Sorrento Therapeutics : adds Mesenchymal Stem Cell Program That Has Been Cleared for a Phase 1 Trial by the FDA to the P

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curncman
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Sorrento Therapeutics : adds Mesenchymal Stem Cell Program That Has Been Cleared for a Phase 1 Trial by the FDA to the P

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Sorrento Therapeutics : adds Mesenchymal Stem Cell Program That Has Been Cleared for a Phase 1 Trial by the FDA to the Pipeline of COVID-19 Focused Rescue Therapies

https://www.marketscreener.com/quote/st ... -31531758/

10/13/2020 | 10:56am EDT
SAN DIEGO - Sorrento Therapeutics, Inc. (Nasdaq: SRNE, 'Sorrento') announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.

The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities.

Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients.

Stem cells represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrento's pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).

Until a time where early treatments are more readily available, it is important to provide patients severely afflicted with COVID-19 multimodal solutions that can help increase survival, reduce the time spent in the hospital and reduce long-term sequelae. The long-term lingering effects of COVID-19 on the body can persist for months after patients leave the hospital, especially for patients that received ventilator support. Shortness of breath, difficulty doing simple tasks and pulmonary fibrosis are among the common complaints of long-term effects of the disease on COVID-19 patients leaving the ICU.

Dr. Robert Harman, CEO of PSC stated, 'We are delighted to be working with a company such as Sorrento, that has the vision and expertise to take our program through the next steps in the clinical development process. Sorrento saw the translational value of our decades of work in animal health and has acknowledged the extensive manufacturing and regulatory work we have done in bringing human cell lines to a Phase 1 FDA clearance. We are looking forward to collaborating on this initiative and beyond.'

Dr. Henry Ji, Chairman and CEO of Sorrento stated, 'Stem cells were a missing piece in our comprehensive portfolio of potential solutions against COVID-19. We now cover multiple stages of the continuum of care from prevention to potential therapeutic solutions for the most advanced stages of the disease. With PSC's Phase 1 product candidate, we hope to move quickly through the next clinical trials, and, if successful, be able to provide a supportive therapy that may save the lives of the most advanced patients and may also ensure patients who have to undergo intensive care can benefit from a therapy with the potential to minimize the long-term effects of the disease due to the lung damage created by the virus early in the infection.'
curncman
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Highly efficient muscle regeneration mechanism discovered

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Highly efficient muscle regeneration mechanism discovered

https://www.regmednet.com/highly-effici ... iscovered/

Cell therapy weekly: US FDA rejects Mesoblast’s lead allogeneic cell therapy candidate
curncman
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Joined: Fri Jun 26, 2020 8:27 am

Arizona State University/Halberd Develop Antibody Against Covid-19

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Arizona State University/Halberd Develop Antibody Against Covid-19

https://finance.yahoo.com/news/arizona- ... 00744.html

JACKSON CENTER, PA / ACCESSWIRE / October 13, 2020 / Halberd Corporation (OTC PINK:HALB) reported that Arizona State University researchers, utilizing the intellectual property of Halberd Corporation, have successfully generated an anti-Spike protein monoclonal antibody against Covid-19. The Spike Protein is a main component of the Covid-19 virus, and is a crucial component in its ability to replicate. In addition, the researchers have sent for synthesis, genes for the creation of new, unique monoclonal antibodies against the SARS-CoV-2 Spike Protein. The performance has exceeded expectations, and Halberd and ASU intend to file for joint patent protection.

Development continues toward three major potential utilizations of the antibody against the Coronavirus:

A Preventative;
A Diagnostic, and
A Therapeutic Treatment.
William A. Hartman, Halberd Corporation Chairman, President & CEO, stated, "We are very excited about our progress to date and plan to issue regular progress reports to keep the public aware of our significant developments."
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