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ActoGeniX announces start of Phase 2A clinical trial

ActoGeniX reaches important milestone in development of a novel treatment for inflammatory bowel disease

Ghent, September 11, 2008 – ActoGeniX, a development stage biopharmaceutical company, announced today that it has initiated a Phase 2A clinical trial with its lead product AG011 in patients with ulcerative colitis (UC). ActoGeniX received CTA approval for this multi-center, international trial from the authorities in Belgium, Sweden and Canada and is awaiting approval in The Netherlands. Patient enrollment has already started in Belgium. The Belgian clinical study centers participating in this trial are the University Hospitals of Leuven, Antwerp and Ghent, and the Imelda Hospital in Bonheiden.

ActoGeniX is focused on the development and commercialization of ActoBiotics™, a novel class of protein-based biopharmaceuticals that can be orally administered. The Company’s lead product AG011 is an ActoBiotic™ for the treatment of inflammatory bowel disease (which includes both Crohn’s disease and UC) and has previously been successfully tested in a Phase 1 clinical trial with Crohn’s disease patients.

Dr. Mark Vaeck, CEO of ActoGeniX, stated: “ We are delighted that development of our lead product AG011 has progressed to this stage within such a competitive timeframe. We are well on track to rapidly move this innovative therapeutic through the development process, so that it can become available to all UC patients in desperate need for novel treatment options.”

Dr. Bernard Coulie, Vice President R&D at ActoGeniX, added: “The objectives of this double-blind, randomized, placebo-controlled Phase 2A study are to determine safety and tolerability as well as efficacy. We intend to recruit up to 60 UC patients for this study, which we expect to be completed by April 2009.”

ActoGeniX is building a diverse portfolio of ActoBiotics™ for the treatment of severe diseases like inflammatory bowel disease, mucositis, allergic asthma and diabetes. Beyond its lead product AG011, currently in Phase 2A clinical development, ActoGeniX also plans to file an IND in the US early next year to initiate a Phase 1B trial with its second product AG013 for oral mucositis in cancer patients.

Notes for the editor:

About Inflammatory Bowel Disease
Ulcerative colitis and Crohn’s disease, collectively defined as Inflammatory Bowel Disease (IBD), are severe and chronic inflammatory diseases of the gastrointestinal tract. IBD comprises those conditions characterized by a tendency for chronic or relapsing immune activation and inflammation within the gastrointestinal tract. Crohn’s disease and UC are the two major forms of idiopathic IBD.

UC is a chronic, relapsing inflammatory disorder that affects the mucosal lining of the rectum and extends proximally to affect a variable extent of the colon. Clinical characteristics include rectal bleeding, diarrhea and abdominal pain. The cause of the disease and the factors determining its chronic course are unknown.

About ActoGeniX
ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics™, a novel class of biopharmaceuticals for the targeted treatment of severe gastrointestinal (GI) diseases, metabolic diseases, immune disorders and allergies. ActoBiotics™ can be orally administered and are designed to be safer and more effective than injectable biopharmaceuticals. ActoGeniX’s initial focus is on GI diseases and its lead product for the treatment of Crohn’s disease and ulcerative colitis (UC) has already been successfully tested in a Phase 1 clinical trial.

ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University. The Company is headquartered in Ghent (Belgium) and employs close to 40 employees, half of whom are PhD’s, MD’s, or PharmD’s. Shortly after its inception, the Company raised 20 million Euro through a Series A equity round from a consortium of leading life sciences investors such as GIMV, Biotech Fund Flanders, Baekeland Fund (Belgium), Life Sciences Partners, Aescap (The Netherlands) and Ventech (France).

ActoGeniX has a strong and broad intellectual property position with a patent estate encompassing 17 distinct patent families. With broad patent claims already granted in major territories like the US and Europe, ActoGeniX is now uniquely positioned to successfully exploit the commercial potential of its promising new class of biopharmaceutical products.

For more information see

For further information please contact:

Dr Mark Vaeck, CEO - Tel. +32 (0)9 261 06 00 -

Publisher Contact Information:

ActoGeniX NV
+32 (0)9 261 06 00

Company profile of ActoGeniX NV (acquired by Intrexon)
Past press releases of ActoGeniX NV (acquired by Intrexon).


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