ImmuneRegenÂ® BioSciences and DelSite Biotechnologies Collaborate on New Flu Treatment
SCOTTSDALE, Ariz.--(BUSINESS WIRE)--ImmuneRegenÂ® BioSciences, Inc., a wholly owned biotechnology product development and licensing subsidiary of IR BioSciences Holdings, Inc. (OTCBB:IRBO), announced today it has commenced a collaboration with DelSite Biotechnologies, Inc., a wholly owned subsidiary of Carrington Laboratories (CARN.OB), to develop a new vaccine adjuvant system that provides both immediate and sustained immunostimulation for more effective protection against a variety of transmittable pathogens.
With an initial focus on an influenza virus vaccine, the collaboration will determine if the combination of ImmuneRegenâ€™s vaccine adjuvant compound, ViprovexÂ®, and DelSiteâ€™s unique adjuvant system, based on the polymer GelSiteÂ®, can potentially augment the ability of vaccine products to produce the enhanced immune response. Viprovex, a formulation of ImmuneRegenâ€™s Homsperaâ„¢, has previously shown vaccine adjuvant activity in boosting immune responses to co-administered influenza vaccine. GelSiteâ€™s drug delivery technology supports injection and intranasal administration of vaccines and drugs, and can be engineered for sustained release of active ingredients over a period of minutes, days or weeks. Comprehensive animal data indicates that GelSiteâ€™s sustained release feature provides adjuvant-like enhancement to vaccines.
â€œOur work with DelSite supports the development of vaccines and adjuvants that can be quickly and easily self-administered,â€ said Michael Wilhelm, president and chief executive officer of ImmuneRegen. Noting that pandemic flu is one of the most significant healthcare risks facing our nation today, he added, â€œViprovex has already shown strength in fighting contagious disease, including two common influenza strains found in humans, H1N1 and H3N2, as well as the potentially pandemic H5N1 (avian flu).â€
Viprovex, administered intranasally, has demonstrated its effectiveness as an adjuvant in the treatment of influenza and as an anti-influenza agent protecting vaccinated animals from a lethal pandemic influenza challenge. Several reported animal studies include:
- Studies in an accepted model for human respiratory virus infection, the Cotton Rat, that show the ability of Viprovex to decrease the symptoms and aftereffects of certain human influenza virus strains;
- Studies of human influenza-infected mice, which showed fewer virus particles in lungs, as visible by electron microscopy;
- Preliminary data from studies in ferrets using the highly pathogenic H5N1 influenza A virus (commonly known as â€œavian fluâ€) that suggest similar anti-viral effects in this well-accepted small-animal model of influenza infection; and
- Studies in the Cotton Rat that show Viprovex enhances the efficacy and safety of Roche's TamifluÂ®, a neuraminidase inhibitor used to combat influenza which is stockpiled by governments around the world to treat potential pandemic avian influenza outbreaks.
- DelSiteâ€™s GelSite polymer is designed to provide controlled release of peptide and protein drugs and vaccines. GelSiteâ€™s unique characteristics include its pH and temperature independence from pH or temperature levels, ability to gel in the presence of live cells and its property of binding to and stabilizing important proteins. The GelSite polymer is classified as â€œgenerally regarded as safeâ€ (GRAS) and is used in the formulation of DelSiteâ€™s GelVacâ„¢ nasal powder bird flu vaccine, which is scheduled to be in human testing later this year.
About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB:IRBO), is a development-stage biotechnology company focused on the research, development and licensing of Homsperaâ„¢, an adult stem cell active compound that can regenerate and strengthen the immune system. To advance its mission, the Scottsdale, Ariz.-based company has forged numerous study partnerships with industry and academic leaders, including Anthrogenesis, Lovelace Respiratory Research Institute, UC Berkeley, HemoGenix and Virion Laboratories. For more information, please visit the companyâ€™s website at www.immuneregen.com.
About Carrington Laboratories, Inc.
Carrington Laboratories, Inc. (OTCBB:CARN) is an ISO 9001-certified, research-based biopharmaceutical and consumer products company currently utilizing naturally occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington, whose technology is protected by more than 130 patents in 26 countries, also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards, and select products carry the CE mark, recognized by more than 20 countries around the world. For more information, please visit the companyâ€™s website, www.carringtonlabs.com.
About DelSite Biotechnologies, Inc.
DelSite Biotechnologies, a wholly owned subsidiary of Carrington Laboratories, Inc., is an early-stage drug delivery and biotechnology company with significant expertise and intellectual property related to the stabilization and delivery of proteins and peptides. DelSite is developing its proprietary GelSiteÂ® technology, which is designed to provide controlled release of peptide and protein-based drugs and vaccines. In conjunction with its partner Brookwood Pharmaceuticals, Inc. (formerly Southern Research Institute), DelSite can provide formulation development, initial stability profiling and toxicology screening. In addition, DelSite resources are available to provide initial manufacturing expertise and production of clinical supplies. For more information, please visit the companyâ€™s website, www.delsite.com.
Statements about ImmuneRegenâ€™s future expectations, including statements about the potential 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 the 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 fact that preliminary results involved only a small number of test mice, the subsequent investigations were limited in scope, 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-QSB for the three months ended September 30, 2007 and on Form 10-KSB for the twelve months ended December 31, 2006 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.