NEW YORK, NY--(Marketwire - December 17, 2012) -
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN
) announces today 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. Information can be viewed by following this link: http://clinicaltrials.gov/ct2/show/NCT01741038?term=Immunovative&rank=1.
The ClinicalTrials.gov Identifier number for the trial is: NCT01741038.
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. 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™ 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."
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™ 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."
About Immunovative, Inc.:
On December 12th, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("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. Please visit IMUN's website at: www.imun.com.
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. ITL specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit ITL's website at: www.immunovative.co.il
Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.