Sunday 13 January 2013

Patrys given nod to advance bone marrow cancer trial

Patrys (ASX: PAB) is progressing its Phase I/IIa PAT-SM6 multiple myeloma trial in Germany after receiving positive safety data from the first group of patients.

The company has received approval from the independent board monitoring the trial to move to begin treatment of the second group of patients after no significant adverse events were reported from the first group.

Multiple myeloma is a cancer of the plasma cells in bone marrow, with the disease characterised by too many malignant (cancerous) plasma cells being produced.

The first group of three patients was treated in the Department of Haematology and Oncology, University Hospital of Würzburg, Germany, with each patient receiving four doses of Patrys’ lead antibody PAT-SM6, at a dose level of 0.3mg/kg.

Full data from this first cohort will be available in the March quarter of 2013.

The recruitment services of the second group of three patients has already begun, and each of the patients will initially receive four doses of PAT-SM6 at a dose level of 1mg/kg.

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, 12 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 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.


Expanding trial

Late last year Patrys received approval to begin the planned Phase I/IIa multiple myeloma trial of its lead anti-cancer product PAT-SM6 in Australia, expanding on earlier approval in Germany.

Approval has been received from the Alfred Hospital Ethics Committee, and the addition of the Australian site will provide Patrys with the option to accelerate patient recruitment rather than relying on a single site.


Growing target market


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.

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.

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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