Patrys (ASX: PAB) has received approval to progress its multiple myeloma – bone marrow cancer - drug PAT-SM6 to its fourth and final group of patients after no adverse events were reported from the third patient group.
The three patients in the third group had received four doses of PAT-SM6 at a dose level of 3 mg per kilogram.
This led the Department of Haematology and Oncology, University Hospital of Würzburg in Germany – the independent board monitoring the trial – to approve the trail to progress to the fourth and final patient group.
Recruitment of this fourth group of three patients has commenced. These patients will initially receive four doses of PAT-SM6 at a dose level of 6 mg/kg, which is twice the amount received by the patients in the third cohort.
This is also more in line with dosing levels of other antibodies currently on the market.
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.
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.
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.
PAT-SM6
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.
Notably, it has shown strong promise towards treating multiple myeloma, a type of bone marrow cancer arising from plasma cells that is estimated to affect 200,000 people worldwide.
The five-year survival of multiple myeloma patients is about 30%.
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.