7)
------------------------------------------------ ----
----- ---------
Death 1 (1.0) 17 (11.0) 10 (6.9) 3 (2
.0)
---------------------------------------------- --------- ---------
Pneumonia
1 (1.0)
---------------------------------------------- --------- --------
-
Viral infection 0 (0.S.
toothache indic
30) -0.0) 22 (14.0) 5 (3.7) 5 (3.0)
3 (2.3) 6 (4.3) 1 (0.7) 0 (0."
The AX-CL-06a clinical phase IIb study of Phenserine
's effects on
beta-amyloid is continuing.S. It can infect organs such as the kidneys, liver,
bones
, muscles, joints, spleen, or eyes.stuffy hufford
The top line outcome was
announced by the Company on February
7, 2005.63 (+/-0.7) 10 (6.3) 6 (4.7)
---------------------------------------------- ---
------ ---------
Depression 0 (0.0) 3 (2.
"Axonyx has halted
additional patient recruitment for the ongoing
phase III clinical trials in order to evaluate the
planned Phenserine
clinical development program," stated Gosse Bruinsma, M., President
and Chief
Executive Officer of Axonyx. Axonyx cannot assure that the
Phase IIb and/or other ongoing Phase III
clinical trials, amendments
thereto or others, if any, with Phenserine will prove successful, that
the safety and efficacy profile of Phenserine exhibited in the
previous small Phase II and Phase
III trials will remain the same, be
better or worse in future clinical trials, if any, that the
preclinical
results related to the regulation of beta-APP will be
substantiated by the Phenserine Phase IIb clinical
trial and that
Phenserine will be able to slow the progression of Alzheimer's
disease, that the
Phase IIb clinical trial data will differentiate
Phenserine from the currently marketed drugs, that
any efficacy and
safety results of the Phase III trial program, if pursued, will prove
pivotal
, that Axonyx will obtain the necessary financing to complete
the Phenserine or other development
programs, that the Company's
development work on Phenserine will support an NDA filing, that the
results of a Phase III program will allow Phenserine to be approved by
the FDA, that the FDA will
grant marketing approval for Phenserine,
that if Phenserine is approved by the FDA, it will prove
competitive
in the market, and that Axonyx will obtain licensing or corporate
partnership agreements
that will enable acceleration of the
development of and optimize marketing opportunities for, Phenserine
,
or that Axonyx will be able to advance any of its other potential
memory enhancing compounds
toward IND status.com
ailments 723
These additional results from the Company's Phase III trial will
be presented on Saturday, March 12, 2005 at the 7th International
Conference on Alzheimer's and
Parkinson's disease in Sorrento, Italy.5 (+/-0.0) 1.0) 0 (0.3) 12 (8.0)
----------------
------------------------------ --------- ---------
Anaemia 0 (0
.0) 1 (0.0) 0 (0.
About Axonyx
Axonyx Inc. Candidemia is the most deadly of the
common hospital-acquired
bloodstream infections, with a mortality rate of approximately 40 percent
. Eraxis has not been studied in
endocarditis, osteomyclitis, and meningitis due to Candida, and
has not been
studied in sufficient numbers of neutropenic patients (those with low white
blood
cell counts) to determine efficacy in this group.Merriam-Webster's Collegiate Dictionary defines folk
medicine as 'traditional medicine as practiced nonprofessionally especially by people isolated from
modern medical services and usually involving the use of plant-derived remedies on an empirical basis
'.
741 madrona
(NASDAQ:
AXYX) today reported additional detailed information from its first
Phase III clinical
trial with Phenserine (PT), in development for mild
to moderate Alzheimer's disease (AD).7)
-
----------------------------------- --------------- ---------------
(a)ITT= Intention to Treat Analysis
(end of study analysis)
Adverse events were monitored during the study and incidence rates
above
2% of the total number of patients are represented in the
following table:
Placebo PT 10mg PT 15mg
(n=76
) (n=150) (n=149)
------------------------------------------------ --------- ---------
Any Adverse Event 36 (47.3) 0 (0)
-------------------------------------
----------- --------- ---------
Serious Adverse Event 2 (2.0) 0 (0.0) 1 (0
.0) 8 (5.7) 2 (1.
The most common treatment-related adverse events for Eraxis in the candidemia
study included lower than normal levels of potassium in the blood (3.ailments hufford
13) 3.70 (+/-1.30)
---
--------------------------------- --------------- ---------------
ADCS- ADL -0.2 (
+/-0.0)
---------------------------------------------------- ------- -------
Pyrexia
0 (0.0) 2 (1.3)
----------------------------------------------
--------- ---------
UTI 1 (1.0) 3 (2.
This press
release may contain forward-looking statements or
predictions.ailments pliny
08)
---------------------------
--------- --------------- ---------------
Modified ADAS cog 0.80) -0.55 (+/-0.4) 95 (63
.0)
---------------------------------------------------- ------- -------
Cardiac Failure
0 (0.7)
---------------------------------------------------- -------
-------
Vomiting 0 (0.3)
---------------------------------
------------- --------- ---------
Pyrexia 1 (1.-based biopharmaceutical
company engaged in
the acquisition and development of proprietary pharmaceutical
compounds for
the treatment of Central Nervous System disorders.
Eraxis builds upon Pfizer's extraordinary
strength in medicines for the
treatment of infectious diseases, particularly antifungal treatments
. Information about Eraxis can also be found at
http://www. 1997;24:723-741, cited in Report 13 of
the Council on Scientific Affairs (A-97), American Medical Assocation)
toenail assocation
After being diagnosed with
probable AD, patients were randomized to
receive placebo, Phenserine 10mg twice daily or 15mg twice
daily, for
a period of 6 months.7) 0.4)
------------------------------------------------
--------- ---------
Drug-related Adverse Event 13 (17.0) 0 (0.0) 5 (3.0) 2
(1.7)
---------------------------------------------- --------- ---------
Bronchitis acute
0 (0.0) 5 (3.7)
---------------------------------------------- --------
- ---------
Oedema peripheral 0 (0. Joseph Feczko,
Pfizer's chief medical
officer. Pfizer's Vfend(R) (voriconazole), also a
product of innovative Pfizer research, is a treatment
for serious mold and
yeast infections.
Eraxis has not been associated with renal toxicity
, and has no clinically
relevant drug-to-drug interactions.remedies toothache
Although Phenserine
demonstrated trends
toward efficacy in the primary efficacy variables,
no statistically significant differences between
the efficacy of the
active and placebo groups were observed in areas of cognition, global
function
, behaviour, and activities of daily living.30 (+/-0.0)
------------------------------------ ---
------------ ---------------
NPI/10 -1.3) 2 (1.3) 15 (10.0)
--------------
-------------------------------- --------- ---------
Agitation 0
(0.
Eraxis is the only medicine that has demonstrated improved efficacy versus
fluconazole
in a pivotal clinical trial for the treatment of candidemia.
Important Safety Information
In clinical studies, Eraxis was as well tolerated as fluconazole and the
total number of drug
-related adverse events was comparable to fluconazole. Eraxis also does not require dose
adjustments
based on gender, race, age, HIV status, hepatic insufficiency or
renal insufficiency.cures soranus
The primary
efficacy parameters were the
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)
and the Clinical Interview Based Impression of Change with caregiver
input (CIBIC+).6) -0.3
) 4 (2.0)
---------------------------------------------- --------- ---------
Constipation
1 (1.3) 7 (4.
About Phenserine
Phenserine is a highly selective
acetylcholinesterase (AChE)
inhibitor that binds with an enzyme that is responsible for the
breakdown
of a neurotransmitter important in memory and cognition.
As stated by David J.
(Hufford DJ.
Primary
Care.
remedies 723
3) 3 (2.ailments stuffy
None of the active
treatment/placebo differences achieved statistical significance
.3) 0 (0.4)
---------------------------------------------- --------- ---------
Abdominal
pain upper 2 (2.7)
---------------------------------------------- --------- -
--------
Diarrhoea 0 (0.4)
--------------------------------------
-------- --------- ---------
Tachycardia 0 (0.0) 2 (1. Food and
Drug
Administration to treat candidemia, a potentially life-threatening bloodstream
infection
.
"In the clinical trial setting, patients taking Eraxis for the treatment
of candidemia had
improved efficacy versus those taking fluconazole, making
Eraxis an important addition to the options
in antifungal treatment," said Dr."
Eraxis, an antifungal medicine of the echinocandin class
, also was
approved by the FDA to treat two additional infections caused by the Candida
fungus
-peritonitis and intra-abdominal abscesses -- as well as esophageal
candidiasis, a fungal infection
of the esophagus. The bloodstream may then spread Candida
to organs and tissues throughout the body
, causing systemic candidiasis. It was also approved
for esophageal candidiasis, an infection of the
esophagus caused by Candida
(relapse rates post-therapy were higher for patients on Eraxis). Strongly
influenced by cultural norms and values, folk medicine generally comprises the 'unofficial' or 'lay
' health beliefs and practices found in all societies.
childrearing soranus
75) -0.75)
-------------------------------
----- --------------- ---------------
CIBIC+ 3.2) -0.
Unlike other AChE inhibitors
, which only suppress the activity of this
enzyme, Phenserine has been shown to have two mechanisms
of action:
(1) the inhibition of the AChE enzyme, and (2) in preclinical studies,
the inhibition
of the synthesis of A(beta), the protein in the brain
that is thought to be a cause of brain cell
death in Alzheimer's
disease.
Annette Reboli, head of the Division of Infectious Diseases at Cooper
University Hospital in Camden, New Jersey, and lead clinical investigator.
About Eraxis
Eraxis is an antifungal agent indicated for the treatment of candidemia
and two other Candida
infections, peritonitis (infection of the abdominal
cavity) and intra-abdominal abscesses.3%).hiccups antifungal
2
(+/-0.35 (+/-0.0)
------------------------------------------------ --------- ---------
Adverse
Event Leading to
Discontinuation 1 (1.7) 1 (0.1)
------------------
---------------------------- --------- ---------
Headache 0 (0.D
.
"In addition, Eraxis has been shown to have a safety profile comparable to
fluconazole and to
be compatible with many medicines commonly used by patients
with candidemia who have other serious
health complications. Both Diflucan and Vfend are azole-type antifungal
treatments.3%) and an increase
of GGT (a liver enzyme)
(1.soranus 723
45) -0.0) 1 (0.0)
----------------------------------------------
--------- ---------
Lymphopaenia 1 (1.3) 3 (2.3)
----------
------------------------------------ --------- ---------
RTI
0 (0.0) 3 (2. People with Weakened Immune Systems and Critically Ill Patients are Among
Those at High Risk for Candidemia Infection
Eraxis Builds on Pfizer
's Strength in Antifungal Medicines
NEW YORK, Pfizer Inc said today that
Eraxis(TM) (anidulafungin
) has been approved by the U. (Safety and effectiveness of Eraxis in pediatric patients
has not been
established. Possible histamine-mediated symptoms
have been reported infrequently with Eraxis, including
rash, urticaria,
flushing, pruritis, dyspnea, and hypotension.amare childrearing
55 (+/-0.73 (+/-0.0) -0.7 (+/-0.6
) 9 (6.3) 8 (5.7)
---------------------------------------------- --------- ---------
Vertigo 3 (3.6) 3 (2.0) 2 (1.0)
--------------------------
-------------------- --------- ---------
Insomnia 1 (1. "This decision
was taken
following recommendations from our Scientific Advisory Board and
Safety Steering Committee
, as well as the Company's desire to examine
opportunities that could optimise further Phenserine
development. "Physicians treating these seriously ill
patients now have an important new treatment
in Eraxis. In the
esophageal candidiasis study, the most common treatment-related adverse events
for Eraxis were headache (1.eraxisrx.madrona assocation
Mean Changes from Baseline in Study Endpoints
(+
/- 1 Standard Errors)(a)
Endpoint Placebo PT 10mg PT 15mg
------------------------------------ --------------- ---------------
Unmodified ADAS cog 0.0
) -0.5 (+/-0.0) 9 (6.7)
---------------------------------------------------- ------- ------
-
Urinary Tract Infection 0 (0.0) 2 (1.8)
------------------------------
---------------- --------- ---------
Vomiting 1 (1.6) 1 (0.3
) 3 (2."
Patients at high risk for candidemia and systemic candidiasis (Candida
infection
that spreads throughout the body) include those with compromised
immune systems, stem-cell and organ
-transplant recipients, patients on
chemotherapy, patients with catheters, critically ill patients
in intensive
care units, surgical patients and patients on prolonged antibiotic therapy.amare pascalite
The Phase
III trial involved 375 patients from 11 different
clinical sites in Austria, Croatia, Spain and the
United Kingdom.1 (+/-1.5)
------------------------------------------------ --------- ---------
The profile of the serious adverse events occurring in the trial
is represented in the following
table:
Placebo PT 10mg PT 15mg
(n=76) (n=150) (n=149)
-------------------------------------
--------------- ------- -------
Pneumonia 1 (1.0) 0 (0.stuffy pascalite
40
(+/-1.3) 86 (57.7)
---------------------------------------------------- ------- -------
Pulmonary
Congestion 0 (0.0) 1 (0.6) 6 (4.0)
----------------------------------
------------ --------- ---------
Dizziness 2 (2.4)
----------
------------------------------------ --------- ---------
Atrial fibrillation
2 (2.0)
---------------------------------------------- --------- ---------
The current
study indicates that Phenserine is generally well
tolerated in patients with probable AD patients
, with an adverse event
profile similar to that of currently marketed therapies. In
the U.S.
Systemic candidiasis is difficult to diagnose and can cause organ failure,
which may result in
death. Hufford, professor in the Department of Humanities at the Penn State College of Medicine:
Folk medicine is a form of complementary and alternative medicine that relies heavily (although not
exclusively) on oral tradition.
741 pascalite
Axonyx to Release Additional Results of Phase III Clinical Trial for
Phenserine in Alzheimer's Disease
Additional study endpoints included the Alzheimer's
Disease
Cooperative Study-Activities of Daily Living Scale (ADCS-ADL)
and the Neuropsychiatric Inventory
(NPI).35 (+/-1.0) 47 (31.0) 3 (2.0)
---------------------------------------------------- ----
--- -------
Gastrointestinal Upset 0 (0.0) 7 (4.3) 4 (2.0) 3 (2
.7)
---------------------------------------------- --------- ---------
Cardiac failure
1 (1.3) 4 (2. is a U., patients with candidemia on average spend an additional
10 days in
the hospital at an average increase in hospital charges of about $39,000 per
patient
.
Pfizer's Diflucan(R) (fluconazole) has been the longstanding gold standard
treatment for candidemia
and other fungal infections, especially opportunistic
infections in HIV/AIDS patients.)
Eraxis
is not approved for use in patients with hypersensitivity to
anidulafungin, any component of Eraxis
, or other echinocandin agents.ailments stuffy
82 (+/-0.1) 48 (32.3) 3 (2.3) 18 (12.3) 3 (2.0) 3 (2. "Bloodstream
infections such as candidemia can spread quickly and are very dangerous,
especially for patients
with weakened immune systems," said Dr.1%), and an increase in ALT (a liver enzyme) (2. In some
patients
with serious underlying medical conditions who were receiving
multiple concomitant medications along
with Eraxis, clinically significant
hepatic abnormalities have occurred.toenail assocation
In the United States
, candidemia affects approximately one in 5,000
people, resulting in an estimated 60,000 cases each
year.
Eraxis was added to the company's antifungal portfolio through the acquisition
of Vicuron
in September 2005.1%),
diarrhea (3.mehl toothache
10 (+/-0.7) 1 (0.3) 2 (1.
Esophageal candidiasis is
a fungal infection of the esophagus that is most
common among people with compromised immune systems
such as people with
HIV/AIDS.3%).
Health care providers can get more information about Eraxis
by calling
1-800-438-1985.remedies pliny
0) 1 (0.7) 1 (0.0) 2 (1.3) 3 (2. These statements represent our
judgment to date, and are
subject to risks and uncertainties that could materially affect the
Company
including those risks and uncertainties described in the
documents Axonyx files from time to time
with the SEC, specifically
Axonyx's annual report on Form 10-K.
Pfizer Receives FDA Approval
for Eraxis(TM) to Treat Candidemia a Potentially Life-Threatening Bloodstream Infection
About Candida Infections
Candidemia is a systemic fungal infection that occurs when Candida
organisms are present in the blood.colds 723
Business Editors/Health Editors
NEW YORK----Axonyx
Inc. Results for these efficacy
parameters are summarized in the following table.08) 3.50 (+/-1
.6)
------------------------------------ --------------- ---------------
NPI/Distress
-1.7)
---------------------------------------------------- ------- -------
Adverse Events
Occurring in Greater than 2% of Patients:
Placebo PT
10mg PT 15mg
(n=76) (n=150) (n=149)
------
---------------------------------------- --------- ---------
Nausea
1 (1.0) 0 (0. Axonyx undertakes no
obligation to publicly release the result of any revisions
to such
forward-looking statements that may be made to reflect events or
circumstances after the
date hereof or to reflect the occurrence of
unanticipated events. 'Folk medicine and health culture
in contemporary society'.
mehl 723
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