PharmAust gets approval for PPL-1 Study in Man

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

The clinical trial will be undertaken by the Royal Adelaide Hospital in approximately 12 to 15 human patients suffering from 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, PharmAust said 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 company said the evaluation of PPL-1 is being undertaken in late stage cancer patients under the supervision of Professor Michael Brown (Principal Investigator).

All patients recruited in the trial will have failed ‘Standard of Care’ and will have been without treatment for at least two weeks.

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.

The recruitment of patients by the Royal Adelaide Hospital will begin as soon as Site Specific Assessments have been undertaken and Governance Approval received.

“This is a ‘First in Man’ study and we are excited about the prospects of evaluating PPL-1 in cancer patients,” PharmAust executive chairman Dr Roger Aston said in the company’s announcement to the Australian Securities Exchange.

“As a ‘First in Man’ rising dose pharmacokinetic evaluation, our priority is to show safety.

“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