Symphogen and Biovitrum Initiate a Second Clinical study with a Novel Treatment of Hemolytic Disease

STOCKHOLM, Sweden and COPENHAGEN, Denmark – Biovitrum AB (publ) (Ticker: STO:BVT) and Symphogen A/S today announced the initiation of a clinical proof of mechanism study to demonstrate the ability of Sym001 (RhD polyclonal antibody) to clear RhD-positive red blood cells from the circulation of RhD-negative healthy volunteers. Clearance of red blood cells by RhD antibodies is an important treatment in preventing hemolytic disease in RhD-positive newborns with RhD-negative mothers. 

Sym001 is a new class of biopharmaceuticals for the prevention of hemolytic disease of the newborn by anti-D prophylaxis (ADP), and for the treatment of Idiopathic Thrombocytopenic Purpura (ITP). 

“Sym001 is an exciting development candidate that represents a novel and attractive therapeutic option for ADP and ITP. The present study will further contribute to the advancement of our project portfolio, which presently includes nine clinical projects. The Sym001 project fits well with Biovitrum´s long experience and broad knowledge within the protein therapeutic area and is perfectly aligned with our specialist care products focus”

 said Martin Nicklasson, CEO of Biovitrum.

“Sym001 is the first ever recombinant 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 polyclonal antibodies as well as single monoclonal antibodies which opens an exciting avenue for development of antibody therapeutics addressing unmet medical needs.” 

This novel treatment 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.

About the Sym001 red blood cell challenge study
The trial will be a dose-adjusting, partly double-blind1 and randomized2 study. Sym001 will be compared with an active control3. The primary objective is to study the ability of Sym001 to clean out RhD-positive red blood cells, following an RhD-positive red blood cell challenge4 to RhD-negative healthy subjects as a model for Anti-D prophylaxis. The study is divided into two parts:  1) In the first part Sym001 or control will be administered intravenously to a maximum of 36 healthy male subjects. 2) In the second part administration will be done intramuscularly to a maximum of 30 healthy male subjects. The trial is conducted at a clinic in Germany and interim results are expected at the end of 2008.  
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 active agent with the desired effect on RhD-positive red blood cells.
4Administration of RhD-positive red blood cells aimed at provoking an immune response, i.e. generation of anti-D antibodies.

About Rh-immunization and Idiopathic Thrombocytopenic Purpura
Hemolytic disease of the newborn 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, i. e. hemolytic disease.  
Idiopathic Thrombocytopenic Purpura is a bleeding disorder characterized by an autoimmune reaction induced abnormally low platelet level, making it difficult for the blood to clot.  

About Sym001
Sym001 is a recombinant polyclonal composition of 25 different Rhesus D antibodies for anti-RhD prevention of hemolytic disease of the newborn and for the treatment of Idiopathic 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  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. Biovitrum has currently a research 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 and eye 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 employing 85 people, based in Copenhagen, Denmark. Refer to www.symphogen.com for further information on Symphogen.