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Onxeo: The French Academy of Sciences Awards the Guy Lazorthes Prize to Doctor Marie Dutreix for Her Innovative Research on the Dbait Technology
Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), a biopharmaceutical company
specializing in the development of innovative drugs for the treatment of
orphan diseases, in particular in oncology, today announced that Doctor
Marie Dutreix has received the Lazorthes Prize, awarded by the
prestigious French Academy of Sciences in Paris, for her research on the
Dbait technology. AsiDNA™, a molecule derived directly from the Dbait
concept, breaks the cycle of tumor DNA repair by inducing the
accumulation of damage in the DNA and cell death in tumor cells, while
sparing healthy cells.
Since acquiring the Dbait technology in February, Onxeo has initiated an
ambitious development program in order to realize the strong potential
of AsiDNA™ in monotherapy or in combination with other anti-cancer
therapies. A first Phase I clinical trial in patients with metastatic
melanoma demonstrated the good tolerance and safety of AsiDNA™ in
intra-tumoral and subcutaneous administration combined with
radiotherapy. This Phase I study also revealed some very promising signs
of efficacy of the molecule used in combination with radiotherapy. Onxeo
has decided to continue to develop this drug for systemic administration
and evaluate the safety and level of tolerance, in monotherapy or in
combination with other treatments, when used in various types of solid
tumours. Therefore, a new Phase I clinical trial will begin in 2017
following regulatory toxicology tests.
At the same time, Onxeo has published the results of preclinical
research studies in Clinical Cancer Research1, which
demonstrate the synergistic effect of AsiDNA™ when combined
with several products from the PARP (Poly ADP-Ribose Polymerase)
inhibitor class. These new data have confirmed the advantages of AsiDNA™
compared to PARP inhibitors alone, as well as the benefits of combining
the two DNA repair inhibitors.
Judith Greciet, CEO of Onxeo, said: "We are delighted that Dr.
Dutreix has been recognised and rewarded by the members of the
prestigious French Academy of Sciences for her research work in the
domain of DNA repair, which generated the breakthrough innovative
technology DBAIT and its first application AsiDNA™. Dr. Dutreix is still
closely involved as a consultant in the development of AsiDNA™.
This technology positions Onxeo at the forefront of medical research
with a promising and innovative therapeutic approach for cancer
patients, while providing strong value-creation for our shareholders".
1 - « Drug
Driven Synthetic Lethality: bypassing tumor cell genetics with a
cobination of Dbait and PARP inhibitors », published the "Clinical
Cancer Research" in September 2016.
About AsiDNA™
AsiDNA is a signal interfering DNA repair
pathway inhibitor being developed by Onxeo as an anti-cancer agent. As
a short double-stranded DNA molecule, AsiDNA utilizes a unique mechanism
of action to break the cycle of tumor DNA repair by interfering at the
core of DNA damage, blocking multiple repair pathways, while sparing
healthy cells. A first-in-human Phase I clinical trial evaluating AsiDNA
in combination with radiotherapy for treatment of patients with
metastatic melanoma showed AsiDNA is well tolerated and demonstrated
proof of efficacy, with an objective response rate of 59% and a complete
response rate of 30% compared to 10% CR with radiotherapy alone. Onxeo
is currently accelerating a comprehensive advancement plan for AsiDNA as
monotherapy and in combination with anti-cancer agents to offer
potential new treatment options for patients suffering from various
types of cancer.
About Onxeo
Onxeo is a biopharmaceutical company
specializing in the development of innovative drugs for the treatment of
orphan diseases, in particular in oncology, driven by high therapeutic
demand in one of the fastest growing segments of the pharmaceutical
industry. Onxeo's objective is to become a major international player in
the field of rare cancers. Its growth strategy is founded on the
development of innovative, effective, and safe drugs based on
breakthrough technologies that can make a real difference in the
treatment of orphan oncology diseases and considerably improve the
quality of life of patients affected by rare and aggressive cancers.
Onxeo's comprehensive portfolio features a broad orphan oncology
pipeline, with four independent programs in various stages of clinical
development, including Onxeo's first approved orphan oncology drug,
Beleodaq®. The Company is headquartered in Paris, France and has
approximately 50 employees. Onxeo is listed on Euronext in Paris, France
(Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark
(Ticker: ONXEO).
Onxeo's orphan oncology products are:
-
Livatag® (Doxorubicin Transdrug™): Currently being evaluated in
a Phase III trial (ReLive) in patients with hepatocellular carcinoma
(primary liver cancer); and in combination with other cancer agents in
first-line HCC
-
Beleodaq® (belinostat): FDA-approved in the US in 2014 under
the agency's accelerated approval program as a second-line treatment
for patients with peripheral T-cell lymphoma (PTCL) and currently
marketed by Onxeo's partner in the US, Spectrum (News - Alert) Pharmaceuticals;
belinostat in combination with other cancer agents is currently in
development in first-line treatment for patients with PTCL (BelCHOP)
and in other solid tumors
-
AsiDNA: The first-in-class siDNA (signal-interfering DNA) which
has successfully undergone a proof-of-concept Phase I trial in
metastatic melanoma
-
Validive® (Clonidine Lauriad®): Positive final results from a
Phase II trial in head and neck cancer patients with severe oral
mucositis
In addition, Onxeo has successfully developed and registered two
non-cancer products, which are currently being commercialized in the
U.S. and Europe.
Learn more by visiting www.onxeo.com.
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Disclaimer
This communication expressly or implicitly
contains certain forward-looking statements concerning Onxeo and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results,
financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Onxeo is providing this communication as of this date and does not
undertake to update any forward-looking statements contained herein as a
result of new information, future events or otherwise. For a discussion
of risks and uncertainties which could cause actual results, financial
condition, performance or achievements of Onxeo to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the 2015 Reference Document
filed with the AMF on April 29, 2016, which is available on the AMF
website (http://www.amf-france.org)
or on the company's website (www.onxeo.com).
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