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news.Chemokine Therapeutics has received notice from the FDA allowing the company to begin a multi-center, randomized, controlled, open-label Phase II study in liver cancer with its lead drug candidate, CTCE-9908.
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The study will evaluate the efficacy and safety of CTCE-9908 administered at a dose of 5mg/kg. 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 or 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, said: “We are pleased the FDA has completed a review of our comprehensive regulatory filing allowing us to move forward with our planned Phase II clinical trial. This will be the company’s first study initiated under an FDA investigational new drug application with CTCE-9908.”