Progen completes PG545 second patient cohort assessment

THE ROADHOUSE PHARMACY: Progen Pharmaceuticals (ASX: PGL) has completed assessment of the second patient cohort in the company’s PG545 Phase 1 clinical trial.

Progen said it had, in conjunction with with an independent medical monitor and the co-ordinating investigators, reviewed the safety data from this cohort and all involved have agreed to progress to the next dose level of PG545.

The company explained each patient in the second cohort received once-weekly 50mg doses of PG545.

No dose limiting toxicities were reported from the group following at least four weeks of treatment.

The recruitment of the third cohort of three patients has commenced.

Each of the patients in the third group will receive 100mg doses of PG545 at once-weekly intervals.

The study is entitled ‘an open-label, multi-centre Phase I study of the safety and tolerability of IV infused PG545 in patients with advanced solid tumours’, and is expected to enrol approximately 25 advanced cancer patients.

The primary objective of the study is the determination of the maximum tolerated dose
(MTD) as defined by significant dose limiting toxicity (DLT).

The secondary objectives are:

Assessment of the safety and tolerability of PG545 following multiple doses in subjects with advanced solid malignancies;

To estimate pharmacokinetic parameters of PG545 and explore pharmacokinetic/pharmacodynamic relationships; and

To document any anti-tumour activity observed with PG545.

The clinical trial is being carried out at three sites in Australia.

Website: www.progen-pharma.com