Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Gl... (//studio-5.financialcontent.com/prnews?P...)

Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma

Date:1/7/2008

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"Fast Track status acknowledges CDX-110's potential to fill an unmet need for glioblastoma patients and gives it priority within the FDA," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Confirmation of the promising results we've already observed is a high priority at Celldex, as it is within the brain cancer community in general."

About CDX-110

CDX-110 is an investigational immunotherapy that targets the tumor specific molecule EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), which is a protein that has been well validated as a target for cancer therapy. This particular variant, EGFRvIII occurs in about 40 percent of Glioblastoma Multiforme (GBM) patients. It was discovered in a collaborative effort between Dr. Bert Vogelstein and Dr Albert Wong at Johns Hopkins University and Dr. Darell Bigner at Duke University. Unlike EGFR, EGFRvIII is not present in normal tissues, suggesting this target will enable the development of a tumor-specific therapy for cancer patients. Furthermore, EGFRvIII is a transforming oncogene that can directly contribute to cancer cell growth. While originally discovered in GBM, the most common and aggressive form of brain cancer, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers. Celldex has exclusive rights to EGFRvIII vaccines and is pursuing the development of CDX-110 for GBM therapy, as well as in other cancers through additional clinical studies.

About Fast Track Drug Designation

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological products means that FDA will take such actio
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