NEW YORK, NY
-- (MARKET WIRE)
Novo Energies Corporation ("Novo") (OTCBB: NVNC) today announced that Immunovative Therapies, Ltd. ("Immunovative") is preparing to launch a potentially pivotal, randomized, controlled Phase II/III clinical trial of its InSituStim product candidate which combines AlloStim with the percutaneous ablation of a selected metastatic tumor to create an in-situ personalized anti-cancer vaccine. The clinical trial will target women with taxane-anthracycline resistant metastatic breast cancer. The lead clinical site for this trial is planned to be at the National Cancer Institute of Thailand located in Bangkok, Thailand with Dr. Wirote Lausoontornsiri, MD as the Principal Investigator. Immunovative today announces the appointment of Asia Global Research Co., Ltd. (AGR) as the Clinical Research Organization (CRO) that will be responsible for obtaining all the required Thai regulatory clearances for conducting this clinical trial and for continuous monitoring of the clinical site for compliance with international standards for Good Clinical Practices (GCP).
AGR is staffed with research professionals, including medical doctors, clinical research assistants (CRA), data management and statistics experts who possess many years of experience managing clinical trials in the global environment. This highly trained group is fully capable of managing complete development programs of complex clinical trials and helps assure the integrity of the clinical data and compliance with U.S. FDA and international standards for clinical research.
Dr. Michael Har-Noy, CEO of Immunovative, stated, "We are pleased to partner with Asia Global Research Co., Ltd. to conduct our planned Phase II/III clinical trial. The InSituStim protocol is extremely complex and involves very complicated logistics. AGR has experienced bi-lingual staff that is capable of assisting us in assuring that this clinical trial is conducted in strict compliance with FDA regulations for Good Clinical Practices so that the results might be used in a possible future licensing application."
"We are very excited to assist in bringing Immunovative's promising technology to Thailand," said Dr. Suthipong Treeratana, CEO of AGR. "The incidence of breast cancer is increasing in Thailand and women with metastatic disease resistant to taxane and anthracycline drugs have no treatment options available. The Phase II/III study is powered to be potentially pivotal, such that if the overall survival milestone is met the data might be used in support of a licensing application in the United States and elsewhere. This places an extra burden to ensure the integrity of the trial data. Our experienced staff will monitor this study closely to assure accurate collection and documentation of clinical data. Our initial efforts are focused on preparing the regulatory documents required to obtain Thai FDA and Ethics Committee approval to initiate this study."
About Asia Global Research Co., Ltd. (AGR)
AGR is a subsidiary of Bumrungrad International Hospital Public Company Limited, based in Bangkok, Thailand. Through its CRO and SMO business segments, AGR offers a broad range of Phase I to IV clinical trials and staffing. AGR's trial management capabilities include establishing and monitoring trials in SouthEast Asia including Thailand, Vietnam, Malaysia, the Philippines, Singapore, Myanmar and India. Please visit AGR's website at: http://www.agr-cro.com/
About Immunovative Therapies, Ltd.: Immunovative Therapies, Ltd. ("Immunovative") is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israel Office of the Chief Scientist. Immunovative is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israel technological incubator program. Immunovative 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. Immunovative 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. Immunovative is developing a new class of immunotherapy drugs designed to harness the power of the immune system to treat cancer. Immunovative has two experimental immunotherapy products for the treatment of cancer in clinical development: AlloStim and AlloVax covered by Immunovative's 10 U.S. patents granted, 15 U.S. patents pending and 26 corresponding applications pending internationally. Please visit Immunovative's website at: www.immunovative.co.il
About Novo Energies Corporation: On December 15, 2011, Novo Energies Corporation ("Novo") signed an exclusive License Agreement (the "License Agreement") with Immunovative. Under the terms of the License Agreement, Novo has been granted an exclusive, worldwide license to commercialize any products covered under Immunovative'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 including. Novo is in the process of transforming into the cancer therapy area and intends to institute a name and symbol change to better reflect the new direction of the Company.
DISCLAIMER 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 Novo'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 Novo has little or no control. Such forward-looking statements are made only as of the date of this release, and Novo 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 Novo's Form 10-K for its fiscal year ended March 31, 2011, and other documents filed from time to time by Novo with the Securities and Exchange Commission.
For more information, please contact:
Mr. Antonio Treminio
Chairman & Chief Executive Officer
Novo Energies Corporation
New York: +1-212-315-9705
Email: Email Contact
Dr. Michael Har-Noy
Founder & Chief Executive Officer
Immunovative Therapies, Ltd.
Israel Tel: +972-2-6506288
US Tel: +1-760-444-9040
Email: Email Contact
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