Bli medlem
Bli medlem

Du är här

2016-04-01

Medigene AG: Medigene announces Start of Phase II trial with DC vaccines and upcoming milestone payment

Medigene AG / Medigene announces Start of Phase II trial with DC vaccines and
upcomingmilestone payment . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
announcement.
Martinsried/Munich, 01 April 2016
.Medigene AG(MDG1, Frankfurt, Prime Standard), a clinical stage
immune-oncology company, announced the treatment start of the first phase
II-patient in its dendritic cell (DC) vaccine clinical phase I/II trial in
acute myeloid leukaemia (AML). This triggers a milestone payment in the
amount of approx. 3.2 m EUR to be made by Medigene AG to former contributing
shareholders of Medigene Immunotherapies GmbH (formerly: Trianta
Immunotherapies GmbH) within the next five months. Medigene intends to settle
this payment through the issuance of new shares from authorised capital. The
milestone payment was an agreed part of the purchase price in the acquisition
of Trianta in January 2014.

Prof. Dolores J. Schendel, CEO of Medigene AG
, comments: "We are glad to announce the start of the clinical phase II trial
of our DC vaccines shortly after the successful completion of patient
recruitment for the phase I part of this trial and the Data and Safety
Monitoring Board's recommendation to continue clinical development in this
project. This demonstrates the steady progress of our clinical programs and
the further validation of our immunotherapies."

Study design:
Medigene's Phase I/II trial (NCT02405338) will include 20 AML patients who
show complete remission after standard chemotherapy but are not eligible for
stem cell transplantation that would reduce the risk of a relapse. Patients
will be vaccinated with Medigene's DC vaccines for 50 weeks with a follow-up
period of one year or until progression of the disease. The primary objective
is to prove feasibility and safety of active immunotherapy with Medigene's
dendritic cells. Secondary objectives of the study are induction of
tumour-specific immune response, control of minimal residual disease (MRD),
and clinical response/time to progression (TTP).

About Medigene's DC vaccines:
The platform for the development of antigen-tailored DC vaccines is the most
advanced of Medigene's highly innovative and complementary immunotherapy
platforms. Currently Medigene evaluates its DC vaccines in a
company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).
Further studies utilising Medigene's DC vaccine technology include two
ongoing clinical investigator-initiated trials (IITs), i.e. a clinical Phase
I/II trial for the treatment of acute myeloid leukaemia (AML) at Ludwig
Maximilians University Hospital Grosshadern, Munich, and a clinical Phase II
trial for prostate cancer treatment at Oslo University Hospital. Moreover,
compassionate use[1]patients are treated with DC vaccines at the Department
of Cellular Therapy at Oslo University Hospital.

Dendritic cells (DCs) are the most potent antigen-presenting cells of our
immune system. Their task is to take up, process and present antigens on
their cell surface, which enables them to activate antigen-specific T cells
for maturation and proliferation. This way T cells can recognise and
eliminate antigen-bearing tumour cells. Dendritic cells can also induce
natural killer cells (NK cells) to attack tumour cells. The team of Medigene
Immunotherapies scientists has developed new, fast and effective methods for
generating dendritic cells ex-vivo, which are able to activate both T cells
and NK cells. The DC vaccines are developed from autologous (patient-derived)
precursor cells, isolated from the patient's blood, and can be loaded with
tumour-specific antigens to treat different types of cancer. Medigene's DC
vaccines are in development for the treatment of minimal residual disease or
for the use in combination therapies.

Further audio-visual information about Medigene's DC vaccines at:
https://vimeo.com/123005832

About acute myeloid leukaemia (AML)

Acute myeloid leukaemia is a malignant disease of the hematopoietic system,
affecting mainly adults above 60 years of age. In Germany, about 3,600
incidences are registered annually.
AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor
cells in the bone marrow. These cells prevent the generation of normal blood
cells, causing a drop in erythrocytes and platelets, for example. Typical
symptoms of AML include anaemia, fever, increased risk of infection, and
blood coagulation disorder. AML progresses rapidly and may be fatal within a
few weeks if untreated.
AML is treated initially with intensive chemotherapy. Another treatment option
is allogeneic hematopoietic stem cell transplantation. Unfortunately the
majority of patients suffer a relapse. Only about 15 - 20 % of the patients
show long-term remission after conventional chemotherapy. Allogeneic
hematopoietic stem cell transplantation is the only treatment option that
offers a more positive prognosis.

Medigene AG
is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company
headquartered in Martinsried near Munich, Germany. The company is developing
highly innovative, complementary treatment platforms to target various types
and stages of cancer with candidates in clinical and pre-clinical
development. Medigene concentrates on the development of personalised
T-cell-based immunotherapies.

For more information, please visitwww.medigene.com

This press release contains forward-looking statements representing the
opinion of Medigene as of the date of this release. The actual results
achieved by Medigene may differ significantly from the forward-looking
statements made herein. Medigene is not bound to update any of these
forward-looking statements. Medigene®is a registered trademark of Medigene
AG. This trademark may be owned or licensed in select locations only.

Contact Medigene

Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

In case you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor@medigene.com). We will then delete your address
from our distribution list.
---------------------------------------[1]Compassionate use: Prescription of as-yet unapproved drugs in particularly
severe cases where there are no treatment alternatives

Press release as PDF
http://hugin.info/132073/R/1999661/737420.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medigene AG via Globenewswire

HUG#1999661

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.