PharmAust gets approval for clinical study

THE ROADHOUSE PHARMACY: PharmAust Limited (ASX: PAA) has received approval from the Royal Adelaide Hospital Governance Committee to begin evaluation of proprietary drug PPL-1 in a Phase I/II clinical trial in man.

This is the final approval required to commence this trial following the earlier approval of the trial from the Royal Adelaide Hospital Ethics Committee.

Following a site initiation visit, PharmAust expects Professor Michael Brown and the team at the Royal Adelaide Hospital will start screening patients for entry into this important clinical trial in coming weeks.

The clinical trial at the Royal Adelaide Hospital will examine PPL-1 in a variety of late stage cancers, potentially including the major cancers such as lung, pancreas, oesophageal, gastric, colorectal, ovarian, breast, prostate, liver, sarcoma, lymphoma, and melanoma. In addition to measuring safety and pharmacokinetics of PPL-1, the trial will determine changes in various cancer markers.

Furthermore, the patient tumours will be biopsied where possible and also studied with the aid of a CT-PET scanner. The study will look at increasing doses of PPL-1 in cohorts of patients with each dose being administered daily for a period of 28 days.

“Pharmaust’s scientific and clinical team, has managed to take a new potential anticancer agent from the bench to approval of ‘first-in-man’ trial within 10 months,” PharmAust executive chairman Dr Roger Aston said in the company’s announcement to the Australian Securities Exchange.

“We are grateful and acknowledge NewSouth Innovations in this discovery and their continued support of the work emanating from the St George Hospital.

“The trial is the culmination of many years of research and development in the laboratory of Professor David Morris.”

Website: www.pharmaust.com.au