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EntreMed starts Phase II study of anticancer drug

US-based EntreMed has commenced a multi-center Phase II clinical study that will assess the safety, tolerability and overall median survival time of pancreatic cancer patients treated with MKC-1, a novel, orally-active cell cycle inhibitor.

The primary objectives of this study will be to determine the antitumor activity of orally-administered MKC-1 in unresectable or metastatic pancreatic cancer patients who have failed at least one prior chemotherapy regimen.

MKC-1 is a novel, 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. Prior preclinical studies have demonstrated that MKC-1 has significant antitumor activity as both a single agent and in combination with an approved epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) inhibitor in pancreatic cancer models.

Carolyn Sidor, vice president and chief medical officer of EntreMed, said: “With this clinical trial initiation, we are now evaluating MKC-1 as a single agent or in combination in patients with pancreatic cancer, metastatic breast cancer, non- small cell lung cancer (NSCLC), and leukemia.”