March 9 /PRNewswire/ -- Baxter Healthcare Corporation and Pharming Group N.V. announced the start of a Phase I clinical study with recombinant human C1 inhibitor in asymptomatic patients with hereditary angioedema. This study will be the first clinical study with any form of recombinant human C1 inhibitor. In this study the safety, tolerability, clearance and activity of the product will be investigated.
``We are very excited with the start of this clinical study'', said Philippe van Holle, Pharming's executive vice president Biotherapeutics. He continued, ``Genetic disorders receive special attention within Pharming. Recombinant human C1 inhibitor has been developed through our breakthrough transgenic technology and we hope it will prove to be a highly effective therapeutic modality in hereditary angioedema. This disorder has a strong impact on quality of life, due to its unpredictable nature, the potential severity of the attacks, which can be life-threatening, and the possible side effects of some currently available therapies.''
``Advancing our recombinant human C1 inhibitor into the clinic is an important milestone for people impacted by the rare but serious disease of hereditary angioedema,'' said Norbert Riedel, Ph.D., president of Baxter BioScience's recombinant business unit. ``In addition, it is a key milestone for Baxter as we continue to build an innovative research pipeline to accelerate future business growth. We are particularly excited to be developing a transgenic product that complements our portfolio of plasma- derived and recombinant therapeutic proteins.''
Hereditary angioedema is characterized by acute attacks of localized swelling of soft tissues, which can become extremely painful or even life- threatening, depending on the actual location of the attack. The patients enrolled in this trial are asymptomatic, i.e. they are diagnosed with hereditary angioedema, but are at present in a stable condition without active symptoms of the disease. Currently, subsequent clinical studies are being designed, which are aimed at evaluating the efficacy of this novel agent in patients suffering from acute attacks.
Two Orphan Drug designations from the FDA have previously been issued for the application of recombinant human C1 inhibitor in acute treatment and prophylaxis of hereditary angioedema. |
