MabCure, Inc. Announces Positive Results for New Ovarian Cancer Diagnostic Blood Test
July 27 2010 - 9:00AM
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.
About MabCure
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.
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