Melbourne, Australia; 10 April, 2013: Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company, is pleased to announce that it has completed the initial treatment of the second group of patients in its Phase I/IIa PAT-SM6 multiple myeloma trial.
The second 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 1.0 mg/kg. To date, no significant safety issues have been observed or reported for any of the three patients treated.
Of significance was that one of the treated patients showed laboratory evidence of stable disease (day +35 post treatment) with a significant reduction in protein M levels in the peripheral blood. This patient had multi-resistance, refractory disease and, prior to inclusion into the trial, had rapidly rising protein M levels indicating progressive disease.
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, 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.
For further information, please contact:
Dr. Marie Roskrow
Chief Executive Officer
P: +61 3 9670 3273
P: 0417 382 391
P: +61 3 9866 4722
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibody therapies for cancer. More information can be found atwww.patrys.com.
The natural human antibody PAT-SM6 has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. More specifically, Patrys has now screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type or patient age, gender or disease stage. With respect to multiple myeloma PAT-SM6 has shown particularly strong promise. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target, and the mechanism of action. Patrys has successfully completed a Phase I clinical trial to evaluate PAT-SM6 as a therapy for melanoma.
About Multiple Myeloma:
Multiple myeloma is a type of bone marrow cancer arising from plasma cells, and new therapies are desperately needed to treat patients who become resistant to established chemotherapeutics. There is an estimated 200,000 cases worldwide and the incidence is increasing. The five-year survival of patients is approximately 30% (at 10 years ~20%). Despite new marketed therapies, multiple myeloma remains largely incurable and fatal. The multiple myeloma market is dominated by three major products: Revlimid, Velcade and Thalidomide with combined net sales greater than US$4.4 Billion in 2011.