZeneca group of
companies. We are confident
that collaborating
on these research programs will move us closer to
finding an effective therapy to restore function
to CF cells in
patients with cystic fibrosis. Predix
will retain the right to develop and commercialize
any compounds
discovered through this second research program.org
About Predix
Predix
is a privately held, clinical stage drug development
company that uses a proprietary discovery and
lead optimization
platform to focus on G-protein coupled receptor (GPCR) and ion channel
drug
targets.cortical mikolaj
CEROVIVE (NXY-059), an
investigational drug under development by AstraZeneca and licensed
from
Renovis, Inc.ischemic ansley
Goodman, Ph.D."
The SAINT trials for CEROVIVE (NXY-059) are being conducted
worldwide in
approximately 400 centers across 40 countries to evaluate the effect of the
compound
in acute ischemic stroke patients., a drug discovery and
development company, and Cystic Fibrosis
Foundation Therapeutics, Inc.lawyersandsettlements.softley menard
It is being studied as a neuroprotectant in
clinical
trials based on effects seen in experimental models of acute ischemic
stroke. Doyle
Emily Poe
(650) 266-1407 212-845-4266
emily. The company will receive
up to $12. The CF Foundation provides support to fund CFFT's
operations, specifically the Therapeutics
Development Program. Development
also will continue on the company's robust pre-clinical pipeline
.guillain microcephaly
Half of the trial's 1,700 patients were randomized to receive CEROVIVE(R)
(NXY-059).
The Phase III SAINT II trial will enable AstraZeneca to complete its
evaluation of the efficacy
and safety profile of CEROVIVE (NXY-059) in acute
ischemic stroke patients. Our forward-
looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions
, joint ventures or investments we may
make.This category is for personal sites of people who have
Cerebral Palsy.
dewees ansley
, President
and Chief Executive Officer of Renovis.
CEROVIVE (NXY-059), an
investigational drug under development by
AstraZeneca and licensed from Renovis, Inc.5 million in
milestone-driven funds over the next three
years through a therapeutics development award from CFFT
for two
programs. This defective channel has
impaired transport of sodium and chloride in and
out of the cells,
leading to thick, sticky mucus in the lungs and the pancreas."
About the
Cystic Fibrosis Foundation and CFFT
The mission of the Cystic Fibrosis Foundation is to assure
the
development of the means to cure and control cystic fibrosis (CF) and
to improve the quality
of life for those with the disease.kayla ansley
A community sponsored library.
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