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Resiniferatoxin

Phase 3

Intractable Cancer Pain | Small Molecules | Oncology |Sorrento Therapeutics, Inc.|Trials Updated: Apr 1, 2021

Resiniferatoxin development status

Highest phase Phase 3 (NCT04386980)
Phase scored for SRNEPhase 1
Registered trials 7 across 1 sponsor since Jul 2017

Resiniferatoxin target and mechanism

Molecular targetTRPV1
Target classAgonist
ModalitySmall Molecules
ChEMBLCHEMBL17976

Also known as RTX

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment111

FDA Designations

No designations recorded

Resiniferatoxin clinical trials

Resiniferatoxin · 2 trials · 3 indications

Phase 1 2
NCT03542838Study of Resiniferatoxin for Knee Pain in Moderate to Severe OsteoarthritisOsteoarthritis, Knee
COMPLETED94 Analytics
NCT03226574Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer PainIntractable Cancer Pain
COMPLETED17 Analytics
PHASE1COMPLETED
Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis
Osteoarthritis, Knee
NCT0354283894
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PHASE1COMPLETED
Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain
Intractable Cancer Pain
NCT0322657417
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Study Endpoints

Primary Endpoints

Safety measurement
baseline through week 52

Incidence and severity of adverse events

Dose limiting toxicity (DLT)
3-month

Grade 3 or 4 Toxicity associated with RTX administration

Maximum tolerated dose (MTD)
3-month

Maximum dose without a Grade 3 or 4 toxicity

Secondary Endpoints

Improvement of knee pain when walking
baseline through week 52
Numeric Pain Rating Scale (NPRS)
Day-28 to Day90 daily
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ResiniferatoxinEXPERIMENTALResiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.
SalinePLACEBO_COMPARATORSaline is administered as a one-time dose, intra-articularly.
RTX epidural injectionEXPERIMENTALEpidural injection of 1.5mL/min RTX under the guidance of epidurogram.

Interventions

NameTypeDescription
ResiniferatoxinDRUGResiniferatoxin is a compound purified from natural sources.
SalineDRUGSaline is a normal physiological solution
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Eligibility Criteria

Age Range35 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: 1. Age: 35 years to 85 years 2. Diagnosis of moderate to severe pain due to OA: Moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria 3. BMI \< 45 kg/m2 4. Pain in the target knee has been treated with at least 2 analgesic agents, including ...

Countries:United States
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Other drugs targeting TRPV1

hydrocodone/acetaminophen ABBV· PHASE2 ABT-102 ABT· PHASE1 AZD1386 AZN· PHASE2 BL1332 BLCO· PHASE2 acetaminophen Caplet JNJ· PHASE3 Capsaicin LLY· EARLY_PHASE1 SAF312 NVS· PHASE2

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