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Spectrum's additional late-stage study of apaziquone in bladder cancer underway; shares up 5%

Published 08/14/2017, 10:11 AM
© Reuters.  Spectrum's additional late-stage study of apaziquone in bladder cancer underway; shares up 5%
SPPI
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  • The first patient has been enrolled in Spectrum Pharmaceuticals ' (SPPI +5.1%) Phase 3 clinical trial assessing Qapzola (apaziquone) in patients with low-to-intermediate risk non-muscle invasive bladder cancer as a surgical adjuvant in patients undergoing TURBT (transurethral resection of the bladder tumor).
  • The company received a CRL in November 2016 citing the need to conduct another late-stage study.
  • The primary endpoint of the 425-subject study is time to recurrence in up to five year. According to ClinicalTrials.gov, the estimated primary completion date is January 2020.
  • Apaziquone is a prodrug that is activated by certain enzymes that are over-expressed in bladder cancer cells. The activation renders it a highly cytotoxic alkylating agent.
  • Previously: FDA rejects Spectrum Pharma's NDA for QAPZOLA (Nov. 18, 2016)
  • Now read: Some Early Observations On The Cempra Merger With Melinta


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