COPENHAGEN, Denmark and STOCKHOLM, Sweden – 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.
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.
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.
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:
CEO of Symphogen
+45 45 26 50 59
+45 22 10 99 59 (cell)
Vice President Clinical Research, Medical and Regulatory Affairs of Symphogen
+45 26 16 53 70 (cell)
CEO of Biovitrum
+46 8 697 20 00