Sorrento Therapeutics Expands Resiniferatoxin (RTX) Clinical Development Program to Life-Threatening Cardiovascular Diseases With Completion of Major Animal Toxicology Study

SAN DIEGO, April 15, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced that its Neuro-Therapeutics unit is pursuing clinical development of resiniferatoxin (RTX) for multiple life-threatening cardiovascular disorders, including IND enabling toxicology and proof-of-principle animal studies.

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).

Dr. Irving H. Zucker, Theodore F. Hubbard Professor of Cardiovascular Research in the Department of Cellular and Integrative Physiology of the University of Nebraska Medical Center and the Editor-in-Chief,  American Journal of Physiology-Heart and Circulatory Physiology, commented, “No new pharmacological therapies for heart failure, hypertension and peripheral arterial disease have become available for many years. The use of site-specific RTX to ameliorate various sequelae of cardiovascular disease is a potential novel target for therapy. The benefits of this therapy greatly outweigh the risks of sensory loss from TRPV1 ablation in this patient population.”

 “We have had a long and productive collaboration with the University of Nebraska Medical Center.  We have just completed a major toxicology study that supports a starting dose for human trials either by direct pericardial injection or localized stellate ganglion nerve block. We are preparing to translate these encouraging animal findings into the next steps towards human trials,” commented Jerome Zeldis, M.D, PhD, Chief Medical Officer for Sorrento Therapeutics.

Sorrento has executed an exclusive license from the University of Nebraska for intellectual property rights relating to RTX applications in cardiovascular disease indications.

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).

About Sorrento Therapeutics, Inc. 

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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Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the expectations for Sorrento's and its subsidiaries' technologies and product candidates, including, but, not limited to, resiniferatoxin (RTX).  Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries' technologies and prospects, including, but not limited to, RTX; risks related to seeking regulatory approvals and conducting and obtaining results of clinical trials, including, but not limited to,  any  prior RTX studies in animals; the clinical and commercial success of RTX; the viability and success of using RTX for treatments in certain therapeutic areas, including cardiovasculars diseases and osteoarthritis and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Contact: Alexis Nahama, Head of Neuro-Therapeutics Business Unit

Telephone: 1.858.203.4120

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ZTlido® and G-MAB™ are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.

Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.

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¹ As reported by Global Data (epidemiology and market sizes)