Sorrento Therapeutics Expands Resiniferatoxin (RTX) Clinical Development Program to Life-Threatening Cardiovascular Diseases With Completion of Major Animal Toxicology Study
Cardiovascular diseases1 are the most common cause of death and disability globally and the approximate annual impact in the US includes over:
- 9 million myocardial infarctions
- 8 million people with peripheral artery disease
- 6 million people diagnosed with Chronic/Congestive Heart Failure (CHF)
- 600,000 people who die of cardiovascular disease each year (1 in every 4 deaths)
Pain, diminished quality of life and/or diminished patient life expectancy are associated with advance stages for all of these diseases.
RTX has potential clinical benefits derived from its ability to modulate neurogenic inflammation and afferent nerve signaling commonly associated with chronic degenerative conditions. RTX specifically ablates sensory nerves that express the TRPV1 receptor. These receptors are present in peripheral sensory neurons responsible for the sensation of pain, inflammation, and detection of high heat thresholds. TRPV1 is also found in central sensory ganglia and appear to play a role in integrating inflammatory signals to the brain. At pharmacological doses of RTX, proprioceptive and motor neurons are not affected.
Animal model data generated by academic institutions in the past years support the potential use of RTX in a variety of cardiovascular disorders. Published data key conclusions:
- Compared to control, RTX administered to the surface of the heart (epicardium) reduced cardiac and renal sympathetic nerve activity in animals who had a myocardial infarction (MI) with resulting chronic heart failure (CHF). In addition, RTX treatment decreased cardiac fibrosis (remodeling), diastolic dysfunction (Wang et al. Hypertension 2014; Wang et al. J. Physiol 2017) and inflammation.
- Rats with CHF who have RTX induced ablation of the TRPV1 sensory thoracic and epicardial afferent nerves survived longer than control treated animals.
- Thoracic epidural RTX administration in spontaneously hypertensive rats reduced blood pressure or prevented the development of hypertension. No effect was observed in normotensive rats.
- Lumbar epidural administration of RTX improved exercise tolerance and reduced pain in a rodent model of peripheral arterial disease.
- Thoracic epidural RTX improved renal function in rats with chronic heart failure.
- Thoracic RTX attenuates input from nociceptors in the lung (Shanks et al. Physiol. Rep. 2018).
“We have had a long and productive collaboration with the
Sorrento has executed an exclusive license from the
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 patients. Delivered peripherally (into the joint space, the epicardial space or as a nerve block) the transient nerve ending ablation effect can have profound clinical benefits lasting for months to years (as shown in canine joint pain studies). Delivered spinally the effect can be profound and lasting (as shown in canine cancer pain studies).
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 cancer patients and Osteoarthritis (OA) patients is also demonstrated by its effort to advance Resiniferatoxin (“RTX”), a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, ZTlido® and SP-102, a non-opioid corticosteroid gel. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients and a Phase 1b trial for OA. ZTlido was approved by US FDA on 02/28/18. SP-102 is in Phase 3 pivotal study for the treatment of lumbar radicular pain/sciatica.
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1 As reported by Global Data (epidemiology and market sizes)
Source: Sorrento Therapeutics, Inc.