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.
AboutAIMSPRO®
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.
About Daval
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