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FDA grants fast track designation for MedPulser Electroporation Therapy System.
2004 JUL 7 - (NewsRx.com & NewsRx.net) -- Genetronics Biomedical Corp. (GEB) has been granted a fast track designation by the U.S. Food and Drug Administration for its MedPulser Electroporation System clinical development program for patients with head and neck cancer.
The fast track designation is intended to facilitate development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs so that an approved product can reach the market expeditiously.
Genetronics is currently conducting two phase III pivotal studies comparing the MedPulser System in combination with the cancer drug, bleomycin, versus surgical resection in patients with recurrent or second primary squamous cell ...
- FDA grants fast track designation for MedPulser Electroporation Therapy System.
- Newspaper article from: Cancer Weekly July 6, 2004 700+ words
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...European pre-sales clinical study using its MedPulser Electroporation Therapy System. This pre-marketing Phase...in a number of hospitals in Europe. The MedPulser Electroporation Therapy System is designed to treat solid...
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...solid tumors requiring potentially disfiguring surgical treatment in a European clinical study using its MedPulser Electroporation Therapy System. This premarketing Phase IV study is a multi-center, open-label study that will measure...
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- Press release article from: PR Newswire March 17, 1999 700+ words
First Milestone in Agreement With Ethicon, Inc. SAN DIEGO, March 17 /PRNewswire/ -- Genetronics Biomedical Ltd. (Amex: GEB; Toronto) today announced approval to affix the CE Mark to the proprietary MedPulser(R) electroporation device used in Electroporation Therapy (EPT) treatment of solid tumors.
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...been granted a fast track designation...Administration for its MedPulser Electroporation System clinical...cancer. The fast track designation...needs. The fast track designation of our MedPulser Electroporation Therapy System...
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- Press release article from: PR Newswire September 20, 2004 700+ words
...diagnosed primary and recurrent head and neck cancers. The MedPulser Electroporation Therapy System is an electroporation device that significantly...and neck. The FDA has also granted the MedPulser System fast track designation. About Genetronics Biomedical Corporation...
- H Lee Moffitt Cancer Center and Genetronics initiate Phase I clinical trial in...
- News wire article from: Asia Africa Intelligence Wire January 13, 2005 700+ words
...an immune response that will eliminate the cancer. The MedPulser electroporation therapy system significantly enhances local cellular uptake...cell carcinomas of the head and neck. The FDA granted fast track status for these trials. Genetronics Biomedical Corp...
- Studies Suggest Alternatives to Surgery are Needed in Treatment of Head and...
- Press release article from: PR Newswire September 15, 2004 700+ words
...diagnosed primary and recurrent head and neck cancers. The MedPulser Electroporation Therapy System is an electroporation device that significantly...head and neck. The FDA also granted the MedPulser System fast track designation. About Genetronics Biomedical Corporation...
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...AND SKILLS 2006/0044 24 March 2006 FAST TRACK TEACHING 'GRADUATES' CONGRATULATED...Twenty-three 'graduates' of the Fast Track Teaching programme were congratulated...play in schools throughout England. Fast Track Teaching is a leadership development...
Source: HighBeam Research, FDA grants fast track designation for MedPulser Electroporation...