SYDNEY, Australia, March 27 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS, Nasdaq: PXSL) today announced that Australian-made Aridol (mannitol) has been included as an approved test by the International Olympic Committee's independent Medical Commission.
The approval was contained in their just-released IOC Consensus Statement on Asthma in Elite Athletes, for athletes competing in the Beijing Olympics. The prevalence of asthma in elite athletes has grown exponentially in recent years, rising from 9% in 1988 to 21% of all athletes at the 2000 Sydney Olympics. The IOC Medical Commission found no evidence that the commonly used asthma treatments known as beta-2 agonists conferred any performance enhancing effect, but they were concerned that elite athletes were diagnosed correctly and received the most appropriate therapy.
In the Consensus Statement (excerpt overleaf), the Commission recommends that in diagnosing asthma in Olympians, a bronchial provocation test (such as Aridol) be used to establish the presence of airway hyperresponsiveness.
Aridol was developed by Australian pharmaceutical company Pharmaxis and has been approved in Australia, several European countries and in parts of Asia. Aridol is recommended in the World Anti-Doping Agency guidelines for testing athletes requesting to use asthma medication.
"Exercise-induced asthma can be a problem for elite athletes," said Pharmaxis CEO Dr Alan Robertson. "Long-term intense endurance training and environmental factors, such as allergens, chlorine derivatives, pollutants or cold air can increase the risk of developing exercise induced asthma.
A simple-to-use airways inflammation test, Aridol is a dry powder administered to patients' lungs via a small hand-held inhaler. Doctors can use the results of this test to identify airway hyperresponsiveness C a hallmark of asthma. Medications can be adjusted according to the severity of the disease. (see below for more detail of how Aridol works)
Dr Robertson said this latest international endorsement of Aridol reinforces the usefulness of the test in tackling asthma worldwide.
"We are pleased that Aridol is becoming globally recognised as a valuable test for identifying airway hyperresponsiveness," said Dr Robertson.
As well being included as one of the tests recommended by the IOC and
the World Anti-Doping Agency, Aridol is also included in the GINA Report of
Global Strategy for Asthma Management and Prevention, in the US Asthma
Management Guidelines and the Australian Asthma Management Handbook.
To find out more about Pharmaxis go to http://www.pharmaxis.com.au .
Excerpt From IOC Consensus Statement on Asthma in Elite Athletes
Diagnosis of asthma in elite athletes Respiratory symptoms such as recurrent breathlessness, cough, wheezing, chest tightness and excessive mucous production are common in athletes and may be suggestive of asthma. As these symptoms alone cannot be relied upon to make a diagnosis of asthma in an athlete and clinical examination may be normal, objective tests are required to confirm the diagnosis. These tests would include spirometry (Forced Expiratory Volume in one second FEV1). Because athletes may have an FEV1 above the normal range, normal spirometry does not exclude variable airway obstruction. If airway obstruction is present, spirometry should be repeated after inhalation of a bronchodilator to test for reversibility. In the absence of airflow limitation, a bronchial provocation test, to establish the presence of airway hyperresponsiveness, is required. If the results of these tests are negative other disorders should be considered.
Aridol is the first and only approved Europe-wide lung function test and the world's first approved indirect challenge test for asthma. The Aridol lung function test, developed by Australian researchers and Pharmaxis, helps doctors more accurately determine the severity of a patient's airways inflammation C a hallmark of asthma -and allow prescription of the right amount of medication. The simple 15-25 minute test uses powdered mannitol, which the patient inhales in increasing doses. In asthmatic patients, this causes the airways to narrow and contract, which is detected by measuring the amount of air a person can exhale in one second. The smaller the dose required to cause contraction, the more severe the patient's asthma. People without airway inflammation do not respond to an Aridol challenge test. Asthma affects 52 million people worldwide, many of whom may be receiving inappropriate medication because of the absence of an objective test - until now. Clinical trial results suggest that 25% of asthmatic patients are being treated with sub-optimal dosages of asthma medication, and up to 17% could reduce their medication without adverse effects.
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and autoimmune diseases. Its development pipeline of products include Aridol for the management of asthma, Bronchitol for bronchiectasis, cystic fibrosis, and chronic bronchitis and PXS64 for the treatment of multiple sclerosis. Founded in 1998, Pharmaxis is listed on the Australian Stock Exchange (symbol PXS), and on Nasdaq Global Market (symbol PXSL). The company is headquartered in Sydney at its TGA-approved manufacturing facilities. For more information about Pharmaxis, go to http://www.pharmaxis.com.au or contact Investor Relations on ph: +61-2-9454- 7200.
The statements contained in this media release that are not purely
historical are forward-looking statements within the meaning of Section 21E
of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this media release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or strategies,
including statements regarding the potential for Aridol and/or Bronchitol.
All forward-looking statements included in this media release are based
upon information available to us as of the date hereof, and we assume no
obligation to update any such forward-looking statement as a result of new
information, future events or otherwise. We cannot guarantee that any
product candidate will receive FDA or other regulatory approval or that we
will seek any such approval. Factors that could cause or contribute to such
differences include, but are not limited to, factors discussed in the "Risk
Factors and Other Uncertainties" section of our Form 20-F lodged with the
U.S. Securities and Exchange Commission.
For more information, please contact:
Chief Executive Officer
|SOURCE Pharmaxis Ltd|
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