Vasogen indentifies best psoriasis treatment schedule
Vasogen Inc VAS
Shares issued 44,893,148 Mar 13 close $7.25
Thu 14 Mar 2002 News Release
Mr. Glenn Neumann reports
VASOGEN CLINICAL TRIAL IDENTIFIES OPTIMAL TREATMENT SCHEDULE ...
Vasogen's open-label clinical trial in moderate to severe psoriasis has
achieved its objective of identifying an optimal treatment schedule for the
company's immune modulation therapy. The trial was conducted at five sites
in Canada, under the direction of Dr. Daniel Sauder, formerly professor and
chief of dermatology at the Sunnybrook Health Sciences Centre, University
of Toronto, and currently professor and chairman, department of
dermatology, Johns Hopkins University.
"Exhibiting none of the safety concerns associated with aggressive
therapies targeting more severe psoriasis, Vasogen's immune modulator shows
considerable potential to address the needs of patients with moderate
disease," said Dr. Sauder, principal investigator for the study. "Given the
therapy's excellent safety profile, tolerability and observed therapeutic
benefits, I also see an important role for this intervention as an adjuvant
therapy for patients with more severe disease. Based on these promising
results, I look forward to participating in the further development of
Vasogen's immune modulation therapy."
The trial enrolled moderate to severe psoriasis patients who were
randomized into one of three groups (group I, n=36; group II, n=38; group
III, n=39), each of which was treated with a different schedule of
Vasogen's immune modulation therapy. Each treatment schedule consisted of
an induction phase followed by a maintenance phase and was administered
over a period of four months. Each group was well matched at baseline in
all important aspects, including demographics and psoriasis area, and
severity index (PASI) score. The study used standard measures of
therapeutic efficacy in evaluating the clinical response to each treatment
schedule.
Over all, the study identified the treatment schedule used in patient group
II as superior to those of groups I and III. Although the open-label trial
design did not allow firm conclusions regarding efficacy to be determined,
the safety, tolerability and changes from baseline observed in a number of
key end points continue to support an attractive therapeutic profile for
Vasogen's immune modulation therapy in psoriasis. A majority of patients
(60 per cent) in group II experienced a clinical improvement based on
maximal PASI scores, with more than 40 per cent of group II patients
improving by 40 per cent or greater, and half of these experiencing a
50-per-cent or greater improvement. Using global physician assessment and
global patient assessment, additional standard measures of therapeutic
efficacy, 26 per cent and 28 per cent of patients in group II achieved an
improvement of 50 per cent to 75 per cent.
Across all three treatment arms, Vasogen's immune modulation therapy was
well tolerated and was shown to be safe, based both on laboratory findings
and clinical monitoring of adverse side effects. As well as showing
superior clinical improvements, the group II schedule also required the
fewest number of treatments, with two consecutive daily treatments for the
induction phase followed by single maintenance treatments given after two
weeks and monthly thereafter. The group II schedule was considered to be
the most convenient and efficient and, therefore, would be expected to
provide the best patient compliance of all three treatment schedules.
"I am pleased that the outcome of this trial has provided us with an
optimal treatment schedule on which to base further clinical development in
psoriasis," said David Elsley, Vasogen's president and chief executive
officer. "It is clear, however, that our recently reported success in
chronic heart failure has positioned the company to accelerate the
timelines for this critical medical problem, making heart failure our top
development priority. Psoriasis continues to represent an important market
opportunity for Vasogen, and we are currently reviewing options for
clinical development targeting underserved segments, such as moderate
disease."
Psoriasis is an inflammatory autoimmune disease of the skin occurring in up
to 2 per cent of the population, with approximately 500,000 individuals in
the United States having moderate disease. It is a life-long condition that
is often emotionally and physically distressing. The cost of care for
psoriasis is estimated to exceed $3-billion annually in the United States
alone, with the moderate segment contributing over $1-billion of that
total.
WARNING: The company relies upon litigation protection for
"forward-looking" statements.
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