Palm Beach, FL –December 9, 2020 – All around the globe, scientists are working hard to develop effective treatments, therapies and vaccines to halt the COVID-19 pandemic. Therapies that are under investigation include drugs that have been used to treat malaria and autoimmune diseases; antiviral drugs that were developed for other viruses, and antibodies from people who have recovered from COVID-19… but also there is a growing impact on the secondary conditions that arise from patients who have or have had the virus. That is the link of Acute Respiratory Distress Syndrome (ARDS) to COVID-19 patients. Reports and articles on the National Institutes of Health website say that: “COVID‐19 ARDS is a predictable serious complication of COVID‐19 that requires early recognition and comprehensive management… This disease is still too strange to us, and there are too many doubts”, says Dr Ling Qin (LQ), after reviewing more than 400 patients with coronavirus disease 2019 (COVID‐19) pneumonia in Wuhan Union Hospital, China. COVID‐19 is a novel disease. We are familiar with acute respiratory distress syndrome (ARDS); however, when it occurs as part of COVID‐19, it has different features and there remain unanswered questions.” ReportsAndData see this as a factor in the growth of the ARDS markets, saying: “The Global Acute Respiratory Distress Syndrome (ARDS) market size was valued at USD 618.82 Million in 2019 and is expected to reach USD 990.88 Million by the year 2027, growing at a CAGR of 6% through the forecast period.” Active healthcare stocks in news today include: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Moderna, Inc., (NASDAQ: MRNA), Pfizer Inc. (NYSE: PFE), INOVIO (NASDAQ: INO), AstraZeneca PLC (NASDAQ: AZN).
The report continues: “Acute respiratory distress syndrome (ARDS) is a rapidly progressive lung disease occurring in critically ill patients. Chief complication in ARDS includes fluid leaks into the lungs, causing difficulties or impossibility in breathing. Acute lung injury (ALI) is a common condition distinguished by acute severe hypoxia. ALI comprises a wide range of changes, both clinical and radiographic, that affect the lungs through acute respiratory distress syndrome. Despite advances in the understanding of the pathophysiology and management of ALI, it is still linked with high mortality. Hospitals are anticipated to account for the largest share in the global acute respiratory distress syndrome market over the forecast period owing to the favorable reimbursement policies in developed countries and more substantial patient footfall. Furthermore, clinics are expected to witness profitable growth due to the increasing cases of sudden respiratory attacks.”
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) BREAKING NEWS – Citius Pharmaceuticals Subsidiary NoveCite Announces Data from a Study of Induced Mesenchymal Stem Cell (“i-MSC”) Therapy in an in vivo Model of Acute Respiratory Distress Syndrome (“ARDS”) – Citius Pharmaceuticals (“Citius” or the “Company”), announced interim data from a proof-of-concept (“POC”) large animal study of its proprietary induced mesenchymal stem cell (” i -MSC”) therapy for acute inflammatory respiratory conditions including COVID-19 related Acute Respiratory Distress Syndrome (“ARDS”). The available results of i- MSC therapy in the study show improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury, compared to the control group. The study was conducted in a widely accepted large animal model.
As previously announced, Citius signed an exclusive worldwide licensing agreement with Novellus Therapeutics Limited to develop and commercialize iPSC-derived i -MSCs. In conjunction with the licensing agreement, the Company established a new subsidiary, NoveCite, Inc., to develop, manufacture and commercialize these induced mesenchymal stem cells. NoveCite has already filed a Pre-Investigational New Drug Application (Pre-IND) with the FDA and has received guidance on the requirements for the proposed trials.
Citius believes that the NoveCite i -MSCs overcome some of the challenges of human donor-derived MSCs which are often associated with limited supply, batch inconsistencies, lower potency, and expensive manufacturing. i -MSCs are derived from engineered iPSCs (induced pluripotent stem cells), a process that facilitates the robust expansion of uniform MSCs that have higher potency, secrete higher levels of immunomodulatory proteins, and offer practically unlimited supply.
“We believe Novellus’s patented, non-immunogenic mRNA cell reprogramming is clearly a superior methodology to generating MSCs compared to the donor-derived model,” said Myron Holubiak , Chief Executive Officer of Citius. “The Novellus process provides a consistent cell bank source, near unlimited supply, greater expansion potential with comparatively less senescent cells. These early results from our proof of concept study are encouraging and indicate potent action which could lead to a treatment candidate for COVID-19 related ARDS.” Mr. Holubiak continued, “The development opportunities are significant, and we believe our breakthrough i -MSC therapy has the potential to be a strong catalyst for the advancement of our business strategy.” Read this full release at: https://ir.citiuspharma.com/press-releases/detail/128/citius-pharmaceuticals-subsidiary-novecite-announces-data
In other healthcare news of note:
Moderna, Inc., (NASDAQ: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, recently announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 million to 7.5 million doses of Moderna’s vaccine candidate against COVID-19, mRNA-1273.
“As we continue to progress the development of mRNA-1273, our COVID-19 vaccine candidate, we appreciate the continued confidence and support shown by the Swiss Federal Government as they increase their supply agreement with us,” said Stephane Bancel, Moderna’s Chief Executive Officer. “Since Moderna’s founding ten years ago, Switzerland has played a key role in Moderna’s development thanks to the long-term support of our Swiss investors. We are building Moderna’s first commercial organization outside of North America in Basel in support of the global response to this pandemic.”
INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, recently announced it has dosed its first subject in a Phase 2 clinical trial evaluating DNA medicine INO-4800, its COVID-19 vaccine candidate, as part of its Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy). The Phase 2 segment of the trial will enroll approximately 400 participants who are 18 years or older at up to 17 U.S. sites to evaluate safety and immunogenicity in order to confirm the dose(s) for the subsequent efficacy evaluation as part of the Phase 3 segment of the trial. INOVIO plans to fully enroll the Phase 2 segment of the trial by the end of this month.
Pfizer Inc. (NYSE:PFE) this week announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC application is in June 2021. “The FDA’s acceptance of our application for 20vPnC is yet another significant milestone in Pfizer’s continuing efforts to help protect adults against pneumococcal disease,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer. “If approved, 20vPnC will cover more serotypes responsible for the majority of pneumococcal disease than any other pneumococcal conjugate vaccine currently licensed or currently in late-stage clinical development. Importantly, 20vPnC has shown to induce immune memory, which provides protection and efficacy against non-bacteremic pneumonia, particularly in older adults.”
A COVID-19 vaccine developed by AstraZeneca PLC (NASDAQ: AZN) and Oxford University showed average efficacy of 70.4% in a pooled analysis of interim data from late stage trials, Oxford said on Tuesday. Much anticipated study results, published in The Lancet medical journal, showed the candidate vaccine’s efficacy was 62% for those given two full doses, and 90% in a sub-group of trial participants given a half then a full dose.
AstraZeneca Chief Executive Officer Pascal Soriot said the drugmaker had begun submitting data to regulatory authorities around the world to seek early approval of the shot. “Our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses,” he said in a statement issued by Oxford University.”
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