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 International - webpage.
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. http://www.proventus.org.uk/page1030.html
AIMSPRO is a pharmaceutically derived biological product that is manufactured and processed using a unique specification that is patent protected. It has passed all of the relevant regulatory authorities and industry standards and is derived from a caprine hyperimmune source"
Aimspro is composed of a set of peptides that act to stimulate the release and regulation of a molecular cascade that modulates the Hypothalamo-Pituitary-Adrenal (HPA) axis. The medication demonstrates powerful anti-inflammatory properties. It contains cytokines that induce a predominantly TH-2 anti-inflammatory profile in the patient.
Some of the peptides in Aimspro are regulated and bound by specific carrier molecules that may regulate the action and release of their ligand (a signal triggering molecule, binding to a site on a target protein). They are probably necessary for the appropriate regulation and pharmacokinetics of the molecular machinery. The carrier molecules also function as a slow release mechanism, releasing bioactive components over several days.
http://www.proventus.org.uk/page11.html
Multiple Sclerosis Case Studies & Single Case Studies - http://proventus.org.uk/page889.html
The MS Society (UK) had posted up on their web site a Fact v Fiction document some of which provided misleading information about Aimspro. Since then the posting has been taken down – http://www.proventus.org.uk/page744.html
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