During her time with the X-Force, Domino came into conflict with Donald Pierce and Lady Deathstrike, who had captured Milo Thurman and were attempting to download his mind to a computer. Dom stopped the process, but it cost Thurman his life.[14]
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KEY TECHNOLOGY AREAS: Chemical/Biological Defense, Biomedical OBJECTIVE: To develop capabilities and obtain FDA approval for dermal dressing technologies that provide multiple advantages over current wound dressings for treating dermal injuries caused by sulfur mustard. DESCRIPTION: Sulfur mustard (military designation HD or H) is a chemical warfare agent that affects multiple tissues, and causes blistering of the skin and mucous membranes on contact. The dermal lesions caused by HD resemble burn lesions, and can cover large portions of exposed skin surfaces. Like burn injuries, HD dermal lesions are extremely painful, can lead to fluid loss, and are highly susceptible to infection. Battlefield management of these wounds by military first responders can be especially challenging due to the high potential for mass casualties, the necessity to treat during ongoing operations in austere environments, and delays in medical evacuation. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) is interested in developing technologies (dressings, treatments, etc.) to treat HD dermal injuries in a battlefield environment. Candidate technologies for this application need to provide physical protection to burn-like injuries, be stable in a large range of conditions (temperature and humidity), be easy to apply, be suitable for application to various surface areas, allow inspection of injuries without removal, provide antimicrobial protection, and pain relief. The ultimate goal is to demonstrate efficacy in treating HD dermal injury in appropriate animal models of HD injury (see Phase II). In addition to being efficacious in protecting and treating HD dermal injuries to allow faster healing, top candidates for consideration will also possess additional desirable properties mentioned above. Among these are ease of application to facilitate use in a mass casualty event, and low logistical footprint (not cumbersome to carry, minimal cold chain storage requirements, sufficient shelf life, etc.). Other desirable properties sought are selective permeability to prevent fluid loss through the wound(s), antimicrobial properties to protect against infections, providing pain relief, and relative ease of removal for performing required treatments after application. These technologies have a broad potential application beyond just HD injuries; hence, they are expected to reduce logistical burden to the military first responder. PHASE I: If the proposed technologies have been previously tested for other injury types, provide in vivo data demonstrating the efficacy of the product when used to treat similar injuries such as burns, severe abrasions, and/or other comparable injuries. Quantitative data that provides clear metrics that allow the comparison of the candidate to other products or standard medical care (wound size reduction over time, time to restoration of dermal layers, etc.) is preferred. Generate and provide a regulatory plan to obtain an FDA approval or an HD dermal injury indication. The plan should align with the timing and funding levels expected for SBIR Phase I and II, with the balance of funding and studies conducted in Phase III of the project. Obtain confirmation from the FDA, via pre-IND, Q-submission or pre-submission, that the regulatory plan is acceptable to obtain the HD dermal injury approval or indication for the candidate technology. A research partner should be identified that can perform the needed pre-clinical animal studies using sulfur mustard. No animal studies are permitted during the Phase I period of performance.PHASE II: Perform an efficacy study in a small animal model. Provide a report of the small animal study to determine if the product should proceed to testing in a large animal model. Plan the large animal study, and submit an estimate of cost for conducting Phase III objectives. If feasible, perform packaging/container designs to allow treatment of larger surface areas and for multiple casualties. At this stage, accelerated stability studies to obtain estimates on storage shelf life and operational conditions should be performed.PHASE III: Perform the efficacy study in a large animal model. Prepare regulatory strategy and submit FDA documentation to add HD injury indication to the product. Submit final reports that include the results of the animal studies, and any relevant FDA information/documents to the JPM CBRN Medical.PHASE III DUAL USE APPLICATIONS: The technologies proposed for development are also applicable to a broad range of battlefield injuries. This significantly increases the value of the technologies and reduces the burden on military first responders since it eliminates the need to carry equipment solely dedicated to chemical agent injuries. Furthermore, the Department of Health and Human Services (HHS) has a similar need for technologies that allow treatment of HD and burn injuries in a mass casualty event. Successful completion of all three phases under this solicitation will support small business valuation by confirming technical merit that invites further investment. This award mechanism will bridge the gap between laboratory-scale innovation and entry into a recognized FDA regulatory pathway leading to commercialization.REFERENCES:1.Etemad L, Moshiri M, Balali-Mood M. Advances in treatment of acute sulfur mustard poisoning - a critical review. Crit Rev Toxicol. 2019; 49(3):191-214.2.Rose D, Schmidt A, Brandenburger M, Sturmheit T, Zille M, Boltze J. Sulfur mustard skin lesions: A systematic review on pathomechanisms, treatment options and future research directions. Toxicol Lett. 2018; 293:82-90.3.Poursaleh Z, Ghanei M, Babamahmoodi F, Izadi M, Harandi AA, Emadi SE, Taghavi NO, Sayad-Nouri SS, Emadi SN. Pathogenesis and treatment of skin lesions caused by sulfur mustard. Cutan Ocul Toxicol. 2012; 31(3):241-249.4.Dachir S, Cohen M, Kamus-Elimeleh D, Fishbine E, Sahar R, Gez R, Brandeis R, Horwitz V, Kadar T. Characterization of acute and long-term pathologies of superficial and deep dermal sulfur mustard skin lesions in the hairless guinea pig model. Wound Repair Regen. 2012;20(6):852-861.5.Ghanei M, Poursaleh Z, Harandi AA, Emadi SE, Emadi SN. Acute and chronic effects of sulfur mustard on the skin: a comprehensive review. Cutan Ocul Toxicol. 2010; 29(4):269-277.6.Dachir S, Cohen M, Fishbeine E, Sahar R, Brandies R, Horwitz V, Kadar T. Characterization of acute and long-term sulfur mustard-induced skin injuries in hairless guinea-pigs using non-invasive methods. Skin Res Technol. 2010;16(1):114-124.7.Laskin JD, Wahler G, Croutch CR, Sinko PJ, Laskin DL, Heck DE, Joseph LB. Skin remodeling and wound healing in the Gottingen minipig following exposure to sulfur mustard. Exp Mol Pathol. 2020; 115:104470.8.Barillo DJ, Croutch CR, Reid F, Culley T, Sosna W, Roseman J. Blood and Tissue Silver Levels Following Application of Silver-Based Dressings to Sulfur Mustard Chemical Burns. J Burn Care Res. 2017; 38(5):e818-e823. 2ff7e9595c
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