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Xenetic Biosciences (XEN)

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Thursday 03 May, 2012

Xenetic Biosciences

Senior Appointment

RNS Number : 6288C
Xenetic Biosciences PLC
03 May 2012



Xenetic Biosciences plc

('Xenetic' or 'the Company')


Senior Appointment


Xenetic Biosciences plc (LSE: XEN.L), a bio-pharmaceutical company specialising in the development of high-value differentiated biological and vaccines and novel cancer drugs, announces that Dr Surender  Kharbanda has been appointed as a specialist consultant to accelerate the development of the Company's OncoHist™  candidate. 


The OncoHist™ trials which the Company expects to commence in early 2013 in the USA are specifically for the treatment of patients of the orphan and rare disease, Acute Myeloid Leukaemia (AML).  OncoHist ™ has received Orphan and Rare Disease designation in both the USA and in Europe and is currently in patient trials in Russia for the treatment of AML and Non-Hodgkin's Lymphoma.


Dr Kharbanda since 1986 has held a number of research and academic positions at the Harvard Medical School and numerous scientific advisory board positions and executive level positions at Boston-based biotech companies focused on cancer drug development.


In 2000-2005, Dr Kharbanda was Head of R&D at ILEX Oncology Inc., an oncology drug development company that was acquired by Genzyme for $1B. During his tenure the group successfully developed three oncology drugs and established ILEX in Boston as a Centre of Excellence for oncology research.  Dr. Kharbanda has worked at the Dana-Farber Cancer Institute and oncology-focused biotechnology companies on the molecular biology of human cancer and the development of anti-cancer agents for nearly 25 years. 


Currently, Dr Kharbanda remains Chief Scientific Officer of Genus Oncology, a company he co-founded and holds the position of Principle Research Scientist at the Department of Medical Oncology at the Dana-Farber Cancer Institute (DFCI) within the Harvard Medical School. DFCI has long been regarded as one of the world's leading cancer centers for clinical research and for treatment and prevention methods to cancer.


With over 25 years of oncology drug development experience, Dr. Kharbanda brings valuable insight and perspective to Xenetic.  Dr Kharbanda will be a key adviser to the Company as it establishes foundation contacts in the oncology field with both Key Opinion Leaders (KOLs - such as those in the DFCI and elsewhere) and with charitable foundations in the USA, which contacts are expected to facilitate access to the development capital required to fund the upcoming OncoHist™ human clinical trials in the USA which the Company hopes to commence in Q1-2013.


Commenting on the appointment of Dr Kharbanda, Scott Maguire, CEO of Xenetic, said: "Dr Kharbanda brings US FDA expertise focused in oncology, a vital component to drive our OncoHist candidate through clinical development.  By aligning this candidate with Dr Kharbanda and the world's leading cancer institute, we bring together a powerful combination of skills aimed at facilitating the rapid advancement of our novel cancer therapy.  The Company looks forward to working with Dr Kharbanda on AML in the first instance while expecting that the OncoHist's product development programme will expand to the treatment of many more cancer therapies. 


The establishment of our new Drug Development centre in Boston lies at the heart of Xenetic's drive to independence made possible by the important equity fund raise successfully completed by the Company in November 2011. Dr Kharbanda's appointment to a key position in just one of the Company's novel drug therapies based on our portfolio of platform technologies (and associated proprietary drug candidates) is a significant step forward in the Company's development as a Speciality Pharmaceutical enterprise.


We expect to shortly be announcing further key appointments as to both full time senior posts within the Company as well as a number of appointments to the newly established Scientific Advisory Board."


Xenetic Biosciences plc

+44 (0)20 3021 1500

M. Scott Maguire, Chief Executive Officer

Singer Capital Markets (NOMAD & Broker)

+44 (0)20 3205 7500

Claes Spång

Walbrook PR

+44 (0)20 7933 8780

Paul McManus (Media Enquiries)

Paul Cornelius (Investor Enquiries)


Notes to Editors


Xenetic Biosciences plc (formerly Lipoxen 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:



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.



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


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 for  a CNS (central nervous system) indication.


MyeloXenTM (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 received regulatory approval to enter Phase I clinical trials in Russia and is currently at the patient-recruitment stage.


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.


StimuXen™ is a long-acting polysialylated form of granulocyte colony stimulating factor (G-CSF). prescribed to stimulate production of neutrophils (a type of white blood cell).


InferoXen® is a proprietary polysialylated interferon alpha-2b product candidate which offers the potential for use as a treatment for Hepatitis C.


HepaXen™ is a liposomal hepatitis B vaccine candidate based on our proprietary co-delivery technology. The vaccine comprises recombinant Hepatitis B surface antigen and a plasmid DNA encoding the same protein entrapped together in the same liposome. This candidate is currently being developed as a prophylactic (preventative) vaccine against hepatitis B but it will subsequently be developed as a therapeutic vaccine to treat patients infected with the hepatitis B virus. and E, as well as other prophylactic vaccines.


LipoNeu™ is a new pneumococcal vaccine product candidate developed to offer immune protection against Streptococcus pneumoniae. S. pneumoniae is a cause of meningitis and other serious infections in infants and children.


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 programme to be moved into Western clinical trials will be ErepoXen and OncoHist.


More news on this front will be announced in June at the global Bio International Convention being held in Boston when the Governor of Massachusetts will be announcing Xenetic's introduction to the Boston Life Sciences hub.


The Company is currently in the process of establishing a world-class Scientific Advisory Board to work alongside and provide strategic guidance to the executive directors and the senior management team, itself about to be strengthened by the appointment of a new VP of Drug Development, based in Boston, around whom the necessary people and facilities will be built as Xenetic's new Centre of Excellence takes shape.  The Company is also recruiting 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 LIPXOEN 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:


This information is provided by RNS
The company news service from the London Stock Exchange