Molecular Templates Reports the US FDA's Clinical Hold on P-I Study of MT-0169 for Relapsed Multiple Myeloma
Shots:
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The US FDA has placed a partial clinical hold on the P-I study of MT-0169 in patients with relapsed multiple myeloma. The decision was based on previously disclosed cardiac events that occurred in two participants who received MT-0169 at a 50mcg/kg dose
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One patient experienced asymptomatic grade 2 myocarditis, while the other had asymptomatic grade 3 cardiomyopathy & the dosage of MT-0169 was reduced by 90% to 5mcg/kg last year. Both the participants completely recovered within 2mos. of these events & no grade 4 or 5 toxicities were observed at 50mcg/kg
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All the participants who are currently enrolled in the clinical trial will continue to take the treatment & no additional patients may be enrolled until the partial clinical hold is resolved
Ref: GlobeNewswire | Image: Molecular Templates
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