Sorento Therapeutics Inc. (NASDAQ:SRNE) has released results of its open-label, multicentre Phase 1b Evaluate Safety and MTD Study of Epidural Resiniferatoxin Injection for treating intractable cancer pain. The company released the results at the 14th Pain Therapeutics Virtual Annual summit held on September 1, 2020.
Sorento report promising RTX study results
Associate professor of Anaesthesia at Harvard Medical School/Brigham &Women’s Hospital Srdjan Nedeljkovic presented the data and indicated that they were encouraged by the study’s initial results. Srdjan stated that RTX administered through epidural injection reduced pain intensity even in individuals with high pain levels without showing any long-term adverse safety effects. He explained that the study participants had intractable pain, which was not responding to standard care treatment. Most importantly, adding RTX in the management of intractable pain in advanced-stage cancer patients shows the potential to reduce suffering and enhance the quality of life.
The open-label, multicentre study recruited 17 subjects with moderate to chronic cancer pain. The adult patients received a one-time dose of RTX through epidural injection at escalating levels groups at 0.4 µg to 25 µg in 3 ml saline in 7 groups. In every cohort, the first subjects acted as the “Sentinel” subject, and the first two dosing groups of 0.4 µg and 1.0 µg had one subject each. The subsequent groups had three subjects each dose at 2,4, 8, 15, and 25 µg.
No toxicities reported in RTX treated subjects
There were no dose-limiting toxicities reported with dose escalation completed at 25 µg. The most common emergent adverse effect from the treatment was transient post-procedural pain reported in 47.1% of the participants. Traditional short term medications were used to manage post-injection-associated pain following RTX injection.
Most importantly, the post-injection RTX associated pain subsided after 8 hours of injection and was resolved in all subjects within 24 hours. The transient reversible adverse effects reported in two subjects treated with RTX were vomiting nausea, and headache. At least 15 adverse serious events were reported, but none was related to RTX treatment.