Patrys completes successful clinical trial
THE PHARMACY: Patrys Limited (ASX: PAB) has received final results from a Phase I/IIa, open-label study of PAT-SM6 in patients with refractory or relapsed multiple myeloma (MM).
Patrys explained the trial was conducted in 12 patients (10 male and 2 female, median age 71 years) with refractory or relapsed MM.
The primary endpoint of the study was safety and tolerability.
The company said at all dose levels tested, PAT-SM6 was well tolerated with no serious adverse events (SAEs) or dose limiting toxicities being reported. A maximal tolerated dose (MTD) was not reached.
Secondary endpoints were designed to measure efficacy as determined by a series of well-established laboratory assays.
Overall, 4/12 patients (33 per cent) treated with PAT-SM6 showed evidence of stable disease (SD) according to the International Myeloma Working Group (IMWG) criteria.
Patrys highlighted that patients treated with PAT-SM6 had a mean time to next therapy of 51 days which, it said is considered clinically significant.
Patients who had received prior treatment with proteasome inhibitors responded much better to PAT-SM6 treatment than patients who had been previously treated with IMIDs or other chemotherapeutics.
The company was excited by this saying it indicates PAT-SM6 may act synergistically with proteasome inhibitors (such as Carfilzomib) to induce better clinical responses.
This will be tested in Patrys’ next clinical trial in which PAT-SM6 will be used in combination with Amgen’s Carfilzomib.
“The trial results are especially exciting because they reflect single-agent activity in a difficult-to-treat population Patrys Limited CEO Dr. Marie Roskrow said in the company’s announcement to the Australian Securities Exchange.
“Due to very high rates of relapse, the combination of multiple agents is increasingly becoming a therapy of choice for patients with MM.
“Therefore, the results obtained in this trial strongly support further evaluation of PAT-SM6 in combination with Carfilzomib which is the basis of our planned Amgen sponsored clinical trial.”
Email: info@patrys.com
Website: www.patrys.com