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."