Immunovative, Inc. announced that Immunovative Therapies, Ltd. (ITL) has registered its phase II/III, randomized, placebo-controlled study in anthracycline/taxane and capecitabine pre-treated metastatic breast cancer on the ClinicalTrials.gov website. ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Information can be viewed on: http://clinicaltrials.gov/ct2/show/NCT01741038?term=Immunovative&rank=1. The ClinicalTrials.gov Identifier number for the trial is: NCT01741038.

The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Registration on the site does not imply approval or endorsement of the trial by any of these government agencies.

ITL has previously released that it has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim(TM) 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(TM) in the USA, EU and other jurisdictions. The clinical trial is scheduled for launch in April 2013. The approved AlloStim(TM) 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."

Seth Shaw, CEO of IMUN, stated: "We are pleased with the progress ITL has made toward obtaining the necessary regulatory approvals required to launch a Phase II/III clinical study designed to test whether AlloStim(TM) may provide late stage, heavily pre-treated metastatic breast cancer patients with a new class of drug as a therapeutic option. We are making significant progress toward assuring that adequate financing is available for the timely launch of this trial and its flawless execution."

In December 2011, Immunovative, Inc. signed an exclusive License Agreement with ITL. Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products.