Sorrento to Present Late Breaking Positive Clinical Trial Data for Resiniferatoxin at Two Prestigious Upcoming Pain Conferences
- Phase 1b/2 OA Knee Pain study completed enrollment of 93 patients, with no dose limiting toxicities observed and significant efficacy signal confirmed in expansion cohorts. The program is expected to move to Phase III pivotal studies in 2Q 2020.
- Phase 1b Cancer Pain completed enrollment of initial cohorts (14 patients) with no dose limiting toxicities observed and efficacy signal confirmed. One expansion cohort (3 to 6 additional patients) was added to allow for better determination of the dosing regimen. The program is expected to move to a registrational study in 2H 2020.
- Submissions for presentation of the positive clinical data from both trials were accepted as late breaking communications at the
American Association of Pain Management(AAPM) to be held in March 2020and Osteoarthritis Research Societymeeting (OARSI) to be held in May 2020.
Registrational studies are expected to commence as early as 2Q 2020 (for osteoarthritis pain) and 2H 2020 (for intractable advanced stage cancer pain).
RTX OA Pre-Pivotal Program
Sorrento has completed enrolling all the patients in the “Phase 1b double-blind study to assess the safety, tolerability and preliminary efficacy of intra-articular administration of resiniferatoxin versus placebo for the treatment of pain due to moderate to severe osteoarthritis of the knee.”
The study enrolled the last of 93 patients in early
No dose limiting toxicities have been observed at any of the doses administered. Statistically significant improvements in pain were established for both doses considered in expansion cohorts (12.5 μg and 25 μg), with the early time points assessed confirming the selection of the 12.5 μg as the most likely dose for the upcoming pivotal studies.
Sorrento has requested a pre-pivotal meeting with the
An abstract has been accepted and clinical data for the RTX osteoarthritis pain trial will be presented at the upcoming
RTX Cancer Pain Pre-Registrational Program
Sorrento has also completed enrolling the initial cohorts in the “A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated with Cancer.”
Fourteen (14) patients were dosed in the initial phase of the study, following a dose escalation plan from 0.5 μg to 15 μg epidural administration. The initial study completed with no dose limiting toxicities and with marked reduction in pain for two out of three of the cancer patients treated at the highest protocol dose (15 μg).
The study was expanded to one additional dose group (25 μg) and is expected to recruit up to 6 additional patients by Q2 2020.
The initial results from the phase 1b study confirmed the potential of RTX for the management of cancer pain and a minimal effective dose has been identified. An optimal dose is being confirmed in the last dosing cohort, which is currently under way.
Sorrento will be submitting the clinical data at the completion of the study and expects to ask the
A late breaking scientific abstract has been accepted and clinical data for the RTX cancer pain phase 1 clinical study will be presented at the upcoming
“Given these initial results and the feedback from our investigators, we have started the process of planning our OA Knee pain and cancer pain pivotal studies to be initiated as soon as we are cleared to proceed by FDA,” stated Dr
About Resiniferatoxin (RTX)
A thousand times “hotter” than pure capsaicin (16 Billion Scoville units versus 16M), and with a high affinity for afferent pain nerves, resiniferatoxin binds to TRPV1 receptors and selectively ablates the nerve endings responsible for pain signals experienced by patients1. Delivered peripherally (into the joint space) the transient nerve ending ablation effect can have profound clinical benefits lasting for months to years (as shown in canine studies2).
About the RTX OA Knee Pain Clinical Study
PTVA-OA-001 is a multicenter, placebo-controlled phase 1b study (being expanded into a phase 2 study) to assess the safety and define the maximally tolerated dose of resiniferatoxin administered in the knee joint for the reduction of moderate to severe pain signal intensity associated with osteoarthritis. The study is a dose-escalation protocol in which cohorts of patients will receive increasing doses of resiniferatoxin until the maximum tolerated dose (MTD) is achieved. The primary objective of the study is to evaluate the safety of resiniferatoxin and identify the recommended phase 2 dose. The secondary objective is to assess the preliminary efficacy of resiniferatoxin measured by assessing changes in the intensity of pain using the WOMAC Index, a widely used proprietary validated pain questionnaire.
More information on this trial can be found at www.clinicaltrials.gov (NCT03542838).
About the RTX Cancer Pain Clinical Study
RTX-001 is a multicenter, open label, phase 1b study to assess the safety and define the maximally tolerated dose of resiniferatoxin administered epidurally for the reduction of intractable pain signal intensity associated with cancer. The primary objective of the RTX-001 study is to evaluate the safety of resiniferatoxin and identify the recommended phase 2 dose. The secondary objective is to assess the preliminary efficacy of resiniferatoxin, measured by assessing changes in the intensity of pain using the Numeric Pain Rating Scale (NPRS) score. The first portion of the study is a dose-escalation phase in which cohorts of patients will receive ascending doses of resiniferatoxin to determine the safety, and the second portion of the study is an expansion phase where patient cohorts will receive resiniferatoxin at the preliminary phase 2 dose to further evaluate the safety and clinical activity.
More information on this trial can be found at www.clinicaltrials.gov (NCT03226574).
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial in terminal cancer patients and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the
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2 Ark Animal Health Internal Data.
Source: Sorrento Therapeutics, Inc.