Cln101 Antibody Compositions and Methods of Use Alone and in Combination with Prostate Specific Antigen and Other Cancer Markers

Abstract

This invention relates to a method for assessing risk of prostate and/or ovarian cancer. Specifically, in one embodiment it relates to utilizing both Cln101 and Prostate Specific Antigen (PSA) in combination to determine the risk of prostate cancer. In an alternative embodiment, the invention is relates to utilizing Cln101 alone or in combination with CA125 to determine the risk of ovarian cancer. The invention further provides isolated anti-prostate or ovarian cancer antigen (Cln101) antibodies that bind to Cln101 in vivo. The invention also encompasses compositions comprising an anti-Cln101 antibody and a carrier. These compositions can be provided in an article of manufacture or a kit. Another aspect of the invention is an isolated nucleic acid encoding an anti-Cln101 antibody, as well as an expression vector comprising the isolated nucleic acid. Also provided are cells that produce the anti-Cln101 antibodies. The invention encompasses a method of producing the anti-Cln101 antibodies. Other aspects of the invention are a method of killing an Cln101-expressing cancer cell, comprising contacting the cancer cell with an anti-Cln101 antibody and a method of alleviating or treating an Cln101-expressing cancer in a mammal, comprising administering a therapeutically effective amount of the anti-Cln101 antibody to the mammal.

1 . A method for assessing risk of prostate cancer in a patient which comprises measuring levels of both Cln101 and Prostate Specific Antigen (PSA) in the patient, analyzing a risk associated with the level of PSA and a risk associated with the level of Cln101, and using the combined risks to assess the risk of prostate cancer in the patient. 
     
     
         2 - 7 . (canceled) 
     
     
         8 . A method for assessing risk of ovarian cancer in a patient which comprises measuring levels of Cln101 in the patient to assess the risk of ovarian cancer in the patient. 
     
     
         9 . A method for assessing risk of ovarian cancer in a patient which comprises measuring levels of both Cln101 and CA125 in the patient, analyzing a risk associated with the level of CA125 and a risk associated with the level of Cln101, and using the combined risks to assess the risk of ovarian cancer in the patient. 
     
     
         10 - 83 . (canceled) 
     
     
         84 . A method for detecting Cln101 overexpression in a subject in need thereof comprising,
 (a) combining a bodily fluid sample of a subject with an isolated Cln101 antibody that binds to mammalian Cln101 in vivo or in vitro under conditions suitable for specific binding of the Cln101 antibody to Cln101 in said bodily fluid sample   (b) determining the level of Cln101 in the bodily fluid sample,   (c) comparing the level of Cln101 determined in step b to the level of Cln101 in a control,   
       wherein an increase in the level of Cln101 in the bodily fluid sample from the subject as compared to the control is indicative of Cln101 overexpression in the subject. 
     
     
         85 - 94 . (canceled)