FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lift­ed a par­tial clin­i­cal hold on Mol­e­c­u­lar Tem­plates’ ear­ly-stage tri­al for a mul­ti­ple myelo­ma drug, the biotech com­pa­ny an­nounced Thurs­day morn­ing.

Reg­u­la­tors had put the tri­al on par­tial hold in ear­ly April, paus­ing pa­tient en­roll­ment, fol­low­ing two ad­verse heart-re­lat­ed events in pa­tients who re­ceived the high­est dose of Mol­e­c­u­lar Tem­plates’ treat­ment MT-0169 last year. One pa­tient had asymp­to­matic grade 2 my­ocardi­tis, or heart mus­cle in­flam­ma­tion, while the oth­er had a grade 3 car­diomy­opa­thy. Both re­cov­ered with­in two months.

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