KERYX Biopharmaceuticals

KinAce Proof of Principle

A Novel Treatment for Hormone Resistant Prostate Cancer

According to the National Cancer Institute, during their lifetime, one in six Americans men will develop prostate cancer, a leading cause of death among males. A specific sub-type of advanced prostate cancer, Hormone-Resistant Prostate Cancer (HRPC), is particularly virulent, and is currently considered incurable. It is estimated that there are over 150,000 cases of HRPC annually in the Western World, representing a potential annual market size in excess of $500 M.

Keryx’s clinical candidate for the treatment of HRPC, KRX-123, represents the first proof-of-concept for the KinAceTM platform. Using the KinAce platform, Keryx discovered a novel connection between over-expression of Lyn kinase and prostate cancer. The KinAce platform also delivered a Lyn kinase derived inhibitor drug, KRX-123, to target hormone-resistant prostate cancer.

KRX-123 represents an exciting potential breakthrough for a condition for which no effective therapies currently exist. KRX-123 has proven significant efficacy in in vivo experiments. These in vivo tests indicate that KRX-123 is well tolerated and may have the potential to prevent proliferation of the malignancy as well as cause reduction in tumor size and restoration of tumor apoptosis in HRPC patients.

KRX-123 is currently in advanced pre-clinical development and Keryx expects to file an Investigational New Drug (IND) application for the initiation of clinical trials in humans for KRX-123 in late 2002.