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Pharmaceutical company Pharmaxis (ASX: PXS) today announced that it has enrolled the first subject in its international clinical trial evaluating Bronchitol® in adults with cystic fibrosis (CF303).

The Phase 3 trial is being conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain approval for Bronchitol (mannitol) to treat cystic fibrosis in the United States. As guided by the FDA, the clinical study protocol closely follows the design of the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302).  The trial is a 26 week randomised, double-blind parallel group investigation of Bronchitol administered twice daily in patients with cystic fibrosis.  The trial will enroll between 350 and 440 cystic fibrosis patients aged 18 years and older, and will assess improvements in lung function, pulmonary exacerbations and safety.

Pharmaceutical development company Pharmaxis today announced that a positive new data analysis from its large scale study of Bronchitol in patients with bronchiectasis (B305) is being presented at the European Respiratory Society (ERS) meeting taking place in Germany from 6-10 September 2014.

The late breaking abstract, to be presented in a thematic poster session by Dr Anthony de Soyza, Honorary Consultant Physician and Senior Lecturer in Respiratory Medicine at Newcastle University UK, examined a higher risk subgroup from the trial who, despite best standard of care, continued to suffer breathlessness even at rest and frequent exacerbation.

In this subgroup analysis of patients from the clinical trial who were at higher risk of further exacerbations, Bronchitol demonstrated both clinically important and significant improvements in exacerbation rate, antibiotic use and total SGRQ* scores on top of existing best standard of care over a 12 month period. The authors concluded the post-hoc findings suggest a greater effect from Bronchitol in higher risk patients than observed in the broader non-CF bronchiectasis population studied.

Pharmaceutical development company Pharmaxis today announced that it has completed preclinical development of its Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor (PXS4728A) and is ready to commence human clinical phase I studies in Q1 2015.

The SSAO/VAP-1 enzyme contributes to various forms of chronic inflammation in humans and is a marker for disease severity in conditions such as atherosclerosis, liver and kidney inflammation. Pharmaxis will focus the clinical development on inflammatory diseases with high unmet clinical need including Chronic Obstructive Pulmonary Disease (COPD) and Non-Alcoholic Steatohepatitis (NASH).