SOURCE: ImmuneRegen BioSciences

ImmuneRegen BioSciences

March 04, 2010 08:00 ET

ImmuneRegen BioSciences Submits Homspera® for FDA Orphan Drug Product Designation for the Treatment of Idiopathic Pulmonary Fibrosis

Company to Continue Developmental Work on Idiopathic Pulmonary Fibrosis in Conjunction With the University of Rochester

SCOTTSDALE, AZ--(Marketwire - March 4, 2010) -  ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company's lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments. 

The United States Orphan Drug Act was created in 1983 to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, a waiver of user fees, the potential for grant funding, and tax benefits for clinical trials. Many orphan products receive expedited review or accelerated approval because they are for serious or life-threatening diseases.

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. Recent research suggests pulmonary fibrosis may be a reaction to microscopic injury to the lung resulting from the inhalation of pollutants, radiation exposure, and other insults.

ImmuneRegen continues to advance the development of its Homspera drug candidate for the treatment of Idiopathic Pulmonary Fibrosis in collaboration with Dr. Jacob Finkelstein at the University of Rochester and several Contract Research Organizations.

"ImmuneRegen is excited to be pursuing the indication of Idiopathic Pulmonary Fibrosis most aggressively, as this disease is still without an effective licensed treatment in the U.S., although many expect InterMune's pirfenidone to eventually be approved. The relative lethality yet low prevalence of IPF confers Orphan Drug Status and Fast Track eligibility for many potential therapeutics, and most analysts believe IPF therapies will have a multi-billion dollar commercial market. Leveraging the support of our industry and academia partners will allow us to expedite the development of Homspera for this indication, and will expand opportunities for more rapid development in the other areas we are and or expect to pursue, such as neutropenia, Influenza and Melanoma," explained ImmuneRegen CEO Michael Wilhelm.

About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera®. 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. 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

Statements about the Company's future expectations, including statements about the potential use and scientific results for the Company'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. The Company 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 the Company's business, are subject to various risks and uncertainties. The Company'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 the Company's periodic report on Form 10-Q for the three months ended September 30, 2009 as filed with the Securities and Exchange Commission and report on Form 10-K for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. There are no guarantees that any of the Company's proposed products will prove to be commercially successful. The Company undertakes no duty to update forward-looking statements.

Contact Information

  • Contact:
    Michael K. Wilhelm
    John Fermanis
    ImmuneRegen BioSciences Inc.
    Phone: 480-922-3926
    Email:Email Contact
    Email:Email Contact