GTHX

Trilaciclib

Metastatic Colorectal Cancer

Phase 3 TBA

Exp Date

TBA

Amp Volatility Score

Catalyst Info & Data Links

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WHAT IS THE CATALYST EVENT?

 

WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA/EVENTS


PRESS RELEASES


May 6, 2020 Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

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MECHANISM OF ACTION / RATIONALE

  • Trilaciclib is a small molecule, competitive inhibitor of cyclin dependent kinases 4 and 6 (CDK4/6), with potential antineoplastic and chemoprotective activities. Upon intravenous administration, trilaciclib binds to and inhibits the activity of CDK4/6, thereby blocking the phosphorylation of the retinoblastoma protein (Rb) in early G1. This prevents G1/S phase transition, causes cell cycle arrest in the G1 phase, induces apoptosis, and inhibits the proliferation of CDK4/6-overexpressing tumor cells. In patients with CDK4/6-independent tumor cells, G1T28 may protect against multi-lineage chemotherapy-induced myelosuppression (CIM) by transiently and reversibly inducing G1 cell cycle arrest in hematopoietic stem and progenitor cells (HSPCs) and preventing transition to the S phase. This protects all hematopoietic lineages, including red blood cells, platelets, neutrophils and lymphocytes, from the DNA-damaging effects of certain chemotherapeutics and preserves the function of the bone marrow and the immune system. CDKs are serine/threonine kinases involved in the regulation of the cell cycle and may be overexpressed in certain cancer cell types. HSPCs are dependent upon CDK4/6 for proliferation. (Source - National Library of Medicine National Center for Biotechnology Information)

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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Recent Posts

See What The Community Is Saying - Click To See Full Post

Trilaciclib NDA Filing (GTHX)...

We are fans of GTHX and hope things go well. But we are worried if NDA for Trilaciclib in NSCLC is accepted and accelerated date is set, that expedited PDUFA is too rushed for FDA during a pandemic. S...

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