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Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Clinical Trial of COVI-MSC in COVID-19 Patients With Persistent Pulmonary Compromise After Recovery (Long-Hauler)
SAN DIEGO, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a PHASE 2A RANDOMIZED, PLACEBO-CONTROLLED STUDY OF INTRAVENOUS ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STROMAL CELLS TO TREAT POST COVID-19 “LONG HAUL” PULMONARY COMPROMISE (NCT04992247). Recent epidemiologic studies in the US and Britain cite that over 1 in every 3 COVID-19 patients might have lingering symptoms long past the time that they’ve recovered from the initial stages of COVID-19 illness. Often referred to as “Long COVID” syndrome, the symptoms in “long haulers” can include fatigue, shortness of breath, persistent cough, “brain fog”, sleep disorders, fevers, gastrointestinal symptoms, anxiety, and depression, and can persist for months and range in level of severity from mild to incapacitating. In some cases, new symptoms arise well after the time of infection or evolve over time. While still being defined, these effects can be collectively referred to as Post-Acute Sequelae of a SARS-CoV-2 infection. The Brazil study is a Phase 2, multi-center, randomized, controlled study to evaluate the safety and efficacy of up to three infusions of COVI-MSC™, administered every other day, to patients experiencing respiratory difficulty recovering from a COVID-19 infection at least 3 months prior to enrollment. The study is expected to enroll 60 patients (in 4 dosing regimen cohorts) in about six months from the date of first enrollment. The primary outcome measure will be improvement in the 6-Minute Walk Distance (6MWD) test at Day 60 post-treatment. Sorrento expects this projected pace of enrollment due to the prior extensive COVID-19 disease burden in Brazil, Sorrento’s partnership with a leading local clinical research organization (Synova Health), and existing relationships with high quality medical centers throughout the country. The current partnership with Synova Health leverages high quality clinical trial sites in addition to a dozen centers that have already participated in other acute COVID-19 studies with Sorrento (Abivertinib and MSC). “We are very satisfied with the progress made in Brazil so far, and we have developed very strong local relationships in support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “We expect this next Phase 2 study to confirm the clinical benefits for long-hauler patients. Long-hauler syndrome is likely to be the next major challenge for medical systems in a post-COVID era, and we intend to be the leaders in addressing this future unmet need.” The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.986743/2021-44, Expediente 3229927/21-4 COMUNICADO ESPECIAL (CE) Nº 0001/22 – GSTCO/DIRE2/Anvis. Details of the Brazilian Clinical Study can be found at: About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. 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”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™. 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 SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia (PHN). RTX has cleared for Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. SEMDEXA announced highly statistically significant positive top-line results from its Phase III Pivotal Trial C.L.E.A.R Program for its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica). ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com Forward-Looking Statements Media and Investor Relations Contact: Dorman Followwill Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2022 Sorrento Therapeutics, Inc. All Rights Reserved. |