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Avicena Clarifies Description Of Creatine Versus PD-02, Company's Lead Drug Compound Used In NIH Phase III Clinical Trial In Parkinson's Disease
Avicena Group,
Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company focused
on commercializing its proprietary cellular energy modulation technology,
wishes to clarify the difference between its compound, PD-02, being used in
the Phase III Parkinson's disease trial announced on March 22, 2007, versus
a common (nutritional supplement) form of creatine.
PD-02, the Parkinson's disease drug candidate being used in this Phase
III clinical trial, is a unique creatine-based formulation that has been
manufactured to strict FDA drug GMP guidelines. PD-02 is produced using a
patented process that ensures a highly purified form of creatine without
the harmful neurotoxins, such as cyanamide, which may be dangerous to
patients with neurodegenerative diseases like Parkinson's. In addition,
only this GMP drug formulation has been shown to be safe and well tolerated
in high doses in previous clinical studies conducted by Karl Kieburtz,
M.D., M.P.H., of the University of Rochester in New York, the lead
investigator of this NINDS sponsored Parkinson's trial.
Dr. Kieburtz pointed out, "There is a critical distinction between the
pharmaceutical grade creatine formulation that is being used in this
Parkinson's disease trial and the creatine that may be sold
over-the-counter in retail stores. It is unwise for Parkinson's patients to
conclude that the common form of creatine has any clinical benefits, and I
recommend against using it."
"We go to great lengths to ensure that Avicena's Parkinson's disease
drug candidate, PD-02, is manufactured under the tightest FDA standards,"
stated Belinda Tsao-Nivaggioli, Avicena's Chief Executive Officer. "Only as
a result of these efforts, can the drug's purity as well as safety and
efficacy profile be guaranteed."
About the Trial
The double-blind, placebo-controlled, phase III study is one of the
largest PD clinical trials to date. It will enroll 1,720 people with early-
stage Parkinson's disease at fifty-one medical centers in the United States
and Canada. Participants in the phase III study will be evaluated on an
ongoing basis for five to seven years. The trial is the first large study
in a series of NINDS-sponsored clinical trials called NET-PD (NIH
Exploratory Trials in Parkinson's Disease). NINDS has organized this large
network of sites to allow researchers to work with Parkinson's patients
over a long period of time, with a goal of finding effective and lasting
treatments. The effort will be led by Karl Kieburtz, M.D., M.P.H., of the
University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the
Medical University of South Carolina in Charleston, and the patients will
be seen by movement disorders specialists at the NET-PD sites across the
United States and Canada.
ABOUT PARKINSON'S DISEASE
Parkinson's disease is a progressive, neurodegenerative brain disorder
that occurs when the neurons within the brain that are responsible for
producing the chemical dopamine die. Primary symptoms of the disease
include involuntary shaking of the arms or legs (tremors), difficulty with
balance, slowness of movement, and stiffness.
According to the Parkinson's Disease Foundation, roughly 1.5 million
Americans are affected by Parkinson's disease, making it the second most
common neurodegenerative disease after Alzheimer's disease. Approximately
60,000 new cases are diagnosed each year in the United States. There
presently is no known cure for Parkinson's disease.
ABOUT AVICENA
Avicena Group, Inc. (OTCBB: AVGO) is a late stage biotechnology company
focused on developing products based on its proprietary understanding of
the regulation of cellular energy processes. The company's core
technologies, supported by a robust IP portfolio, have broad applications
in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical
program centers on rare neurological disorders (orphan diseases). The
company is currently analyzing data from its Phase IIb/III trial in ALS
(Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). Near term,
Avicena intends to initiate a Phase III trial in Huntington's disease to
accompany the NIH sponsored Phase III trial in Parkinson's disease
described in this release. Avicena's science is well established and its
products are safe and well tolerated. Unlike traditional biotechnology
companies, Avicena's clinical programs are largely funded by government and
non-profit organizations. Avicena presently derives revenue from the sale
of proprietary ingredients to skin care.
SAFE HARBOR
This release may contain forward-looking statements within the meaning
of the federal securities laws. Such forward-looking statements reflect,
among other things, management's current expectations, plans and
strategies, and anticipated financial results, all of which are subject to
known and unknown risks, uncertainties and factors that may cause our
actual results to differ materially from those expressed or implied by
these forward-looking statements. Many of these risks are beyond our
ability to control or predict. See "Risk Factors" under "Item 6.
Management's Discussion and Analysis of Financial Condition and Results of
Operation" from our Annual Report on Form 10-KSB for the year ended
December 31, 2005, and other descriptions in the company's public filings
with the Securities and Exchange Commission for a discussion of such risks,
including the company's need for additional funds, the company's dependence
on a limited number of therapeutic compounds, the stage of the products the
company is developing, uncertainties relating to clinical trials and
regulatory reviews, competition and dependence on collaborative partners,
the company's ability to avoid infringement of the patent rights of others,
and the company's ability to obtain adequate patent protection and to
enforce these rights. Because of these risks, uncertainties and
assumptions, you should not place undue reliance on these forward-looking
statements. Furthermore, forward-looking statements speak only as of the
date they are made. Avicena does not undertake any obligation to update or
review any such forward-looking information, whether as a result of new
information, future events or otherwise.
Avicena Group, Inc.
http://www.avicenagroup.com/
Avicena clarificã descriere a creatin faþã de PD-02, societãþii de plumb de droguri nih compus utilizat în studiul clinic de fazã III, în boala Parkinson - Avicena Clarifies Description Of Creatine Versus PD-02, Company's Lead Drug Compound Used In NIH Phase III Clinical Trial In Parkinson's Disease - articole medicale engleza - startsanatate