Ημερομηνία: 12/3/2007 9:04:00 πμ Περιοχή: Νέα Υόρκη ΗΠΑ Από: BW
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( BW)(SYMPHOGEN) Symphogen and Biovitrum Initiate Phase 1 Clinical
Trial with The First Recombinant Polyclonal Antibody to Enter Clinical
Evaluation
Sym001 to be Evaluated for Rare Blood Diseases and Anti-RhD
Prophylaxis
Symphogen and Biovitrum are developing a recombinant, polyclonal
antibody for the treatment of Idiopathic Thrombocytopenic Purpura
(ITP) and anti-RhD prophylaxis of Hemolytic Disease of the Newborn
(HDN). The product, Sym001, consists of 25 different recombinant
anti-Rhesus D antibodies.
Business Editors/Health/Medical Writers/International Writers
COPENHAGEN, Denmark & STOCKHOLM, Sweden--(BUSINESS WIRE)--March
12, 2007--Symphogen and Biovitrum today announced the initiation of a
Phase 1 clinical trial to test the safety, pharmacokinetics and
pharmacodynamics of Sym001 (Anti-RhD) in healthy volunteers. 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 Thrombocytopenic Purpura (ITP) and for the
prevention of Hemolytic Disease of the Newborn (HDN). Symphogen and
Biovitrum are jointly developing Sym001 under a co-development and
commercialization agreement announced in February 2006.
"Sym001 is the first ever recombinant polyclonal antibody to enter
human clinical trials. The approval from the FDA to enter Phase 1 and
the dosing of our first subjects are very significant milestones for
Symphogen, and they serve as a demonstration of our successful
partnership with Biovitrum," said Kirsten Drejer, Ph.D., CEO of
Symphogen. "This landmark achievement for us is a clear validation
that our platform technologies are able to generate consistent batches
of important products which can progress now into clinical
evaluation."
Mats Pettersson, CEO of Biovitrum, said, "We are very happy that
we now have six projects in the clinic. We are gearing up for an
intense year with a very strong news flow from our pipeline both in
terms of results from ongoing trials and initiation of new trials
especially within our protein-based specialist programs. Our
partnership with Symphogen is of great strategic value and fits well
with Biovitrum's long experience and broad knowledge within the area
of protein therapeutics. Symphogen's technology platform with
a recombinant polyclonal antibody product enables us to focus on
diseases currently treated by traditionally produced immunoglobulins.
This new approach has a broader therapeutic potential and the concept
is well showcased in our partnership."
About the Sym001 Phase 1 Trial
Up to 39 RhD positive and 18 RhD negative healthy volunteers will
be enrolled in the double-blind, randomized, placebo-controlled, dose
escalation Phase 1 trial. The primary study objective is to assess the
safety and tolerability of Sym001 following a single intravenous
infusion. Secondary trial objectives are to evaluate the
pharmacokinetic profile (binding, distribution, excretion), the
pharmacodynamic profile (clinical activity) and any potential
immunogenicity (immune system reaction) of Sym001. The trial is being
conducted at a clinic in the United States and the study is expected
to be completed with results at the end of 2007.
To the Editor:
About the Market
Conventional immunoglobulin products are isolated from the blood
of donors, and therefore subject to potential safety issues due to the
risk of disease transmission, as well as to supply shortages caused by
dependence on donor blood availability. Symphogen and Biovitrum's
recombinant polyclonal antibodies can be produced in unlimited supply,
and they carry decreased risk of viral or prion transmission,
qualities that the Companies believe make them a more attractive
therapeutic option for both ITP and prophylaxis of HDN.
Symphogen's technology can also address the large markets
currently targeted by monoclonal antibody therapies, and Symphogen's
preclinical pipeline includes products targeting infectious diseases
and cancer.
About Sym001
Sym001 consists of 25 different recombinant polyclonal anti-Rhesus
D antibodies for the treatment of Idiopathic Thrombocytopenic Purpura
and for the 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. Symphogen has a co-development and commercialization
agreement with Biovitrum AB for Sym001.
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 may result when a RhD-negative woman becomes sensitized to RhD
while carrying a 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.
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 common
diseases and conditions that affect smaller patient populations.
Biovitrum has a broad and balanced R&D portfolio with several projects
in clinical and preclinical phases for the treatment of obesity,
diabetes, inflammation and eye and blood diseases as well as a number
of well defined niche indications. 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 550
employees. Biovitrum is listed on the Stockholm Stock Exchange 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 75
employees, based in Copenhagen, Denmark. Refer to www.symphogen.com
for further information on Symphogen.
CONTACT: Symphogen:
Kirsten Drejer
CEO
+45 45 26 50 59
Cell: +45 22 10 99 59
kd@symphogen.com
or
Christian Meyer, MD, PhD
Vice President, Clinical Development
+45 45 26 63 70
Cell: +45 26 16 53 70
cme@symphogen.com
or
MacDougall Biomedical Communications
Kari Watson, 508-647-0909
kwatson@macbiocom.com
or
Biovitrum:
Mats Pettersson
CEO
+46 08-697 23 27
mats.pettersson@biovitrum.com
or
Anna Karin Kallen
Vice President Communications
+46 8-697 20 85
Cell: +46 73-433 20 85
annakarin.kallen@biovitrum.com
KEYWORD: DENMARK SWEDEN INTERNATIONAL EUROPE
INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY MARKETING
AGREEMENTS
SOURCE: Symphogen
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