EntreMed received a no objection letter from the Therapeutic Products Directorate of Health Canada on its clinical trial application to conduct the clinical trial in leukemia patients. A Canadian clinical trial application is similar to a US investigational new drug application.
The drug, MKC-1, is an orally active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. In previous studies, MKC-1 demonstrated broad-acting anti-tumor effects, including tumor growth inhibition or regression in multiple preclinical models, even in paclitaxel-resistant models, the company says.
MKC-1 showed potent, dose-dependent activity against a variety of cell lines derived from cancers of human blood cells, and inhibited growth of primary cells derived from acute and chronic myelogenous leukemia (AML and CML) patients in vitro. MKC-1 was also shown to inhibit PI3-Kinase and mTOR pathways by inducing a dose-dependent reduction in the levels of the activated forms of the oncogenic kinases Akt and p70S6K. These signaling pathways are linked to cancer proliferation and survival.
Carolyn Sidor, EntreMed’s vice president and chief medical officer, said: “This is a significant milestone for EntreMed and the MKC-1 clinical development program. The CTA represents our first regulatory submission to Health Canada and provides us with the opportunity to expand clinical studies with MKC-1 to institutions outside the US.”