Zalicuslicious, I pulled this info off an older press release.
ITL has previously released that it has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to Phase II/III development. The details of the Study design are now available to the public on the ClinicalTrials.gov website. The primary end-point of the Study is overall survival. The study has been powered to detect a difference of 50% or greater in overall survival between the treatment and control arms. If successfully executed and the pre-defined overall survival end-point reaches statistical significance, ITL expects that the clinical data from this trial can be used to support possible marketing applications for AlloStim™ in the USA, EU and other jurisdictions. The clinical trial is scheduled for launch in April 2013. The approved AlloStim™ Phase II/III clinical trial will be conducted at the National Cancer Institute of Thailand ("NCI-Thailand") located in Bangkok, Thailand and the Principal Investigator will be Wirote Lausoontornsiri, MD, a US licensed physician that is board certified in hematology/oncology and serves as the Head of the Clinical Trials and Academic Research Unit at the NCI-Thailand.
Dr. Michael Har-Noy, CEO and founder of ITL, stated: "We are currently preparing our manufacturing and clinical operations to conduct this advanced clinical trial. Our plan is to launch this trial on or about April 2013. We are working carefully to put in place the quality assurance procedures and monitoring procedures necessary to assure the safety of the drug production, the integrity of the data and that the Study is conducted in compliance with international standards for Good Clinical Practices (GCP). The Study will have an independent Data Safety Monitoring Board (DSMB) assigned and will be regularly audited by experienced independent third party professionals."
Blackcat7717
AI
