Daval International announced the completion of the treatment period of its randomised, placebo-controlled, double blind Phase II Study, Treating Patients with Bladder Dysfunction with Aimspro in Secondary Progressive Multiple Sclerosis (SPMS). Standard clinical measures and assessment scores recorded on patients who have MS, as well as novel biomarkers will be used to investigate safety, efficacy and response to treatment.
Daval expects to have the initial results from this trial by the end of the summer of 2011, with secondary and tertiary outcomes (biomarker data) being made available shortly thereafter. The study completion marks more than 10 years of research and development undertaken by Daval with Aimspro.
"Daval is extremely delighted to have completed this very complicated study, which is breaking new boundaries in the quest to find a cure for Secondary Progressive Multiple Sclerosis. This study was an important step towards further understanding how much Aimspro could really help people with this disease, for which there is currently no cure or therapy and the results are eagerly awaited" said Professor Syed Haq, MBBS, BSc, PhD, DIC, MCRP(UK) - Chief Scientific Officer at Daval.
About the Study
20 patients participated in this randomised, placebo-controlled, double blind, crossover Phase II trial comparing Aimspro with a placebo. Subjects in both the placebo and treatment groups of the trial were given the treatment by subcutaneous injection twice weekly for 4 weeks. After a 6 week wash-out period they crossed over to receive 4 weeks of Aimspro or placebo. The primary endpoint of the study is the change in average voided volume at weeks 0 to 4 and weeks 10 to 14 respectively. The secondary endpoints of the study are to assess the efficacy of Aimspro as a therapeutic agent for SPMS noting the change in average 24-hour frequency; change in visual acuity and colour vision; change in I-QOL score; change in Kurtzke EDZ assessment; change in MS Impact Scale; change in MS Functional Composite and the change in the MS Walking Scale.
Aimspro is a subcutaneously delivered peptide/polyclonal "large biologic" technically described as hyperimmune caprine serum raised against an inactivated HIV IIIB viral lysate. Aimspro has demonstrated powerful and well-tolerated anti-inflammatory capabilities. Aimspro exhibits tri-partite functionality by targeting the HPA axis and other pathways and by regulating several key intracellular protein kinases via a highly coordinated mechanism that gives the drug considerable biodiversity and possible application.
Read more about Aimspro - http://www.proventus.org.uk/page11.html