VIENNA, Austria, Nov. 11 /PRNewswire/ -- igeneon, a biopharmaceutical company focused on cancer immunotherapy, today announced that it will start two additional pivotal trials with its cancer vaccine candidate IGN101. The first is a placebo controlled Phase III study in metastatic colorectal cancer, which will include up to 24 European clinical centers. The second is a controlled Phase III study in adjuvant breast cancer, which will be conducted in cooperation with the Austrian Breast & Colorectal Cancer Study Group (ABCSG). It is the first pivotal trial with a breast cancer vaccine in the adjuvant setting (i.e. after surgery) worldwide. A placebo-controlled Phase II/III trial in adjuvant NSCLC (non small cell lung cancer) is ongoing.
The placebo-controlled colorectal cancer trial will be conducted in up to 24 European centers and include up to 700 patients. Patients with metastatic colorectal cancer will receive IGN101 or placebo in addition to 1st line chemotherapy. The primary endpoint of the Phase III CRC trial is overall survival, with the secondary endpoint being time to disease progression. Annually, in the US and Europe alone, about 360 000 patients are diagnosed with colorectal cancer, which is the second-leading cause of malignancy related death in these regions.
The controlled breast cancer trial will include up to 25 Austrian centers and 600 patients. Patients in the adjuvant stage with increased risk for relapse will receive either standard chemotherapy or standard chemotherapy plus IGN101. Vaccinations will be started immediately after surgery, with the primary tumor removed and no metastases present. The primary endpoint of the Phase III trial in adjuvant breast cancer is relapse free survival. About 410,000 women are diagnosed with breast cancer in the US and Europe each year. It is the leading cancer indication for women.
"To our knowledge, this is the first pivotal trial with and immunotherapy in adjuvant breast cancer worldwide", says Prof. Raimund Jakesz, MD, head of the Vienna General Hospital and University ClinicÂ´s Division of General Surgery and President of the ABCSG study group.
"For igeneon, the start of these controlled Phase III trials is an important milestone. IGN101 is a broadly applicable cancer vaccine candidate with a consequently high market potential. We are now testing IGN101 in three major cancer indications, both in adjuvant and metastatic settings", says Dr. Hans Loibner, CEO of igeneon. "There is a high need for innovative therapies that can complement standard of care treatments like chemotherapy to further improve survival in these indications."
IGN101 is a candidate cancer vaccine that triggers an immune response to EpCAM (epithelial cell adhesion molecule), a membrane protein that is almost always expressed -- and often over-expressed -- on epithelial cancer cells. It aims at the selective destruction of disseminated tumor cells and may thus prevent or delay the formation of metastases.
So far, 350 patients have been treated with IGN101 in clinical studies, with IGN101 showing an excellent side effect profile. Already in Phase I a significant reduction in the number of circulating tumor cells in blood was noted as early evidence of efficacy. In a Phase II trial it was shown that the vaccine induces a strong immune response (95% seroconversion rate) despite concomitant chemotherapies -- a scientifically noteworthy result that delivered the basis to test IGN101 in a variety of clinical settings. A placebo-controlled Phase II/III study in NSCLC (non small cell lung cancer) with up to 760 patients is ongoing. The multi-centric European study started in 2001.
igeneon is a biopharmaceutical company which focuses on the development of active and passive cancer immunotherapies designed to prevent or delay the development of metastases in cancers of epithelial origin. The company has built up a diversified portfolio consisting of broadly applicable three lead products in clinical trials up to Phase III as well as a number of innovative follow-up projects. igeneon is privately held. Investors include 3i, Novartis Venture Fund and Deutsche Venture Capital. The company is based in Vienna, Austria. For further information, visit http://www.igeneon.com/.
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