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The FDA’s partial hold means that no new patients with either leukemia or lymphoma can be enrolled onto the trial.
Curis, Inc. announced that the Food and Drug Administration (FDA) placed a partial hold on a phase 1/2 open-label clinical trial, known as TakeAim Lymphoma, which is evaluating the proper dose of emavusertib in patients with B-cell malignancies.
The announcement from Curis came one week after the FDA issued a partial hold on the TakeAim Leukemia clinical trial which was also investigating emavusertib in a group of patients with leukemia.
“We reiterate our previous comments: we are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients' lives,” James Dentzer, CEO of Curis, said in a company-issued press release. “Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with B-cell cancers, (acute myeloid leukemia), or (myelodysplastic syndromes).”
When the FDA issues a partial hold on a clinical trial, no new patients are allowed to be enrolled onto the study. However, patients currently participating in the trial and benefiting from therapy can continue to receive treatment with study drug after reconsenting to staying in the trial.
The FDA, according to the release, has asked Curis to provide further information regarding the drug’s safety and efficacy, including data related to rhabdomyolysis, which is the breakdown of damaged muscle which results in the release of muscle cell contents into the blood which may be fatal.
The goal was for approximately 181 patients to be enrolled onto the TakeAim Lymphoma study. The plan for the first part of the trial was to assess escalating doses of the study drug either as a single-agent treatment or in combination with Imbruvica (ibrutinib) in patients with non-Hodgkin lymphoma, Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. Once a targeted dose has been determined for the combination treatment, researchers intend to expand the trial to assess the safety and efficacy of the drug.
The company said that it expects to provide updated information on its request for approval with the FDA after the partial trial holds have been resolved.
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