Patrys posts strong results from myeloma trial


By Dylan Bushell-Embling
Thursday, 27 March, 2014


Patrys posts strong results from myeloma trial

Patrys (ASX:PAB) has announced promising final results from a phase I/IIa trial of drug candidate PAT-SM6 in patients with refractory and relapsed multiple myeloma.

The study met its primary endpoint of demonstrating safety and tolerability, with PAT-SM6 proving to be well tolerated at each dose level tested - 0.3, 1, 3 and 6 mg/kg. No significant adverse events or dose-limiting toxicities were reported.

In addition, four of the 12 treated patients showed evidence of stable disease, based on the International Myeloma Working Group criteria. Of these, two patients showed stable disease for more than 130 days.

Specifically, a patient receiving 3 mg/kg doses was stable for 138 days before additional therapy was needed, and one receiving the highest dose has been stable for 154 days and counting.

Patients treated with PAT-SM6 had a mean time to next therapy of 51 days.

The open-label trial assessed the effect of four intravenous PAT-SM6 doses, after which patients were assessed for a response at 36 days post final treatment. On average, each patient had undergone five prior lines of therapy prior to the trial.

The data also include indications that PAT-SM6 may work synergistically with other cancer drugs. Patients who had received prior treatment with proteasome inhibitors, such as Amgen’s Carfilzomib, responded far better to PAT-SM6 than patients treated with immunomodulatory drugs or other chemotherapeutics.

And of the 11 patients going on to additional salvage therapy, seven displayed a partial response and three responded with stable disease. This suggests that PAT-SM6 may make cancer cells more sensitive to other chemotherapy drugs.

Patrys’s next clinical trial for PAT-SM6 will involve using the treatment in combination with Carfilzomib and will test the synergy hypothesis.

“Due to very high rates of relapse, the combination of multiple agents is increasingly becoming the therapy of choice for multiple myeloma,” Patrys CEO Dr Marie Roskrow said. “Therefore, the results of this trial strongly support further evaluation in PAT-SM6 in combination with Carfilzomib.”

Patrys (ASX:PAB) shares were trading unchanged at $0.045 as of around 1 pm on Thursday.

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