• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

ImmuneRegen Responds to National Institute of Allergy and Infectious Diseases Request for Information

Posted on: Wednesday, 10 August 2005, 09:03 CDT

SCOTTSDALE, Ariz., Aug. 10 /PRNewswire-FirstCall/ -- Research and development biopharmaceutical company ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (BULLETIN BOARD: IRBO) , announced today that it will respond to a Request for Information (RFI) from The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) regarding the development of efficacious vaccines against HIV and AIDS. ImmuneRegen will respond with test protocols for its proprietary treatment, Viprovex(TM), which is currently under development. According to the RFI, DAIDS anticipates that up to four contracts will be awarded for a period of five years, beginning approximately May 3, 2006.

ImmuneRegen's formal response to the RFI will refer to its drug Viprovex, currently in development for the application of infectious diseases such as ARDS, SARS, Hong Kong virus and avian flu. Past studies have shown that the administration of Viprovex may dramatically regenerate the immune system, protecting the body from an array of infectious diseases. ImmuneRegen has seen results of a strengthened immune system in studies where 50% of mice treated with the same compound survived a lethal dose of radiation. ImmuneRegen BioSciences has begun preparations to produce Viprovex on a large scale should such potential purchases occur. The company's current production of Viprovex is manufactured under cGMPs.

The primary objective of the RFI is to solicit proposals for the development of new, safe, and immunogenic vaccine candidates for HIV that merit further evaluation in large human trials. To augment the vaccine product pipeline, DAIDS is seeking opportunities to advance concepts toward the product stage via a focused, development-based approach. Any company awarded a contract will be required to show how the vaccine concept advances along a well-defined development path in a timely manner to a product and into clinical testing by the beginning of the fifth year of the award period.

The formal response will be submitted to DAIDS within the deadline of September 26, 2005. This response will include the following specific information on Viprovex: Product Description, Description of Mechanism of Action, Description of Proposed Dosage Form, Dosing Information, Proposed Indications for Use, Proposed Production Process and Current State of GMP Compliance, Estimate of Production Capacity, Timelines and Cost, Product Development Plan and Overall Stage of Product Development.

About ImmuneRegen BioSciences, Inc.

IR BioSciences Holdings Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is developing a family of treatments, Homspera(TM) and its derivatives Radilex(TM) and Viprovex(TM), for multiple applications, including infectious diseases and homeland security threats such as biological warfare agents and Acute Radiation Sickness (ARS) from a dirty bomb or nuclear disaster. This positions the base compound Homspera as a potential Universal Protectant. Homspera is derived from modified homeostatic substance P, a naturally occurring immunomodulator with the dual effect of improving pulmonary function and the stimulation of the human immune system. Further advances with the Office of Naval Research (ONR) and the U.S. Air Force are currently being pursued. The development of Homspera and its derivatives is pursuant to the U.S. Food and Drug Administration's "animal efficacy" rule, which allows an expedited approval process. For more information, please visit the company's website at http://www.immuneregen.com/.

Statements about the Company's future expectations, including future revenues and earnings, 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. 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 collaborations, clinical trials and product development programs, the evaluation of potential opportunities, the level of corporate expenditures, capital market conditions, and others set forth in the Company's periodic report on Form 10-Q for the three months ended September 30, 2004 as filed with the Securities and Exchange Commission.

Contact: W. Jason Grimley Spelling Communications 310-477-9500 jgrimley@spellcom.com

ImmuneRegen BioSciences, Inc.

CONTACT: W. Jason Grimley of Spelling Communications, +1-310-477-9500,jgrimley@spellcom.com, for ImmuneRegen BioSciences, Inc.

Web site: http://www.immuneregen.com/

Source: PRNewswire-FirstCall

More News in this Category