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Company Highlights
- PXS25 Phase I trial complete
- Pharmaxis completes acquisition of Topigen Pharmaceuticals Inc.
- FDA Advisory Committee recommends approval of Aridol
- Sustained benefit with Bronchitol in Phase 3 cystic fibrosis trial
PXS25 Phase I trial complete tolerance and pharmacokinetic profile of PXS25 following intravenous administration.
The trial investigated five ascending doses of PXS25 in 40 subjects. At all doses, PXS25 was found to be safe and well tolerated with a pharmacokinetic profile consistent with a drug that could be delivered once per day.
Pharmaxis CEO Dr Alan Robertson, said "We have seen encouraging results from PXS25 in pre clinical testing that suggests it will be active in a range of fibrotic diseases. I am therefore delighted that, based on the results from this Phase I study, PXS25 fulfils many of
the other criteria we look for in a drug. I'd like to thank those involved in this study and we look forward to developing PXS25 further."
Additional Phase I trials will be completed before PXS25 is evaluated in patients with lung disease.
PXS25 is being developed as a potential new treatment for pulmonary fibrosis, which has a mortality rate that exceeds many cancers and affects over 5 million people worldwide.
Pharmaxis completes acquisition of Topigen Pharmaceuticals Inc.
Pharmaxis has completed the acquisition of Canadian based private biopharmaceutical company Topigen Pharmaceuticals Inc.
Pharmaxis issued 3.2 million shares on completion of the acquisition and an additional 5.0 million shares will be issued subject to the achievement of certain preclinical and clinical milestones specified in the purchase agreement.
The Topigen portfolio includes a number of innovative therapeutic candidates for respiratory disorders based on its multi-targeted oligonucleotide technology.
The lead drug candidate, TPI ASM8, is in Phase 2 clinical development for the management of moderate to severe asthma. A second drug candidate, TPI 1100, is in preclinical development for Chronic Obstructive Pulmonary Disease.
FDA Advisory Committee recommends approval of Aridol
The Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to recommend the approval of Aridol for use as a bronchial test to assess bronchial hyperresponsiveness to aid in diagnosing patients who have symptoms of asthma or symptoms that are suggestive of asthma.
The recommendation was made by the FDA's Pulmonary-Allergy Drugs Advisory Committee following a meeting on 20 November 2009.
"Pharmaxis is please that the committee has recognised the effectiveness and safety profile of Aridol" said Dr Alan Robertson "Today's discussion marks an important step in expanding the role of pulmonary function tests for patients suspected of having asthma and we look forward to working with the FDA to further address the points raised by the panel."
In making its decision, the Advisory Committee reviewed efficacy and safety data from two Phase 3 trials that were conducted in more than 1000 people.
The FDA often seeks the advice of its own advisory committees when evaluating potential new products but is not required to follow its recommendation. If approved, the FDA will determine final prescribing information. Pharmaxis filed and NDA for Aridol in March 2009 and the FDA is scheduled to advise the result of its review on 27 December 2009.
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Sustained benefit with Bronchitol in Phase 3 cystic fibrosis trial
Significant headline results have been announced for the second six-month dosing Phase 3 trial of Bronchitol in people with cystic fibrosis. The lung function of patients treated with Bronchitol for a full twelve months improved from 6.5% at six months to 8.0% (p<0.001) at the end of twelve months treatment. In addition, the lung function of patients who were on placebo for the first six months of the study improved by 10.3% (p<0.001) when switched to Bronchitol.
This clinical trial of Bronchitol was conducted in two phases. The first six month, placebo controlled blinded phase reported in May 2009 and met its primary endpoint by improving lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1) by a statistically significant 6.5% (p=0.003 versus placebo).
The second six month unblinded, non-placebo controlled phase was to determine the safety of Bronchitol in patients with cystic fibrosis following twelve months of treatment and to assess the long term effects on lung function. In addition, those patients who had been treated with placebo during the initial six-month blinded phase of the trial were switched to Bronchitol during the subsequent six month open phase.
Dr Alan Robertson, Pharmaxis Chief Executive Officer said: "These results are very impressive and are of significant clinical relevance. For cystic fibrosis patients, consistent loss of lung function, averaging 1-2% per year is the leading cause of death. The improvements now shown with Bronchitol treatment over a 12 month period hold out the promise that, with longer usage, Bronchitol can change the course of cystic fibrosis. Bronchitol is the first dry powder formulation to report results of this nature in CF and it offers convenience for patients who otherwise have to deal with complex daily treatment regimens. Many people have been involved in the development of Bronchitol and this result is a tribute to their dedication and effort."