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news.Tolero Pharmaceuticals has signed an agreement to use Eutropics PraediCare Dx platform in the clinical development of alvocidib, a flavonoid alkaloid cyclin-dependent kinase 9 (CDK9) inhibitor to treat acute myeloid leukemia (AML).
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Preliminary studies have demonstrated that PraediCareDx can be used to find AML patients who respond to alvocidib.
Tolero is currently starting a randomized Phase II biomarker study in previously treated AML patients using PraediCareDx.
Alvocidib blocks super enhancer-regulated transcription of MCL-1 and places AML cells in a heightened state of sensitivity to apoptosis-inducing agents.
Apart from the Phase II study, Tolero aims to start a randomized Phase III study in previously treated AML patients comparing alvocidib, given in timed-sequential-therapy with cytarabine and mitoxantrone (FLAM), to cytarabine and mitoxantrone alone (AM).
The primary endpoint of the registration study will be the rate of complete remission.
Tolero Pharmaceuticals CEO David Bearss said: "If the results of the Phase II biomarker study are positive, we may be able to greatly accelerate the development of alvocidib and potentially reduce the size and cost of the registration program.
"Furthermore, the link of PraediCareDx to the function of MCL-1 further substantiates the clinical mechanism of action of alvocidib through CDK9-dependent suppression of MCL-1 expression, a major signaling pathway in the biology of AML."