Prima BioMed Receives UK Approval for AIPAC Study
(firmenpresse) - SYDNEY, AUSTRALIA -- (Marketwired) -- 12/19/16 --
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.
Prima BioMed is listed on the Australian Securities Exchange, and on the NASDAQ in the US. For further information please visit .
Mr Matthew Beck
The Trout Group LLC
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Mr Matthew Gregorowski
Citadel Communications
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Datum: 20.12.2016 - 00:00 Uhr
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