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Nanoparticles in clinical trial trends : comments & focus on Abraxane

There are currently 70 clinical trials mentionning “nanoparticles” registered in the Clinicaltrials.gov database.  As shown in the dedicated Nanocolors trend chart dashboard, these are mostly Phase I and Phase II trials either recruiting patients or active and not recruiting. The number of new trials per year increased every year between 2004 and 2008 – and it is likely this trend will go on for a few more years. 

The majority of these 70 nanoparticle-mentionning trials take/took place in the USA and deal with nanoparticle formulations for the treatment of patients suffering from cancer, the most visible sponsors being Abraxis Bioscience and the National Cancer Institute.

Abraxis Bioscience’s drug “Abraxane“, based on a  proprietary nanoparticle albumin-bound (nab) technology, was approved by the American FDA in 2005 in metastatic breast cancer. More precisely, “Abraxane is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated“. There are now close to 1200 clinical trials mentionning Abraxane registered on Clinicaltrials.gov – although only a small percentage of them explicitely mention nanoparticles. The marketing of Abraxane is now developping, the most recent country launches currently taking place in Europe


4 Responses

  1. nanoparticle should have been developed for ANDA within the studies of animals and should have been checked for effective dose varation befoe going to clinical trials.

  2. Thanks for your comment. For visitors less familiar with pharma : ANDA stands for “Abbreviated New Drug Application”.

  3. […] # Nanoparticles in clinical trial trends : comments and focus on Abraxane […]

  4. […] Nanoparticles in clinical trial trends : comments & focus on Abraxane ]]] […]

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