News ImmuneRegen NewsRecent Study Finds Aerosol Treatment Best Bet Against Dirty BombDecember 07, 2004 09:30:00 (ET) SCOTTSDALE, Ariz., Dec 7, 2004 /PRNewswire-FirstCall via COMTEX/ IR BioSciences Holdings, Inc. (IRBO, Trade), owner of biotechnology research and development company ImmuneRegen BioSciences, Inc., has completed its sixth study of the company's proprietary substance, Radilex™, on exposure to fatal doses of radiation. This study was requested by the Department of Counter-Terrorism of the U.S. Food and Drug Administration to determine the most effective method of administering Radilex™. The study results found aerosol delivery of Radilex™ to be superior over direct muscle injection in preventing acute radiation sickness (ARS) post lethal exposure (PLE). ImmuneRegen also found that Radilex™ may have efficacy in reducing the negative effects of radiation treatment on cancer patients, such as hair loss, wound healing difficulties, and immune system suppression. "The results of this study have strengthened our confidence in utilizing an aerosol method of delivery and brought us yet another step closer to FDA approval," says Michael Wilhelm, CEO of ImmuneRegen BioSciences, Inc. "It has also put us further ahead of the pack in the pursuit of developing a treatment for ARS. All the other research available shows comparable therapies are being tested at sub-lethal levels of radiation exposure. After completing six rounds of testing with lethal dosages of radiation, we're confident our treatment can save lives and better prepare our country for terrorist attacks." Conducting the study at the University of Arizona, Dr. Mark Witten, PhD, co-founder and Chief Scientific Officer of ImmuneRegen BioSciences, Inc., found aerosol to be the superior methodology over direct muscle injection. Past aerosol tests showed up to a 50% survival rate post lethal exposure (PLE) to radiation. While further study is needed, Dr. Witten believes this finding may be due to a difference of neurokinin receptors in the lungs to those in skeletal muscle. Past research shows the predominant neurokinin receptor in rat skeletal muscle was demonstrated to be the neurokinin-2 receptor. The predominant neurokinin receptor in the lungs is the neurokinin-1 receptor. Radilex™ is known to be a neurokinin-1 receptor agonist. In study number six, Dr. Witten and his team made a new discovery that could lead to an additional possible application for Radilex™. During the testing, some of the subjects developed open wounds from natural causes. During the 60-day period, during which half of the subjects were injected with the Radilex™, those in the control groups remained injured and those that were treated healed. "What's exciting about these results is that we found something we weren't looking for. We already know that Radilex™ has the ability to treat acute radiation sickness and that it can greatly increase a person's chance of survival after a nuclear attack. In this study, we discovered a wound healing property that no one even thought to look for," says Dr. Witten. "This find has sparked a need to study all methods of delivery further. At first glance, we think Radilex™ can be developed into a treatment that would allow cancer patients to undergo radiation treatment without the debilitating side effects which are so common." The test subjects consisted of 300 mice separated into three groups of 100. Each group was exposed to different levels of radiation -- 7 gray, 8 gray (fatal dose) and 9 gray (fatal dose) -- and consisted of 25 male subjects treated with Radilex™, 25 female subjects treated with Radilex™, and the corresponding control subjects. Each mouse was given a single dose of radiation, then all non-control mice received a dose of Radilex™ by direct muscle injection on a daily basis for 60 consecutive days. 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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