Keyhole limpet hemocyanin composition with enhanced...

A - Human Necessities – 61 – K

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A61K 39/39 (2006.01) A61K 35/56 (2006.01) A61K 38/16 (2006.01) A61K 39/385 (2006.01) C07K 14/435 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2121296

ABSTRACT The present invention i directed to a stabilized keyhole limpet hemocyanin (KLH) composition in which (i) its intact non-degraded subunit is approximately 400,000 in molecular weight based on SDS-PAGE analysis; and (ii) are contained at least about 50% didecameric or higher KLH multimers, based on sedimentation-equilibrium and/or sedimentation-velocity ultracentrifugation analyses. The KLH composition is stabilized at 4°C by dissolving and storing it in an isotonic buffer preferably containing calcium and magnesium. It is critical that the KLH not have been frozen or lyophilized during its preparation or storage. The KLH composition demonstrates enhanced immunogenic activity, particularly enhanced anti-tumor activity, which is reduced if the KLH is frozen or lyophilized. The KLH composition of the present invention exhibits enhanced anti-tumor activity in a murine bladder tumor model and thereby represents a new and useful anti- tumor immunotherapeutic anti-bladder cancer.

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