Melbourne, Australia; 22 August, 2011: Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company, is pleased to provide an update on data collected from patients in its PAT-SM6 melanoma clinical trial currently being held at the Royal Adelaide Hospital.
The primary trial objective is to establish safety and tolerability. To date no safety issues have been observed or reported for any patients treated with PAT-SM6. The secondary trial objective is to examine multiple secondary endpoints aimed at measuring the anti-tumour activity of PAT-SM6.
Each patient had a biopsy of their melanoma tumour both before and after treatment with PAT-SM6. In preliminary results, the Company has found the presence of PAT-SM6 in post-treatment tumour biopsies taken from two different patients. These results indicate the strong utility of the therapy and potential for it to be an effective therapeutic for the treatment of melanoma.
“We are very excited to report the detection of the PAT-SM6 product in tumours taken from patients in both the first and second dose groups. At this stage trial doses are substantially below anticipated therapeutic levels and the detection of PAT-SM6 in tumours is thus very encouraging,” said Dr Marie Roskrow, Patrys’ Chief Executive Officer.
“In both cases, PAT-SM6 was detectable in biopsy samples taken post-treatment. Neither patient had any detectable PAT-SM6 in biopsies taken pre-treatment. In addition, tissue analysis to date is suggestive the PAT-SM6 leads to apoptosis (cell death) in biopsies collected.”
Under the trial design different dosages will be evaluated in patients with a particular form of the disease called “in-transit” melanoma. This cancer is limited to a single limb and has usually undergone multiple treatments prior to the PAT-SM6 trial.
By recruiting patients with in-transit disease, Patrys can collect tissue samples to study the effects of PAT-SM6 on the tumours, although in line with standard industry practice the primary aim of this study is to measure the safety and tolerability of the drug.
Patrys recently announced The Royal Adelaide Hospital is currently recruiting the third group of patients.