Circassia Achieves Successful Phase II Clinical Results With Toleromune(R) Anti-Allergy Technology
Circassia Ltd, a
specialty biopharmaceutical company focused on controlling immune system
responses, announced positive results from a phase II clinical study
of its anti-allergy technology, ToleroMune(R), in the field of cat allergy.
The trial showed that ToleroMune treatment can substantially reduce
allergic reactions to the allergen that causes most cat allergies, and
importantly was well tolerated by all patients.
Circassia conducted the double-blind study in Germany, where patients
with a confirmed history of cat allergies received a single dose of
ToleroMune therapy or placebo. The 88 study participants were divided into
groups, with each receiving a different dose, either via subcutaneous or
intradermal injection to compare the two routes of administration. To test
the effect of the treatment, patients received a microscopic dose of cat
dander (the main allergen responsible for cat allergies) into their skin
several weeks later. Patients who received ToleroMune therapy via the most
effective administration route had markedly reduced skin reactions to the
cat allergen at all of the five dose levels tested compared with placebo.
The most effective dose reduced reactions by over 40%, compared with 10%
for placebo. Throughout the study the ToleroMune treatment proved well
tolerated, with no serious or severe adverse events experienced in any of
the groups, despite the steadily increasing doses.
"These results are extremely encouraging, both for Circassia and the
huge number of people who suffer from allergies. Current treatment options
address the symptoms only or require repeated administrations over many
months under specialist supervision because of the potential for serious
and even life-threatening side effects, which is a particularly important
issue for cat allergy therapies. Therefore, achieving a marked reduction in
allergic responses after just a single dose is remarkable, and we aim to
build on this by testing short treatments of several doses in future
trials," said Steve Harris, Circassia’s CEO. "Our goal for ToleroMune is to
provide a range of allergy therapies that effectively and quickly treat the
underlying disease while also offering excellent safety. Consequently,
these positive clinical results will not only contribute to the development
of our cat allergy product, but will also provide the foundations for our
other allergy programmes that utilize our ToleroMune technology."
In addition to their potential clinical benefits, Circassia’s
anti-allergy products would have significant market opportunities.
Currently, over 150 million people suffer from allergic rhinitis in the US
and Europe and the market for current treatments, despite their
limitations, is approximately $12 billion per year. The prevalence of
cat-dander allergy is high, with 1-in-6 Americans and nearly 10% of
Europeans suffering from the condition. Existing treatments have a number
of issues, either providing symptomatic relief only or requiring lengthy
supervision by specialist physicians. In contrast, Circassia’s ToleroMune
technology has the potential to rapidly desensitize sufferers using
extremely small sections of allergens (termed T-cell epitopes), which
minimizes the potential for adverse reactions.
About Circassia
Circassia is a specialty biopharmaceutical company focused on
developing medicines designed to control immune system responses. The
company has a highly experienced management team with a proven track record
in product development and commercialization, and having successfully
completed two fundraising rounds is backed by a syndicate of world-class
venture capital and institutional investors, including Imperial
Innovations, Lansdowne Partners, Goldman Sachs and Invesco Perpetual.
Circassia’s lead products target allergies utilizing the company’s
proprietary T-cell epitope desensitization technology, ToleroMune. The
company is also developing its ToleroTrans organ anti-rejection technology,
which uses a similar approach to down-regulate immune responses in
transplant patients.
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