Patrys multiple melanoma trial faces delays
Patrys (ASX:PAB) will likely have to delay a planned clinical trial of PAT-SM6 in multiple myeloma due to complications with the manufacturing process.
The company recently completed the manufacture of bulk material for the next clinical trial, Patrys said in a market update.
But perhaps because the company had to make changes to the manufacturing process to obtain approval for the trial, the material produced has not met some of the required release specifications.
As a result, Patrys said it is unlikely that the next clinical trial will commence in the second quarter as originally planned.
The company noted that such delays are not uncommon in the manufacturing of biological drugs.
While it is working to have the issues resolved as quickly as possible, the anticipated timing of the trial cannot be determined until an investigation is complete.
Patrys recently revealed that a phase I/IIa trial of the drug candidate in multiple myeloma met its primary safety and tolerability endpoints.
Multiple myeloma is a cancer of the plasma cells in bone marrow. Around 1500 new case are diagnosed in Australia every year.
Patrys (ASX:PAB) shares were trading 25% lower at $0.012 as of around 1 pm on Friday.
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