News ImmuneRegen NewsImmuneRegen BioSciences Signs Lovelace Respiratory Research Institute as Development and Regulatory PartnerLovelace Senior Scientific Advisor to Assist ImmuneRegen with Preclinical Studies and Clinical Trials for Homspera(TM) Tuesday February 19, 6:30 am ETSCOTTSDALE, Ariz.--(BUSINESS WIRE)--ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBO - News), today announced it has finalized an agreement with Lovelace Respiratory Research Institute (LRRI) in Albuquerque, N.M., to provide a broad range of product development services pertaining to inhalation and intranasal drug delivery, and associated regulatory affairs support. This strategic relationship is expected to support ImmuneRegen’s preparation for an Investigational New Drug Application (IND) for Homspera™. Lovelace is a private biomedical research institute with a broad range of research capabilities and research alliances that bear on respiratory health issues of concern to government, industry, university, and health advocacy organizations, as well as the public. Lovelace is committed to the cure of respiratory diseases through research aimed at understanding their causes and biological mechanisms, eliminating exposures to causal agents, and developing improved treatments. This focus parallels that of ImmuneRegen’s research and development activities for Homspera, making LRRI an ideal partner for ImmuneRegen’s development activities. In addition, Lovelace’s research will support ImmuneRegen’s previous evaluations conducted for the National Institute of Health (NIH) to address the organization’s inquiries regarding potential Homspera treatment of radiation sickness, influenza, and SARS. Once addressed, the NIH is expecting to independently evaluate the efficacy of Radilex in preventing or treating radiation sickness in an animal model. NIAID will evaluate Radilex for possible activity as a medical countermeasure for application in a radiation/nuclear emergency, including a terrorist attack. These evaluations are funded as part of the NIH Radiation/ Nuclear Countermeasures Product Development Program. The goal of this program is to increase the U.S. government’s knowledge base, and support private sector product development surrounding potential medical countermeasures. ImmuneRegen also announced that Chet Leach, Ph.D., previously Director of Preclinical Toxicology for Lovelace and Director of Life Science Research and Development at Nektar Therapeutics, will serve as an independent consultant to the company, assisting in planning upcoming clinical trials and non clinical studies, and helping to prepare for eventual clinical trials of Homspera. Leach has nearly 30 years experience in toxicology and pulmonary drug development, having also held positions at IIT Research Institute, Battelle Pacific Northwest Laboratories, and 3M Pharmaceuticals, where he was Head of Preclinical Pulmonary Drug Development. Michael Wilhelm, president and chief executive officer of ImmuneRegen, said, “We are thrilled to work with Lovelace, a worldwide leader in research on the prevention, treatment, and cure of respiratory disease. Respiratory disease is a significant business opportunity for ImmuneRegen, and Lovelace’s expertise in this area will be a valuable asset to our scientific team. There is a great comfort knowing that such an exceptional assembly of experts will be assisting ImmuneRegen with our drug delivery work, IND advancements, and submission initiatives, as well as facilitating significant progress among our drug candidates development in areas such as H5N1 infection, stem cells, wound healing, cancer, etc.” Wilhelm continued, “Dr. Chet Leach is an experienced consultant in drug development who has assisted over 20 biotechnology and pharmaceutical companies with a range of regulatory filings, and has a number of significant drug development efforts to his credit. We are confident that his input into our clinical trials and regulatory strategy will help to ensure our future success.”
About ImmuneRegen BioSciences, Inc.a wholly owned subsidiary of IR BioSciences Holdings, Inc., (OTC BB:IRBS.OB - News) is a development-stage biotechnology company focused on the research, development and licensing of Homspera™ and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex®, a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. To advance its mission, the Scottsdale, Arizona based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems. For more information, please visit www.immuneregen.com. Statements about ImmuneRegen's future expectations, including statements about the potential use and scientific results for ImmuneRegen's drug candidates, science and technology, and all other statements in this press release other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen's business, are subject to various risks and uncertainties. ImmuneRegen's actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen's periodic report on Form 10-Q for the three months ended June 30, 2008 and on Form 10-KSB for the year ended December 31, 2007 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen's proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements. Contact: or
### Copyright © 2003-2008, ImmuneRegen Biosciences, Inc. All rights reserved. |
|