NetworkNewsBreaks – Aditxt Inc. (NASDAQ: ADTX) Moves One Step Closer to In-Human Trials with Completion of Preclinical Toxicity Study
Aditxt Inc. (NASDAQ: ADTX), a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, has successfully completed a toxicology study evaluating Adimune(TM), its proprietary therapeutic program. The study indicates the safety profile of ADI(TM)-100, ADTX’s immunotherapeutic technology drug, which is designed to treat the rejection of transplanted organs, skin allografting, autoimmune diseases and allergies. Calling the study results “promising,” the company noted that those results will provide vital supporting evidence when Aditxt moves forward with an investigational new drug (“IND”) application with the regulatory agencies. According to the announcement, ADI-100 is made of two DNA molecules that together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. The process of modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, the company noted, and has potential to offer huge efficacy and safety benefits because no immunosuppression is involved. “Our drug is truly antigen-specific in the treatment of autoimmune diseases,” said Aditxt senior vice president of clinical development-autoimmunity Joachim-Friedrich Kapp, MD, PhD, in the press release. “In preparation of the clinical study, we performed a toxicology study and found no premature death; no signs of local intolerance; no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No antinuclear antibodies, no macroscopic postmortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all preclinical experiments before. . . . In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect. This was shown in safety studies, when using a listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.”
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Aditxt Inc. (NASDAQ: ADTX), a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, has successfully completed a toxicology study evaluating Adimune(TM), its proprietary therapeutic program. The study indicates the safety profile of ADI(TM)-100, ADTX’s immunotherapeutic technology drug, which is designed to treat the rejection of transplanted organs, skin allografting, autoimmune diseases and allergies. Calling the study results “promising,” the company noted that those results will provide vital supporting evidence when Aditxt moves forward with an investigational new drug (“IND”) application with the regulatory agencies. According to the announcement, ADI-100 is made of two DNA molecules that together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. The process of modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, the company noted, and has potential to offer huge efficacy and safety benefits because no immunosuppression is involved. “Our drug is truly antigen-specific in the treatment of autoimmune diseases,” said Aditxt senior vice president of clinical development-autoimmunity Joachim-Friedrich Kapp, MD, PhD, in the press release. “In preparation of the clinical study, we performed a toxicology study and found no premature death; no signs of local intolerance; no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No antinuclear antibodies, no macroscopic postmortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all preclinical experiments before. . . . In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect. This was shown in safety studies, when using a listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
