Daval International Announces Completion of Phase II Trial for the Treatment of Bladder Dysfunction With AIMSPROÂ® in Secondary Progressive Multiple Sclerosis
EASTBOURNE, England, July 20, 2011 /PRNewswire/ –
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.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic unpredictable neurological disease
affecting 2.5 million people worldwide. Multiple sclerosis can cause blurred
vision, loss of balance, poor coordination, slurred speech, tremors,
numbness, extreme fatigue, difficulties with memory and concentration,
paralysis, stiffness, bladder problems and blindness. Though most people
with multiple sclerosis are diagnosed between the ages of 20 and 40, the
unpredictable physical and emotional effects are life-long. The progress,
severity, and specific symptoms of multiple sclerosis vary greatly from
person to person. Because of the complexity of the disease, the cause and
pathology of multiple sclerosis are still not known.
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 improves 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.
Daval routinely posts information and latest news, including press
releases, which may be important to shareholders, health care professionals
and patients in the News & Resources section of the company’s web site,
http://www.davalinternational.com/. The company encourages all
interested parties to consult these sections for more information on Daval
and its business.
SOURCE Daval International