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Proof-of-Concept Phase 2 Trial of DDP225 for Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome Initiated

WALTHAM, Mass., Oct. 17 /PRNewswire/ -- Dynogen Pharmaceuticals, Inc. announced today that it has initiated a Phase II proof-of-concept trial of DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d), and the first patients have been dosed. DDP225 is an orally-active compound that targets two key pathways that control the gastrointestinal (GI) system, thus giving it the potential to address multiple symptoms associated with IBS-d. This DDP225 Phase II trial is a randomized, double-blind, placebo controlled study that is enrolling patients with IBS-d at multiple centers in Canada and is assessing safety and pharmacodynamic efficacy as well as symptom-based endpoints. In September 2005, Dynogen began dosing patients in a Phase II study of DDP733 for the treatment of patients with constipation-predominant IBS (IBS-c), the other common form of IBS.

"The achievement of this important milestone for Dynogen highlights the successful implementation of our in-licensing strategy. In less than two years since acquiring rights to this compound, we have conducted extensive in vivo preclinical research and initiated this Phase II proof-of-concept trial," said Lee R. Brettman, M.D., Chief Executive Officer at Dynogen. "Dynogen now has two promising and complementary drugs in Phase II proof-of-concept trials that address the two major types of IBS: DDP225 for patients with diarrhea- predominant IBS and DDP733 for patients with constipation-predominant IBS. We plan to continue this momentum with the initiation of additional human clinical trials before the end of the year."

"DDP225 is a unique and very promising compound because of its dual mechanism of action," said Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. "It possesses both noradrenaline reuptake inhibition and 5-HT3 receptor antagonist properties. We are particularly excited about the potential for DDP225 for the treatment of IBS-d because this two-pronged attack may yield significant advantages in addressing the multi- symptomatic nature of a disorder that has proven difficult to treat."

About DDP225
DDP225 is both a noradrenaline reuptake inhibitor and a serotonin type 3 receptor (5-HT3) antagonist. Noradrenaline and serotonin are neurotransmitters that are known to be involved in the control of the gastrointestinal system. The unique combination of noradrenaline reuptake inhibition and 5-HT3 antagonism in one orally delivered compound represents a novel approach to treating IBS-d and other functional GI diseases. Dynogen licensed preclinical and clinical data related to DDP225 from Mitsubishi Pharma in October 2003.

About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome is a chronic condition that is believed to be caused by the abnormal function (dysfunction) of the muscles and/or nerves of the organs of the GI tract. Patients with IBS experience abdominal pain, discomfort and bloating accompanied by altered bowel habit that can include either diarrhea, constipation or both. IBS has prevalence of up to 12% of the general population and females under the age of 45 account for 80% of the patient population with severe cases. It is the most common disease diagnosed by gastroenterologists and one of the most common disorders seen by primary care physicians.

Source: Dynogen Pharmaceuticals, Inc.

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