SCOTTSDALE, Ariz., March 8 /PRNewswire-FirstCall/ -- ImmuneRegen BioSciences, a wholly-owned subsidiary of IR BioSciences Holdings, Inc. announced today that ongoing analysis of data acquired from previously performed animal efficacy studies has revealed evidence that ImmuneRegen’s developmental stage product, Radilex(TM), may stimulate hematopoietic stem cells.
Studies performed at the Oak Ridge National Laboratory reveal that ImmuneRegen’s potential radioprotectant product, Radilex, not only prolonged survival of animals exposed to lethal gamma irradiation, but appeared to have increased platelet concentrations in surviving animals. As the experimental protocol required these animals to be subject to repeated blood sampling as well as irradiation, saline injections were relied on for plasma volume restoration. In the face of the resulting hemodilution, compensatory hematopoietic mechanisms were nonetheless adequately stimulated to enable survival of a number of Radilex-treated, but no untreated, animals. Blood cell quantitation showed trends in the surviving animals toward neutrophil replenishment as well. ImmuneRegen has since filed a provisional patent entitled “Method to Treat Blood Cell Depletion” to provide intellectual property protection for this finding regarding Radilex.
Continuing radiation studies will be performed at both the Translational Genomics Research Institute (TGen) and TGen Drug Development Services (TD2, its drug development arm) and at the Pacific Northwest National Laboratory to further explore the impact of radiation on the hematopoietic system of Radilex-exposed animals. ImmuneRegen’s ongoing studies will be designed to examine mechanistic indicators at both high levels of radiation where Radilex has shown protection, as well as at lower levels. If successful, these studies will enable Radilex to address both the government market, as a countermeasure to radiological dispersion devices (“dirty bombs”), as well as the cancer market, as an adjuvant treatment candidate potentially ameliorating the side effects resulting from cancer radiotherapy.
“Recognizing our candidate product has this effect is very motivating. These results suggest a myriad of potential applications in which stem cell replenishment is clinically useful, and not just leukemias and lymphomas. We are excited about our research program and while focused on our current development plan, fully expect to broaden our understanding of the potential of Radilex based on upcoming and planned studies at Battelle and TGen” said ImmuneRegen CEO Michael Wilhelm.
Hollis-Eden and Cleveland BioLabs recently reported results on their respective radioprotectants in development. Hollis-Eden reported on the effects of NEUMUNE(R) (HE2100) in non-human primates exposed to 0.6 Gy total body irradiation and without clinical support such as antibiotics, IV fluids and platelet transfusions. They show an increase in survival in monkeys injected daily with NEUMUNE for 5 days despite severe neutropenia and thrombocytopenia. Of particular note, they find the platelet-restoring effect of their steroid to be most predictive of survival in treated animals. Studies carried out by Cleveland BioLabs have revealed the ability of their CBLB502 radioprotectant to protect non-human primates from the hematopoietic (as well as gastrointestinal) damage of gamma radiation. Also, their CBLB612 compound has been reported to increase bone marrow hematopoietic stem cells and enhance mobilization of these cells from bone marrow. They hypothesize that these cells are useful in repopulating irradiated animals with functionally competent hematopoietic components, thus enhancing survival following lethal doses of radiation.
ImmuneRegen has routinely utilized lethal total body radiation doses (7-9 Gy) in previously reported animal studies of Radilex and has never artificially accelerated morbidity, or provided clinical support, to post- radiation post-Radilex animals. Thus, these future studies at TD2 and Pacific Northwest National Laboratory have the potential to accelerate ImmuneRegen’s Radilex development program, and may support Radilex evaluation in non-human primates later this year while advancing the understanding of the underlying mechanisms by which its radioprotectant activity is achieved.
About Radilex(TM) and Viprovex(TM)
Radilex(TM) is the trade name used in referring to formulations of Homspera(TM) for potential indications for treatment of exposure to ionizing radiation. Viprovex(TM) is the trade name used in referring to formulations of Homspera for potential indications for treatment of viral and bacterial infections. Homspera is a generic name used by the Company to describe the synthetic peptide Sar9, Met (O2)11-Substance P, an analog of the naturally occurring human neuropeptide Substance P, which can be found throughout the body, including in the airways of humans and many other species. All of the Company’s research and development efforts are early, pre-clinical stage and Homspera, as Viprovex(TM) and Radilex(TM), has only undergone exploratory studies to evaluate its biological activity in small animals.
About ImmuneRegen BioSciences, Inc.
IR BioSciences Holdings, Inc., through its wholly owned subsidiary ImmuneRegen BioSciences, Inc., is a development stage biotechnology company focused on the research and development of Homspera(TM) and its derivatives Radilex(TM) and Viprovex(TM), which are designed to be used as countermeasures for multiple homeland security bioterrorism threats. Homspera is derived from Substance P, a naturally occurring peptide immunomodulator and homeostatic compound with the dual effect of improving pulmonary function and the stimulation of the human immune system. For more information, please visit the company’s website at www.immuneregen.com.
Statements about the Company’s future expectations, including statements about the potential 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 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 the Company’s periodic report on Form 10-QSB for the three months ended September 30, 2006 and on Form 10-KSB for the twelve months ended December 31, 2005 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: MEDIA CONTACT: W. Jason Grimley Spelling Communications 310-477-9500 jgrimley@spellcom.com INVESTOR CONTACT: Josh Reynolds CEOcast, Inc. 212-732-4300 jreynolds@ceocast.com IN-HOUSE INVESTOR CONTACT: Bill Lane ImmuneRegen BioSciences, Inc. 480-922-3926 blane@immuneregen.com
IR BioSciences Holdings, Inc.
CONTACT: Media, W. Jason Grimley of Spelling Communications,+1-310-477-9500, jgrimley@spellcom.com, for IR BioSciences Holdings, Inc.;or Investors, Josh Reynolds of CEOcast, Inc., +1-212-732-4300,jreynolds@ceocast.com; or In-House Investor Contact, Bill Lane ofImmuneRegen BioSciences, Inc., +1-480-922-3926, blane@immuneregen.com
