OncoMethylome Publishes Positive Clinical Trial Results for
Urine-based Bladder Cancer Test
Liege (Belgium) - September 18, 2007, 8:00am CET - OncoMethylome
Sciences (Euronext Brussels: ONCOB, Euronext Amsterdam: ONCOA)
published interim data from its ongoing bladder cancer clinical
trial. The trial results showed that the urine test that
OncoMethylome is developing can successfully detect bladder cancer,
especially when the cancer is in early stages of its development and
most difficult to detect. In addition, the test's performance was
drastically superior to that of cytology, which is currently the most
widely used urine test for bladder cancer.
OncoMethylome is developing a sensitive urine test for detecting
early-stage bladder cancer and for early detection of cancer
recurrence. Currently, bladder cancer is detected via microscopic
analysis of urine (cytology), which detects approximately 38% of
cancers, plus cystoscopy, which is a manual examination of the
bladder with a scope inserted through a patient's urethra. As
cytology is not adequately sensitive, and the cystoscopy procedure is
invasive and carries the risk of infection, OncoMethylome believes
that an accurate and reproducible urine test would be of great value
to urologists and patients.
The interim results from the ongoing clinical trial showed that
OncoMethylome's urine-based test detected early-stage bladder cancer
with 88% sensitivity and 93% specificity. This means that the test
detected 88% of early-stage cancers, and correctly identified as
non-cancerous 93% of controls, even when those controls consisted of
other abnormal bladder conditions. The molecular test in development
is made up of 5 methylation makers, and is run on DNA isolated from
urine. All of the methylation markers used in the test are the result
of OncoMethylome's proprietary marker discovery program, and were
identified and developed by OncoMethylome.
The published data presented today at the AACR conference on
Molecular Diagnostics in Cancer Therapeutic Development represent
interim findings from 218 participants in an ongoing clinical trial
expected to enroll 400 people at its completion.
"We are very proud that our test is successfully detecting
early-stage bladder cancer in urine. Early detection of cancer and
cancer recurrence is critical for effective treatment," stated Dr.
Jim DiGuiseppi, Chief Technology Officer of OncoMethylome Sciences.
"Based on these strong clinical trial results, we will move ahead
with product development and will also evaluate our distribution and
commercialization alternatives for this product."
OncoMethylome's bladder cancer clinical trial is conducted in
conjunction with urology and pathology departments from University of
Liege and Citadelle Hospital in Belgium, the Erasmus Medical Center
in the Netherlands, and Cambridge University in the UK.
To download this press release as a PDF, click here: Press Release
To download clinical data presented at the AACR Molecular Diagnostics
in Cancer Therapeutic Development conference, click here: Clinical
About Bladder Cancer
In the Western world, bladder cancer is the fourth most common cancer
in men and the eight most common cancer in women. Five-year survival
is excellent (>90%) in people whose cancer is diagnosed in the early
stages, but it drops to 5% if the cancer is detected late. Because
bladder cancer recurs in up to 70% of patients, frequent and ongoing
testing is recommended for all people with a history of bladder
cancer. Due to the benefits of early cancer detection and the
frequent testing of bladder cancer survivors, a need exists for an
accurate and non-invasive test for bladder cancer.
About Methylation and Methylation Markers
Methylation is a natural control mechanism that regulates gene
expression in DNA. Abnormal methylation of certain genes, such as
tumor suppressor genes, can silence gene expression and is associated
with cancer development. Genes, whose methylation is linked to
cancer, are called methylation markers. OncoMethylome owns
proprietary technology that is highly sensitive and capable of
detecting methylation markers, and thereby cancer, even in early
stages of cancer development. In the case of bladder cancer, this
technology identifies methylation of genes, or methylation markers,
that have been shown to be associated with bladder cancer.
About OncoMethylome Sciences
OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam:
ONCOA) is a molecular diagnostics company developing gene methylation
tests to assist physicians in effectively detecting and treating
cancer. Specifically, the company's tests are designed to help the
physician (i) accurately detect cancer in early stages of cancer
development, (ii) predict a patient's response to drug therapy, and
(iii) predict the likelihood of cancer recurrence.
OncoMethylome boasts a broad product development pipeline consisting
of ten products and a solid partnering record. The company
collaborates with leading international molecular oncology research
centers, such as The Johns Hopkins University, and has a number of
commercial and collaborative partnerships with Veridex LLC, a Johnson
& Johnson company, Schering-Plough Corp., Millipore Corporation's
BioScience Division, and EXACT Sciences Corp. OncoMethylome's
products are based on methylation technology invented by Johns
Hopkins University (USA).
Established in January 2003, OncoMethylome has offices in Liege and
Leuven (Belgium), in Durham, NC (USA), and in Amsterdam (the
For more information please contact:
or visit: www.oncomethylome.com