Xenetic Biosciences (XEN) - Commencement of Phase I/II(a) clinical trial RNS Number : 3945R Xenetic Biosciences PLC 19 November 2012 Xenetic Biosciences plc ('Xenetic' or 'the Company') Commencement of Phase I/II(a) Clinical Trial for MyeloXen™, a novel MS vaccine Xenetic Biosciences plc (LSE: XEN), a bio-pharmaceutical company specialising in the development of high-value differentiated biologics and vaccines and novel cancer drugs, announces the commencement of a Phase I/II(a) human clinical trial of MyeloXen™, its novel vaccine candidate for the treatment of Multiple Sclerosis (MS). The three-part, multicentre, open-label study is being conducted in compliance with Russian regulations under a protocol that includes a total of 26 subjects. The trial will be carried out in three Parts, being: Part 1: Comprises 6 healthy volunteers Part 2: Comprises 10 patients for the dose-escalation phase Part 3: Comprises 10 patients being dosed at the dose levels determined in Part 2 All six healthy volunteers in Part 1 have now commenced dosing. Patient subjects in Parts 2 and 3 are from groups diagnosed with relapsing, remitting and secondary progressive MS. The end point of the trial is to demonstrate that this novel candidate is safe and well tolerated in patient use; additionally, surrogate efficacy and mechanism of action indicators will be examined. The vaccine has been formulated using the Company's patented ImuXen™ liposomal entrapment technology and is one of up to six candidates (including both novel biologic and vaccine candidates) under the Co-Development Agreement (CDA) between Xenetic and Pharmsynthez in St Petersburg. MyeloXen™ is the first product to enter human clinical trials under that CDA and addresses an MS global market currently estimated at ~US$20 billion. Peer-reviewed pre-clinical studies recently published in "The Federation of American Societies for Experimental Biology Journal" (Epub 2012, Oct 9) showed that MyeloXen™ delivered improved responses when compared to Copaxone®, one of the MS market's leading therapies, with estimated current sales of ~US$2.6 billion for Teva Pharmaceuticals. This trial is externally managed and monitored by OCT in St Petersburg, an internationally recognised Clinical Research Organisation, thus ensuring Good Clinical Practice, the prevailing international standard for clinical trials. M. Scott Maguire, CEO of Xenetic, has commented: "The commencement of this MyeloXen™ trial represents two pivotal "firsts" for our Company. It is the very first vaccine candidate developed under our ImuXen™ technology to enter human clinical trials; it is also the first product candidate to emerge from our collaboration with Pharmsynthez. I expect that it will not be the last on either count! This important outcome validates the de-risking strategy that has been adopted by the Company and increases the number of candidates now in clinical development to four, being in six distinct therapeutic areas - MyeloXen™ for MS, ErepoXen® (our anaemia candidate developed with Serum Institute of India, shortly to enter Phase II(b) trial in India), SuliXen® for both diabetes (due to commence Phase II(a) trials in Russia) and for a CNS indication currently in a Phase I trial in Russia), and OncoHist® , our novel oncology therapy in Phase I/II(a) clinical development in Russia for both Acute Myeloid Leukaemia and Non-Hodgkin's Lymphoma indications. This latest advance should serve to encourage shareholders that, for a small biotech company, Xenetic has a growing pipeline that is set for further expansion in the short-medium term, thus underpinning the realistic prospect of having a proprietary product pipeline in clinical development that will be the envy of many larger biotechs, whether here in Europe or in the USA." Enquiries: Xenetic Biosciences plc www.xeneticbio.com M. Scott Maguire, Chief Executive Officer +44 (0)20 3021 1500 N+1 Singer (NOMAD & Broker) +44 (0)20 3205 7500 Aubrey Powell Walbrook PR +44 (0)20 7933 8780 Paul McManus (Media Enquiries) email@example.com Paul Cornelius (Investor Enquiries) firstname.lastname@example.org Notes to Editors Xenetic Biosciences plc (formerlyLipoxen plc) is a biopharmaceutical company focused on the development of new and improved biologic drugs and vaccines. Xenetic's technology is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of its products using its three proprietary patented technology platforms: 1. PolyXen™ for extending the efficacy and half-life of biologic drugs 2. ImuXen™ for creating new vaccines and improving existing vaccines 3. OncoHist™ for oncology drugs The Company has multiple drug and vaccine programmes in pre-clinical development with three products currently in human clinical development: SuliXen®: A long-acting insulin with two ongoing trials in Russia being, (a) for the treatment of diabetes, and (b) for a central nervous system (CNS) condition. ErepoXen®: A long-acting erythropoietin (EPO) currently in Phase II(b) trials in India. ErepoXen is a novel therapy for the treatment of anaemia in both End Stage Renal Disease patients and for those undergoing chemotherapy OncoHist™: A recombinant human histone H1.3 molecule in Phase I clinical trials in Russia for refractory Acute Myeloid Leukaemia (AML) and Non Hodgkin's Lymphoma (NHL) The Company has an important license agreement with Baxter International Inc to develop a novel series of polysialylated blood coagulation factors, including Factor VIII. In 2010, Xenetic and Baxter announced positive results with a PSA-Factor VIII candidate in a series of preclinical studies and the selection of a lead candidate, providing confidence in the programme's potential to transition into clinical development. The success of the Baxter programme will ultimately result in the development of novel longer-acting therapies for the treatment of haemophilia. Xenetic's ongoing clinical proprietary product pipeline includes: ErepoXen^® (Polysialylated Erythropoietin) ErepoXen® is a new product candidate from Xenetic, currently undergoing Phase II(b) clinical trials. The product offers an improved form of erythropoietin (EPO). EPO is a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia. Chronic renal (kidney) failure or chemotherapy to treat cancer can cause anaemia. In cases of renal failure, the kidneys no longer manufacture enough EPO hormone and this causes anaemia. EPO therapy is the treatment of choice for this type of anaemia. The benefits of ErepoXen® are: 1. Reduction in the frequency of dosage 2. Reduction in immunogenicity 3. Reduction in toxicity A further potential benefit of ErepoXen^® is that it uses polysialic acid (PSA). PSA is a polymer of sialic acid (a sugar) and it is found naturally in the human body. Most importantly, PSA is completely biodegradable and does not accumulate in the body over time. ErepoXen^® is currently in Phase II clinical development in collaboration with our partner, the Serum Institute of India. SuliXen^® (Polysialylated Insulin) SuliXen^® is a proprietary human insulin new product candidate from Xenetic, which offers potential for the treatment of type II diabetes. It is a long acting injected form of insulin with a performance profile modelled on the existing "best in class" product. The compound has successfully completed Phase I clinical studies in Russia where it has also commenced a Phase I trial fora CNS (central nervous system) indication. MyeloXen^TM (Liposomal Multiple Sclerosis vaccine) MyeloXen™ is a liposomal vaccine being developed in collaboration with Pharmsynthez for the treatment of multiple sclerosis. Multiple sclerosis is a progressive disease of the central nervous system accompanied by various neurologic symptoms. The disease usually occurs in young and middle age people under the influence of a series of internal and external factors. Multiple sclerosis progresses through initial difficulties in moving through to full paralysis, sensory loss as well as loss of control over neuropsychological processes. Hundreds of thousands of people suffer from Multiple sclerosis. Therefore it is extremely important to develop novel that drug products that are superior to current treatments. This product has commenced Phase I/II(a) human clinical trials in Russia. OncoHist™ (Recombinant human Histone H 1.3) OncoHist is a novel bio-therapeutic molecule for the treatment of tumours, in particular, haematologic malignancies. It is being jointly developed by Xenetic and our recently acquired German subsidiary, SymbioTec GmbH. The product is currently in human clinical trials in Russia for the treatment of both refractory Acute Myeloid Leukaemia and for Non Hodgkin's Lymphoma. The Company's pre-clinical pipeline includes these candidates: Xenetic's H1N1 influenza vaccine candidate is based on our proprietary liposomal co-delivery technology and is not reliant on the classical egg-based methods of manufacture, which are time-consuming and expensive. Our preclinical data has demonstrated that a single dose of vaccine can induce protective immunity using less antigen than is found in conventional flu vaccines. Business model, strategic equity placing and current developments The Company has a low-risk business model and out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities. Xenetic currently has commercial agreements with some of the world's leading biotechnology and pharmaceutical companies including Serum Institute of India (the Company's second largest shareholder) Baxter (also one of the Company's largest shareholders) and Schering-Plough (part of the global Merck group). In November 2011 Xenetic completed an important equity raise with the newly-formed Russian entity, SynBio LLC. SynBio brought together the skills base of two of Russia publicly traded life sciences corporations (Pharmsynthez and Human Stem Cell Institute) with the capital of Rusnano, the Russian state-controlled nanotechnology fund which, together with the state-sponsored Skolkovo project, is intended, inter alia, to establish a domestic Russian pharmaceutical industry, this being one of the key objectives in Russia's strategic development plan to evolve from a resource-dependent economy to a knowledge-based one. Concomitant with the equity placing with SynBio, the two companies entered into an important 6-product Co-Development Agreement under the terms of which SynBio is to carry out all necessary pre-clinical development on each product and, as appropriate, move the products into Phase I human clinical trials. Based on the output of this work (all of which data is available to Xenetic) the Company can make an informed and data-supported decision to take each successful product into clinical trials in the West. This approach substantially de-risks the clinical trial process for Xenetic as each decision can be based on known success in the relevant Russian trials. The CDA with SynBio substantially mirrors an earlier agreement with Pharmsynthez under which contract a further six candidates are in course of development, with one vaccine product ready to enter human clinical trials this year. The SynBio transaction (which resulted in a current holding of around 45% in Xenetic's equity capital) injected more than £12m of new equity capital into Xenetic which funds are being applied to reduce the company's dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline. A key part of this strategy is the establishment in Boston, Mass., of a new drug development centre of excellence and the recruitment of new senior executive management with strong drug development and regulatory experience. The first two programmes to be moved into Western clinical trials will be ErepoXen and OncoHist. The Company has established a world-class Scientific Advisory Board to work alongside and provide strategic guidance to the executive directors and the senior management team, around whom the necessary people and facilities will be built to form Xenetic's new Drug Development Centre of Excellence in Massachusetts.The Company has also recruited leading practitioners to provide hands-on consulting services for the advancement of specific products into the clinic. Xenetic was founded in 1997 as Lipoxen Technologies Limited, which company was admitted to AIM in January 2006 as LIPOXEN plc. The Company trades on the AIM Market of the London Stock Exchange under the ticker symbol XEN. More information can be found at the Company's website: www.xeneticbio.com This information is provided by RNS The company news service from the London Stock Exchange END MSCFFAEFAFESEIF -0- Nov/19/2012 07:00 GMT
Xenetic Biosciences XEN Commencement of Phase I/II(a) clinical trial
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