News ImmuneRegen NewsImmuneRegen BioSciences Get Critical Guidance from FDA and Division of Counter Terrorism OfficialsEfficacy of Company's Homspera Analyzed for Acute Radiation SicknessSCOTTSDALE, Ariz., March 17 /PRNewswire/ -- ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC Bulletin Board: IRBOE.OB) announced it recently completed a meeting with the Food and Drug Administration's (FDA) newly developed Division of Counter Terrorism, along with various other departments of the FDA, where they discussed potential efficacy of their proprietary compound Homspera in treating acute radiation sickness (ARS). This meeting was a direct result of ImmuneRegen's pre-IND (Investigational New Drug) meeting last November, during which they discussed similar topics. The FDA offices participating in the meeting include: the Division of Counter Terrorism (DCT), the Division of Gastrointestinal and Coagulation Drug Products (DGCDP), the Office of Counterterrorism and Pediatric Drug Development (OCTAP), the Office of Drug Evaluation (ODE), the Division of Therapeutic Biological Oncology Products (DTBOP), and the Division of Medical Imaging and Radiopharmaceutical Drug Products (DMIRDP), as well as various team leaders. This meeting with FDA officials focused on the efficacy of Homspera in treating acute radiation sickness, which can occur from any number of sources, such as bombs, chemical spills, and terrorist attacks. Officials offered guidance on the structure of ImmuneRegen's upcoming large animal trials to ensure they are completed to the FDA's satisfaction. Based on the advice received, the Company is adjusting future plans accordingly in preparation for their IND submission, planned for later in the year. This could potentially lead to a New Drug Approval (NDA) from the FDA. Additionally, officials suggested the Company look into additional forms of delivering their Homspera compound other than the current inhalation method. They suggested an auto-injection method, to help regulate the dose given and speed absorption into the body. "This meeting was a significant milestone as we move towards approval for Homspera in treating acute radiation sickness," explains Michael K. Wilhelm, CEO of ImmuneRegen BioSciences, Inc. "We are taking the FDA's comments and feedback to heart and are incorporating them into our future research studies. We are also adding new studies to address their suggestion of an alternative delivery method for Homspera." 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
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