Novo Energies Corporation Announces the Appointment of Immunovative Therapies, Ltd.'s GCP and GMP Experts
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/15/12 -- Novo Energies Corporation ("Novo") (OTCBB: NVNC) today announced that Immunovative Therapies, Ltd. ("Immunovative") has retained the services of Andra E. Miller, Ph.D. and Holly M. Scott of Biologics Consulting Group, Inc. to provide Immunovative with in-depth assistance and compliance with U.S. Food and Drug Administration (FDA) regulations and requirements with respect to Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). The appointments of Dr. Miller and Ms. Scott are part of Immunovative's commitment to build a world-class clinical research and GMP biologics manufacturing organization.
Andra Miller, Ph.D. is the Director, Cell and Gene Therapies for Biological Consulting Group. She has nine years' experience as a product reviewer with the FDA, serving as the Gene Therapy Group Leader and as Expert Microbiologist in the FDA's Center for Biologics Evaluation and Research (CBER) Division of Cellular and Gene Therapies. FDA/CBER is the regulatory organization that reviews Immunovative's product submissions. Dr. Miller has been very influential in the development of policy in the cell and gene therapy areas. The focus of Dr. Miller's consulting with Immunovative will be to advise on regulatory strategies for product development, including interpretation of FDA guidelines, assisting in the review and preparation of FDA submissions, and providing advice on cGMP and quality system development and compliance.
Holly Scott joined Biologics Consulting Group as a Senior Consultant in 2009. She has approximately 19 years of multi-office experience with the FDA, including four years as a Consumer Safety Officer with FDA/CBER, and 15 years as a Field Investigator with the FDA Office of Regulatory Affairs/ Florida District Office (Miami & Orlando). As an FDA Field Investigator, Ms. Scott was Level II certified and performed GMP Compliance inspections of Blood & Blood Products, Plasma-derived products, Human Tissue establishments, Drug and Dietary Supplement Manufacturers, GCP inspections of Clinical Investigators, IRBs, and Sponsors, as well as performing quality systems inspections. As a Senior Field Investigator, Ms. Scott was also responsible for the training of new field personnel and development of District Procedures. Ms. Scott will use her experience to provide a continuous program of compliance analysis of both the Immunovative's manufacturing operations under GMP and the clinical operations under GCP.
Immunovative Therapies, Ltd. has recently completed a licensing agreement with Novo for funding the continuing clinical development of its lead product candidates: AlloStim™ and AlloVax™. Novo has already provided the first tranche of funding pursuant to the licensing agreement. Immunovative is using these funds with the goal of building a world-class clinical research organization and to upgrade its GMP manufacturing facilities to comply with regulations for advanced clinical development. These efforts are conducted as part of preparations to obtain FDA regulatory clearance to launch a potentially pivotal, randomized, controlled Phase II/III clinical trial that is designed to test the safety and efficacy of its novel InSituStim™ in-situ cancer vaccine which combines cryoablation (freezing) or radiofrequency ablation of a selected metastatic tumor to release tumor antigens into the surrounding microenvironment and the injection of AlloStim™ as an adjuvant into the ablated tumor to create a personalized anti-cancer vaccine inside of the body (in-situ).
This clinical trial is planned to be conducted in collaboration with the National Cancer Institute of Thailand in women with taxane-anthracycline resistant metastatic breast cancer. Breast cancer remains the most common form of cancer in women in the United States, with over 180,000 new cases diagnosed each year and 40,000 deaths annually. Despite initial treatment with surgery followed by chemotherapy and/or radiation, 40% of these patients will go on to develop metastatic disease. Women with metastatic breast cancer commonly develop disease resistant to anthracycline and taxane chemotherapy, which presents a major obstacle to therapy and leaves few effective treatment options.
Immunovative's product candidates are complex. The lead AlloStim™ product contains living immune cells attached to monoclonal antibody-coated microparticles as the active ingredient. The second product in clinical development, AlloVax™, is a personalized cancer vaccine manufactured from a small sample of a patient's own tumor. AlloVax™ contains an enriched fraction of chaperone proteins which carry a wide repertoire of tumor-specific antigens necessary to educate the immune system to identify and kill the tumors where ever they may reside in the body. The manufacturing and quality control testing methods to assure the consistent production of these products in order that they meet pre-defined identity, function and safety requirements differs significantly from that for drugs and medical devices, and requires specific expertise such as that available from the Biologics Consulting Group in order to successfully develop, test, mass produce and distribute these products.
Dr. Michael Har-Noy, Founder and Chief Executive Officer of Immunovative stated: "We are very pleased to be able to attract the expertise and talent of Dr. Miller and Ms. Scott to our team. We know they will make a great contribution in assisting us to develop and maintain compliant manufacturing and clinical operations. Our initial focus will be to address current FDA issues with respect to the clinical hold and then next to focus on regulatory submissions to obtain clearance for our planned Phase II/III clinical trials."
Antonio Treminio, Chief Executive Officer of Novo, commented: "We support Immunovative's commitment to develop a world class manufacturing and clinical development organization. The addition of these highly qualified regulatory professionals should greatly assist Immunovative to advance the development of its product candidates. Now that we have begun to provide the funding necessary for advancing the development of these product candidates, we expect that Immunovative will be announcing additional high level appointments in its clinical and manufacturing organizations in the near future."
Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug and device products. The staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of the consultants are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry. Please visit BCG's website at
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:
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 AlloStim™ and AlloVax™. 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.
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
Montreal: +1-514-840-3697
Email:
Dr. Michael Har-Noy
Founder & Chief Executive Officer
Immunovative Therapies, Ltd.
Israel Tel: +972-2-6506288
US Tel: +1-760-444-9040
Email:
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Datum: 15.03.2012 - 05:00 Uhr
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