Australia-based biotechnology firm Patrys will present the updated results from its PAT-SM6 Phase I/IIa clinical trial in multiple myeloma (MM) at the 55th American Society of Hematology (ASH) Annual Meeting.
The event will be held 7-10 December 2013 in New Orleans, Louisiana, US.
So far, 11 out of a total of 12 patients are currently available for response evaluation, including two out of three from the fourth and final treatment group, while the 12th patient is not yet evaluable.
The final group were given four doses of PAT-SM6 at 6mg/kg/dose as per the protocol, under which four out of 11 patients (36%) with end-stage, multi-resistant MM have shown evidence of stable disease according to the International Myeloma Working Group criteria.
The nine male and two female patients, with a median age of 71 years, were given five prior lines of therapy including autologous stem cell transplantation and other novel compounds such as Velcade and Revlimid.
Patrys said that therapeutic options for such patients are usually limited to clinical trials and their median overall survival is around nine months.
The trial showed that all of the 11 evaluable patients tolerated PAT-SM6 very well and no drug-related serious adverse events or dose-limiting toxicities were reported.
University Hospital of Würzburg Department of Haematology and Oncology lead clinical investigator Leo Rasche will present the updated results of the trial under a presentation 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’.
Patrys CEO Marie Roskrow said: "This 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."