Biovitrum and Symphogen have Successfully Completed Phase I Clinical
Trial with Recombinant Polyclonal Antibody
Biovitrum and Symphogen are developing a recombinant, polyclonal
antibody (Sym001) for the treatment of Idiopathic Thrombocytopenic
Purpura (ITP) and prophylaxis of hemolytic disease of the newborn.
The phase I clinical trial was initiated in March 2007 and the
results from the study show that Sym001 is safe and well tolerated.
STOCKHOLM, Sweden and COPENHAGEN, Denmark - Biovitrum and Symphogen
today announced the completion of a phase I clinical trial to test
the safety and tolerability of Sym001 in healthy volunteers. The
results from the dose-escalation, placebo-controlled study show that
Sym001 is well tolerated.
Sym001 is a recombinant, polyclonal antibody product candidate,
comprised of 25 different anti-Rhesus D antibodies. Sym001 is in
development for the treatment of Idiopathic/Immune Thrombocytopenic
Purpura (ITP) and for Anti RhD Prophylaxis (ADP) of hemolytic disease
of the newborn. Symphogen and Biovitrum are jointly developing
Sym001 under a co-development and commercialization agreement
announced in February 2006.
Further clinical development of Sym001 will now be pursued in both
indications.
Martin Nicklasson, CEO of Biovitrum, said, "We are very happy to see
this advancement in our project portfolio which presently includes
nine projects in the clinic. Our partnership with Symphogen is of
great strategic value. It fits well with Biovitrum's long experience
and broad knowledge within the area of protein therapeutics and
matches perfectly our focus on specialist indications.""Sym001 is the first ever recombinant polyclonal antibody product to
enter human clinical trials. The successful completion of this phase
I trial is a very significant milestone for Symphogen", said Kirsten
Drejer, CEO of Symphogen. "Symphogen's antibody technology platform
offers the opportunity to generate compositions of recombinant
polyclonal antibodies as well as single monoclonal antibodies which
opens an exciting avenue for development of antibody therapeutics
addressing large and unmet medical needs."
About the Sym001 phase I trial
Altogether 59 RhD-positive (to support further studies in ITP) and 18
RhD-negative (to support further studies in ADP) healthy male
volunteers were enrolled in the double-blind1, randomized2,
placebo-controlled3, dose-escalation phase I trial. The study
objective was to assess the safety and tolerability of Sym001
following a single intravenous infusion. The trial was conducted at a
phase I unit in the United States.
1Neither individuals nor researchers know who belongs to the control
group and the experimental group during the active phase of the
trial.
2Volunteers are divided between experimental and control groups at
random.
3Results will be compared with individuals treated with an agent
without any actual medicinal effect; the control group.
To the Editor:
About the Market
Conventional immunoglobulin products are isolated from the blood of
donors, and therefore are subject to potential safety issues due to
the risk of disease transmission, relatively low batch to batch
consistency, as well as to supply shortages caused by dependence on
donor blood availability. Biovitrum's and Symphogen's recombinant
fully human product Sym001 can be produced in unlimited supply, it
carries no known risk of viral or prion transmission and the
manufacturing process brings the composition of antibodies under
control, qualities that the Companies believe makes it a more
attractive therapeutic option for both ITP and ADP.
About Sym001
Sym001 is a recombinant polyclonal composition of 25 different
anti-Rhesus D antibodies for the treatment of Idiopathic
Thrombocytopenic Purpura and for Anti RhD Prevention of hemolytic
disease of the newborn. Preclinical studies of Sym001 demonstrated
its binding potency and biological function similar to existing
plasma-derived anti-RhD products.
Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding
disorder characterized by abnormally low platelet levels, making it
difficult for the blood to clot normally. Hemolytic disease of the
newborn occurs when an RhD-negative woman becomes sensitized to RhD
when carrying an RhD-positive child. This immune reaction can
trigger a maternal antibody response in subsequent RhD-positive
pregnancies, causing the breakdown of fetal red blood cells, i. e.
hemolytic disease.
About Biovitrum
Biovitrum is one of the largest biopharma companies in Europe. With
operations in Sweden and in the UK Biovitrum conducts research and
develops pharmaceuticals for unmet medical needs both for conditions
that affect smaller patient populations and for common diseases.
Biovitrum has currently a broad and balanced R&D portfolio with
several projects in clinical and preclinical phases for a number of
well defined specialist indications as well as for common diseases
within obesity, diabetes, inflammation, eye and blood diseases.
Biovitrum develops and produces protein-based drugs on a contractual
basis and markets a range of specialist pharmaceuticals primarily in
the Nordic countries. 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 since September 15, 2006. For more
information see www.biovitrum.com.
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 has established
collaborations with international pharmaceutical companies.
Symphogen is a private biopharmaceutical company with over 80
employees, based in Copenhagen, Denmark. Refer to www.symphogen.com
for further information on Symphogen.
For further information please contact:
Symphogen A/S
Kirsten Drejer, CEO
Phone: +45 45 26 50 59, Mobile: +45 22 10 99 59
kd@symphogen.com
Christian Meyer, Vice President, Clinical Development of Symphogen
Phone: +45 45 26 63 70, Mobile: +45 26 16 53 70
cme@symphogen.com
Biovitrum AB (publ)
Martin Nicklasson, CEO
Phone. +46 8 697 20 00
martin.nicklasson@biovitrum.com
Göran Arvidson, CFO
Phone: +46 8 697 2368, Mobile: +46 70 633 30 42
goran.arvidson@biovitrum.com
Erik Walum, Director, Science Communication
Phone. +46 8 697 32 40, Mobile: +46 70 312 90 75
erik.walum@biovitrum.com