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Citius Pharmaceuticals, Inc. was one of the sponsors for the Benzinga Global Small-Cap Conference that took place on December 8-9, 2020. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
Despite current medical advances, there are still many medical conditions with unmet needs. For example, long-term patients with Central Venous Catheters (CVCs) for dialysis or cancer treatment are still at risk for complications related to bloodstream infections that might be fatal.
Complications associated with CVC placement can present a 12%-25% morbidity and mortality, resulting in burdening hospitals and healthcare institutions with costs, hospital days, and patient quality of life. Thus, management and prevention should be the ultimate goal for positive treatment outcomes.
A company that understands the importance of unmet needs is Citius Pharmaceuticals, Inc. (NASDAQ: CTXR). The company is a specialty pharmaceutical company dedicated to developing and commercializing novel critical care drug products.
Citius is currently advancing three proprietary product candidates: Mino-Lok, CITI-002 (Halo Lido) and CITI-101 (Mino-Wrap). They also have therapy for treating ARDS, including ARDS associated with COVID-19. This is what you need to know.
Citius In The Prevention Of Catheter-Related Bloodstream Infections (CRBSI) And Central Line-Associated Bloodstream Infections (CLABSI)
Infected catheters can become fatal, presenting patients with a host of new health problems, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.
Currently, there are no approved therapies to salvage infected CVCs, the standard treatment is removing and replacing (R&R) infected catheters. From the 7,000,000 CVCs used annually in the U.S., up to 472,000 become infected, leading to severe, life-threatening infections called CRBSI/CLABSI. Besides, it is important to acknowledge that hospitals are penalized for reporting high infection rates. The cost to R&R is around $10,000. However, if the patients get an infection, the costs and potential patient harm increases significantly.
Through Citius novel therapy Mino-Lok solution, catheters can be disinfected and salvaged to prevent the need to replace and restart a deadly and costly process. Additionally, the market opportunity for this therapy treatment is estimated at $750 million per year in the U.S. and is projected to reach $1.84 billion globally in 2028.
Clinicians and technologists developed Mino-Lok at M.D. Anderson Cancer Center. Mino-Lok is currently being tested in a Phase 3 trial with the primary endpoint being catheter failures, and it has the potential to change the standard of care for the management of these severe infections.
Stem-Cell Therapy For Acute Respiratory Distress Syndrome (ARDS)
Another treatment being developed by Citius is stem-cell therapy for acute respiratory distress syndrome (ARDS) under the name Novellus. Matt Angel, Ph.D., CSO of the company, is working with mesenchymal stem cells (MSCs), which have been shown to be safe in over 900 clinical trials and in treating several inflammatory diseases, including ARDS.
ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Its symptoms include shortness of breath, rapid breathing, and bluish skin coloration. For those who survive, a decreased quality of life is common.
Citius Pharmaceuticals Opportunity Overview
Companies such as Pfizer, Inc. (NYSE: PFE), Merck & Co. (NYSE: MRK), Syndax Pharmaceuticals (Nasdaq: SNDX) and Amgen, Inc. (Nasdaq: AMGN) are all examples of companies that display heavy R&D efforts to bring effective pharmaceutical products to market. Several of these companies have taken similar approaches to Citius Pharmaceuticals’ development and commercialization strategies, but none are currently working on the various pipelines that Citius is bringing to market.
In addition to addressing unmet medical needs, the company has an experienced management team that, along with founders, has invested $26.5 million into Citius Pharmaceuticals. In addition, these are few highlights:
The company’s portfolio addresses recognized unmet medical needs with cost-saving or cost-effective solutions with low-risk development pathways.
The company’s Mino-Lok is supported by a robust intellectual property portfolio Composition of Matter patent that provides protection until June 7, 2024, and formulation Patent has been issued and will add protection through 2036.
Citius Pharmaceuticals signed an exclusive worldwide licensing agreement with Novellus Therapeutics for unique i-MSC-therapy for acute inflammatory respiratory conditions including COVID-19 related Acute Respiratory Distress Syndrome (ARDS) in October 2020.
The company received an FDA response on a pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (i-MSCs) to treat Acute Respiratory Distress Syndrome (ARDS) in patients with COVID-19 in June 2020.
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