FDA Authorizes Sorrento Phase 2 Trial of Epidural Resiniferatoxin for the Orphan Indication of Control of Intractable Cancer Pain

SAN DIEGO, Oct. 13, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”) announced that the company has received FDA clearance to proceed with a global Phase 2 clinical study of resiniferatoxin (RTX), 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 Phase 2 trial, a multi-center, double blind, controlled study will assess the “efficacy and safety of several RTX doses vs. placebo controls to manage intractable pain in up to 120 patients with advanced cancer” (NCT05067257). Three RTX dose groups (15, 20 and 25 mcg) will be evaluated against both a vehicle control group and a concurrent control group over a year of follow up. The primary objective of the study is to identify the recommended Phase 3 dose for later studies.

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