Press Release PEP503 (NBTXR3) phase II/III registration trial (pivotal study) in soft tissue sarcoma has approved to start in France by ANSM Taipei, Taiwan, October 16, 2014 – PharmaEngine, Inc. (TWO: 4162) announces that PEP503 (aka NBTXR3) global pivotal trial (phase II/III registration trial) in soft tissue sarcoma (STS), co-sponsored by Nanobiotix and PharmaEngine, has been approved by the French regulatory authority (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé) to start in France. Approximate 25 to 30 hospitals in European countries will join this pivotal trial, and Nanobiotix expects to enroll the first patient in Europe by the end of 2014. PharmaEngine is preparing the related clinical trial applications for Asia-Pacific countries. For further information, please visit PharmaEngine’s website at http://www.pharmaengine.com Contact Peter Wu, Director, Corporate Development Telephone No.: (+886)-2-2515-8228, ext. 300 Mobile phone No.: (+886)-935-154-559 Email: [email protected] 1
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