Late yesterday evening, Sorrento Therapeutics Inc. (SRNE:NASDAQ)announced "positive preliminary results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS)."
The firm advised that the Phase 1b study of PSC-CP-004, which is still ongoing, is a non-randomized, single arm trial that was designed to evaluate the preliminary efficacy and safety of COVI-MSCs administered in three separate infusions every other day giving the patient a total of 1 x 106 cells/kg.
The company indicated that the trial's primary goal is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. The secondary objective is to analyze the efficacy variables to formulate guidance regarding the risk/benefit ratio in patients afflicted with COVID-19 respiratory distress.
The firm stated that "the first three patients enrolled tolerated treatment well and improved rapidly and that each of the three patients were discharged from the hospital within a week of starting the patient's COVI-MSC infusions."
The principal investigator in the ongoing Phase 1 PSC-CP-004 study, Dr. Eyad Almasri, associate professor of medicine, pulmonary, critical care and sleep medicine at UCSF Fresno, commented, "I am excited to see how well-tolerated this promising treatment is to date and am very encouraged by the early signals we are seeing from the first few patients. I am looking forward to working with Sorrento in continuing to offer COVI-MSC treatments to patients in this study and in the proposed controlled phase 2 study."
Sorrento explained that stem cells have shown to support resolution of symptoms in numerous diseases and may be beneficial in reducing long-term effects from pulmonary tissue damage. The company relayed that the GMP manufacturing partner for its COVI-MSC is adipose-derived stem cell company Personalized Stem Cells Inc.
Sorrento is a clinical stage biopharmaceutical company based in San Diego, Calif., that concentrates its efforts on the development of new therapies to treat cancers and COVID-19. The company stated that "its multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms." These include fully human antibodies, clinical stage immuno-cellular therapies, antibody-drug conjugates and clinical stage oncolytic virus. The firm is also presently heavily focused on creating potential antiviral therapies and vaccines against coronaviruses. The company listed that these include "COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™, COVI-MSC™ and COVI-DROPS™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™."
Sorrento started off the day with a market capitalization of around $2.7 billion with approximately 262.9 million shares outstanding and a short interest of about 28.0%. SRNE shares opened 3% higher today at $10.74 (+$0.32, +3.07%) over yesterday's $10.42 closing price. The stock has traded today between $10.45 to $17.03 per share and is currently trading at $14.06 (+$3.64, +34.93%).
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