Symphogen and Biovitrum have Initiated a Novel Treatment Study in
Autoimmune Bleeding Disorder (ITP) Patients
COPENHAGEN, Denmark and STOCKHOLM, Sweden- July 16, 2008.
Symphogen A/S and Biovitrum AB (publ) (STO:BVT) today announced the
recruitment of the first patient into a Phase II clinical trial,
initiated in June, to evaluate the safety and efficacy, and explore
the dose range of Sym001 in Idiopathic Thrombocytopenic Purpura (ITP)
patients. Sym001 is a recombinant, polyclonal anti-Rhesus D antibody
product candidate. Symphogen and Biovitrum are jointly developing
Sym001 under a 50/50 co-development and commercialization agreement
announced in February 2006."A recombinant polyclonal Anti-D product will provide an improved
treatment alternative for ITP patients compared to the existing
plasma derived Anti-D immunoglobulins, as supplies of the current
products are limited and subject to potential safety concerns due to
their blood plasma origin. The initiation of the second phase II
trial with Sym001 this year is a major step to further validate the
potential of recombinant polyclonal antibodies as a new class of drug
and to highlight progress in our pipeline." said Kirsten Drejer, CEO
of Symphogen."The potential of Sym001 as a new treatment modality for unmet
medical needs fits well with Biovitrum's specialist care and
biopharma focus and strengths. Moreover, the initiation of this Phase
II trial is a successful milestone in our working collaboration with
Symphogen." said Martin Nicklasson, CEO of Biovitrum.
About the Sym001 Phase II Study
Up to 55 RhD-positive adult non-splenectomized patients with ITP will
be enrolled in this first exploratory open label safety, efficacy and
dose-finding trial. The study objective is to evaluate the safety of
Sym001 following a single intravenous dose. In addition, the study
will determine the appropriate dose range in preparation for Phase
III trials by assessing the increase in platelet levels and explore
the mechanism of action of Sym001 by assessing its binding to red
blood cells. Symphogen is sponsor for the Phase II study which is
being conducted at 23 sites in Europe.
About Sym001
Sym001 is a recombinant polyclonal composition of 25 different Rhesus
D specific antibodies for the treatment of Idiopathic
Thrombocytopenic Purpura and for Anti-RhD prophylaxis (ADP) in
prevention of Hemolytic Disease of the Newborn. In February 2008,
Symphogen and Biovitrum reported results from a Phase I
dose-escalation, placebo-controlled trial, demonstrating that Sym001
was safe and well tolerated. In April 2008, a proof of mechanism
study for ADP was initiated to demonstrate the ability of Sym001 to
clear RhD-positive red blood cells from the circulation of
RhD-negative healthy volunteers.
About Idiopathic Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding
disorder characterized by abnormally low platelet levels, making it
difficult for the blood to clot normally. ITP is a chronic and
debilitating disease, associated with increased bleeding risk and
impaired quality of life.
About Symphogen
Symphogen is the leader in developing recombinant polyclonal
antibodies (pAb), a new class of biopharmaceuticals for the treatment
of serious human diseases. By employing its pioneering antibody
discovery and manufacturing technologies, Symphogen generates
recombinant antibody compositions that capture the diversity and
effectiveness of the natural immune system. Symphogen is building a
proprietary product pipeline within several disease areas, including
infectious diseases and cancer.
Symphogen is a private biopharmaceutical company with over 80
employees, based in Copenhagen, Denmark. Refer to www.symphogen.com
for further information on Symphogen.
About Biovitrum
Biovitrum is a specialty pharmaceutical company with operations in
Sweden and in the UK. Biovitrum markets a range of specialist
pharmaceuticals primarily in the Nordic countries. The company has a
research portfolio with several projects in clinical and preclinical
phases for a number of well defined specialist indications. Biovitrum
has the expertise and experience to take its projects all the way to
the market. Biovitrum develops and produces protein-based drugs and
also has small molecule research expertise and capabilities.
Biovitrum has revenues of approximately SEK 1.2 billion and around
500 employees. Biovitrum's share is listed on the OMX Nordic Exchange
in Stockholm. For more information see www.biovitrum.com
For more information please contact:
Kirsten Drejer, CEO of Symphogen: +45 45 26 50 59 or +45 22 10 99 59
(cell) kd@symphogen.com
Christian Meyer, Vice President Clinical Research, Medical and
Regulatory Affairs of Symphogen: +45 26 16 53 70 (cell)
cme@symphogen.com
Martin Nicklasson, CEO of Biovitrum: +46 8 697 20 00
martin.nicklasson@biovitrum.com