News

For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.

26th Mar 19

US FDA Convenes Advisory Committee to Advise on Use of Bronchitol

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced the US Food and Drug Administration (FDA) will convene a Pulmonary-Allergy Drugs Advisory Committee (PADAC) on 8 May 2019 (US time) to make recommendations on the use of Bronchitol® for adult cystic fibrosis patients in the United States.

The Bronchitol New Drug Application was resubmitted to the FDA in December 2018 by Pharmaxis licensee, Chiesi Group (Chiesi) who are responsible for the regulatory approval process. Pharmaxis is supporting Chiesi in its preparations for the PADAC meeting.

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25th Feb 19

Boehringer Ingelheim Completes Enrollment of Phase 2a Clinical Trial of Pharmaxis Developed Drug in NASH

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced completion of enrollment in Boehringer Ingelheim’s Phase 2a clinical trial in patients with non-alcoholic steatohepatitis (NASH). The trial is assessing BI 1467335 (formerly known as PXS-4728A), an oral inhibitor of amine oxidase, copper containing 3 (AOC3), that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH. BI 1467335 was acquired from Pharmaxis in May 2015 and is also in an ongoing Boehringer Ingelheim Phase 2a clinical trial for diabetic retinopathy.

The Phase 2a NASH trial is a multi-centre, double-blind design in 114 patients with clinical evidence of NASH. The trial is being conducted in nine countries across North America and Europe. The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335. Patients have been randomized to either one of four dosages of BI 1467335 or to placebo for a 12-week treatment period followed by a 4-week observation period. The trial is expected to report in the second half of 2019. A subsequent Phase 2b study will seek to confirm and extend these findings.

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22nd Feb 19

Pharmaxis Commences Phase 1 Clinical Trial of Compound Targeting Pancreatic Cancer

Pharmaceutical research company Pharmaxis (ASX: PXS) today announced dosing of the first subject in its Phase 1 clinical trial of an anti-fibrotic Lysyl Oxidase (LOX) inhibitor focused on treating pancreatic cancer.

The double-blind placebo controlled study will consist of two stages. The first single ascending dose stage will be conducted in 40 healthy subjects divided into five groups with each taking a different single dose or placebo.  The second multiple ascending dose stage will be conducted in 16 healthy subjects divided into two groups with each group receiving a different dose or placebo for 7 days. The clinical trial is due to report in June 2019.

The program compound is an oral once-a-day drug that inhibits all lysyl oxidase family members (LOX, LOXL1, 2, 3 & 4). The compound successfully cleared pre-clinical safety and toxicity studies in the third quarter of 2018 and has shown significant reductions in fibrosis in in-vivo models of kidney fibrosis, lung fibrosis, myelofibrosis and pancreatic cancer. It is suited to the treatment of severe fibrosis as well as cancer with prominent stroma (connective tissue) or fibrotic metastatic niches. Pharmaxis plans to initially develop the compound for pancreatic cancer.

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