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news.Shares in immunotherapy products developer Northwest Biotherapeutics Inc have rocketed almost 46% after it received clearance from the FDA to begin assessment of its lead product candidate in a phase III clinical trial in prostate cancer.
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The trial is based on promising clinical data from a previously conducted phase I/II clinical trial and is expected to enroll about 600 patients at 30-50 sites throughout the US.
“The initiation of this phase III trial for non-metastatic hormone independent prostate cancer patients represents a major milestone achievement for our lead product candidate, DCVax-Prostate,” stated Dr Alton Boynton, president, COO, and a co-founder of Northwest Biotherapeutics.
The company previously received clearance through the FDA for a phase II clinical trial for DCVax-Brain, a promising new treatment for glioblastoma multiforme, the most common form of brain cancer. The company intends to begin this multi-site clinical trial later this year.
In addition, the DCVax platform can be used for multiple cancer indications, and Northwest Biotherapeutics has completed preclinical work targeted for a phase I clinical trial for non-small cell lung cancer and head and neck cancer.