Citius Pharmaceuticals Addresses Unmet Needs for Patients with CVCs
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What happens when the one product keeping you alive becomes infected?
Central venous catheters (CVCs) are important life lines for treating many patients, including those with cancer, coagulopathy, hemodialysis, and even those in intensive care units. These CVCs deliver vital fluids, blood, nutrition, medication, and hemodynamic therapies to critically ill patients. However, these devices, unfortunately, pose a significant risk of device-related infections, negating their very purpose which is to keep patients alive and well.
Almost 7% of patients receiving the 7 million CVCs used annually develop catheter-related bloodstream infections (CRBSIs), putting patients with infected CVCs at a higher risk of morbidity and mortality. The current solution to this problem? Removing the CVC, replacing it with a new one, and having to choose a new access port in the meantime. This process is costly, difficult, and sometimes even dangerous, with a complication rate of about 15% to 20%.
One company has set out to find a better way to address these infections: Citius Pharmaceuticals (NASDAQ: CTXR). Thanks to its new antibiotic lock therapy Mino-Lok®, patients may soon have a new solution for salvaging infected catheters.
Mino-Lok contains minocycline, EDTA, and ethyl alcohol, all of which combine to break down bacterial biofilms that form inside a CVC. Essentially, it cleans the catheter, allowing it to remain in use and saved from having to be removed from the patient. A Phase 2b trial proved to be a success: The product saved 100% of the infected CVCs with zero side effects, compared to the 18% adverse effect rate seen in the cohort where patients had their infected CVC removed and replaced.
Recently, an interim review of data in the company’s Phase 3 trial by an independent Data Monitoring Committee resulted in a recommendation to continue the trial with no modifications. In addition, thanks to receiving the Qualified Infectious Disease Product designation, Mino-Lock qualifies for additional incentives such as "Fast Track" Designation, Priority Review for development, and five years of market exclusivity if approved. Mino-Lock has the potential to be the first and only FDA-approved product to salvage infected CVCs.
The plan is to file a New Drug Application in 2022, following the anticipated completion of the Phase 3 trial, which is more than 80% enrolled. With $103.7 million in cash, there is plenty of cushion to complete the trial and plan for commercial launch of the product which could potentially save countless lives. Not to mention, the current trial is partnered with a leading cancer center, and is supported by leaders in the medical field.
Citius Pharmaceuticals has a dedicated management team with a sustained record of accomplishments in the commercialization of pharmaceutical products, and we expect Mino-Lock will be no exception. Other products in their pipeline include an induced mesenchymal stem cell therapy being developed for the treatment of acute respiratory distress syndrome (ARDS), often associated with COVID-19, Halo-Lido (CITI-002), potentially the first and only FDA-approved prescription product for the treatment of hemorrhoids, and Mino-Wrap (CITI-101), a bio-absorbable film used for reducing inflammation post-mastectomy and breast reconstruction surgery.
With the belief that its work is filling a gap in current unmet medical needs, Citius Pharmaceuticals' forward-thinking products look to make a real difference in the lives of many.
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