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Processa Pharmaceuticals Announces Positive Preclinical Data for NGC-Iri
Delivers more cancer-killing SN-38 molecules to tumor than irinotecan and Onivyde® Studies support potential benefit as an improved treatment with fewer side
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Delivers more cancer-killing SN-38 molecules to tumor than irinotecan and Onivyde® Studies support potential benefit as an improved treatment with fewer side effects HANOVER, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announces positive data from preclinical studies that support the potential for NGC-Iri to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde® (the liposomal formulation of irinotecan). Next Generation irinotecan (NGC-Iri) is a prodrug of SN-38, which is the active anticancer metabolite of irinotecan. In two studies with the human melanoma xenograft mouse model, the accumulation of SN-38 in the tumor plasma and other tissues following treatment with NGC-Iri and Onivyde® were compared with the accumulation following treatment with irinotecan. One study compared NGC-Iri with irinotecan, and the other compared Onivyde® with irinotecan. The two studies demonstrated that in mice that were administered the same amount of SN-38: Accumulation of SN-38 in the tumor compared with other tissues, such as muscle, was greater after NGC-Iri administration than after irinotecan or Onivyde® administration, as demonstrated by the tumor-to-muscle ratio of approximately 200 for NGC-Iri and less than 15 for irinotecan and Onivyde®;More SN-38 accumulated in the tumor after NGC-Iri administration than after irinotecan or Onivyde® administration, as demonstrated by the tumor-to-plasma ratio being approximately 10 for NGC-Iri and less than 7 for irinotecan and Onivyde®; andLess SN-38 accumulated in non-cancer tissues, such as muscle, after NGC-Iri administration than after irinotecan or Onivyde® administration, as demonstrated by the muscle-to-plasma ratio being less than 0.10 for NGC-Iri and greater than 0.4 for irinotecan and Onivyde®, supporting the potential for a better NGC-Iri safety profile. “Many patients are unable to complete their treatment regimen due to the significant side effects related to irinotecan and Onivyde®, both of which have black box warnings in their labels,” stated David Young, PharmD, Ph.D., President of Research and Development at Processa Pharmaceuticals. “Given the greater SN-38 exposure in tumors, and less exposure in tissue outside the tumors, we believe NGC-Iri may have a mor...