ActoGeniX receives IWT grant for treatment of oral mucositis and starts clinical trial with AG013


ActoGeniX, a development stage biopharmaceutical company, announces that it has been awarded a EUR 0.9 million grant (USD 1.3 million) from the Flemish government through IWT (Institute for Promotion of Innovation by Science and Technology in Flanders), to support the clinical development of AG013, a novel ActoBiotic™ for the treatment of oral mucositis in cancer patients.

The IWT grant will be used to fund further development of AG013, including a phase 1B clinical study which ActoGeniX has initiated this month. This is the second clinical development program in ActoGeniX’s portfolio, next to a phase 2A clinical trial with AG011 in inflammatory bowel disease, for which results are expected in October 2009.

In May of this year, the United States Food and Drug Administration (FDA) approved ActoGeniX’s Investigational New Drug (IND) application, allowing the Company to
initiate a phase 1B clinical trial with AG013 in cancer patients at risk of developing oral mucositis. Meanwhile, ActoGeniX has started this clinical study in collaboration with six reputed oncology centers in the US. The primary aim of the study is to evaluate safety and tolerability of AG013, but it will also allow collection of initial efficacy data.

Dr. Mark Vaeck, CEO of ActoGeniX, comments: “This IWT grant is a strong endorsement of our AG013 program, and allows ActoGeniX to rapidly move forward to develop this product in the clinic. Oral mucositis is a significant challenge in the treatment of cancer, as close to 50% of all cancer patients undergoing chemotherapy or radiation therapy are developing this condition. With AG013 we look forward to offer new and more effective treatment perspectives for these patients.”

Oral mucositis is a painful inflammation of the oral mucosa, affecting cancer patients and making daily activities such as eating, drinking and talking difficult or impossible. It is a severe and debilitating condition, for which no effective cure is available today. Given the high unmet need and the significant number of oral mucositis patients (approximately 2 million new cases in the US and Europe every year), an effective new product for this indication has a substantial revenue potential, estimated by experts to be in the range of USD 1 billion annually.

AG013 is based on ActoGeniX’s proprietary TopAct™ technology platform, and consists of an oral rinsing solution that delivers a potent healing factor to the damaged mucosa in the oral cavity. In preclinical studies, AG013 has already shown significant efficacy and safety results, suggesting that it holds great promise for the treatment of oral mucositis.

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