Positive Phase II Results for AIMSPRO In Scleroderma Announced PDF Print E-mail
Tuesday, 11 October 2011 12:02
Daval International announced yesterday, 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 amongst others, 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.

At the end of the 26 week period AIMSPRO proved to be 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. There were also trends towards benefit for lung function measures.

"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 use basis and the results from the 52 week visit will be presented as an addendum to the initial study report.

Daval is now assessing the biomarker data collected in this clinical trial and correlating this with the changes observed, so as to shed more light into the mechanism of action of AIMSPRO in the context of Late Stage Established Diffuse Cutaneous Systemic Sclerosis.

Source: PRNewswire
 
More articles :

» Godrick Weekes

I am thirty seven years old and I have for the past four years. For me, it has been a roller coaster ride with this condition and its symptoms. In the beginning, I first noticed that my fingers were always swollen on mornings, I could not bend them...

» Frequency of Sexual Dysfunction In Women With Rheumatic Diseases

Sexuality is part of human life and of quality of life, accounting for individual well-being. It relates not only to sexual intercourse itself, but also to a whole spectrum that ranges from self-image and self-valuing to relationship with the...

» Prevention Of Vascular Damage In Scleroderma With Angiotensin-converting Enzyme (ACE) Inhibition

Great strides have been made in identifying and managing the organ-based complications of  systemic sclerosis (SSc). There is no room for the nihilism towards treating this disease that used to be so prevalent. However, there is still...

» Leeds Study Could Help Treat Potentially Fatal Condition

A trial of special insoles is being masterminded by Leeds-based researchers to see if they can help sufferers of a potentially fatal tissue disorder. Patients with , a rare but serious connective disorder which leads to the thickening of body...

» The registry of the German Network for Systemic Scleroderma

N. Hunzelmann, E. Genth, T. Krieg, W. Lehmacher, I. Melchers, M. Meurer, P. Moinzadeh, U. Mu¨ ller-Ladner, C. Pfeiffer, G. Riemekasten, E. Schulze-Lohoff, C. Sunderkoetter, M. Weber, M. Worm, P. Klaus, A. Rubbert, K. Steinbrink, B. Grundt, R. Hein,...

» Shyanne Adams Heading To London Courtesy Of The Make-A-Wish Foundation

It wasn't until Shyanne Adams started feeling better recently that she realized just how hard the past year has been. “I think I was in shock the whole year,” said the 14-year-old Eagle Valley Middle School eighth-grader. “I was depressed. I...

Comments  

 
0 #2 marley 2012-09-29 14:26
This is very good news... :-)
Report to administrator
 
 
0 #1 marley 2012-09-29 14:23
:-)
Report to administrator