Patrys cleared to extend myeloma trial

Patrys (ASX:PAB) has won ethics approval for an Australian leg of a phase I/IIa trial of anti-cancer candidate PAB-SM6 in multiple myeloma.

The ethics committee of Victoria's Alfred Hospital has approved the trial design, meaning Patrys can now conduct the trial across two sites.

The company revealed in September that it had won regulatory approval to commence the trial at the University Hospital of Würzburg.

Patrys CEO Dr Marie Roskwrow said adding an Australian site will give the company the chance to accelerate patient recruitment instead of being forced to rely on a single site.

“The approval...gives Patrys additional confidence that we will be able to recruit patients in a timely manner,” she said. “As the trial is an open-label multi-dose escalation study we will be able to release data on an ongoing basis. Initial data should be available in 1Q13.”

Patrys intends to enrol 12 patients in the trial, primarily those who have failed currently marketed cancer drugs and have a very poor prognosis.

The principal investigator for the Australian arm of the trial is Professor Andrew Spencer, head of Alfred Hospital's Malignant Haematology and Stem Cell Transplantation Service.

Spencer is a noted authority on myeloma – he also serves on the scientific advisory boards of the International Myeloma Foundation, the International Myeloma Working Group and the European Myeloma Network.

This study follows a phase I safety and tolerability trial in melanoma patients which wrapped up early this year.

Published results from the trial show that no patients demonstrated significant adverse effects during infusion, following dosing or at one-month follow up. One subject also showed increased cancer cell death following dosing at phase I levels.

PAB-SM6 is a natural human antibody with anti-cancer properties. While multiple myeloma and melanoma are the initial targets, it has potential applications across a range of tumour types.

Patrys (ASX:PAB) shares were trading 23% higher at 3.7c as of 3.20pm on Thursday.