With Mounting Evidence CV-19 Causes Severe Lung Damage, This Biotech Firm Could Play a Major Role in Its Treatment
U.S. FDA Says Citius Pharmaceuticals (STOCK:CTXR) Can Apply for Fast-Track Designation
The CV-19 pandemic is sparking a surge of acute respiratory distress syndrome (ARDS) in intensive care units all over the world.(1)
But there’s an even bigger problem.
There are no treatments(2), which opens the door to BIG opportunity for Citius Pharmaceuticals (STOCK:CTXR). According to Myron Holubiak, chief executive officer, Citius:(6)
“ARDS is the most common cause of respiratory failure and mortality in CV-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven CV-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS.”(3)
According to the National Institutes of Health about 80% of COVID-19 infections are mild or asymptomatic and never require hospitalization but about 5% of patients become critically ill and develop acute respiratory distress syndrome.(4)
Johns Hopkins Medical added that CV-19 can cause lung complications such as pneumonia and, in the most severe cases, acute respiratory distress syndrome.(5)
This is where Citius Pharmaceuticals (STOCK:CTXR) Comes Into Play
Specialty pharmaceutical company, Citius Pharmaceuticals (STOCK:CTXR) signed an exclusive agreement to in-license a stem-cell therapy for acute respiratory distress syndrome or ARDS from a subsidiary of Novellus Inc.
Novellus’s patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid or mRNA molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells or MSCs with superior immunomodulatory properties.
MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.
U.S. FDA Says it Can Apply for Fast-Track Designation
To date, the company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of ARDS.(6)
The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials.
Better, the company plans to initiate actions on the FDA’s recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the CV-19 Treatment Acceleration Program (CTAP).
Holubiak added, “No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus’s iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible.”(7)
Citius Pharmaceuticals (STOCK:CTXR) Created an ARDS Scientific Advisory Board
Citius Pharmaceuticals formed the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with CV-19.(8)
The ARDS Advisory Board consultants include:
- Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. Dr. Matthay’s basic research has focused on the pathogenesis and resolution of the acute respiratory distress syndrome (ARDS), with an emphasis on translational work and patient-based research, including clinical trials. Dr. Matthay’s recent research has focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for ARDS. He is currently leading the “Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT),” a United States Department of Defense supported study of MSCs for ARDS.
- Mitchell M. Levy, MD, Chief, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Warren Alpert Medical School of Brown University, where he is Professor of Medicine. Dr. Levy also serves as Medical Director of the Medical ICU at Rhode Island Hospital. He has been an investigator on numerous pharmacologic and biologic trials intended to treat sepsis, cardiovascular and pulmonary pathology. He has expertise in trial design, clinical trial execution and trial management and is one of the three founding members of the Surviving Sepsis Campaign (SSC). Dr. Levy is Past-President of the Society of Critical Care Medicine (2009).
- Lorraine B. Ware, MD, Professor of Medicine and Ralph and Lulu Owen Endowed Chair, Professor of Pathology, Microbiology and Immunology, Vanderbilt University; Director, Vanderbilt Medical Scholars Program. Dr. Lorraine Ware’s comprehensive bench-to-bedside research program centers on the pathogenesis and treatment of sepsis and acute lung injury with a current focus on mechanisms of lung epithelial and endothelial oxidative injury by cell-free hemoglobin. Dr. Ware is also a lead investigator for the “Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)” study.
Citius Pharmaceuticals (STOCK:CTXR) Exposed to a $400 Million Opportunity
Outside of ARDS, the company just announced progress in the development of Mino-Wrap, which may be able to help reduce post-operative infections associated with surgical implants.
Mino-Wrap is a gel-containing a film that is used to wrap the tissue expander used in breast reconstructive surgeries. In order to stimulate early consultation and potentially speed the development of Mino-Wrap, the company has submitted a briefing package to the FDA Division of Anti-Infective Products.
“The published rate of infection for tissue expanders used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%. We believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient,” added Holubiak.(9)
“We currently expect to have a PIND meeting with the FDA before the end of the year and begin a Phase 2 clinical study in 2021. The market opportunity for Mino-Wrap in preventing infections following breast implant surgeries following mastectomies is estimated to be $400 million,” added the company.
Citius Pharmaceuticals (STOCK:CTXR) Also Exposed to Explosive $1.84 Billion Opportunity
The company’s Mino-Lok product is an antibiotic lock solution that used to treat patients with catheter-related bloodstream infections, or CRBSIs.
“CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge,” says the company.(10)
In a Phase 2b trial, the Mino-Lok product appeared to have demonstrated a 100% efficacy rate in salvaging colonized CVCs; the Mino-Lok product is claimed to have had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
It’s now currently in a Phase 3 superiority trial.
If successful, this could expose CTXR to a massive $1.84 billion market by 2028. It was worth $1.24 billion in 2017, according to Delve Insight. In addition, the total incidence of CRBSI in the global market is as high as four million patients.(11)
Incidence could be as high as 4.22 million by 2028.
The Top Reasons to Consider Citius Pharmaceuticals (STOCK:CTXR)
- One, currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven CV-19 patients with ARDS responded to MSC therapy.”
- Two, Citius Pharmaceuticals (STOCK:CTXR) signed an exclusive agreement to in-license a stem-cell therapy for acute respiratory distress syndrome or ARDS from a subsidiary of Novellus Inc. Novellus’s patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid or mRNA molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells or MSCs with superior immunomodulatory properties.
- Three, the U.S. FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials.