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Daval International Announces Positive Phase II Results for AIMSPRO® as a Monotherapy in Established Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
Date:10/10/2011

nds towards benefit for lung function measures. The Forced Expiratory Volume in one second (FEV1) decreased in the placebo group as compared to baseline at 26 weeks (change: -5.6%; p=0.0582) with no such deterioration being observed in the AIMSPRO treated group. Similarly, the Forced Vital Capacity (FVC) was observed to decrease in the placebo group as compared to baseline at 26 weeks (change: -5.6%, p=0.1038), but not in the AIMSPRO treated group, where the FVC showed an increase (change:+1.8%, p=0.3225).

"Although requiring further confirmatory studies, these results are quite exciting, especially when compared to what has been seen in other pilot trials in scleroderma as there is a clear unmet medical need for patients suffering with this life-threatening disease" said Professor Christopher Denton, Professor of Experimental Rheumatology at the Royal Free Hospital in London, United Kingdom, the principal investigator for the trial. "The important value of the safety data from such a well-conducted trial in such a serious disease is clear, apart from the signals of therapeutic benefit."

Daval's Clinical and Scientific Director, Professor Syed Haq commented, "This study, conducted at one of the world's leading scleroderma centres, was an important first step towards understanding whether AIMSPRO could significantly help patients with diffuse scleroderma and potential overlapping connective tissue disorders, for which there is no cure, by arresting the disease even in its latter stages. AIMSPRO has been shown to be well-tolerated and safe and with the several positive therapeutic signals demonstrated, some of which were significant, it certainly warrants further investigation on a larger scale to determine the full efficacy of AIMSPRO in Late Stage Established Diffuse Cutaneous Systemic Sclerosis."

At the completion of the 26 week period of the study, AIMSPRO was offered to the patients on a compassionate
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