Corporate | 23 September 2009 07:30
Nanostart AG / Miscellaneous
23.09.2009
Dissemination of a Corporate News, transmitted by
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- Critical milestone achieved toward successful conclusion of phase II
clinical trials
- Application for regulatory approval of Nano-Cancer(R) therapy later this
year
- Sales and marketing within European Union expected to begin in 2010
Frankfurt/Berlin - September 23, 2009 - MagForce Nanotechnologies AG, a
majority-owned subsidiary of Nanostart AG, has recruited the last remaining
patients into the ongoing phase II clinical trials to demonstrate the
efficacy of its proprietary Nano-Cancer(R) therapy in cases of recurrent
glioblastoma. With this milestone, the necessary number of patients for
statistical evaluation has been attained, marking the last key prerequisite
to successfully conclude these clinical trials and proceed to regulatory
approval. Glioblastoma is the most commonly occurring type of malignant
brain tumor in adults.
The results of these phase II clinical trials will serve as the basis for
the conformity evaluation procedure required under the German Medical
Devices Act (Medizinproduktegesetz). This procedure qualifies medical
devices for CE marking, which certifies conformity with health and safety
regulations throughout the European Economic Area. MagForce hopes to
establish its new therapy, which is virtually free of patient side effects,
as a fourth pillar alongside the existing standard cancer treatment
methods: surgery, radiation and chemotherapy.
'We plan on preparing the statistical data in the fourth quarter of 2009,
as soon as enough patients have concluded the post-observation period or
have otherwise reached the study endpoint, so that we will be able to have
the product file put together before the end of this year. Once we have
received the CE marking, we hope to be in a position already next year to
commence marketing of Nano-Cancer(R) therapy throughout Europe,' said Dr.
Uwe Maschek, CEO of MagForce Nanotechnologies AG.
Marco Beckmann, CEO of Nanostart AG, added that 'we are watching with great
excitement as regulatory approval for the unique Nano-Cancer(R) therapy
from our subsidiary MagForce Nanotechnologies gets closer and closer. The
completion of patient recruitment marks one of the final milestones toward
this goal.'
Nanostart AG, the leading nanotechnology investment company, owns 77
percent of the shares of the Berlin-based cancer research company.
About Nanostart:
Nanostart AG is the world's leading nanotechnology investment company. The
Frankfurt-based company provides venture capital financing for
nanotechnology companies in various growth phases. It also provides the
benefits of its experience and expertise to developers of financial
instruments and to investors in the nanotechnology sector. For further
information about the company, please visit www.nanostart.de.
About MagForce Nanotechnologies AG:
MagForce Nanotechnologies AG is the world's leading company in the area of
nanotechnology-based cancer treatment. Its patented therapy allows the
targeted destruction of tumors using magnetic nanoparticles. MagForce's
nanotechnology represents a revolutionary approach to the future successful
treatment of solid tumors. www.magforce.com
Disclaimer:
This notice constitutes neither an offer to sell nor a solicitation of
offers to purchase or subscribe to securities. There will be no public
offering of securities of Nanostart AG in conjunction with the existing
listing of its shares in the 'Entry Standard' segment of the regulated
unofficial market (Freiverkehr) on the Frankfurt Stock Exchange. This
notice does not constitute a securities prospectus. Neither this notice nor
the information contained within is intended for direct or indirect
distribution within the United States of America, Canada, Australia or
Japan.
Media contact:
Nanostart AG
Public Relations
Dr. Hans Joachim Dürr
Goethestrasse 26-28
D-60313 Frankfurt
Germany
phone: +49 (0)69-21 93 96 111
fax: +49 (0)69-21 93 96 122
e-mail: presse@nanostart.de
23.09.2009 Financial News transmitted by DGAP
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