10 Apr 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Patrys completed initial treatment of second group of three patients in its phase I/IIa PAT-SM6 multiple myeloma trial. The group 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 1.0 mg/kg.
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 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.
Dr Rasche said, "Here in Würzburg we are excited to have completed the initial dosing for the second cohort of patients in this clinical trial. All of the patients we treated have very advanced and rapidly progressing disease and we are delighted that one of them has shown stabilisation of his disease. In such resistant patients, this is a significant observation."
Patrys CEO, Dr Marie Roskrow, added, "We continue to observe excellent safety and tolerability in all of the patients that we have treated to date. In addition, we are now observing definite signs of immunological responses in these patients indicating that PAT-SM6 is binding to the tumour cells and stimulating the immune system. We are very encouraged by what we are observing and are looking forward to treating the next cohort of patients as soon as possible."
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.