Chemokine Therapeutics Receives Approval From FDA to Commence Phase II Study
- Category: Proteins and Peptides
- Published on Wednesday, 09 January 2008 13:32
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Chemokine Therapeutics Corp. today 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
VANCOUVER, Canada | January 8, 2008 | Chemokine Therapeutics Corp. (the "Company") (TSX:CTI)(OTCBB:CHKT), a biotechnology company developing chemokine-based therapies to treat cancer, blood disorders, and vascular diseases, today 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."
About Liver Cancer
Liver cancer is the fifth most common cancer worldwide. Approximately 500,000 cases of liver cancer are diagnosed each year and it is the third cause of cancer-related deaths. Hepatocellular carcinoma (HCC), the most common form of liver cancer, occurs more often in males than females and is most common in people over 50 years of age.
The reported prognosis for advanced liver cancer is poor with most patients dying within a year regardless of the treatment they receive. This represents a significant unmet medical need.
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.
About Chemokine Therapeutics Corp. (TSX:CTI)(OTCBB:CHKT)
Chemokine Therapeutics is a product-focused biotechnology company developing drug candidates in the field of chemokines. Chemokines are a class of signaling proteins that play a critical role in the growth, differentiation, and maturation of cells necessary for fighting infection as well as tissue repair and regeneration. Chemokines also have an important role in cancer metastasis and growth. Chemokine Therapeutics is a leader in research in the field of chemokines and has several products in various stages of development.
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SOURCE: Chemokine Therapeutics Corp.