RNS23 Oct 2013 08:09
Xenetic Biosciences
Phase II Dosing Commenced
RNS Number : 1476R
Xenetic Biosciences PLC
23 October 2013

Xenetic Biosciences PLC
('Xenetic' or the 'Company')
Phase II Clinical Trial for ErepoXen® commences with Dosing of First Patient
Xenetic Biosciences PLC (LSE: XEN), a bio-pharmaceutical company specialising in the development of high-value differentiated biologics, vaccines and novel cancer drugs, announces that as part of its western Phase II study of ErepoXen®, its Contract Research Organisation ("CRO") Novotech, has dosed the first patient.
ErepoXen® is a novel therapy for the treatment of anaemia in End Stage Renal Disease patients. Anaemia in subjects with chronic kidney disease is often accompanied by a decreased quality of life and an increased need for red blood cell transfusions. The dominant treatment for this condition is recombinant human erythropoietin ('rHuEPO') replacement therapy with an erythropoiesis-stimulating agent ('ESA'), which has been associated with an improved quality of life and fewer Red Blood Cell ('RBC') transfusions.
ErepoXen® is Xenetic's polysialylated erythropoietin (PSA-EPO) candidate for the treatment of patients with chronic anaemia. The product contains the identical amino acid sequence of isolated natural human EPO and the polysialic acid used is a natural hydrophilic polymer derived from the cGMP fermentation of E. Coli strain K1. Polysialylation of EPO helps in reducing the required frequency of dosing compared to existing ESAs due to its longer in-vivo half-life.
The primary endpoint of this Phase II, open-label, multi-centre and sequential dose finding trial is to assess the efficacy and safety of multiple doses of polysialylated recombinant human erythropoietin (PSA-EPO) in chronic kidney disease ('CKD') subjects who are not receiving dialysis nor receiving erythropoiesis stimulating agents (ESAs). The trial is being conducted in compliance with Australian and New Zealand regulations under a clinical protocol that includes eight centres in Australia and an additional two in New Zealand. The trial is expected to be active for up to 14 months with up to 72 males and females over the age of 18 enrolled. The first report on this trial is expected during H2-2014.
The treatment has been formulated using the Company's patented PSA and PSA-EPO technologies. If successful the proprietary PSA-EPO treatment will address an anaemia market currently estimated at US$7.2 Billion.
M. Scott Maguire, CEO of Xenetic, commented: "This is a pivotal moment for the Company as this first western clinical trial gets under way on our lead biologic product candidate, ErepoXen®. Based upn the excellent work and positive clinical trial results already achieved in India by our co-development partner Serum Institute of India, the Xenetic Board is confident of achieving a positive outcome to this latest