Biovitrum Advances Novel Factor VIII Long-Acting Hemophilia A Therapy into Clinical Trials

17-Dec-2009 - Biovitrum AB announced that the first patient was dosed in a phase I/IIa study of its long-acting fully-recombinant Factor VIII Fc fusion (rFVIIIFc) protein. The phase I/IIa open-label study will assess the safety, tolerability and pharmacokinetics of rFVIIIFc in severe, previously-treated, ...

Biogen Idec and Biovitrum Announce Decision to Advance Long-Acting Hemophilia B Therapy into a Registrational Trial

21-Oct-2009 - Biogen Idec and Biovitrum AB announced that they plan to advance the companies' long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients. The decision to advance the program is based on promising data from a Phase I/IIa ...

Biovitrum's and Syntonix's Novel Factor IXFc for Hemophilia B has Received Orphan Drug Designation From the FDA

27-Nov-2008 - Biovitrum AB and Syntonix Pharmaceuticals, Inc., a subsidiary of Biogen Idec announced that the company's FIXFc compound for the control and prevention of hemorrhagic episodes in patients with hemophilia B has received an orphan-drug designation from the US Food and Drug Administration (FDA). ...

Biovitrum and Symphogen Report Positive Clinical Results in Novel Rh-immunization Prevention Project

24-Nov-2008 - Biovitrum AB 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. ...

Biovitrum Implements Strategic Restructuring of the R&D Organization

Running R&D expenses estimated to be reduced by MSEK 115 on a rolling twelve-month basis

19-May-2008 - Biovitrum AB announced that it has completed the review of its research and development organization as announced in November 2007, when the company's new business strategy was initiated. In the new strategy, Biovitrum will focus on specialist care pharmaceuticals, as well as taking its projects ...

Biovitrum and Symphogen Initiates a Second Clinical study with a Novel Treatment of Hemolytic Diseases

21-Apr-2008 - Biovitrum AB and Symphogen A/Sannounced 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 ...

Biovitrum and Syntonix begin phase I/IIa clinical trial of long-acting recombinant Factor IXFc for treatment of Hemophilia B

06-Mar-2008 - Biovitrum AB and Syntonix Pharmaceuticals, Inc. have obtained approval from the US Food and Drug Administration to commence a clinical phase I/IIa study of a long-acting, recombinant Factor IXFc for the treatment of Hemophilia B. The US Food and Drug Administration (FDA) has approved the ...

Biovitrum and Symphogen have Successfully Completed Phase I Clinical Trial with Recombinant Polyclonal Antibody

07-Feb-2008 - Biovitrum and Symphogen 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 ...

Results from Biovitrum's Phase II Clinical Trial of Novel Pain Treatment

14-Dec-2007 - Biovitrum evaluates a novel method for treating pain in a phase II clinical trial. The recruitment of patients to the study has now been completed and the results are expected to be presented already early second quarter 2008. The treatment aims at neuropathic pain, which is a chronic form of ...

Biovitrum Initiates Phase II Clinical Trial of Novel Pain Treatment

04-May-2007 - Biovitrum examines a novel method for treating pain in a phase II clinical trial. The treatment aims at neuropathic pain, which is a chronic form of pain resulting from nerve injuries. Contrary to current treatments that act in the brain, Biovitrum's substance is expected to act peripherally, ...