Patrys (ASX: PAB) has completed the treatment of patients in the Phase I trial of its PAT-SM6 anti-cancer antibody for the treatment of melanoma with the highest dose levels shown to be safe.
Importantly, the company has met its primary endpoint for the trial which was to establish safety and tolerability of the drug, and no significant safety issues were observed or reported for any of the patients treated.
PAT-SM6 is a natural human antibody that has shown promise as a potential treatment for multiple types of cancer including melanoma.
It is the first reported clinical product to target an important protein on the surface of cancer cells called GRP78 that plays a number of key roles in cancer cell survival, growth and metastasis.
The secondary objective of the Phase I trial was to examine multiple secondary endpoints aimed at measuring the antitumour activity of PAT-SM6. Patrys expects the full trial data to be available by the end of March.
In August 2011, the company reported that analysis of tumour samples from two patients treated with PAT-SM6 found that the antibody had penetrated into the tumour biopsies, even though the doses were substantially below the anticipated therapeutic levels.
Patrys will now move forward with the planning of its next PAT-SM6 clinical trial for patients with the blood cancer, multiple myeloma.
A Phase I/IIa open-label, multi dose escalation trial in relapsed and multi-resistant patients is planned to be undertaken at the University of Würzburg Phase I/II unit in Germany.
The initiation of this trial follows on from preclinical studies that have shown that PAT-SM6 is able to specifically target bone marrow cells sourced from multiple myeloma patients, with either advanced or refractory disease, confirming the presence of the target on these cells.
In addition, treatment of primary multiple myeloma cells isolated from patients or cancer cells lines with PAT-SM6 caused significant cell death in all samples tested.
The study is expected to begin in April and take around 12 months to complete.