iBio Announces Successful Completion of H1N1 Influenza Vaccine Phase 1 Clinical Trial
NEWARK, Del., March 21, 2012 /PRNewswire/ -- iBio, Inc. (NYSE AMEX: IBIO) today announced completion of the first human trial of iBioLaunch-produced H1N1 influenza vaccine (HAC1) that began September 13, 2010. This Phase 1, single-blind, placebo-controlled, dose-escalation study was conducted to assess the safety and reactogenicity and immunogenicity of HAC1 produced by iBio's research collaborator, the Fraunhofer USA Center for Molecular Biotechnology. The trial was supported by funding from the Defense Advanced Research Projects Agency (DARPA) and was conducted at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC). Safety and reactogenicity assessments were completed at WRAIR-CTC and immunogenicity evaluation was performed by the Influenza Division of the Centers for Disease Control and Prevention.
The final analyses confirm the results of the June 2, 2011 announcement of the safety and immunogenicity of the HAC1 vaccine which was found to be safe and well tolerated at all dose levels, with or without adjuvant. There were no reported serious adverse events or dose-limiting toxicities. No subjects withdrew from the study as a consequence of an adverse event. The analyses also showed that the HAC1 vaccine elicited high levels of immune responses which correlated directly with the amount of antigen administered when the vaccine was not adjuvanted. The immune response was the highest in subjects who received the non-adjuvanted highest HAC1 dose which was comparable with the immune response of the licensed, control H1N1 vaccine.
A manuscript is under preparation to be published in a peer-reviewed journal.
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch™ platform, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. The iBioLaunch platform is a proprietary, transformative technology for development and production of vaccines and therapeutic proteins using transient gene expression in green plants. The technology has been applied successfully to proteins difficult or impossible to produce with other methods, as well as proteins representative most important classes of biologic pharmaceuticals. Advantages of the iBioLaunch platform over other systems include enablement of rapid development and validation of modular, scalable, and optionally robotic, multi-product manufacturing facilities; production time measured in weeks instead of months or more; product entry that is unconstrained by traditional process patents; and significantly lower capital and operating costs for comparable production. Further information is available at: www.ibioinc.com.
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist with the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Further information is available at www.fraunhofer-cmb.org.
Statements included in this news release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.
SOURCE iBio, Inc.