18 January 2013 | News | By BioSpectrum Bureau
Good news for multiple myeloma patients - Patrys gets nod to progress clinical trials to second patient group
Singapore: Patrys, a clinical stage biopharmaceutical company, received approval to progress its phase I/IIa PAT-SM6 multiple myeloma trial based on safety data from its first group of patients. The first group of three patients was treated in the Department of Haematology and Oncology, University Hospital of WÃ¼rzburg, Germany. Each patient in this group received four doses of Patrys' lead antibody PAT-SM6, at a dose level of 0.3 mg/kg.
No significant adverse events were reported. Accordingly, the independent board monitoring the trial has given approval for the trial to progress to the second patient group. Full data from this first cohort will be available in the first quarter of 2013. The recruitment of the second group of three patients has commenced. Each of the patients in the second group will initially receive four doses of PAT-SM6, at a dose level of 1 mg/kg.
Professor Max Topp and Dr Leo Rasche, both from the University Hospital of WÃ¼rzburg, are responsible for recruiting and treating patients in the trial. The specialist clinic is headed by Professor Dr Hermann Einsele, who is also a member of the Medical Advisory Board for the European Network of Myeloma Patient Groups, a non-profit network organisation of multiple myeloma patient groups dedicated to raising the awareness of multiple myeloma.
The trial is an open-label multi dose escalation trial in relapsed and multi-resistant patients with multiple myeloma who have failed all currently marketed drugs and have a very poor prognosis.
Initially, 12 patients will be enrolled in four dosing groups and will receive a minimum of two cycles (four doses) of treatment. If a patient shows a partial response to treatment with PAT-SM6 an additional cycle (two doses) of treatment will be offered. The primary objective of the study is to
evaluate the safety and tolerability of escalating doses of PAT-SM6 and the secondary objective is to measure efficacy as determined by a series of well-established laboratory assays.