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Phosphagenics Reports Superior Pre Clinical Cholesterol Results From APA 01 And Atorvastatin Combination
Phosphagenics
Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY)
announced results of a pre-clinical study demonstrating that the
combination of its APA- 01 product candidate and the statin atorvastatin
(Lipitor(TM)) significantly reduced serum lipids and inflammatory proteins
involved in the development of atherosclerosis.
Study Design
The purpose of the study was to determine whether a combination of the
statin drug atorvastatin and APA-01 could reduce serum lipids, inhibit
atherosclerotic lesion progression and reduce proinflammatory cytokines and
other biomarkers of inflammatory disease more effectively than the statin
alone.
Studies were performed in ApoE mice, animals that spontaneously form
atherosclerotic plaques and represent a well-established model of human
atherogenic hyperchosterolemia.
During the first 16-weeks of this 24-week study, all animals in the
experimental group were maintained on a standard diet, followed by an eight
week treatment period in which this diet was supplemented with 21% fat and
0.15% cholesterol, an atherogenic diet expected to accelerate
atherosclerotic progression. All animals in the experimental groups
received drug treatment in both their normal and high-fat diets at various
dosing regiments throughout the 24-week study. Control group animals
received no drug treatment and were maintained on either the same diet as
the treatment groups or on a standard diet.
Study Results
Effects on Serum Lipids
The study results indicated that among the animals treated with the
APA-01 and atorvastatin combination, total cholesterol levels fell by up to
an additional 12% compared to those animals treated with atorvastatin
alone. Total HDL-C (good cholesterol) levels increased by up to 37% in
combination drug-treated animals, while LDL-C (bad cholesterol) levels were
further reduced by up to 24% with the combination, as opposed to
atorvastatin alone. The combination also caused a decrease of 92% in
triglycerides levels compared to 72% with atorvastatin alone.
Effects on Biomarkers of Inflammation
APA-01, combined with atorvastatin, enhanced the statin's effects on
lowering inflammation that contributes to the development of
atherosclerotic plaques. Reductions occurred in final plasma levels of 23
cytokines that were measured. Following 24 weeks of treatment with various
doses of APA-01 and atorvastatin, a statistically significant reduction
occurred in a number of cytokines including IL-1B, IL-10, G-CSF, GM-CSF,
IFN-y, MCP-1, and RANTES compared to control and these decreases were
greater than with either compound alone and appeared to be somewhat
dose-dependent.
Effects on Atherosclerotic Plaque Progression
Atherosclerotic lesions were significantly elevated following
incorporation of the high-fat high-cholesterol diet in all animals compared
to animals maintained on the regular, rodent diet for the 24-week study
period. The effect of the combination treatment of APA-01 combined with
atorvastatin appeared to cause a trend toward decreased aortic lesions, but
these were not statistically significant.
Commenting on the study results, Dr. Esra Ogru, Executive Vice
President of Research and Development at Phosphagenics, said, "Current
therapies for atherosclerosis focus on drugs that lower serum cholesterol
levels. Experimental and clinical evidence suggests that the efficacy of
these drugs may also be related to their ability to reduce oxidative stress
and inflammation in the endothelium, or blood vessel lining, where
atherosclerotic plaques develop. We believe that APA-01's apparent
enhancement of a statin's anti-inflammatory functions could potentially
provide a novel therapeutic approach to treating atherosclerosis."
Atorvastatin is the world's largest selling drug with sales of US$13.6
billion annually and is the primary contributor to the US$35.2 billion
market for statin drugs globally.
"In particular there is an unmet need for a more effective treatment
for elevated triglycerides and APA-01 has demonstrated efficacy in this
area in this preclinical study. We are now assessing the impact of these
results before determining our future strategy. However, the insulin,
oxycodone and Phospha E(R) clinical programs will remain our priority for
this year," Dr. Ogru said.
About Atherosclerosis
Atherosclerosis, or the build-up of fatty deposits (plaques) on
interior blood vessel walls, is a progressive process initially involving
endothelial dysfunction and accumulation of lipids on the linings of blood
vessel. Atherosclerotic lesions develop as a result of inflammatory
stimuli, subsequent release of various cytokines, proliferation of smooth
muscle cells, synthesis of connective tissue matrix, and accumulation of
macrophages and lipids. Atherosclerosis is involved in the development of
coronary heart disease, myocardial infarction, and stroke, among other
diseases.
About Phosphagenics Limited
Phosphagenics is a Melbourne-based, globally driven biotechnology
company focused on the discovery of new and cost effective ways to enhance
the bioavailability, activity, safety and delivery of proven pharmaceutical
and nutraceutical products.
Phosphagenics' core technology is built around the science and
application of phosphorylation, a process where the addition of a phosphate
group has been found to enhance the bioavailability, activity and safety of
existing pharmaceuticals and nutraceuticals, as well as to assist in the
production of drug delivery platforms.
Phosphagenics' shares are listed on the Australian Stock Exchange (POH)
and the London Stock Exchange's Alternative Investment Market (PSG). An ADR
-- Level 1 program was established in the U.S. with The Bank of New York
Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the
'over-the- counter' market. In July 2007, this was upgraded to the
International OTCQX, a new premium market tier in the U.S. for
international exchange-listed companies, operated by Pink Sheets, LLC.
For more information, please visit Phosphagenics' web site at
http://www.phosphagenics.com.
Safe Harbor Statement
This press release contains forward-looking statements based on current
expectations of future events. If underlying assumptions prove inaccurate
or unknown risks or uncertainties materialise, actual results could vary
materially from the Phosphagenics' expectations and projections. Risks and
uncertainties include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate fluctuations;
technological advances and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and governmental laws
and regulations.
Phosphagenics Limited
http://www.phosphagenics.com
View drug information on Oxycodone and Aspirin.
Phosphagenics superior pre clinice, rapoarte de colesterol rezultate de la APA 01 ºi atorvastatina combinaþie - Phosphagenics Reports Superior Pre Clinical Cholesterol Results From APA 01 And Atorvastatin Combination - articole medicale engleza - startsanatate