Notable and CicloMed Initiate Phase 1B/2A Clinical Trial of Fosciclopirox in Acute Myelogenous Leukemia Under Co-Development Agreement
Notable Will Leverage Its High-Fidelity Predictive Precision Medicines Platform With The Goal Of Assessing Patient Responsiveness To Fosciclopirox
FOSTER CITY, Calif. and KANSAS CITY, Mo.--(BUSINESS WIRE)--#drugdevelopment--Notable Labs, Inc. (Notable), a clinical-stage predictive precision therapeutics company and CicloMed LLC (CicloMed), a developmental-stage pharmaceutical company 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. 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.
“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.
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.
About CicloMed LLC
CicloMed is a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, and fosciclopirox (formerly Ciclopirox Prodrug, CPX-POM) is its lead drug development candidate. CicloMed is a portfolio company of BioNovus Innovations LLC, a unique venture formed to invest in individuals and organizations that are transforming healthcare. BioNovus is charting a new path with the financial investment and commitment to bring novel solutions to reality. Visit www.ciclomed.com and www.bionovus.com for more information.
Notable is a clinical-stage platform therapeutics company designing and delivering predictive precision medicines, a new class of medicines. Notable aims to be the leader in predictive precision medicine and revolutionize the way in which patients seek and receive treatments that work best for them – patient by patient, and cancer by cancer. By transforming historical standards of care, Notable expects to provide dramatic impact for patients and the healthcare community.
Notable’s proprietary predictive precision medicines platform bio-simulates a patient’s cancer treatment and predicts whether a patient will respond to a specific cancer treatment.
Using its high-fidelity platform, Notable can identify and select clinically responsive patients prior to their treatment and fast-track clinical development in this patient population. Notable has created a targeted, triple de-risked in-licensing strategy to deliver a product’s medical impact and commercial value faster, higher, and more likely than traditional drug development.
Investors in Notable include B Capital Group, Lifeforce Capital, Builders VC, Founders Fund, Lightspeed Venture Partners, Y Combinator, First Round Capital as well as 11.2 Capital, Refactor Capital, Upside Partnership, and Fuel Ventures.
Notable is headquartered in Foster City, California. Learn more at www.notablelabs.com and follow us @notablelabs.