Prima BioMed (PBMD) Granted Approval for Third Cohort of Ph1 Melanoma Trial

Source: Street Insider, April 2017

Prima BioMed Ltd (NASDAQ: PBMD) announced that approval has been granted for the third cohort of its Phase I clinical trial for IMP321 in combination with KEYTRUDA® being conducted in Australia. The third cohort will recruit six patients with unresectable or metastatic melanoma.

Interim data results from the first patient cohort released in December 2016 indicate IMP321 at the 1mg dose level is safe and well tolerated. Out of the six patients in the first cohort (all with suboptimal response to KEYTRUDA® monotherapy) two patients had a partial or complete radiological tumour response according to immune related response criteria (irRC).

The positive safety profile was also confirmed in the second cohort dosed with 6 mg of IMP321. None of the 6 patients treated with KEYTRUDA® plus IMP321 at this higher dose level experienced any serious adverse reaction nor dose limiting toxicity. As a result, the independent Drug Safety Monitoring Board (DSMB) has granted approval for the third cohort, at the 30mg dose level, to commence with the first patient to be dosed in due course.
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