Development ActivitiesImmuneRegen BioSciences, Inc., is engaged in the research and development of the potential drug candidates Homspera and its derivatives, Radilex and Viprovex. Our goals include developing these potential drug candidates to be used as possible countermeasures for homeland security threats, including radiological, chemical and biological agents, and to meet the commercial need for similar beneficial effects in conditions such as radiation therapy, influenza, anthrax and potentially other microbial ailments. We have discovered activities of Homspera that may potentially open additional commercialization opportunities in areas such as vaccine adjuvants, which stimulate the immune system above that of a stand-alone vaccine, human adult stem cell stimulation and wound healing. The active ingredient, Homspera, is chemically equivalent in both Radilex and Viprovex; however, since both Radilex and Viprovex are to be used in different potential applications, and thus have distinct indications for use, we anticipate several formulations in the future that will support appropriate (and possibly different) modes of administration. For this reason, we have created the trade names to more easily differentiate the potential formulations, and applications, with respect to their development and potential future market opportunities. The initial pre-clinical applications we are researching include: (i) stem cell activity/immune system strengthening (Homspera); (ii) wound healing (Homspera); (iii) treating the effects on the body caused by exposure to radiation (Radilex); (iv) treating the effects on the body caused by infectious disease and harmful biological materials (Viprovex); (v) vaccine adjuvants (Viprovex); and, (vi) treating the effects on the body caused by exposure to harmful chemical agents (Viprovex). In addition to these six potential applications, we continue to explore the potential capabilities of Homspera and strive to better understand the mechanisms of this compound in order to further our development efforts with regard to not only our current application research, but also potential future applications. All our product candidates are in the pre-clinical stage of development. They have only been introduced to FDA via the pre-IND filings, submissions to which the FDA offers no judgment thereon. To date we have been issued two Pre-Investigational New Drug (PIND) numbers by the U.S. Food & Drug Administration (FDA). One is for the potential use of Radilex in the treatment of acute radiation syndrome and one is for the potential use of Viprovex in the treatment of avian influenza. The table below illustrates our current product candidates and their current stage of development within the FDA approval process.
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