On February 24, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported an update to shareholders on recent developments with the company regarding active clinical trials, current partnership developments, and cash reach in conjunction with the release of the Half Year report for the period ended 31 December 2016 (Filing, Q2, Prima Biomed, 2017, FEB 24, 2017, View Source [SID1234517894]).
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Clinical Trial Updates: IMP321
Prima is pleased to announce the following updates on our clinical applications of IMP321:
AIPAC (Active Immunotherapy PAClitaxel), completed the safety-run in phase in December 2016. The randomized phase started in January 2017 with 30 mg of IMP321 as the recommended phase 2 dose. First patients have been recruited and we plan to open further clinical sites in the near term to ramp up the patient recruitment. In total, the trial aims to recruit up to 226 patients in a randomized, placebo-controlled, double blind setting.
TACTI-mel (Two ACTive Immunotherapeutics in melanoma), our Australian melanoma trial is progressing well with the first patient cohort of this Phase 1 dose escalation study completed in December 2016. The second cohort, receiving 6 mg of IMP321, is underway and already 4 out of 6 patients have been successfully treated; no dose limiting toxicity has yet been reached. The open label, Phase 1 study is designed to recruit 18 patients and anticipated to be fully recruited in the third quarter of 2017. Patients with unresectable or metastatic melanoma that have had a suboptimal response to KEYTRUDA are being dosed with IMP321 in combination with KEYTRUDA and there should be multiple data readouts throughout 2017.
A data update – including efficacy of all 15 patients from the safety-run in phase of AIPAC (open label) is expected to be published in mid-2017.
Financials
As a result of careful financial management, Prima remains in a solid financial position with approximately $15.5M cash as of mid-February 2017. Based on our forecast, the current operational cash reach has been extended to end of first quarter calendar year 2018.