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

Main Category: Blood / Hematology
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 Dec 2009 - 3:00 PDT

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Biovitrum AB (publ) (STO: BVT) 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, hemophilia A patients. The rFVIIIFc program and international study are partnered with Biogen Idec (NASDAQ: BIIB).

Hemophilia A patients require frequent Factor VIII injections, which create a significant burden for these individuals. The rFVIIIFc molecule is being investigated for the potential to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy in Hemophilia A. Preclinical studies showed improved half-life of rFVIIIFc, which is based on Biogen Idec's monomeric Fc-fusion technology (recently presented 7 December 2009 at the American Society of Hematology conference).

"We are excited about bringing rFVIIIFc into the clinical stage together with Biogen Idec and, thereby adding another significant collaboration project to the ongoing recombinant Factor IX Fc fusion (rFIXFc) clinical program. The innovative rFVIIIFc program holds great potential in offering true value to hemophilia A patients, and is thus a prioritized therapeutic and business area within Biovitrum," said Peter Edman, CSO of Biovitrum.

About Hemophilia A

Hemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Hemophilia A occurs in about 1 in 10,000 male births annually and is caused by having substantially reduced or no factor VIII protein, which is needed for normal blood clotting. People with hemophilia A therefore need injections of factor VIII to restore the coagulation process and prevent frequent bleeds that could otherwise lead to pain, irreversible joint damage and life-threatening hemorrhages. Prophylaxis treatment with infusions three times per week or every second day to maintain a sufficient circulating level of coagulation factor is being increasingly used, and long-term studies demonstrate that such regimens increase the patient's life expectancy and greatly reduce if not eliminate progressive joint deterioration. The current global market for recombinant Factor VIII products is over 4 BUSD annually.

Source
Biovitrum

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