• Galena Biopharma (GALE) Phase 2b Results of NeuVax for Breast Cancer

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    Biotech_Forecast
    Clinical and Regulatory
    Event Type: Phase 2b Results
    Timing: Q4 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Oncology
    Indication: Breast Cancer
    Lead Indication?: Yes
    Treatment Name: NeuVax

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Galena Biopharma
    Stock Symbol: GALE
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://d1lge852tjjqow.cloudfront.net/CIK-0001390478/dd5f4b76-2044-4ca9-9256-052355d1cddf.pdf?noexit=true
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    We currently have two investigator-sponsored trials ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche). The combination of trastuzumab and NeuVax has been shown pre-clinically and in a pilot study to be synergistic. Our Phase 2b clinical trial is a randomized, multicenter, investigator-sponsored, 300 patient study enrolling HER2 1+ and 2+, HLA A2+, A3+, A24 and/or A26, node positive, and high-risk node negative patients. The endpoint is disease free survival and preliminary safety data will be presented in the fourth quarter of this year.

     


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