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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

EASTBOURNE, England, October 10, 2011 /PRNewswire/ --

Daval International today announced positive results from its Double-Blind Placebo-Controlled Phase II Clinical Study evaluating the safety and tolerability of AIMSPRO given as a monotherapy to patients with Late Stage Established Diffuse Cutaneous Systemic Sclerosis (diffuse scleroderma).  The study evaluated the effects of 4.5mg/ml doses of AIMSPRO, administered subcutaneously, twice weekly for 26 weeks compared with placebo.

The primary endpoint of the study was to evaluate the safety and tolerability of AIMSPRO in the treatment of twenty patients with Systemic Sclerosis (diffuse scleroderma) through a period of 26 weeks of study participation. The secondary outcome measures of the study were to assess the efficacy of AIMSPRO as a therapeutic agent for scleroderma using inter alia the Scleroderma Health Assessment Questionnaire, the Modified Rodnan Skin Score, the Scleroderma UK Functional Score, the Patient and Physician Global Assessment (VAS), the SF-36 (Short form 36) and the MRC Sum Score.

Significantly, at the end of the 26 week period AIMSPRO proved it was a safe and well-tolerated medication when administered to these especially sick patients at such a late-stage of the disease. There was no deterioration in haematological, biochemical, immunologic, cardiologic or in pulmonary parameters that were measured. In addition to the positive safety result, there were encouraging signals of clinical benefit in the secondary outcome measures. The results for the Modified Rodnan Skin Score, a validated measure of disease severity, recorded a worsening in the patients receiving placebo (changes: -27.07%, p=0.29) whereas stability was noted on the patients on AIMSPRO treatment.  Furthermore, there was a distinct improvement in the overall SF-36 scores (changes: +41.6%, p=0.184) for the patients receiving AIMSPRO.

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SOURCE Daval International
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