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ImmuneRegen Biosciences Announces Update on FDA-Requested Homspera Study

SCOTTSDALE, Ariz., Aug 17, 2004 (BUSINESS WIRE) -- ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (IRBO, Trade), provided an update on the FDA-requested study evaluating the efficacy of Homspera™ as a treatment against gamma radiation when administered via direct muscle injection.

"Although we are only at the half-point of this study, we are encouraged to see that direct muscle injection of the Homspera compound is already eliciting a similar positive response previously seen with aerosol administration," said Michael Wilhelm, CEO of ImmuneRegen Biosciences.

"The significance of these initial observations is two-fold. First, direct injection of the compound may allow the military and first responders to treat themselves more quickly with Homspera in an emergency situation. Second, animals in this study, which are being kept in special sterile environments compared to our previous studies, are showing better immune system responses. While we cannot make conclusions about the survival rate at this point, we are taking both the direct muscle injection administration and sterility chambers into account as we continue to assemble the Rapid Response Team."

The 90-day study was initiated on June 28, 2004 by Dr. Mark Witten, Research Professor in the Department of Pediatrics at the University of Arizona College of Medicine, in which mice were exposed to three different doses of gamma radiation, and administered a direct muscle injection of placebo or the Homspera compound. The mice were also sheltered in specially designed micro-isolator chambers within a "clean room" to minimize bacterial and viral contaminations from the air. The endpoint of the study, to be measured on day 90, will be survival.

The firm has been requested by the Federal Drug Administration (FDA) to form a BioTerrorism Rapid Response Team to help assist local, federal and international officials deal with the possible threat of another terrorist attack.

 

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:
Amendola Communications for ImmuneRegen
Jan Shulman, 480-664-8412 ext. 12
jshulman@ACmarketingPR.com

or


Jodi Amendola, 480-664-8412 ext 11
jamendola@ACmarketingPR.com

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