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news.US-based pharmaceutical firm G1 Therapeutics has started a randomized, placebo-controlled, single ascending dose Phase I clinical trial of G1T28-1, a highly potent and selective CDK4/6 inhibitor with broad potential in multiple oncology indications.
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The trial is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of G1T28-1 in healthy volunteers, who are currently being enrolled in the Netherlands.
The company is conducting the trial in collaboration with PRA Health Sciences and the data collected from it will inform dose and schedule for further development of G1T28-1, either as a bone marrow chemoprotectant or as an antineoplastic agent.
G1 chief medical officer Dr Raj Malik said G1T28-1 is a first-in-class therapy for protecting the bone marrow from chemotherapy-induced myelosuppression in patients with CDK4/6-independent tumors, and has the potential to be best-in-class as an antineoplastic agent in patients with CDK4/6-dependent tumors.
"Preclinical data demonstrate that G1T28-1 is differentiated from currently available therapies for myelosuppression in that it protects all hematopoietic lineages, including red cells, platelets, granulocytes and lymphocytes, before damage is done by chemotherapy," Malik said.
The company is focused on developing small-molecule therapies to address significant unmet needs in oncology.