Patrys (ASX: PAB) has received full regulatory approval from the Paul Ehrlich Institut in Germany to begin its planned Phase I/IIa multiple myeloma trial of the company’s lead product PAT-SM6, marking a significant milestone for the company.
The trial is scheduled to begin in the December quarter of 2012 at University Hospital in Würzburg.
PAT-SM6 is an anti-tumour antibody that has shown promise as a potential treatment for multiple types of cancer including melanoma and multiple myeloma.
Multiple myeloma is a type of bone marrow cancer arising from plasma cells, for which new therapies are needed to treat patients who become resistant to established chemotherapeutics.
There is an estimated 200,000 cases of myeloma worldwide with only 40% of patients surviving over five years.
The multiple myeloma market is currently dominated by three major products – Revlimid, Velcade and Thalidomide – with combined net sales greater than US$3 Billion in 2010.
The planned trial will be an open-label multi dose escalation trial in relapsed and multi-resistant patients.
Twelve patients will be enrolled in four dosing groups and will receive a minimum of two cycles of treatment, with additional cycles of treatment offered if a patient shows a partial response.
The patients in the Phase I/IIa trial 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, while the secondary objective is to measure efficacy as determined by a series of well-established laboratory assays.
A trial in patients with this disease is attractive from a development perspective as it is possible to determine very quickly whether the product is working by assessing routine blood counts and bone marrow samples.
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.
The company has successfully completed a Phase I clinical trial to evaluate PAT-SM6 as a therapy for melanoma.
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