Press release from Business Wire
Meridian Life Science® Successfully Manufactures Influenza Challenge Stock for Immune Targeting Systems
Tuesday, July 30, 2013
Meridian Life Science® Successfully Manufactures Influenza Challenge Stock for Immune Targeting Systems07:00 EDT Tuesday, July 30, 2013
CINCINNATI (Business Wire) -- Meridian Life Science, Inc., (MLS) of Memphis, Tennessee, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), is proud to announce that MLS manufactured an H1N1 influenza A challenge stock for Immune Targeting Systems, Ltd. Immune Targeting Systems contracted Meridian Life Science to manufacture the influenza A challenge stock resulting in a 12-month, highly collaborative production program culminating in the successful release of the challenge stock. Meridian Life Science manufactured the influenza A challenge stock according to appropriate current Good Manufacturing Practices (cGMP) parts 21 CFR Parts 210 and 211 for use in Phase 1 human clinical trials to the desired specifications and under aggressive timelines; allowing Immune Targeting Systems to meet critical clinical development timelines.
Challenge stocks are infectious viral stocks capable of inducing disease. Challenge stocks permit clinical investigators to conduct carefully controlled studies where the precise timing, route of administration, and dose can be administered to healthy human volunteers with a well defined health history. Challenge studies can be used to test vaccines or therapeutics for efficacy. Traditional infectious disease efficacy studies relying on randomly infected individuals often require treatment of very large numbers of potential participants with incomplete health history information and limited precision regarding the timing of infection. Challenge studies can minimize the number of trial participants required to demonstrate statistical significance, appreciably reduce clinical development costs and speed important vaccines and therapeutics to market.
Victor Van Cleave, Ph.D., Vice President of Research and Development (R&D) at Meridian Life Science, stated, “Meridian is pleased to have been selected by Immune Targeting Systems for the cGMP manufacture of this H1N1 influenza A challenge stock. This project was an excellent fit for Meridian's core virology and virus based product manufacturing capabilities. The collaboration with Immune Targeting Systems has been a very close partnership with scientists from Immune Targeting Systems working alongside Meridian scientists to ensure successful and timely production of this important clinical research tool. Meridian and our scientists are proud to be a part of this development effort that could significantly impact the incidence and severity of influenza infections.”
Dr. Campbell Bunce, R&D Director of Immune Targeting Systems, commented, “Meridian has done a good job in generating a significant clinical stock of cGMP H1N1 influenza A. Manufacture of this virus allows us to move to the next phase of clinical development of our lead vaccine program; Flunisyn – a pan influenza A vaccine inducing a cross-protective cell mediated immune response to all influenza A viruses. Testing of the virus, manufactured in alignment with advice and guidance provided by multiple regulatory agencies including the US FDA, has been approved as an investigational medicinal product (IMP) for an initial clinical titration study. The study is being carried out by an international CRO with bespoke quarantine facilities designed for controlled live virus human challenge studies. Once established, the optimal virus challenge dose will be used to assess the impact of Flunisyn on influenza infection.”
ABOUT MERIDIAN BIOSCIENCE, INC.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company's shares are traded on NASDAQ's Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
ABOUT IMMUNE TARGETING SYSTEMS
Established in 2005, with headquarters in London UK and a presence in California, USA Immune Targeting Systems is an emerging leader in the development of synthetic vaccine products that work by promoting broad T cell responses against viruses and cancers (“T cell vaccines”) irrespective of ethnicities. The Company's vaccines are based on a proprietary DepoVaccineTM technology that utilizes a fluorocarbon chain linked to a long native peptide sequence containing high density clusters of CD4+ and CD8+ T cell epitopes (DensigenTM). The fluorocarbon chain provides a unique self-adjuvanting property to boost vaccine immunogenicity and prolong half-life in situ. ITS has three product development pipelines.
Flunisyn™ - A synthetic, broad cross-reactive DepoVaccine for improved efficacy against pandemic and seasonal influenza A. completed three clinical trials.
Hepsyn-B™ - A therapeutic DepoVaccine™ is entering GMP manufacture and is anticipated to start human trials in 2014.
Oncosyn – A therapeutic DepoVaccine™ currently undergoing lead optimization and preclinical screening.
Company website: www.its-innovation.com
For more information about Bioline, please visit www.bioline.com
For more information about Meridian Life Science, Inc., please visit www.meridianlifescience.com
For more information about Meridian Bioscience, Inc., please visit www.meridianbioscience.com
Richard L. Eberly, President, Meridian Life Science, Inc., firstname.lastname@example.org
Immune Targeting Systems: Dr. Benjamin Chen, +44 20 7691 4908, + 1 (415) 690 9650, email@example.com
Meridian Life Science, Inc.
Richard L. Eberly, 513-271-3700