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Galena's NeuVax well-tolerated in mid-stage breast cancer study; shares ahead 13% premarket

  • Nano cap Galena Biopharma (GALE) perks up 13% premarket on robust volume in response to its announcement of positive safety data from a Phase 2 clinical trial assessing NeuVax (nelipepimut-S), combined with trastuzumab (Roche's Herceptin), to prevent recurrence in HER2-positive (HER2 3+) breast cancer patients. The results were presented at the American Association for Cancer Research Annual Meeting in Washington, DC.
  • The interim analysis showed that NeuVax was well-tolerated with no increased cardiotoxicity. There were no significant differences in toxicities between the vaccine group (n=22) and control group (n=28), although the incidences of Grade 2 (moderate) and Grade 3 (severe, not life-threatening) were slightly higher in the NeuVax cohort (3.2% vs. 1.5% and 0.8% vs. 0%, respectively). There was no significant difference in cardiac ejection fraction pre- to post-treatment in either group.
  • Enrollment should be completed by year-end. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint of disease-free survival is October 2018. The estimated study completion date is October 2019.
  • NeuVax is an HER2-directed immunotherapy being investigated for the prevention of breast cancer recurrence after standard-of-care treatment in the adjuvant setting. Adjuvant therapy is any treatment given after primary (first-line) therapy.

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