Xenetic Biosciences plc commences Phase I/IIa IV trial for ErepoXen®

Xenetic Biosciences plc commences Phase I/IIa IV trial for ErepoXen®

Xenetic Biosciences plc, a bio-pharmaceutical company specialising in the development of high-value differentiated biological and vaccines and novel cancer drugs, announces that, in a Phase I/IIa IV (intra venous) clinical trial, its co-development partner, the Serum Institute of India, has dosed its first patient with their jointly-owned ErepoXen® candidate.

The 6-month trial is being conducted by India-based contract research organization SIRO Clinpharm Pvt. Ltd. SIRO is a leading full-service CRO with operations in India, the Middle East, Europe and the USA.  The trial will encompass 40 Chronic Renal Failure patients on dialysis and the end points will be to confirm safety and reductions in the frequency of dosage.  ErepoXen® is Xenetic's polysialyated erythropoietin (PSA-EPO) candidate for the treatment of patients with chronic anaemia.

EPO is a hormone produced by the kidneys that controls the production of red blood cells (RBCs). Because haemoglobin, found inside RBCs, normally carries oxygen from the lungs to the tissues, anemia leads to hypoxia (a lack of oxygen) in organs; since all human cells depend on oxygen for survival, this can have a wide range of clinical consequences. EPO is the hormone produced by the kidneys that stimulates the production of RBCs and so such therapy is the treatment of choice for affected patients.

In the case of End Stage Renal Disease (ESRD) patients, EPO is administered intravenously three times per week. Xenetic's ErepoXen has already demonstrated in Phase I and II(a) clinical trials based on the subcutaneous method of administration that it has the potential to be a long-acting version with a likely dosing profile of once per month.

The Phase II(a) clinical trials already completed successful by Serum Institute of India Ltd. were run on the subcutaneous method of administration method which accounts for around 20% of the global usage of EPO.  The new trial addresses the remaining 80% of the market and, upon completion, next stage Phase II(b) trials in India will be harmonised as to methods of administration, thereby compressing the timelines to complete the clinical trial process required prior to the market launch of the product. SIIL is also conducting repeated dosing toxicity studies which are designed to facilitate the early commencement of Phase III trials.

The global market for EPO drugs is estimated to be in the region of US $9billion. ErepoXen® is a performance-enhanced polysialyated form of EPO based on Xenetic's PolyXen enabling platform technology which, at its core uses Xenetic's all-natural PSA bio-polymer.  In earlier clinical trials ErepoXen has positively differentiated itself against its currently-marketed peers in terms of biodegradability, efficacy and is non-toxic, especially when compared to the PEGylated versions of currently marketed EPO drugs.

Xenetic's PolyXen enabling platform is increasingly demonstrating attractive performance characteristics in the development of a number of bio-superior biologic drug candidates in the Company's current extensive product pipeline.

Commenting on the Phase I/IIa trial, M. Scott Maguire, CEO of Xenetic, said: "The commencement of our IV patient trials in India with ErepoXen® is an exciting step forward in combining the two methods of EPO administration.  We have previously announced positive Ph IIa subcutaneous results and now, with the intravenous trial, we cover the full $9B market potential of EPO. We now have four drug candidates under clinical development with our partners including two via our recent acquisition of SymbioTec in Germany. Our aim is to fund ErepoXen®through to an FDA Phase IIa at which point we will seek to out-license this candidate."

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