Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
HOUSTON–(BUSINESS WIRE)–Celltex, a Houston, Texas-based biotechnology company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).
“The FDA’s approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19. Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation’s leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial. I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come,” says David G. Eller, Celltex Chairman and Chief Executive Officer.
Trial Design
This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19. Celltex will enroll 200 patients in the study (https://www.clinicaltrials.gov/ct2/show/NCT04428801) who have never been infected by COVID-19. One hundred patients will receive intravenous infusions of autologous AdMSCs while 100 will receive placebo treatments. The primary objective of the study is to evaluate overall safety of AdMSCs, and the secondary objective is to demonstrate the efficacy of AdMSCs as a prophylactic medicine for those at a high risk of contracting the virus.
About Celltex
Celltex Therapeutics Corporation is a Houston, Texas-based biotechnology company founded in 2011 and a pioneer in autologous MSC technology. Celltex is the nation’s leading commercial MSC banking company and focuses on spearheading breakthroughs in regenerative medicine using autologous MSCs. The Company uses its own proprietary technology in its Houston-based, cGMP laboratory to isolate, cryopreserve and grow hundreds of millions of autologous, superior grade MSCs for therapeutic use.
Celltex has dedicated years to researching safety and efficacy from the use of MSCs for those suffering from injuries, pain and maladies associated with autoimmune, vascular and other debilitating diseases, including inflammatory lung conditions, pneumonia and chronic obstructive pulmonary disease (COPD).
Celltex’s intellectual property (IP) portfolio encompasses over 1,500 clients, who have received over 9,000 MSC therapies for various diseases without incurring any adverse events. These diseases include acute respiratory distress syndrome (ARDS), inflammatory lung disease, influenza and other viruses similar to coronavirus (COVID-19). Celltex’s cGMP manufacturing processes provide Celltex with unique commercial advantages. The Company has also acquired the intellectual property rights and holds an Exclusive License Agreement with Texas A&M University System that includes several patents pending and an A-1 Exosome Patent Application covering composition of matter and methods claims in the U.S., Europe, Mexico and Saudi Arabia.
Celltex’s headquarters and primary laboratory are located at 2401 Fountain View in Houston, Texas 77057. It is recognized as the leader in commercial MSC banking both in the United States, and in Mexico. The headquarters and laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia, in Cancún, Quintana Roo, Mexico. Hospital Galenia is a private modern hospital that holds three award accreditations from the field of health: two International and one National, with advanced medical technology, a vanguard infrastructure and a highly trained and well-accredited team.
In Mexico, the Company sponsors a Phase III Protocol/Clinical Trial for COVID-19 with Hospital Juarez, a government hospital, to treat COVID-19 symptoms, such as respiratory complications, pulmonary complications and pneumonia. It also sponsors an ongoing 400-person Phase IIb clinical trial (rheumatoid arthritis and osteoarthritis) at Hospital Galenia in Cancún. Both trials have been authorized by COFEPRIS, the Mexico equivalent of the U.S. FDA.
In the United States, the Company sponsors a Phase 1-2a IND for rheumatoid arthritis (https://clinicaltrials.gov/ct2/show/NCT04170426) and a Phase 2 IND for osteoarthritis (https://clinicaltrials.gov/ct2/show/NCT04448106) with the FDA. Celltex has also recently filed an additional IND application that will investigate allogeneic (donor) MSCs for the treatment of COVID-19-induced symptoms.
For more information, please visit www.celltexbank.com or call (713) 554-6802.
About Celltex Therapeutics Corporation
Celltex uses proprietary technology that isolates, multiplies and cryopreserves autologous (one’s own) adult mesenchymal stem cells (MSCs), to be used in regenerative therapy for injuries and chronic pain, as well as many other conditions, including vascular, degenerative and autoimmune diseases. Celltex is registered with the U.S. Food and Drug Administration (FDA) as an HCT/P establishment that multiplies human cells and cellular products. The Houston-based biotechnology company operates in a state-of-the-art laboratory compliant with Current Good Manufacturing Practice (cGMP) standards as recommended by the FDA for the manufacturing of biological products. To learn more about Celltex, visit www.celltexbank.com
Contacts
Lisa Spence
Lisa.spence@loveadv.com
713-552-1055
