Exiqon A/S (NASDAQ OMX Copenhagen: “EXQ”) today announced the presentation of data, using the company’s proprietary LNA™ based in situ hybridization (ISH), from a clinical study including all stage II colon cancer patients in Denmark in the year 2003 with associated 6 years follow-up data at the 2012 ASCO annual meeting; Clin Oncol 30, 2012 (suppl; abstr 3513).
The study holds promise to add prognostic information to the European guidelines for treatment of stage II colon cancer patients. The study has also been selected for presentation at “Best of ASCO®” on 16 July 2012.
In collaboration with Vejle Hospital in Denmark Exiqon has analyzed all patients diagnosed with stage II colon cancer in Denmark in the year 2003 (a total of 711 patients), representing a population of five million people in total. The study includes 6 years clinical follow up data and demonstrates the prognostic value of Exiqon’s proprietary LNA™ detection technology for in situ hybridization of microRNA-21 as an indicator for disease free survival.
The study demonstrated that among the 33% of the patients with the highest microRNA-21 levels, only 75% survived four years after surgery, whereas the same rate was 88% among the 33% of the patients with the lowest microRNA-21 levels. For the medium group, 82% survived four years after surgery.
In a comment, Professor Nils Brünner, Faculty of Health and Medical Sciences, University of Copenhagen said: “The prognostic value of microRNA21 is significantly independent from the parameters used today to classify stage II colon cancer patients in Europe. Therefore the test has the potential to be included as standard of care”.
In a comment, President & CEO Lars Kongsbak said: “This is not only our second study documenting the prognostic value of microRNA-21 in stage II colon cancer, it is also to the best of my knowledge the biggest validation study ever conducted on microRNAs demonstrating that microRNAs hold great promise as a novel group of biomarkers” adding: “We are now in the process of identifying a commercial partner who can help us effectively market the product”.
This study is the second independent validation of this test and should fulfill requirements by authorities for validation on independent populations. The study results may require separate validation to fully benefit from different platforms.
The test is based on standard FFPE (formalin-fixed paraffin-embedded) samples which are routinely sampled upon surgery. The test only requires a one probe in situ hybridization process. In situ hybridization processes are extensively applied in hospitals and other clinical laboratories around the world that may be effectively served by a simple kit for diagnostic use.
Exiqon already offers research reagents and kits that support the necessary analyses for research use.
The incidence of colon cancer has been increasing for decades. A considerable fraction of stage II patients receiving surgery alone will experience recurrence within few years and may benefit from adjuvant chemotherapy. The microRNA-21 test holds great promise as a novel means to direct adjuvant therapy only to those patients in need and thereby not only secure optimal treatment of these patients but at the same time also spare the low risk patients for side effects of chemotherapy.
Annually, colon cancer affects about 108,000 people in the U.S. with 25% of them diagnosed as stage II. Colon cancer is currently the third leading cause of cancer death in the U.S. In Denmark alone, approximately 2,450 patients are diagnosed with colon cancer annually, and approximately 800 of these are diagnosed stage II patients.
Additional information
Lars Kongsbak, President and CEO, tel. +45 4566 0888 (cell: +45 4090 2101)
Hans Henrik Chrois Christensen, CFO, tel. +45 4566 0888 (cell: +45 4090 2131)
