SOURCE: Prima BioMed Ltd

December 19, 2016 19:00 ET

Prima BioMed Receives UK Approval for AIPAC Study

SYDNEY, AUSTRALIA--(Marketwired - Dec 19, 2016) -

  • Competent Authority and Ethics Committee approval received in the United Kingdom for AIPAC
  • Recruitment of patients in second cohort of AIPAC study completed
  • Interim data for AIPAC and TACTI-mel trials of IMP321 due in December 2016

Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) announces that it has received approval from the Competent Authority and Ethics Committee in the UK for its Phase IIb, AIPAC clinical trial of IMP321. Following conclusion of the safety run in phase, expected in late December, and subject to the dose escalation committee meeting, screening for the larger, randomised phase of the trial is expected to commence in January 2017.

AIPAC (Active Immunotherapy PAClitaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321-plus-paclitaxel in metastatic breast cancer. The safety run-in phase of the first cohort of 15 patients is being conducted across 11 clinical sites in Belgium, The Netherlands and Hungary. Recruitment of the last two patients in this cohort was completed in October. The first safety and pharmacokinetic data from these 15 patients is expected in late December 2016. As previously announced, AIPAC's expected duration based on forecast recruitment times and patient follow up is approximately three years.

Prima also confirms that interim data from the first cohort of patients in its Phase I, TACTI-mel clinical trial of IMP321 together with KEYTRUDA® for metastatic melanoma patients is also expected in late December 2016.

About Prima BioMed

Prima BioMed is listed on the Australian Securities Exchange, and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.

Contact Information

  • For further information please contact:

    U.S. Investors:
    Mr Matthew Beck
    The Trout Group LLC
    +1 (646) 378-2933
    mbeck@troutgroup.com

    Australia Investor/Media:
    Mr Matthew Gregorowski
    Citadel Communications
    +61 (0) 422 534 755
    mgregorowski@citadelpr.com.au