Patrys Limited (PATZF.PK) Receives Australian Ethics Approval for Multiple Myeloma Trial
11/2/2012 3:07:47 PM
• Approval received from The Alfred Hospital Ethics Committee for Phase I/IIa multiple myeloma clinical trial
• Multiple myeloma trial to commence in fourth quarter 2012
• Initial data expected in the first quarter of 2013
Melbourne, Australia; 1 November, 2012: Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company, is pleased to announce that it 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 announced that it 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. Professor Spencer is Head of the Malignant Haematology & Stem Cell Transplantation Service at The Alfred Hospital, Melbourne; Professor of Haematology, Monash University; and, Head of the Myeloma Research Group at the Australian Centre for Blood Diseases, Melbourne. He is involved in both translational and early phase clinical research with particular interest in mechanisms of drug resistance and the development of novel therapeutic approaches for the treatment of haematological malignancies. Additionally, Professor Spencer 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, Patrys’ CEO said: “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.
Multiple myeloma is a cancer of the plasma cells in bone marrow. When a person develops this disease, too many malignant (cancerous) plasma cells are produced. This leads to bone disease, anaemia, kidney problems, reduced immunity and infections. With a five year survival rate of approximately 40%, multiple myeloma remains largely incurable. New therapies are desperately needed to treat patients with this disorder.
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For further information, please contact:
Patrys Limited: Patrys IR: Patrys Media:
Dr. Marie Roskrow Rebecca Wilson Shevaun Cooper
Chief Executive Officer Buchan Consulting Buchan Consulting
P: +61 3 9670 3273 P: 0417 382 391 P: +61 3 9866 4722
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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 40% (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.