Chemokine Therapeutics Receives Approval From FDA to Commence Phase II Study

10-Jan-2008

Chemokine Therapeutics Corp. announced that it has received notice from the U.S. food and Drug Administration (FDA) allowing the Company to begin a Phase II study in liver cancer with its lead drug candidate, CTCE-9908.

The Phase II trial will be a multi-centre, randomized, controlled, open label study assessing the efficacy and safety of CTCE-9908 administered at a dose of 5 mg/kg. The primary end point will be to determine the response rate of tumours 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 tumour and angiogenic factors.

"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," said Walter Korz, Vice President of Drug Development. "This will be the Company's first study initiated under an FDA investigational new drug (IND) application with CTCE-9908."

CTCE-9908 is a peptide analog of the chemokine SDF-1, and an antagonist of its receptor, CXCR4. SDF-1 is the only known naturally occurring chemokine that binds to CXCR4, which is present on many cancer cells as well as cancer support cells such as cells making up new blood vessels. This binding process is believed to be critical in the SDF-1 induced migratory processes. The anti-migratory property of CTCE-9908 is pivotal in not only reducing recruitment of support cells that allow survival and growth of the primary tumor, but also metastasis (or spread) of cancer cells to distant locations in the body, where they form secondary tumors. Approximately 90% of cancer deaths are due to metastasis and disease progression. We believe that CTCE-9908 has the potential to shrink the primary tumor and delay the occurrence of new tumors due to its anti-angiogenic properties and anti-metastatic activity.

https://www.bionity.com/en/news/76315/chemokine-therapeutics-receives-approval-from-fda-to-commence-phase-ii-study.html