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2016-10-11

Hansa Medical: First patient treated with IdeS in Phase II study in acquired Thrombotic Thrombocytopenic Purpura (TTP)

Hansa Medical AB (publ) today announced that the first patient has
been recruited and treated in a Phase II clinical study with IdeS in
the acute autoimmune disease acquired Thrombotic Thrombocytopenic
Purpura (TTP) at University College Hospital in London.

Acquired TTP is a severe and acute autoimmune blood disorder in which
the presence of autoantibodies can result in systemic life
threatening micro-clotting in vital organs. The Hansa
Medical-sponsored study with IdeS in TTP is an open-label study to
evaluate the safety, tolerability, efficacy, pharmacodynamics and
pharmacokinetics of IdeS in asymptomatic patients with acquired TTP.

The patients in the study will have low ADAMTS13 activity. ADAMTS13 is
a significant component in the coagulation system. An important goal
of the study is to investigate if one dose of IdeS results in
increased ADAMTS13 activity by cleaving ADAMTS13 autoantibodies. The
Clinical Investigator, Dr. Marie Scully, consultant haematologist at
UCLH, is a leading expert in patient care and clinical research in
TTP.

The study will include up to six patients with acquired TTP and low
ADAMTS13 activity who are asymptomatic at the time of enrolment into
this study. The study is expected to be completed during 2017.

"This novel therapy, initially investigated to determine safety and
efficacy, could provide an innovative treatment for acute TTP,
clearing the antibodies against ADAMTS 13, aiding response to
remission and reducing morbidity and mortality", says Dr. Scully, who
is supported by the National Institute for Health Research University
College London Hospitals Biomedical Research Centre.

"We are happy to now announce our progress into the autoimmune space
through the initiation of this explorative Phase II trial with IdeS
in acquired TTP. The effective and fast IgG-cleaving mode-of-action
of IdeS makes it highly relevant to evaluate the efficacy and safety
of IdeS in this potentially devastating acute condition", says Göran
Arvidson, CEO of Hansa Medical AB.

The information in this press release is disclosed pursuant to the EU
Market Abuse Regulation. The information was released for public
disclosure through the agency of Göran Arvidson stated below on
October 11, 2016 at 08.30 CET.

For further information, please contact:
Emanuel Björne, Vice President Business Development and Investor
Relations, Hansa Medical AB (publ)

Mobile: +46707175477
E-mail: emanuel.bjorne@hansamedical.com
Göran Arvidson, CEO
, Hansa Medical AB (publ)
Mobile: +4670633 3042
E-mail: goran.arvidson@hansamedical.com

About acquired TTP
Acquired TTP is an ultra-rare, acute, auto-immune blood clotting
disorder, affecting 1/100,000 inhabitants. It has a sudden onset
caused by impaired activity of the ADAMTS13 enzyme (typically <10% of
that in plasma of healthy individuals), leaving ultra-large Von
Willebrand Factor (vWF) molecules un-cleaved (vWF is an essential
protein involved in the blood clotting process). These ultra-large
vWF molecules bind to blood platelets, resulting in severe
thrombocytopenia (very low platelet counts) and formation of
micro-clots in small blood vessels throughout the body. Acquired TTP
is associated with severe morbidities of the brain, heart and kidney
and affects life expectancy and quality of life. Mortality is high at
10-15% within 2 weeks after initial diagnosis. Moreover, the risk of
recurrences is high in patients with persistently low levels of
ADAMTS13 after treatment with the current standard of care, which
consists of daily plasma exchange and immune-suppressants.

About IdeS

IdeS, a unique molecule with a novel mechanism, is an enzyme that
specifically cleaves human IgG antibodies. IdeS has been evaluated in
a Phase I study in healthy subjects and in a Phase II study in
sensitized patients awaiting kidney transplantation demonstrating
that IdeS is highly effective in reducing anti-HLA antibodies to
levels acceptable for transplantation with a favorable safety
profile. The efficacy and safety of IdeS in transplantation are
currently investigated in three on-going Phase II studies in
sensitized kidney patients in Sweden and the US. In addition to
transplantation, IdeS has potential applications in a variety of rare
autoimmune diseases and currently, the efficacy and safety of IdeS
are investigated in a Phase II study in acquired Thrombotic
Thrombocytopenic Purpura.

About Hansa Medical AB (publ)
Hansa Medical is a biopharmaceutical company focusing on novel
immunomodulatory enzymes. The lead project IdeS is an
antibody-degrading enzyme in clinical development, with potential use
in transplantation, rare autoimmune diseases and oncology. Additional
projects focus on development of new antibody modulating enzymes, as
well as HBP, a diagnostic biomarker for prediction of severe sepsis
at emergency departments that is already introduced on the market.
The company is based in Lund, Sweden. Hansa Medical's share (ticker:
HMED) is listed on Nasdaq Stockholm.

About UCLH
UCLH (University College London Hospitals NHS Foundation Trust),
situated in the West End of London, is one of the largest NHS trusts
in the United Kingdom and provides first-class acute and specialist
services. The state-of-the-art University College Hospital which
opened in 2005, is the focal point of UCLH alongside four
cutting-edge specialist hospitals. UCLH is committed to research and
development and forms part of UCL Partners which in March 2009 was
officially designated as one of the UK's first academic health
science centres by the Department of Health. UCLH works closely with
UCL, translating research into treatments for patients. For more
information, visit: www.uclh.nhs.uk, Facebook (UCLHNHS), Twitter
(@UCLH) or Youtube (UCLHvideo).

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http://news.cision.com/hansa-medical/r/first-patient-treated-with-ides-i...
http://mb.cision.com/Main/1219/2097725/572928.pdf

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