Xenetic Biosciences XEN Commencement of Phase I/II(a) clinical trial

  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)              paul.mcmanus@walbrookpr.com
Paul Cornelius (Investor Enquiries)       paul.cornelius@walbrookir.com





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
 
Press spacebar to pause and continue. Press esc to stop.