10 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Patrys, an Australian clinical stage biopharmaceutical company, has completed the initial treatment of the first group of patients in its phase I/IIa PAT-SM6 multiple myeloma trial. The first group of three patients was treated in the Department of Haematology and Oncology, University Hospital of Würzburg, Germany.
Each patient in this group received four doses of Patrys' lead antibody PAT-SM6, at a dose level of 0.3 mg per kg. To date, no significant safety issues have been observed or reported for any of the three patients treated.
Professor Max Topp and Dr Leo Rasche, both from the University Hospital of Würzburg, are responsible for recruiting and treating patients in the trial. The specialist clinic is headed by 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, twelve 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. As the trial is an open-label multi-dose escalation study, data will be released on an ongoing basis.
Dr Rasche said, "We are very excited to have completed the initial dosing for the first cohort of patients in this clinical trial so quickly. As we unfortunately see many patients in our clinic who have relapsed on all currently-available therapies we are confident that we will be able to continue to recruit patients in a timely manner."
Patrys CEO Dr Marie Roskrow added, "We are delighted that our clinical investigators Professors Einsele and Topp and Dr Rasche are very enthusiastic about our clinical trial and have managed to complete the first cohort so quickly. We look forward to moving into the second cohort and releasing full data in respect of this first cohort as soon as possible."