The US Food and Drug Administration (FDA) has placed a partial hold on Molecular Templates’ Phase I trial of MT-0169 in patients with relapsed multiple myeloma.
The partial hold is based on the previously disclosed cardiac adverse events that occurred in two participants who received MT-0169 at 50mcg/kg dose.
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One patient experienced asymptomatic grade 2 myocarditis, while the other had asymptomatic grade 3 cardiomyopathy.
Both the participants completely recovered within two months of these events.
As a result of the events, the dosage of MT-0169 was reduced by 90% to 5mcg/kg last year.
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All the participants who are currently enrolled in the clinical trial will continue to take the treatment, but no new participants will be enrolled until the FDA lifts the partial clinical hold.
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By GlobalDataMolecular Templates chief medical officer Roger Waltzman said: “Patient safety is our highest priority. The 5 and 10mcg/kg cohorts have been completed and we have not observed any cardiac adverse events or other serious adverse events at these lower doses.
“One patient dosed at 5 mcg/kg is in a stringent complete response and is in his seventh month of therapy.
“We look forward to sharing these data with the FDA and are confident in the benefit-risk profile of MT-0169 at these lower doses.”
Molecular Templates recommenced treatment in the patients at 5mcg/kg after filing a protocol amendment in January last year.
In the trial, four participants received 5mcg/kg dose and there were no cardiac adverse events and no adverse events greater than grade 1.
The regulator requested the company to provide a report on the two patients who experienced cardiac adverse events at 50mcg/kg dose as well as explanation for the revised 5mcg/kg dose.
It has also asked to provide data assessing the clinical benefit-to-risk ratio observed with reduced doses.
