Biovitrum and Symphogen Report Positive Clinical Results in Novel
Rh-immunization Prevention Project
STOCKHOLM, Sweden and COPENHAGEN, Denmark - November 20, 2008.
Biovitrum AB (publ) (STO:BVT) and Symphogen A/S have completed the
first part of a clinical proof of mechanism study of the recombinant
human polyclonal antibody product Sym001 for future prevention of
Hemolytic Disease of the Newborn (HDN) that can occur in RhD-negative
mothers carrying a RhD-positive fetus. This can lead to an immune
reaction causing destruction of the red blood cells in the newborn,
which may give rise to severe anemia, jaundice, and even cause heart
failure and fatality.
This part of the first clinical study investigated the ability of
Sym001 to clear RhD-positive red blood cells given intravenously to
24 RhD-negative healthy males. Positive control was the
plasma-derived product Rhophylac®, given to 12 subjects. The
preliminary results demonstrate that the recombinant human polyclonal
antibody product is able to clear RhD-positive blood cells at five
days after dosing in a dose dependent manner.
Biovitrum and Symphogen are now planning for the next step of the
clinical programme which should lead to a decision to initiate phase
III studies in the intended label population, namely Rh-negative
mothers carrying an Rh-positive fetus"Clearance of RhD-positive red blood cells from the circulation is
key for the prevention of HDN and thereby constitutes a significant
medical need. It is therefore with great satisfaction we note these
positive results which advances the development of this innovative
biotechnology therapy to prevent newborns from developing HDN.", said
Martin Nicklasson, CEO of Biovitrum."Sym001 is the first ever recombinant human polyclonal antibody
product to have entered human clinical trials and this red blood cell
challenge study is an important step in the further development of
Sym001", said Kirsten Drejer, CEO of Symphogen. "Symphogen's antibody
technology platform offers the opportunity to generate compositions
of recombinant human polyclonal antibodies as well as single
monoclonal antibodies which opens an exciting avenue for development
of antibody therapeutics addressing unmet medical needs."
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 Research, Medical and
regulatory affairs
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
Erik Kinnman, Vice President, Investor Relations & Public Affairs
Mobile: +46 73 422 15 40
erik.kinnman@biovitrum.com
To the Editor:
About the Sym001 red blood cell challenge study
The results show that Sym001 cleared the RhD-positive red blood cells
and that the clearance is dose dependent. At the highest dose level
of Sym001 studied (900 µg) the clearance at five days after dosing
(primary end-point) was comparable to that of Rhophylac®. Sym001 was
found to be safe and well-tolerated at all doses studied.
The study included 24 subjects at three dose levels of Sym001 and 12
subjects given 300 µg Rhophylac®. The study was carried out at a
single center in Berlin.
The study was a dose-adjusting, randomized1 and partly double-blind2
clinical trial. Sym001 was compared with an active control3. The
primary objective was to study the ability of Sym001 to clear
RhD-positive red blood cells, following their administration to
RhD-negative healthy subjects (so-called RBC challenge4) as a model
for Anti-D prophylaxis.
The full trial comprises two parts: In the first part (just completed
with interim results presented above) Sym001 or control was
administered intravenously to a 36 healthy male subjects. In the
second part administration is planned to be done intramuscularly to a
maximum of 30 healthy male subjects. The trial is conducted at a
clinic in Germany.
1 Volunteers are divided between experimental and control groups at
random
2 Neither individuals nor researchers know who belongs to the control
group and the experimental group during the active phase of the
trial..
3 Results will be compared with individuals treated with an active
agent with the desired effect on RhD-positive red blood cells.
4 Administration of RhD-positive red blood cells aimed at provoking
an immune response, i.e. generation of anti-D antibodies.
About Anti- D Prophylaxis (ADP) and Hemolytic Disease of the Newborn
(HDN)
HDN occurs when an RhD-negative woman becomes sensitized to RhD when
carrying an RhD-positive fetus. This immune reaction can trigger a
maternal antibody response in subsequent RhD-positive pregnancies,
causing the breakdown of fetal red blood cells in the newborn, i. e.
hemolytic disease. Anti-D prophylaxis (ADP) means prevention of such
maternal antibody response by administration of anti-D products
(Rh-immunization) which clear fetus's RBC before they trigger
sensitization of the maternal immune system.
About Sym001
This novel intervention does not carry with it the risks of current
immunoglobulin therapies related to their blood donor origin.
Symphogen and Biovitrum are jointly developing Sym001 under a
co-development and commercialization agreement. A phase 1 clinical
study completed in February 2008 showed that Sym001 is safe and well
tolerated in healthy volunteers.
Sym001 is a human recombinant polyclonal composition of 25 different
human IgG1 (Rhesus-D specific) antibodies for anti-RhD prevention of
Hemolytic Disease of the Newborn and for the treatment of Immune
Thrombocytopenic Purpura. Preclinical studies of Sym001 demonstrated
a binding potency and biological function similar to existing
plasma-derived anti-RhD products. A phase 1 clinical trial was
completed in February 2008 and the results showed that Sym001 is safe
and well tolerated in healthy volunteers.
About the Market
Conventional immunoglobulin products are isolated from the blood of
donors. They 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 dependency on donor blood
availability. Biovitrum's and Symphogen's recombinant human
polyclonal antibody 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, product qualities which the Companies believe makes it a
more attractive therapeutic option for both ITP and ADP.
About Biovitrum
Biovitrum is a pharmaceutical company with operations in Sweden and
in the UK. The company markets a range of specialist pharmaceuticals
primarily in the Nordic countries. Using its expertise and experience
Biovitrum takes scientific innovation all the way to the market and
to specialist indication patients with significant medical need.
Research expertise and capabilities include development and
production of biotechnology therapeutics, as well as small molecule
discovery and development. With revenues of approximately SEK 1.3
billion and around 500 employees, Biovitrum is a significant European
specialty pharmaceutical player. Biovitrum's share is listed on the
OMX Nordic Exchange in Stockholm. For more information go to
www.biovitrum.com
About Symphogen
Symphogen is the leader in developing recombinant humanpolyclonal
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 employing 85 people,
based in Copenhagen, Denmark. Refer to www.symphogen.com for further
information on Symphogen.