On November 27, 2019 Nerviano Medical Sciences, the NMS Group company leader in the discovery and development of oncology drugs, reported the enrollment and treatment of the first patient with the PARP inhibitor NMS-293 in a phase 1 study aimed at patients with advanced solid tumors (Press release, Nerviano Medical Sciences, NOV 27, 2019, View Source [SID1234551736]).
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"The treatment of the first patient in our Phase 1 study represents a turning point in the process of developing a new, safe and effective treatment for patients who need alternative care compared to what is available today and we are very happy about this. proud, "said Gregory Wu, Ph.D., CEO of Nerviano Medical Sciences. "Thanks to the unique preclinical characteristics of NMS-293, we are confident that we can expect important clinical developments, both as a single agent and in combination with other drugs, and we look forward to sharing positive results over the next year."
NMS-293 is a "small molecule" with oral administration, inhibitor of the poly (ADP-ribose) polymerase-1 enzyme (PARP-1) that has shown high anti-tumor efficacy in preclinical models lacking some repair mechanisms, such as mutated tumors in the BRCA1 and BRCA2 genes. These mutations are particularly common in breast, ovarian, pancreatic and prostate cancers.
NMS-293 has unique characteristics compared to other PARP inhibitors that have been approved or under development, such as its selectivity for the PARP-1 vs PARP-2 isoenzyme and the lack of "entrapment" effects, which could lead to a better tolerability in terms of lower hematological effects, in particular when administered together with chemotherapy. Furthermore, the high cerebral penetration of the compound offers a potential for the treatment of brain tumors and brain metastases.
This clinical study will be conducted in two parts and involves enrollment of up to 100 patients in China, Europe and the United States. The first part will consist in the evaluation of tolerability and pharmacokinetics and in the determination of the recommended dose for phase 2. The second part of the study will allow to have a preliminary evaluation of the efficacy of NMS-293 administered at the recommended dose to patients with different types of mutated tumors in BRCA genes.