The results from the trial showed statistical and near statistical significant changes in key clinical outcomes, such as a reduction in the Modified Rodnan Skin Score, mRSS (p=0.041); a responder rate of 50% (AIMSPRO) vs. 10% (placebo) (p<0.061); improved Forced Vital Capacity (FVC) (p=0.029); Forced Expiratory Volume in 1 second (FEV1) (p=0.079) and in the Neuropathic Visual Analogue Scale (VAS) (p=0.046). In addition,no treatment-related serious adverse were recorded during the entire duration of the trial.
Professor Syed Haq, Daval's Chief Medical & Scientific Director commented, "this is the first time that AIMSPRO has appeared in an international peer-reviewed journal focusing on a complex heterogenous connective tissue disorder and it is extremely satisfying to witness that AIMSPRO is receiving this exposure,as a well-defined clinical trial, by healthcare professionals and researchers in rheumatic diseases."
Professor Denton was the principal investigator and Doctor Quillinan was the clinical research fellow on the recently completed 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). They are both from the University College London Medical School, Centre for Rheumatology and Connective Tissue Diseases at the Royal Free hospital in London. Professor Haq, Jeffrey Vernes and Doctor McIntosh are with Daval International, who were the sponsors of the trial.
To view the abstract of the publication, please click on this link:http://ard.bmj.com/content/early/2013/09/25/annrheumdis-2013-203674.abstract
The full publication is available for download for those with a subscription or it can be viewed in the Annals of the Rheumatic Diseases journal, October 2013 edition and the reference is Ann Rheum Dis doi:10.1136/annrheumdis-2013-203674
Notes to Editors
About AIMSPRO®
AIMSPRO® (HyperimmuneCaprine Sera, HICS) is a proprietary, purified, protein-multi-peptide conjugate complex being developed as a novel, first-in-class biological treatment for a number of immune diseases where regulation and stabilisation of the immune system is required. It is believed that the drug has a unique mechanism of action that supports its broad potential application in neuro-degenerative diseases. AIMSPRO has been granted a Specials License by the UK's MHRA and is also available in Australia under Categories A and B of the TGA's Special Access Scheme.
About Daval International Limited
DAVAL INTERNATIONAL LIMITED is an emerging life sciences company focused on the development and delivery of novel and distinctive treatments for serious unmet medical needs through a combination of innovation, dedication, entrepreneurship, skilled science and partnership. From its inception in 2000, the founder and management team of Daval have had a vision of bringing effective treatments that noticeably improve the quality of life of patients suffering from the most serious debilitating neuro-degenerative, inflammatory and autoimmune diseases and to offer a choice over and above some of the disease modifying treatments available currently.
SOURCE Daval International
