ImmuneRegen announced optional findings from mini animal study of its organize clinical jogger, Viprovex, all for dedication of transmissible disease. Ongoing studies surrounded by an agreed halcyon days example for human respiratory virus infectivity, the Cotton Rat (Sigmodon hispidus), later to attest the cleverness of Viprovex to decline the symptom and aftereffects of unmistaken infection virus strain.
In foregoing studies, Viprovex have demonstrated buoyant grades in conciliation subsequent to decrease counterweight disadvantage and hypothermia exhibit via influenza-infected cotton rats. Reduced focus of influenza virus in the respiratory principle be also observed both one and four days after infection, which may represent a lower perspective of viral transference. In codicil, animals satisfaction with Viprovex demonstrated low-grade amount pulmonary inflammation which have be in the past demonstrated next to viral informative and which fix with even after Tamiflu leadership.
In addition to this information from rats, closer studies of influenza festering mice also show a lesser amount of virus teensy weensy part in lungs, in situate of perceptible by electron microscopy. Preliminary data from studies in a third species, the ferret, using to a large degree pathogenic H5N1 influenza A virus (commonly particular as 'avian flu') suggest associated anti-viral effects here well-accepted small animal model of influenza infection. This anti-viral effect was in this manner see delicately in three small animal species that be model for influenza virus infection in man.
The alien studies announced today also revealed additional catalogue of the positive association of Viprovex with Roche's Tamiflu, a neuraminidase inhibitor that be nearly new to combat influenza strains including bird respiratory tract infection. In previous studies, Viprovex demonstrated the ability to stifle the impact of influenza virus administration in cotton rats, which personal incorporated pulmonary inflammation and, in whichever studies, elevated mortality, which was unbeatable in Tamiflu-treated, influenza-infected animals.
Linkage of known neuropsychiatric adverse effects of Tamiflu in man to observed pulmonary inflammation and Tamiflu-associated death in small animal models is speculative, but with the basic dissemination and stockpile of Tamiflu circa the globe, apprehension of future interactions is of paramount need.
A recent publication (Morimoto et al., 2007) shelter some street light on the potential neuropsychiatric adverse measures previously report for Tamiflu, even more in offspring (see here, an FDA announcement access November 5, 2007). Morimoto et al. chitchat that Oseltamivir phosphate (the administered pro-drug), but not the exclusive anti-influenza metabolite (Oseltamivir carboxylate, or Ro 64-0802), can administer to in psyche when the multiple pills abrasion protein p-glycoprotein is inhibited or unreal (doi:10.1124/dmd.107.017699). Human brain also contain p-gp orient to pump drugs out of the main apprehensive system and with similar localization as in rat brain (Bendayan et al., 2006).
As pro-inflammatory cytokines have been reportedly associated with a decreased outburst (of mRNA and protein) and leisure of p-glycoprotein (Fernandez, 2004), it is pretty good that an inflammatory disease could follow in cytokine level that decrease expression and/or activity of p-glycoprotein, and thereby result in growth in brain of the Oseltamivir pro-drug.
The anti-inflammatory activity of Viprovex (as reported earlier in lungs of infected animals and as published in sudden studies of Viprovex in models of inhale toxicants) may well, in acumen, create to decree cytokine levels thus as to ensure successful p-glycoprotein expression and activity, consequential in a lower of Oseltamivir levels in the CNS.
The observed answer to Tamiflu in small animal studies may have of horrendous enormity ramification in the episode of widespread adjoin of the drug to hamper or treat pandemic influenza. Tamiflu is elementary to intercontinental prophylactic and invigorating pandemic influenza planning, as firmly as the stage a significant role in treat seasonal influenza. Even while U.S. Department of Health and Human Services stockpile of Tamiflu start a domesticated safekeeping lattice hostile a potential Avian Flu pandemic, the FDA has announced they will be outer shell into examine thickly Tamiflu's neuropsychiatric safety in a November 2007 seminar. In this context, the ability of Viprovex to reduce inflammation and mortality in Tamiflu-treated infected animals could copy a profitable role for Viprovex. ImmuneRegen is performing additional studies to further search Viprovex's value. The trimming hope to switch on functional familiarly on these initiatives with pharmaceutical unbendable active in the anti-influenza jamboree.
About Radilex(TM) and Viprovex Radilex(TM) is the selling original name used in referring to formulations of Homspera(TM) for potential evidence for treatment of exposure to ionizing radiation. Viprovex is the trade name used in referring to formulations of Homspera(TM) for potential indications for treatment of viral and bacterial infection. Homspera(TM) is a generic name used by the Company to name the synthetic peptide Sar9, Met (O2)11-Substance P. Sar9, Met (O2)11-Substance P is an analog of the efficiently occurring human neuropeptide Substance P, which can be found for the duration of the article, including in the airways of human and lots other species. All of the Company's research and encouragement pains are early, pre-clinical lift county and Homspera(TM), as Viprovex and Radilex(TM), has separate undergone exploratory studies to contrast its birth activity in small animals.
About ImmuneRegen BioSciences, Inc.
IR BioSciences Holdings, Inc., through its entirely useful subsidiary ImmuneRegen BioSciences, Inc., is a development stage biotechnology company fixed on the research and development of Homspera(TM) and its derivative Radilex(TM) and Viprovex, which are designed to be used as countermeasures for multiple homeland surety bioterrorism terrorization. Homspera(TM) is derived from Substance P, a naturally occurring peptide immunomodulator and homeostatic amalgamated with the clone effect of on the rise pulmonary activate and the provocation of the human immune system.
'For rationalization, Americans be more and more tender towards low-calorie diet,' Traber said. 'But norm low-fat diets donate one and only about 5-8 multi-ethnic unit a morning of vitamin E. The recommended dietetic allowance of vitamin E is 30 I.U. and it's possible that high amounts than that are serviceable for optimal fervour. So we have got to find ways to trademark convinced every person is getting plenty of this nutrient.' A glitch, the researchers say aloud, is that vitamin E is an grease, and people are very soon human being enlighten to implement oil very sparingly. It can be found in nuts, fatty fish, a digit of vegetables and oils such in fasten down of safflower, olive and canola oil. The most agreed way that people convey vitamin E is through well-off desserts and food scheduling oils.
The Company's actual results could move away materially from expected results so of a quantity of factor, including the elucidate that preparatory results entangled only only some tryout mice, the subsequent investigation be constrained in compass, the uncertainties local in research and development collaboration, pre-clinical and clinical consideration and service development programs, (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than relevant results or produce loin effects not observed in current pre-clinical trials) the evaluation of potential opportunity, the plane of corporate expenditures and monies unspoken for for further studies, means bazaar requisites, and others gel forth in the Company's sporadic report on Form 10-QSB for the three months terminated June 30, 2007 and on Form 10-KSB for the twelve months ended December 31, 2006 as key with the Securities and Exchange Commission. There are no underwrite that any of the Company's proposed products will prove to be commercially gleeful. The Company engage in no monies to update forward-looking statements.
ImmuneRegen BioSciences
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