Patrys cleared for multiple myeloma trial

Patrys (ASX:PAB) has received the required approvals for a German clinical trial of anti-tumour antibody PAT-SM6 in multiple myeloma.

The phase I/IIb trial will now take place at the University Hospital of Würzburg, starting in the fourth quarter.

Most of the 12 patients to be enrolled in the trial will have failed currently marketed cancer drugs and have a very poor prognosis, Patrys said.

Patients will be split into four dosing groups, and receive at least two cycles of treatment. Additional cycles will be offered to patients showing a response to the treatment.

The primary objective is to evaluate the safety and tolerability of PAT-SM6 in increasing doses, while the secondary endpoint is efficacy.

Multiple myeloma is a form of bone marrow cancer arising from plasma cells. Around 200,000 cases have been diagnosed worldwide. Existing chemotherapeutic treatments for the condition often lose effectiveness as patients build up a resistance.

The German study will be Patrys' second clinical trial for PAT-SM6. The first, a phase I safety and tolerability trial in melanoma patients, 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.

Patrys this month closed a $2.5 million capital raising to help fund the German trial, as well as outlicensing activities for lead compound PAT-SC1 as a gastric cancer treatment and clinical development of a third candidate PAT-LM1.

In August, the company reported a 31.2% reduction in its net loss for FY12, thanks largely to decreased R&D expenses as it shifts focus from pre-clinical development to the clinical trial stage.

Patrys (ASX:PAB) shares were trading 25% higher at 2.5c by 2pm on Thursday.