2013-02-07 10:08:17 -

Apogenix /
Apogenix Receives FDA Orphan Drug Designation for Apocept(TM) to Treat 
Myelodysplastic Syndromes and Initiates Clinical Phase I Study 
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Heidelberg,   Germany,  February  7, 2013 -  Apogenix  GmbH,  a  clinical  stage
biopharmaceutical   company   developing  novel  protein  therapeutics  for  the
treatment  of cancer  and inflammatory  diseases, announced  today that its lead
product, Apocept(TM) (APG101), has been granted orphan drug designation from the
US  Food  and  Drug  Administration  (FDA)  for the treatment of Myelodysplastic
syndromes  (MDS). MDS are clonal hematopoietic stem   cell disorders characterized
by ineffective hematopoiesis leading to blood cytopenias, especially anemia.

Simultaneously,  Apogenix announced the  initiation of a  clinical Phase I trial
with  its lead compound Apocept(TM) in patients  with MDS. The clinical trial is
designed  as an open-label study and is conducted in clinical centers throughout
Germany.  Recruitment  of  MDS  patients  for  the study began in January 2013.
Endpoints of the study include efficacy (improvement of erythropoiesis), safety,
and tolerability parameters. Results of the trial are expected by mid-2014.

Apocept(TM)  binds to the CD95  ligand (CD95L) and blocks  the activation of the
CD95 receptor. Excessive stimulation of the CD95 receptor on hematopoietic cells
present in the bone marrow of MDS patients inhibits erythropoiesis. As a result,
transfusion-dependent   anemia   develops,   which   is   mostly  refractory  to
erythropoiesis-stimulating  agents. Preclinical studies using hematopoietic stem
cells   obtained  from  MDS  patients  show  that  Apocept(TM)  dose-dependently
stimulates erythropoiesis and thus may help treat anemia.

Dr. Harald Fricke, COO/CMO of Apogenix, commented: "MDS is the second indication
for which Apocept(TM) received orphan designation in the US. With its novel mode
of  action, Apocept(TM) restores the causal impairment of erythropoiesis in MDS.
After  the  successful  proof  of  concept  in  a randomized controlled trial in
glioblastoma  demonstrating excellent efficacy of Apocept(TM) both in prolonging
progression-free survival as well as overall survival, we are confident that the
success  story of  Apocept(TM) will  continue, with  MDS representing the second
field of application."

About Apogenix
Apogenix,  a  spin-out  from  the  German  Cancer  Research  Center  (DKFZ),  is
developing   novel   protein  therapeutics  for  the  treatment  of  cancer  and
inflammatory  diseases  based  either  on  the  targeted modulation of apoptosis
(programmed  cell death) or on blocking the growth of tumor cells. The company's
lead product candidate Apocept(TM) (APG101) is being developed for the treatment
of  glioblastoma, the  most common  and aggressive  type of primary brain tumor.
Since  its inception in 2005, the company has  raised more than €50 million with
dievini  Hopp  BioTech  Holding  GmbH  &  Co.  KG as main investor, and has been
awarded public grants totaling over €8 million. Apogenix is based in Heidelberg,
Germany.

About Apocept(TM) (APG101)
The company's lead product candidate, Apocept(TM), a first-in-class, fully human
fusion  protein combining the extracellular domain  of the CD95 receptor and the
Fc  portion of IgG, successfully completed a  Phase I study in 2009. In December
2009, Apogenix  started a  controlled Phase  II trial  with the compound for the
treatment  of recurrent glioblastoma. The patient recruitment for this study was
completed  in  September  2011. The  primary  endpoint  as  well  as a number of
secondary endpoints of the trial were successfully reached in 2012. Apogenix was
granted  orphan drug  designation for  Apocept(TM) in  2009 for the treatment of
glioblastoma in Europe and in the US.

About Myelodysplastic Syndrome
Myelodysplastic  syndromes (MDS)  are clonal  hematopoietic stem  cell disorders
characterized   by   ineffective  hematopoiesis  leading  to  blood  cytopenias,
especially anemia. The median age for MDS is higher than 60 years. The incidence
rate  for MDS is about 4/10,000 per year and increases to 20-50/10,000 above the
age of 70. The disease is often diagnosed during routine check-ups. MDS patients
suffer  from a reduced red blood cell  count (anemia), feel tired, and are prone
to  infections. In  most cases,  this anemia  is treated with blood transfusions
resulting  in an iron overload, which can  damage the liver, for example. At the
same  time,  the  number  of  thrombocytes  (blood  platelets,  responsible  for
coagulation)  and leucocytes (white blood cells, responsible for immune defense)
is  decreasing. As a result, MDS  patients frequently suffer from infections and
bleedings, which can prove fatal.

For more information about MDS, please visit www.marrow.org.


  Contact

  Dr. Thomas Höger

  CEO/CFO

  Apogenix GmbH

  D-69120 Heidelberg, Germany

  Phone: +49 (6221) 5 86 08-0

  Email: contact@apogenix.com

  www.apogenix.com



  Media Contacts

  U.S.A.                                     Europe

  Martina Schwarzkopf, Ph.D.                 Raimund Gabriel

  Russo Partners                             MC Services AG

  Phone: + 1 (212) 845 4292                  Phone: +49 (89) 210 228 30

  martina.schwarzkopf@russopartnersllc.com   raimund.gabriel@mc-services.eu
                                             

Press release (PDF): 
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