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* Critical milestone achieved toward successful conclusion of phase II clinical trials
* Application for regulatory approval of Nano-Cancer® therapy later this year
* Sales and marketing within European Union expected to begin in 2010
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® 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® 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® 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.
For further information about MagForce and its Nano-Cancer® therapy, visit //www.nanostart.de/en/portfoliodivision/portfolio/magforcenanotechnologiesag/1973..html
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.
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
For more information, please click here
Dr. Hans Joachim Dürr
D-60313 Frankfurt Germany
phone: +49 (0)69-21 93 96 111
fax: +49 (0)69-21 93 96 122
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