"Obtaining Fast Track for NOV-002 is a further validation of Novelos' development progress, as we commence a pivotal Phase 3 NSCLC trial under a SPA", said Harry Palmin, President and CEO of Novelos.
"It recognizes that Novelos' clinical and non-clinical data demonstrated NOV-002's potential to address significant unmet medical need in advanced lung cancer patients."
NOV-002 is a small molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. Novelos has recently finalized the protocols for a Phase 3 trial with the USFDA.
Source: Novelos (pdf file)
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