Melbourne, Australia; 7 November, 2012: Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company, is pleased to announce that it has enrolled the first patient in its Phase I/IIa PAT-SM6 multiple myeloma trial.
The trial is an open-label multi dose escalation trial in relapsed and multi-resistant patients with multiple myeloma who have typically 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 of treatment. If a patient shows a partial response to treatment with PAT-SM6 an additional cycle 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. Initial data should be available in the first quarter 2013.
Multiple myeloma is a cancer of the plasma cells in bone marrow. This disease is characterised by too many malignant (cancerous) plasma cells being produced. This leads to bone disease, anaemia, kidney problems, reduced immunity and infections. With a five year survival rate of approximately 30%, multiple myeloma remains largely incurable. New therapies are desperately needed to treat patients with this disorder.
The trial is being conducted in the Department of Haematology and Oncology, University Hospital of Würzburg, Germany. This 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. In addition to Professor Einsele, Professor Max Topp and Dr. Leo Rasche are responsible for recruiting and treating patients in the Patrys clinical trial.
Dr. Rasche said: “We are very excited to have commenced this clinical trial, following the successful preclinical studies that were conducted here in Würzburg. In our clinic we see many patients who have unfortunately relapsed on all currently-available therapies and so we are very enthusiastic to enrol patients into the Patrys trial as quickly as possible.”
Patrys CEO, Dr. Marie Roskrow, added: “We are delighted to have enrolled the first multiple myeloma patient into our clinical trial and we look forward to recruiting additional patients into this trial as soon as possible.”
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 at www.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$3 Billion in 2010.