 |
 |
 |
 |
 |
 |
 |
 |
|
ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is announcing today the submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to begin human clinical testing of Homspera, an analog of the endogenous neurokinin Substance P. The company plans to evaluate Homspera initially as a treatment for Idiopathic Pulmonary Fibrosis, a condition for which there are no consistently effective drugs approved for human use in the U.S.
“This marks a major milestone in our efforts to explore the molecular mechanisms and capabilities of Homspera and its potential to treat a range of complications arising from damage to the immune system,” commented ImmuneRegen BioSciences CEO Michael K. Wilhelm. “We are encouraged by the results of pre-clinical studies of Homspera and look forward to taking our research to this next important level,” he added.
Idiopathic Pulmonary Fibrosis is a progressive interstitial lung disease characterized by scarring of lung tissue. Over time, the formation of scars replaces air sacs with fibrotic tissue, preventing the lung from effectively transferring oxygen into the bloodstream. The disease currently afflicts 5 million people worldwide and kills 40,000 annually, though these numbers are believed to be artificially low due to misdiagnosis (http://www.pulmonaryfibrosis.org/ipf.htm). Recent research suggests Pulmonary Fibrosis is a reaction to microscopic injury to the lung resulting from the inhalation of pollutants, radiation exposure, and other insults.
About Homspera
Homspera is an adult stem cell active compound that has been shown in study results to regenerate and strengthen the immune system and enhance wound healing. Originally identified as providing protection from the lethal effects of acute radiation exposure, Homspera has been shown to affect a number of immunological and non-immunological cell types via its receptor-binding activity at the neurokinin-1 receptor (NK-1R). Studies also demonstrate the compound’s hematopoietic stem cell stimulatory activity as well as immunomodulatory and anti-inflammatory activity in a number of model systems. To date, the FDA has issued Pre-Investigational New Drug (PIND) numbers to two derivatives of Homspera: one for Radilex® as a potential treatment of acute radiation exposure, and the other for Viprovex® as a potential treatment for novel forms of influenza.
About ImmuneRegen BioSciences, Inc.
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, 2008 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:
Michael K. Wilhelm OR John N. Fermanis
ImmuneRegen BioSciences Inc.
Phone: 480-922-3926
E-mail: mwilhelm@immuneregen.com
E-mail: jfermanis@immuneregen.com
###