- 115 patients have been randomized and 153 have signed the informed consent in the STS pivotal clinical trial. The target of 104 patients needed for the interim readout has been reached. A total of 156 STS evaluable patients is expected in the "act.in.sarc" Phase II/III trial (www.actinsarc.com).
- The Company expects to release the conclusion of the interim analysis conducted by an independent committee of experts in the coming months. This analysis will be performed four months after the 104th patient has been randomized (time to complete treatment plus readout).
- PharmaEngine has started a new clinical trial in Asia in October 2016 for head and neck patient's population receiving chemotherapy in combination with radiotherapy.
- A Phase I/II prostate cancer trial has been initiated in the US and now recruiting at Ronald Reagan UCLA Medical Center, Los Angeles and Thomas Jefferson University Hospital, Philadelphia. Dana Farber Cancer Institute, Boston should be joining the trial soon.
|Soft Tissue Sarcoma (locally advanced)||Phase II/IIIEU, Asia-Pac, South Africa||Recruiting 115 patients randomized, 153 patients signed the informed consent||Interim readoutSpring 2017|
|Head and Neck cancer (RTx alone in elderly patients)||Phase I/IIEU||RecruitingSafety and feasibility established||Complete data to be presented in H2 2017|
|Liver cancers (HCC & Mets)||Phase I/IIFrance||Recruiting||First data readout on safety and feasibility on first patients treated: before end of 2016|
|Prostate cancer||Phase I/IIUSA||Recruiting||Interim readout on safety and feasibility|
|Rectum cancer||Phase I/IIAsia-pacific region||Recruiting||First data readout on safety and feasibility upon completion of PI portion|
|Head and Neck cancer (RTx plus Chemo)||Phase I/IIAsia-pacific region||Recruiting||First data readout on safety and feasibility upon completion of PI portion|
- Clinical Cancer Research - on NBTXR3 in Soft Tissue Sarcoma Phase I/II Trial : " First human study testing a new concept of radio enhancement using nanoparticles (NBTXR3) activated by radiation therapy in patients with locally advanced soft tissue sarcomas (STS)", published 6 October 2016. Sylvie Bonvalot, Cécile Le Pechoux, Thierry Debaere, Guy Kantor, Xavier Buy, Eberhard Stoeckle, Paul Sargos, Philippe Terrier, Jean-michel Coindre, Nathalie Lassau, Rafik AIT SARKOUH, Mikaela Dimitriu, Elsa Borghi, Laurent Levy, Eric Deutsch and Jean Charles Soria. 10.1158/1078-0432.CCR-16-1297
- Poster presented at SITC conference " Hafnium oxide nanoparticles, a radiation enhancer for in situ cancer vaccine", authored by Paris S., Pottier A., Levy L., and Lu B.
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