MabCure's blood test for ovarian cancer gets positive results
12 August 2010
Cancer diagnostics developer MabCure, Inc. has announced that a confirmatory study demonstrated the company’s proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94% accuracy) and with no false positives or cross-reactions with benign ovarian tumours or healthy blood.
MabCure says its serum diagnostic test is the first to recognize unique tumour markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers.
“The availability of a simple blood test with the ability to diagnose the presence of ovarian cancer early and to differentiate it from benign tumours has the potential to save thousands of lives and reduce the need for unnecessary surgeries,” said Amnon Gonenne, Ph.D., CEO of MabCure. “Our findings are an important step in that direction and also have significant implications for the future development of cancer-specific targeted therapies.”
All antibodies currently approved to treat cancer are considered “targeted therapies” but not against exclusive cancer targets. These antibodies target normal proteins that are over-expressed by cancer cells in some patients, but are also found in normal cells. In contrast, MabCure’s MAbs recognize markers or antigens that are apparently unique to all cancer cells of a given type. MabCure’s study, along with a growing body of research, suggest a paradigm shift toward treatments that only target cancer cells without harming any normal cells.
MabCure conducted a blinded study of several of its ovarian cancer MAbs against 54 different blood samples in collaboration with the Department of Gynecological Oncology at UZ Hospital in Leuven, Belgium. The samples were comprised of 17 patients with ovarian cancer, 5 patients with benign tumours of the ovaries, 24 healthy young females and 8 males. Results showed that each of MabCure’s MAbs correctly diagnosed 16 of the 17 ovarian cancers, with a diagnostic sensitivity of 94% and 100% correct diagnosis of benign tumours.
This study confirms findings from an earlier study, which demonstrated the ability of each of the antibodies tested by MabCure to detect low levels of ovarian cancer-specific antigens in the blood of patients. Namely, a number of patients who were judged to be in clinical remission, following chemotherapy, were found to still have residual disease by MabCure’s MAbs. All of these patients had baseline levels of the standard ovarian cancer marker, CA-125, in their blood, suggesting that MabCure’s MAbs serum marker test may be effective in detecting early-stage disease when the level of circulating cancer antigens in the blood is presumably low.
The antibodies developed for detecting ovarian cancer and used in the MabCure study were created by MabCure’s proprietary hybridoma technology and carefully selected from more than 30,000 MAbs, all of which recognize ovarian cancer. MabCure is currently seeking patents for these discoveries. In addition, it is evaluating its other MAbs for early diagnostic tests of prostate cancer and colon cancer. MabCure business strategy is to use such discoveries as the basis for the development of highly specific imaging agents and a new generation of targeted anti-cancer drugs.
MabCure will soon commence a follow-on study in collaboration with one of the foremost experts in women’s cancers, Ignace Vergote, M.D., Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, Belgium. The study will access a large number of previously collected clinical blood samples stored at the Bio-bank of the Catholic University Hospital, Leuven.
Following the conclusion of this study, MabCure plans to launch a multi-center prospective trial in Europe and in the U.S., as well as initiate commercialization of its diagnostic ovarian cancer MAbs in Europe through strategic partnerships and licensing. In parallel, MabCure plans to embark on the regulatory process for obtaining marketing approval in the U.S.
MabCure is currently evaluating the diagnostic potential of it MAbs in detecting ovarian cancer in high-risk patients in a clinical study in Thailand.