Clinical trial confirms novel EGFR antibody targets tumors but not normal tissues

Results from study accepted for publication at 2006 ASCO Meeting

Monday 5th June 2006, New York - The Ludwig Institute for Cancer Research (LICR) and Life Science Pharmaceuticals (LSP) today announced the results of the first clinical trial of monoclonal antibody (mAb) 806, which demonstrate that 806 specifically targets epidermal growth factor receptor (EGFR) on a wide range of tumor types but has no uptake by normal tissues. This result is markedly different to other mAbs, which target wild-type (wt) EGFR on normal tissues.

According to Andrew M. Scott, M.D., the Director of LICR's Melbourne Centre for Clinical Sciences and principal investigator on the trial, extensive characterization of both mAb 806 and its epitope have been performed by LICR investigators in Melbourne and New York. "We have shown that the 806 antigen is not exposed on inactive wild-type EGFR, but is exposed on a transitional form of the EGFR. The epitope studies are supported by immunohistochemistry demonstrating that the 806 antibody binds to a broad range of epithelial cancers and to gliomas, but not to normal human tissues. These and other preclinical data suggest that 806 would not have the side-effects observed with other EGFR-targeting mAbs."

The 806 antibody has been licensed exclusively to LSP, which is working closely with LICR investigators to develop its commercial potential. "We think the unique targeting capabilities of 806 represent a new and exciting paradigm for cancer treatment," says James Fiore, President and CEO of LSP. "This mAb has a potent anti-tumor activity, with no targeting of normal tissues, in xenograft models, and now this clinical study has validated its target-specificity and safety in humans."

The clinical trial confirmed the excellent targeting of ch806 to cancers including squamous cell carcinomas of the lung, head and neck and skin, colorectal cancer, mesothelioma and glioma. Importantly, there was no evidence of localization of ch806 to normal tissue. No significant toxicities were observed. The results were published in the Proceedings of the American Society for Clinical Oncology's Annual Meeting being held currently in Atlanta, GA. The mAb 806 is an investigational drug and it is not approved for use in any indication in any country at this time.

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