CALGARY, Nov. 30 /PRNewswire-FirstCall/ -- Patch International Inc. (PAII: OTCBB, PQG: Berlin Bremen Stock Exchange) reported that Pharmaxis (PXS: Australian Stock Exchange) has announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). The IND is the first formal step in conducting a US clinical trial which will support a marketing application for Aridol in the USA in 2005. Patch holds 11.2 million shares in Pharmaxis and is the company’s second largest shareholder behind the Rothschild Group.
The Phase III clinical trial will be conducted over ten sites in the US and will recruit 130 subjects. The objective of the trial is to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of Asthma.
Asthma is a public health problem affecting over 20 million people in the USA. The diagnosis and management of asthma is most commonly based on observation of symptoms. New tools are needed that can reduce the cost of asthma on healthcare systems and improve patient well being. In the USA, asthma cost the healthcare system $15 billion last year and 4,500 people died from the condition.
The trial will be conducted in accordance with the International Committee of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).
Aridol is a patented, inhalable, dry powder that can be administered using a convenient, hand-held device. The test does not require specialist equipment and can be performed in a general practitioner’s surgery. It is manufactured by Pharmaxis in the company’s TGA-approved facility.
ABOUT PHARMAXIS
Pharmaxis is a specialist pharmaceutical company committed to the research, development, and commercialization of human therapeutic products for chronic respiratory and autoimmune diseases.
Pharmaxis is focused on the development of its two leading technologies. The first technology includes Bronchitol(TM) and Aridol(TM), which are inhaled non-ionic osmolytes. Bronchitol(TM) is being developed for the treatment of respiratory diseases -- in particular, cystic fibrosis, bronchiectasis, and chronic bronchitis. Aridol(TM) is an improved lung function test and is currently in a 600 subject multicentre Phase III study and over 250 subjects have been enrolled to date.
The second technology focuses on new immune response modifiers -- PXS25 and PXS2000 -- for the treatment of multiple sclerosis and rheumatoid arthritis. The company has a pipeline of products in different stages of development, including four projects at clinical study stage (in patients), two projects in pre-clinical evaluation, and one research project to identify a compound for development.
Pharmaxis operates a first class, TGA-licensed manufacturing facility at Frenchs Forest, near Sydney, Australia.
Pharmaxis was founded in 1998 and is chaired by Denis Hanley, former Chairman and CEO of Memtec Limited. He has extensive experience in growing Australian technology corporations to become successful global entities.
Pharmaxis was listed on the Australian Stock Exchange in November 2003. For additional information on Pharmaxis, please visit the corporate website at http://www.pharmaxis.com.au/.
ABOUT PATCH INTERNATIONAL
Patch International was a private corporation acquired by publicly traded Praxis Pharmaceuticals early this year. Patch trades under the symbol PAII. It is also listed on the Berlin Bremen Stock Exchange where it trades under the symbol PQG.
In addition to its major investment interest in Pharmaxis (PXS: Australian Stock Exchange) where it is one of the largest shareholders, along with CIBC, HSBC, and the Rothschild Group, Patch is involved in oil and gas projects in Saskatchewan, Texas, and the East Corning area in Northern California.
For further information visit our corporate website at http://www.patchenergy.com/.
Contact: Investor Relations Tel: 604-688-2790 Fax: 604-688-5390 Email: info@patchenergy.com
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made on behalf of the Company. All such forward-looking statements are, by necessity, only estimates of future results and actual results achieved by Patch International Inc. may differ materially from these statements due to a number of factors. Patch International Inc. assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such statements. You should independently investigate and fully understand all risks before you make investment decisions.
Patch International Inc.
CONTACT: Investor Relations, Tel: (604) 688-2790, Fax: (604) 688-5390,Email: info@patchenergy.com
