On December 1, 2021 Notable Labs, Inc. (Notable), a clinical-stage predictive precision therapeutics company and CicloMed LLC (CicloMed), a developmental-stage pharmaceutical company reported that they have initiated a Phase 1B/2A clinical trial of fosciclopirox in patients with refractory acute myelogenous leukemia (AML) under the terms of a co-development agreement (Press release, Notable Labs, DEC 1, 2021, View Source [SID1234596343]). In the ongoing open-label, Phase 1B/2A trial currently underway at The University of Kansas Cancer Center, Notable is applying its high-fidelity predictive precision medicines platform with the goal of assessing patient responsiveness to fosciclopirox.
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"Notable’s unique predictive precision medicines platform has the potential to develop cancer treatments precisely for the patients predicted to respond, reducing the risks for patients of receiving treatments that don’t work for them. Moreover, developing a treatment in selected clinical responders enables smaller clinical trials and the potential to expedite development timelines," said Thomas Bock, M.D., Chief Executive Officer of Notable. "Fosciclopirox is a strategically and deliberately selected program, as it has already performed well on our predictive precision medicines platform."
"The initial phase of our collaboration with Notable focused on optimizing the Notable predictive precision medicine platform for sensitivity to fosciclopirox on AML patient samples," said Tammy Ham, CEO of CicloMed. "The encouraging results from this work led to our co-development agreement and the initiation of our on-going clinical trial."
Under the terms of the co-development agreement, CicloMed holds the primary responsibility for executing clinical trial operations while Notable is primarily focused on optimizing Notable’s predictive precision medicine platform. Both parties will be responsible for the costs associated with the on-going clinical trial.
About Fosciclopirox
Fosciclopirox was discovered by scientists at The University of Kansas Cancer Center, a National Cancer Institute designated cancer center and the Institute for Advancing Medical Innovation (IAMI), University of Kansas Medical Center’s product development enterprise. Fosciclopirox is part of an open-label, Phase 1B/2A study to characterize the efficacy, safety, PK, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with relapsed or refractory AML. CicloMed was formed in 2016 as a public-private partnership between BioNovus Innovations LLC and IAMI, with fosciclopirox as the partnership’s lead drug development candidate.