Data from Patrys' PAT-SM6 Phase I/IIa trial in multiple myeloma to be presented at ASH Annual Meeting

Patrys LimitedNov 29 2013

Patrys Limited (ASX:PAB), a clinical stage biotechnology company has announced that updated results from its PAT-SM6 Phase I/IIa clinical trial in multiple myeloma (MM) will be presented at the 55^th American Society of Hematology (ASH) Annual Meeting in New Orleans, LA on 7- 10 December 2013.

To date eleven out of a total of twelve patients are currently available for response evaluation, including two out of three from the 4^th and final treatment group. The 12^th patient is not yet evaluable. This final group received four doses of PAT-SM6 at 6mg/kg/dose as per the protocol. To date, four out of eleven of the patients (36%) with end-stage, multi-resistant MM have shown evidence of stable disease according to the International Myeloma Working Group criteria.

The eleven patients (9 male and 2 female, median age 71 years) had, on average, received five prior lines of therapy including autologous stem cell transplantation and other novel marketed compounds including Velcade and Revlimid. Therapeutic options for such patients are usually limited to clinical trials and their median overall survival is around nine months.

All of the eleven evaluable patients tolerated PAT-SM6 very well. There were no drug-related serious adverse events and no dose-limiting toxicities.

These updated results will be presented by lead clinical investigator Dr. Leo Rasche from the Department of Haematology and Oncology, University Hospital of Würzburg. His presentation is titled "A monoclonal IgM antibody with specificity to heat shock protein GRP78/BIP shows anti-myeloma activity in vitro and in vivo, synergy in combination with Lenalidomide and safety in a pilot Phase I study".

"Our trial with PAT-SM6 has produced some very exciting clinical data and it is particularly encouraging to see four patients, with end-stage multiple myeloma, respond so positively to treatment with this novel antibody," commented Patrys' CEO, Dr. Marie Roskrow. "These clinical data, in conjunction with an extensive preclinical package, have positioned our lead product, PAT-SM6, for the next clinical trial to be sponsored by Onyx Pharmaceuticals, a subsidiary of Amgen".