Study Results Show 94 Percent Accuracy in Confirming Diagnosis of Ovarian Cancer
HASSELT, Belgium--(BUSINESS WIRE)-- Biotechnology company MabCure, Inc. (OTCBB: MBCI) today announced that a confirmatory study demonstrated the company’s proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood. MabCure’s serum diagnostic test is the first to recognize unique tumor markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers.
According to the U.S. National Cancer Institute, just 15 percent of ovarian cancers are diagnosed and treated early, when the five-year survival rate is 94 percent. Unfortunately, the majority of women are diagnosed after the disease has already metastasized, when the five-year survival rate drops to 23 percent.
“The availability of a simple blood test with the ability to diagnose the presence of ovarian cancer early and to differentiate it from benign tumors 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 tumors 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 percent and 100 percent correct diagnosis of benign tumors.
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.
About Ovarian Cancer
Each year, 230,000 women worldwide are diagnosed with ovarian cancer, or cancer that forms in the tissues of the ovary, accounting for three percent of cancers in women. More than 125,000 women die from ovarian cancer annually, making it the fifth leading cause of cancer death in women and the deadliest of all gynecological cancers.
About MabCure’s Technology
MabCure has re-engineered classic hybridoma technology. Classic hybridoma technology is based on the generation of immortal hybrid cells or hybridoma, which follows the fusion of antibody-producing B-cells with myeloma tumor cells. Each hybridoma continuously manufactures a single monoclonal antibody. MabCure’s enhanced technology has improved upon this process by increasing MAb yield, improving production times exponentially, and enhancing specificity.
MabCure has successfully generated hybridoma libraries for four different cancers that produce, respectively, antibodies to melanoma, to an aggressive form of prostate cancer, to ovarian cancer, and to colon carcinomas. These antibodies have been shown to be specific and "universal" to each cancer, respectively, (i.e. they recognize every cancer from different individuals having that particular disease and do not react with any normal antigen tested so far). These MAbs are the first candidates for the development of novel diagnostic tools, imaging agents and drugs to treat the corresponding cancers.
MabCure is a biotechnology company whose mission is to change the perception of cancer as being a largely incurable disease. MabCure owns proprietary technology for the creation of unique and highly specific monoclonal antibodies (MAbs), which the company plans to develop as diagnostic tools, imaging agents and therapeutic drugs to treat lethal cancers. The company’s initial focus is on the development of novel diagnostic tests for the early detection of ovarian, prostate, and colorectal cancers, each with multi-billion dollar global market potential. MabCure is also currently exploring the potential of its anti-melanoma antibodies for the development of imaging and therapeutic agents. For more information about MabCure and to sign up for e-mail updates, visit www.mabcure.com.
This news release contains “forward-looking statements.” Statements in this news release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the change of business focus of the management of the Company and the inability of the Company to pursue its current objectives. These forward-looking statements are made as of the date of this news release and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.
Lissette Capati, 202-965-7807
KEYWORDS: United States Belgium Europe North America
INDUSTRY KEYWORDS: Health Biotechnology Oncology Research Science General Health