1st Patient Treated for Osteoarthritis Knee Pain in Sorrento Resiniferatoxin Phase 1B Trial Meets Both Safety and Efficacy Expectations
“Joint pain affects over 30 million patients in major markets, half of which suffer from knee osteoarthritis pain1. A clear unmet need for a single administration long-lasting non-opioid and non-steroidal pain control solution exists for this degenerative joint disease” stated Dr.
This “Phase 1b double-blind study to assess the safety, tolerability and preliminary efficacy of intra-articular administration of resiniferatoxin (Potent Transient Vanilloid Receptor 1 Ablator, PTVA) versus placebo for the treatment of pain due to moderate to severe osteoarthritis of the knee,” is expected to continue recruiting until planned 40 patients have been enrolled in up to 5 dose level cohorts or until a maximum tolerated dose (MTD) is reached. The study could be stopped early if a clearly effective dose or a maximum tolerated dose is reached prior to the highest dose scheduled to be received. It is anticipated this trial will be completed within the first half of 2019.
In this first patient a response suggestive of a pharmaceutically active dose was noted. Prior to resiniferatoxin, the pain score for this patient ranged from 4 to 8 (median 6) on a 10 points scale. During the one-week period following treatment, the patient’s pain score was reported to be between 0 and 2 with no individual pain score above 2. The patient also reported not taking any pain medications since the day of the resiniferatoxin treatment. No conclusion can be drawn from a single patient outcome and the hope is to see consistent and similar results for the next patients treated. Duration of pain relief has not yet been established and will be tracked as the study progresses.
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 felt by patients.
“Treating the first patient in the PTVA-OA-001 trial represents a milestone for the resiniferatoxin development program. We are translating valuable lessons gathered from companion animals afflicted with naturally occurring chronic diseases (such as OA joint pain) to our human programs. By doing so, we significantly decrease our risk of unexpected outcomes and can accelerate our human trial time to completion. Our first human patient’s pain relief the day following injection is very similar to what was observed in dogs with joint pain. If all continues to go as planned, we could expect functional pain relief that lasts months with a single intra-articular injection. In a dog study that followed 8 pets treated for about a year, the median duration of pain relief was 150 days with one dog having no signs of pain for 370 days. A larger study in dogs is currently on-going and continues to provide valuable insights as we proceed with human trials” said Dr
About the PTVA-OA-001 Study
PTVA-OA-001 is a multicenter, placebo-controlled phase 1b 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.
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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1 GlobalData Epicast (2017 report) states for year 2016: 17M cases of symptomatic hand OA (7 Major Markets, 7.6M in the
Source: Sorrento Therapeutics, Inc.