Sorrento Therapeutics Releases Positive Results of Phase 1B Trial of Resiniferatoxin (RTX) Epidural in Cancer Patients with Reported Intractable Pain

• Seventeen subjects with advanced cancer pain received epidural RTX (0.4 to 25 mcg).
  
• No dose limiting toxicities were reported.
• A majority of patients reported meaningful pain reduction of 30% or more from baseline.
• Sorrento expects to submit to the FDA a request to proceed with a Phase 3 clinical trial in this orphan indication imminently.

SAN DIEGO, Sept. 22, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced the public release of the results of its’ multicenter, open-label, Phase 1b Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for the Treatment of Intractable Cancer Pain, at the 14th Annual Pain Therapeutics Summit held virtually from September 21 to 22, 2020. Data was presented by Srdjan Nedeljkovic, MD, Associate Professor of Anesthesia, Harvard Medical School/Brigham & Women's Hospital.

“We are extremely encouraged by the results of this initial study. Even in patients with high levels of pain, RTX given via an epidural injection has been found to reduce pain intensity without having any long-term adverse safety consequences,” said Associate Professor of Anesthesia, Srdjan S. Nedeljkovic, M.D. from the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital at Harvard Medical School. “The patient population had intractable pain that did not respond to other standard therapeutic approaches, including opioids. The addition of RTX to the management of patients with intractable advanced-stage cancer pain offers the prospect of reducing suffering and improving quality of life for this underserved patient population”.

This multicenter, open-label study enrolled 17 adults with intractable moderate to severe cancer pain. Subjects were treated with a one-time epidural administration of RTX at escalating dose level cohorts, ranging from 0.4 µg to 25 µg in 3 ml saline, in seven cohorts. The first participant in each cohort served as the “Sentinel” subject. The first two dosing cohorts (0.4 µg and 1.0 µg) each included one subject. Subsequent cohorts proceeded with three subjects each (2, 4, 8, 15 and 25 µg).

Enrollment of dose escalation cohorts has completed, with 17 subjects receiving RTX. 65% were women and 35% were men. The median age was 58 years (range 28-82 years). The baseline numerical pain rating scale (NPRS) average score was a mean of 6.8 (standard deviation (S.D.) of 1.65), and the baseline NPRS worst score was a mean of 7.9 (S.D. of 1.26).