PITX2 Prostate Cancer Molecular Classification Test Successfully Transferred to Affymetrix Diagnostic Platform
* Concordance study demonstrated excellent agreement between Epigenomics’ chosen commercial diagnostic test platform and prototype research assays.
* Based on a prior FDA Early Collaboration Meeting, Epigenomics believes a “de novo 510(k)” will be a least burdensome approach for regulatory clearance.
* Product development is on track with pivotal clinical studies scheduled to commence in 2007.
Tuesday, 12.12.2006, Berlin, Germany and Seattle, WA, USA Epigenomics AG (Frankfurt, Prime Standard: ECX) announced today that it successfully transferred its prostate cancer molecular classification test, based on the PITX2 biomarker, to the Affymetrix GeneChip™ platform. This step, a milestone towards completing product development and initiating pivotal studies, was accomplished only six months after concluding a strategic partnership with Affymetrix Inc. (NASDAQ: AFFX). As previously reported, this partnership provides Epigenomics with access to Affymetrix’s industry leading in vitro diagnostic microarray platform for commercialization of Epigenomics’ tissue based product portfolio. The concordance study demonstrated that the prototype real-time PCR assays used in the research phase could be transferred to the Affymetrix platform. An excellent 97.8% agreement between the methods was observed.
“Our depth of prior experience with DNA methylation microarrays made it possible to achieve this important step in product development on such a short timeline. We are now looking forward to moving this product into clinical validation.” said Dr. Michael Wandell, Senior VP Clinical, Regulatory & Quality, Head of Epigenomics Product Development. “We expect that this assay will provide physicians and patients with valuable new information for more accurate prediction of prostate cancer relapse, based on the tumor’s molecular signature.”
The successful completion of the concordance study now paves the way for pivotal clinical studies to commence, as scheduled, in 2007. Epigenomics will review its clinical study plan with the FDA later this week in a Pre-IDE Meeting, and then immediately begin recruitment of the clinical trial sites in the US and Europe. “We are pleased with the progression of events which allows us to continue to meet our product and clinical development timelines,” added Dr. Wandell. Based on an Early Collaboration Meeting with the FDA in August this year, Epigenomics is confident that it will fulfill regulatory requirements through submission of a “de novo 510(k)” for this test. FDA makes this regulatory pathway available to allow faster market introduction of lower risk medical devices. In addition, Epigenomics will file an Investigational Device Exemption (IDE) in Q1 2007 to support this application.
About Epigenomics’ Prostate Cancer Molecular Classification Test
Prostate cancer is the most common cancer in American and European men. With an annual incidence of approximately 470,000 cases in the US and Europe, one in six men will be diagnosed with prostate cancer in his lifetime and about 115,000 men will die from the disease every year. Surgical removal of the prostate (radical prostatectomy) is performed as potentially curative treatment in about 40% of patients diagnosed with prostate cancer. Nevertheless, the disease recurs in about one in seven prostatectomy patients. However, the difficulty clinicians have is that even with the use of current prognostic parameters, there still remains considerable uncertainty concerning which patients will eventually relapse. Epigenomics is developing a prostate cancer molecular classification test based on the DNA methylation biomarker PITX2 that will provide physicians and patients with prognostic information on disease recurrence by identifying those prostatectomy patients at increased risk.
Currently, prognostic information is mainly derived from clinical and histopathological parameters, such as tumor size, Gleason score and pre-surgery PSA levels. In a study published at the 2006 annual AACR meeting, Epigenomics has shown that DNA methylation of PITX2 constitutes a strong prognostic marker for outcome prediction after radical prostatectomy. In this study, PITX2 separated post-prostatectomy cancer patients into two distinct groups: Those with a high likelihood of cancer recurrence and those with a low likelihood of cancer recurrence. Furthermore, PITX2 methylation added significant information to established clinical parameters. Remarkably, the PITX2 biomarker was able to predict outcome in patients diagnosed with Gleason grade 7, for which reliable prognosis based on conventional parameters is particularly difficult. The demand among physicians for such a molecular diagnostic test is high, since it identifies patients with a poor prognosis that are possibly under-treated.
About DNA Methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. Methylation is responsible for controlling the activity of genes by turning them off when not needed. Measuring the differences in the methylation patterns between healthy and diseased tissue can be used to detect a change in gene activity that could trigger diseases such as cancer. Epigenomics develops molecular diagnostic tests based on routine processes that were developed to reliably read and interpret these methylation patterns.
About Epigenomics AG
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics’ defined business strategy covers two complementary core business areas. In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer. Based on easily obtainable body fluid samples, these tests are aimed at finding colorectal, prostate, breast, and lung cancer at an early stage before symptoms occur. The company has entered into a global development, marketing and sales partnership with Roche Diagnostics covering three screening tests for colorectal, prostate and breast cancer.
As a second core business area, Epigenomics develops tissue-based prognostic tests for prostate and breast cancer patients. With a strong focus on prostate cancer applications, these tests are developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). In this area Epigenomics retains the flexibility to decide on potential partnerships for marketing and sales. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.
This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
- Contact Information
- Dr. Achim Plum
- Vice President Corporate Communications
- Epigenomics AG
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