Information  X 
Enter a valid email address
  Print      Mail a friend       More announcements

Monday 07 November, 2011

Transgene

Transgene's Therapeutic HCV Vaccine TG4040 Comb...




Transgene  /
Transgene's Therapeutic HCV Vaccine TG4040 Combined with Commonly Used Treatment 
Achieves Substantial Viral Suppression in Randomized Phase II trial 
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement. 

  * 64% cEVR in one experimental arm vs. 30% in the control arm
  * Multiple options for further clinical development



Strasbourg,   France,   November   7, 2011 -  Transgene  S.A.  (Euronext  Paris:
FR0005175080)  announces  today  the  publication,  during  the  AASLD  congress
(American  Association for the Study of Liver Diseases), of interim data showing
a  substantial viral  suppression at  12 weeks by  using the  combination of its
therapeutic  vaccine TG4040 with the commonly used treatment regimen in patients
with  chronic hepatitis  C. These  data were  observed in  a randomized Phase II
trial that has included 153 patients (the "HCVac" study).

"The  magnitude of improvement in early  viral suppression observed in the HCVac
trial  is  unheard  of  in  the  immunotherapy  of this pathology" said Philippe
Archinard,  Chairman and CEO of Transgene.  He added: "We will immediately start
discussing  with possible partners  so as to  envisage the future development of
TG4040.  Among  the  options,  there  is  a  strong rationale to go to treatment
regimens without interferon".

The  HCVac study  is a  three-arm (one  control and  two experimental  arms with
different  schemes of administration)  randomized Phase II  trial evaluating the
safety  and  efficacy  of  TG4040,  a  therapeutic  vaccine, in combination with
ribavirin  ("RBV") and pegylated alpha interferon ("Peg-IFN"), the commonly used
treatment regimen in the indication.

The  study evidenced activity of the therapeutic vaccine in the two experimental
arms  with a substantial early viral suppression  in arm C, with 64% of patients
who achieved complete Early Virologic Response ("cEVR"), the primary endpoint of
the  study,  compared  to  30% in  the  control  arm.  The  cEVR patients had no
detectable viral load 12 weeks after the beginning of the treatment with Peg-IFN
and RBV. The detection limit of the blood hepatitis C virus in the study was set
at  10 IU/ml  (using  the  Roche  COBAS®  HCV  TaqMan®  assay).  The table below
summarizes these findings:

+------------------+------------------------------+----------------------+
|       Arm        | Number of evaluable patients | cEVR (% of patients) |
+------------------+------------------------------+----------------------+
| A (control)      |              30              |         30%          |
+------------------+------------------------------+----------------------+
| B (experimental) |              61              |         46%          |
+------------------+------------------------------+----------------------+
| C (experimental) |              53              |         64%*         |
+------------------+------------------------------+----------------------+
*p=0.003

The  experimental arms tested the same  dosage of the therapeutic vaccine (10(7)
pfu)  injected subcutaneously under two  different schemes of administration: in
the  arm B, the TG4040 dosage was  administered 6 times and Peg-IFN and RBV were
given 4 weeks prior to the initiation of TG4040 while in arm C the TG4040 dosage
was administered 13 times and the Peg-IFN and RBV were introduced 12 weeks after
the initiation of treatment with TG4040.

Two  of the  three adverse  events reported  on October 11, 2011 occurred in the
experimental  arm B, while one occurred in the experimental arm C. These adverse
events  are still under investigation. However,  it could already be noted that:
(i)  TG4040 was administered at ten times higher dosage in the previous clinical
trial  (Phase  I)  without  any  of  such  adverse events reported, (ii) the 56
patients  treated in the experimental arm  C have received TG4040 in monotherapy
(7  injections over  12 weeks) before  Peg-IFN and  RBV introduction and no such
adverse events were observed during this monotherapy phase of the treatment and,
finally,  (iii) the three  adverse events occurred  in patients who received co-
medications   which   could   possibly  have  induced  hematological  toxicities
independently of those usually documented with the usage of Peg-IFN and RBV.

Data were reported in a poster presented today at AASLD that can be consulted at
www.transgene.fr.

+------------------------------------------------------------------------------+
|Transgene will host a conference call for analysts on November 8, 2011        |
|(Tuesday) at 8am CET. The dial-in numbers are as follows:                     |
| |               |                 |                                          |
| |France:        |+33 1 72 00 14 02|- toll free: 0805-638852                  |
| |               |                 |                                          |
| |United Kingdom:|+44 207 7509903  |- toll free: 0808-2381771                 |
| |               |                 |                                          |
| |United States: |+1-347-6377291   |- toll free: 1-866-9286050                |
| |               |                 |                                          |
|                                                                              |
|                                                                              |
|                             Pin code: 29598380#                              |
+------------------------------------------------------------------------------+


About TG4040:

Transgene's  TG4040 vaccine candidate  is a recombinant  vector based on the MVA
virus  carrying and expressing three of  the major non-structural proteins (NS3,
NS4  and NS5B)  of the  hepatitis C  virus ("HCV").  The MVA  vector is a highly
attenuated strain of vaccinia virus, which has been tested extensively in humans
as  a vaccine  against smallpox  and is  known to  strongly stimulate innate and
adaptive immune responses to antigens.

About TG4040 clinical development program:

Phase I

Phase  I clinical results  in 39 treatment naïve  genotype 1 HCV patients showed
that  the  product  is  safe  and  well  tolerated  at  all  dose levels tested.
Immunological  analyses  on  15 treatment  naive  patients  were encouraging and
supported  the expected mechanism of action of  TG4040 which aims at inducing an
effective  HCV-specific  T  cell  based  immune  response, able to control viral
replication.  Phase I  data were  published in  the journal Gastroenterology and
reported in Nature Reviews in 2011.

Phase II

The  153 patients in the HCVac study were recruited in five countries in Europe,
in the United States and in Israel, and were randomized in the three arms of the
study  (one  control  arm  without  TG4040  and  two  experimental  arms). HCVac
investigates   the   efficacy   and   safety   of  two  different  schedules  of
administration  of TG4040 administered in subcutaneous injections at the dose of
10(7) pfu in combination with Peg-IFN and RBV.

About chronic hepatitis C:

Hepatitis  C currently represents a major  public health concern. The population
chronically  infected with HCV  in the world  is estimated at 170 to 200 million
and  hepatitis-C-related  deaths  at  approximately  470,000 annually.  Peak  of
prevalence  of  HCV-related  diseases  is  expected  to  occur  in  2025-2030 in
developed countries.

HCV  infection leads  to liver  diseases such  as fibrosis,  cirrhosis and liver
carcinoma,  which are the prime indications  for liver transplants. The commonly
used  treatment  regimen  for  patients  infected  with  the  HCV  genotype 1 (a
combination  of  Pegylated  Interferon alpha  and  Ribavirin)  is lengthy, often
poorly  tolerated and effective in only approximately 50% of patients completing
therapy.  In addition, a  substantial number of  patients never receive therapy.
Therefore,  there  is  a  strong  medical  need  for new alternative approaches,
including combination therapies.

About Transgene:

Transgene,  a member of the Institut Mérieux  Group, is a publicly traded French
biopharmaceutical  company dedicated to the  development of therapeutic vaccines
and  immunotherapeutic products in oncology and infectious diseases and has four
compounds  in  Phase  II  clinical  development:  TG4010 and JX594/TG6006 having
already  completed initial  Phase II  trials, TG4001  and TG4040.  Transgene has
concluded  strategic agreements for the development  of two of its immunotherapy
products:  an option  agreement with  Novartis for  the development of TG4010 to
treat various cancers and an in-licensing agreement with US-based Jennerex, Inc.
to  develop  and  market  JX594/TG6006,  an  oncolytic virus. Transgene has bio-
manufacturing  capacities for viral-based products. Additional information about
Transgene is available at www.transgene.fr.

Disclaimer:

This  press release  contains certain  forward-looking statements.  Although the
company  believes its  expectations are  based on  reasonable assumptions, these
forward-looking  statements  are  subject  to  numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated. In
particular,  the Company's ability to commercialize its first product depends on
the  continuing  success  of  clinical  studies,  ongoing  financing for further
product  developments and marketing launch, a positive response from the medical
community  regarding the product's costs and  effectiveness. For a discussion of
risks  and  uncertainties  which  could  cause  the  company's  actual  results,
financial  condition, performance or achievements to differ from those contained
in  the forward-looking statements, please refer  to the Risk Factors ("Facteurs
de  Risque") section of the Document de Reference prospectus, which is available
on  the  AMF  website  (

http://www.amf-france.org)  or  on  Transgene's  website
(www.transgene.fr).  This press release and  the information contained herein do
not  constitute  an  offer  to  sell  or  a  solicitation  of an offer to buy or
subscribe to shares in Transgene in any country.

Contacts:

 Transgene                                          MC Services



 Philippe Archinard, CEO                            Raimund Gabriel

 Phone: +33 (0)3 88 27 91 22                        Phone: +49 89 210 228 30



 Stéphane Boissel, Executive Vice President & CFO   Shaun Brown

 Phone: +33 (0)3 88 27 91 02                        Phone: +44 207 148 5998



 Elisabetta Castelli, Director IR

 Phone: +33 (0)1 44 08 55 05
                                                    

 --- End of Message --- 

Transgene 
Boulevard Gonthier d’Andernach Illkirch-Graffenstaden France



Press Release PDF: 


http://hugin.info/149737/R/1561691/483384.pdf




This announcement is distributed by Thomson Reuters on behalf of 
Thomson Reuters clients. The owner of this announcement warrants that: 
(i) the releases contained herein are protected by copyright and 
    other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and 
     originality of the information contained therein. 
    
Source: Transgene  via Thomson Reuters ONE

[HUG#1561691]