05 Nov 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Patrys has received approval to commence its planned phase I/IIa multiple myeloma trial with lead anti-cancer product PAT-SM6 in Australia. On 20 September 2012, Patrys had received regulatory approval to commence the trial at the University Hospital, Würzburg in Germany.
The addition of the Australian site will provide Patrys with the option to accelerate patient recruitment rather than relying on a single site. Patrys intends to commence patient dosing at the German clinical site in the fourth quarter of 2012.
The principle investigator at the Australian site is Professor Andrew Spencer, head, malignant haematology and stem cell transplantation service, Alfred Hospital, Melbourne; professor of haematology, Monash University; and, head, myeloma research group, Australian Center for Blood Diseases, Melbourne. He also serves on the scientific advisory boards of the International Myeloma Foundation (IMF), the International Myeloma Working Group (IMWG) and the European Myeloma Network (EMN) and is presently President of the Haematology Society of Australia and New Zealand.
The planned trial will be an open-label multi dose escalation trial in relapsed and multi-resistant patients with multiple myeloma. Twelve patients will be enrolled in four dosing groups and will receive a minimum of two cycles of treatment. If a patient shows a partial response to treatment with PAT-SM6 an additional cycle of treatment will be offered.
Dr Marie Roskrow, CEO, Patrys, said that, "The approval to commence the trial at this second site gives Patrys additional confidence that we will be able to recruit patients in a timely manner. As the trial is an open-label multi dose escalation study we will be able to release data on an ongoing basis. Initial data should be available in the first quarter of 2013."
The patients in the phase I/IIa trial, which will commence in Germany initially, have typically failed all currently marketed drugs and have a very poor prognosis. 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.