SuppreMol's SM101 shows a sustained clinical activity and a favorable safety profile in Primary Immune Thrombocytopenia (ITP) patients
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SuppreMol's SM101 shows a sustained clinical activity and a favorable safety
profile in Primary Immune Thrombocytopenia (ITP) patients
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Munich, Germany, December 10, 2012: SuppreMol GmbH, a biopharmaceutical company
focused on the development of novel therapeutics for the treatment of autoimmune
diseases, today announced the presentation of interim results from an ongoing
Phase Ib/IIa clinical trial in ITP patients. In the dose escalation part of the
study, patients were treated at dose levels between 0.3 and 12 mg/kg and
received 5 injections of SM101 during the 8 week treatment cycle. Three out of
four patients treated with 12 mg/kg of SM101 showed a clinically important and
sustained increase in platelet count after a single cycle of treatment with
SM101. At dose levels of up to 12 mg/kg SM101, no safety concerns have been
identified.
The data were reported in a poster presentation (abstract # 3388) today at the
54(th) American Society of Hematology (ASH) Annual Meeting in Atlanta, GA.
"The interim data of SM101 in patients suffering from chronic ITP are very
encouraging", comments Dr. Tatyana Semenovna Konstantinova of GUZ Sverdlovskaya
Regional Clinical Hospital #1, Yekaterinburg, Russia, a Principal Investigator
for the ongoing Phase Ib/IIa study. "The combination of sustained platelet
response after a single cycle of SM101 and the favorable safety profile
certainly warrants further development of this exciting therapeutic approach."
"Current therapies of chronic ITP all have important limitations", comments Dr.
David Kuter from Massachusetts General Hospital, Harvard Medical School, an
expert in the treatment of ITP. "SM101 has a novel mechanism of action that is
designed to selectively modulate the immune response. Early clinical data
presented at ASH suggest that it has the potential to provide a prolonged
increase in platelet counts in patients with ITP."
SuppreMol has an ongoing dose-escalation trial in ITP in Europe and intends to
initiate a randomized Phase II clinical trial in ITP in the US and Europe in
2013.
The poster presented at ASH can be found at
http://www.suppremol.com/tl_files/pdf/Poster/SuppreMol-ASH2012-poster_SM101.pdf
About SM101
SuppreMol's lead candidate, SM101, is a recombinant, soluble, non-glycosylated
version of the Fc-gamma-receptor IIB. The protein binds to
autoantibody/autoantigen complexes and blocks the activation of Fc receptors on
the surface of immune cells. As a result, the immune response is down regulated
as is the associated inflammation cascade, typically observed in autoimmune
diseases. The efficacy of SM101, including a reduction of inflammation and
immune parameters, has been demonstrated in relevant animal models. Currently,
SM101 is being evaluated in a Phase II trial in ITP. SM101 has received orphan
drug designation in the US and Europe for ITP. In addition, SM101 is being
studied in a Phase II, double-blind clinical trial in patients with Systemic
Lupus Erythematosus (SLE). SM101 also has a potential in a number of other B
cell driven autoimmune diseases, including Rheumatoid Arthritis (RA).
About Primary Immune Thrombocytopenia
ITP is a severe autoimmune disease mediated by antibodies of the patient's
immune system targeting and destroying the patient's platelets. An adequate
number of platelets is essential for the control of bleeding. The immune
response to platelets in ITP can result in extremely low platelet counts, which
can result in severe, sometimes fatal, bleeding. ITP occurs in about 10 of
100,000 people and is more prevalent in women compared to men. Current treatment
includes long-term treatment with corticosteroids, IVIg, splenectomy, other
chronic immunosuppressive therapies (including B cell depleting antibodies) and
thrombopoetin (TPO) receptor agonists.
About SuppreMol
SuppreMol GmbH is a privately held biopharmaceutical company developing novel
therapeutics for the treatment of autoimmune and allergic diseases. The company
is pioneering the development of soluble Fc-gamma receptors (FcgRs), which are
recombinant autologous therapeutic proteins with a specific immunoregulatory
potential. The company is developing FcgRs in two ongoing Phase II studies for
the treatment of ITP, Systemic Lupus Erythematosus (SLE) and potentially for
Rheumatoid Arthritis (RA) and other autoimmune conditions. SuppreMol's pipeline
includes two antibody development programs utilizing the inhibitory effect of
FcgRIIB suitable for alternative treatment strategies and indications as well as
an anti-IL-3 antibody to treat RA.
Contact
SuppreMol GmbH
Prof. Dr. Peter Buckel
Chief Executive Officer
Tel: +49 89 30 90 50 680
E-mail: info(at)suppremol.com
www.suppremol.com
Press Release PDF:
http://hugin.info/155552/R/1663764/539619.pdf
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Source: SuppreMol GmbH via Thomson Reuters ONE
[HUG#1663764]
Unternehmensinformation / Kurzprofil:
Datum: 10.12.2012 - 16:06 Uhr
Sprache: Deutsch
News-ID 211241
Anzahl Zeichen: 6044
contact information:
Town:
Martinsried/Munich
Kategorie:
Business News
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