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news.Chemokine Therapeutics has received a no objection letter from Health Canada allowing the company to start a Phase II study in liver cancer with its lead drug candidate, CTCE-9908. The company also recently received FDA approval for the study.
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The Phase II trial will be an international, multi-centre, randomized, controlled, open label study assessing the efficacy and safety of CTCE-9908 that will include up to 123 patients. The primary end point will be to determine the response rate of tumors in patients with liver cancer treated with CTCE-9908 following transarterial chemoembolization (TACE) (a therapy used for non-resectable liver cancer) compared with patients receiving TACE alone. The company will follow patients to also determine progression free survival, overall survival, as well as various tumor and angiogenic factors.
Walter Korz, vice president of drug development at Chemokine, said: “We are pleased that Health Canada has agreed to allow the company to expand its Phase II clinical trial to include sites in Canada which will allow access to this therapy by Canadian patients suffering from liver cancer.”