Sorrento Therapeutics Inc. (NASDAQ: SRNE) had initially announced that its subsidiary Levena (Suzhou) Biopharma Cop. Ltd and its partner Escugen Biotechnology Co. Ltd had received an authorization letter from the National Medical Products Administration’s Centre for Drug Evaluation for the application for clinical trials of recombinant humanize anti-trop2 Mab-SN38 conjugate (ESG-401).
Sorrento receives FDA clearance to proceed with ESG-401 studied
Now, Sorrento has announced that the US FDA has issued clearance to continue with clinical trials in patients with refractory or relapsed solid tumors. ESG-401 addresses unmet needs for multiple solid tumors treatment that include urothelial carcinoma and triple-negative breast cancer.
Also, the FDA has given Sorrento cleared to continue with the global Phase 2 clinical trial of resiniferatoxin. The study is entitled, “A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated with Advanced Cancer.” The double-blind, multicentre, controlled trial will evaluate the “efficacy and safety of several RTX doses vs. placebo controls to manage intractable pain in up to 120 patients with advanced cancer.” Over the course of a year, three RTX dose groups (15, 20, and 25 mcg) will be compared to vehicle control and concurrent control groups.
Procedural pain most prevalent adverse event following resiniferatoxin administration
This indication’s conclusions are based on a review of the significant observations from the Phase 1b study results (NCT03226574). Notably, the Phase 1 trial evaluated the safety and preliminary efficacy of epidural administration of resiniferatoxin for cancer-related intractable pain treatment in 17 individuals. After epidural administration of RTX at dosages up to 30 mcg, the most prevalent adverse event was “procedural pain,” which was experienced by just over half of the patients (52.9%). All of these occurrences were of mild severity and lasted only a few hours. In nearly all of the participants, pharmacokinetic sampling revealed no detectable systemic RTX levels.
