OUR NEW PROFILE IS: NASDAQ: CTXR
Citius Pharmaceuticals was recently Added to Russell 2000® Index
Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial
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*****Citius Pharmaceuticals Acquires Dr. Reddy’s Laboratories’ License for Late-Phase 3 Oncology Immunotherapy*****
The market just opened and we have CTXR on our radar.
This is a company that you are going to want to take a look at.
Citius Pharmaceuticals, Inc. (Citius) is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a diversified pipeline of anti-infectives in adjunct cancer care, stem cell therapy and unique prescription products. Three of its four pipeline candidates would be the first and only prescription treatments in their indications, if approved by the FDA. A Phase 3 pivotal superiority trial is currently underway for its lead product candidate, Mino-Lok®, an antibiotic lock solution to salvage infected central venous catheters (CVCs) of patients with catheter-related bloodstream infections (CRBSIs). Mino-Lok® was granted Fast Track designation by the FDA and would be the first and only FDA-approved treatment to salvage infected CVCs. Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell (i-MSC) treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions. Citius’s two additional product candidates are Halo-Lido, potentially the first and only FDA-approved prescription treatment for hemorrhoids, and Mino-Wrap, potentially the first and only to prevent infection in tissue expanders and breast implants post mastectomy.
*****BREAKING NEWS RELEASED JUST MINUTES AGO*****
Citius Pharmaceuticals Acquires Dr. Reddy’s Laboratories’ License for Late-Phase 3 Oncology Immunotherapy (E7777) for the Treatment of Cutaneous T-Cell Lymphoma and other Cancer Indications
CTXR PIPELINE: FOUR ACTIVE PROGRAMS
Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.
Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. Mino-Lok® is being developed to address the complications, discomfort and cost of CVC removal and replacement. The are currently no FDA-approved products to salvage infected CVCs.
- Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs
- In a Phase 2b trial, Mino-Lok® demonstrated a 100% efficacy rate in salvaging colonized CVCs; Mino-Lok® had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced. Learn more…
- A multicenter Phase 3 pivotal superiority trial is currently underway. Learn more…
- Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036
- Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center.
How it works
Mino-Lok® contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok® is used in two-hour locking cycles, allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.
Prescription strength topical for symptomatic hemorrhoid treatment
Halo-Lido (CITI-002) is a proprietary topical formulation of halobetasol and lidocaine that is intended to provide anti-inflammatory and anesthetic relief to individuals suffering from hemorrhoids. In the United States, hemorrhoids affect nearly 5% of the population, with approximately 10 million patients annually reporting symptoms.
- There are no FDA-approved prescription products on the market for hemorrhoids
- Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States
- According to IMS, over 25 million units of topical combination prescription products for are sold in the US
Although there are numerous prescription and over-the-counter (OTC) products commonly used to treat hemorrhoids, none currently possess safety and efficacy data generated from rigorously-conducted clinical trials. Citius believes its proprietary formulation will become an important treatment option for physicians who want to provide their patients with a therapy that has demonstrated safety and efficacy in treating hemorrhoids, an uncomfortable and often recurring condition.
If Citius receives FDA approval for its topical halobetasol-lidocaine combination formulation for the treatment of hemorrhoids, it may qualify for three years of market exclusivity for its dosage strength and formulation. In that case, Halo-Lido may be the only product on the market proven to be safe and effective for the treatment of hemorrhoids.
NCi -MSC (Stem Cells)
Next-generation engineered stem cell platform of induced mesenchymal stem cells (i-MSCs)
Citius is developing a unique, proprietary stem cell platform for the treatment of respiratory conditions associated with acute inflammation, with an initial indication in the treatment of acute respiratory distress syndrome (ARDS).
Citius’ i-MSCs are derived from iPSCs originating from a qualified single-donor dermal fibroblast, resulting in one homogeneous, validated source for all future cells. A patented synthetic, non-immunogenic mRNA (non-viral) high efficiency cell reprogramming technique is applied and expanded under cGMP guidelines to create a clonal iPSC Master Cell Bank. The i-MSCs produced from this clonal technique are differentiated from human donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In vitro studies showed that Citius’s i-MSCs exhibit superior potency and high cell viability. Moreover, i-MSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with ARDS. Citius believes that the characteristics of its single-donor i-MSCs support clonal production at scale with consistent quality and greater potency, and may offer patients and clinicians a promising treatment option for ARDS.
- Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS)
- i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process
- No FDA-approved treatment for ARDS exists today
- Preclinical activities are underway
Stem cells are an exciting new area of focus as potential therapies for ARDS, and are currently the subject of ongoing research efforts worldwide. Citius believes mesenchymal stem/stromal cells (MSCs) offer considerable promise for ARDS. Several donor-derived MSC therapies under investigation have demonstrated that MSCs may reduce inflammation, enhance clearance of pathogens and stimulate tissue repair in the lungs. MSCs have also been shown to restore endothelial and epithelial barrier integrity, enhance the clearing of fluid from the lungs, and may exhibit antimicrobial properties.
Citius is exploring the potential of its i-MSCs to overcome the limitations of MSCs derived from adult donors. Positive interim results from a proof-of-concept study demonstrate a marked improvement in i-MSC-treated animals over control animals in key clinical parameters. Learn more….
Bioabsorbable extended-release antimicrobial wrap for the prevention of breast tissue expander infections.
Mino-Wrap (CITI-101) is a malleable, bio-absorbable film impregnated with minocycline and rifampin. It is a novel therapeutic designed to significantly reduce infections associated with the use of breast tissue expanders (TE) used in patients that elect to undergo reconstructive breast surgery.
- Potential to be first and only FDA-approved product to prevent infections associated with post mastectomy breast implants
- Currently in pre-clinical development
- Development in partnership with The University of Texas MD Anderson Cancer Center and support from medical thought leaders
How it Works
Mino-Wrap is designed to allow the temporary tissue expander used in breast reconstruction surgeries to be inflated without any restrictions, and to aid in the prevention of infection and biofilm formation on the implant over longer durations than current practice. It is placed over or wrapped around the TE in the surgical pocket as a solid film. It swells and liquefies in situ for a specified period of time to provide extended protection against infection from the most likely pathogens.
Citius Pharmaceuticals, Inc. Provides First Half 2021 Business Update, Highlights Upcoming Milestones
– Phase 3 Mino-Lok® trial proceeding as planned following recommendation by independent Data Monitoring Committee (DMC), highlighting important safety and efficacy signals –
– Mino-Lok® New Drug Application (NDA) submission planned for 2022 following anticipated completion of Phase 3 trial by the end of 2021 or early 2022 –
– Citius financial flexibility expanded with $127.6 million in financing activities during the first half of 2021, including $16.9 million in cash proceeds from warrants exercised during the quarter ended June 30, 2021 –
CRANFORD, N.J., July 7, 2021 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today provided a business update for the six-month period ended June 30, 2021 and reported on recent corporate developments.
Recent Highlights and Upcoming Milestones
- On July 1, 2021, Citius reported that the independent DMC recommended continuation of the Phase 3 Mino-Lok® pivotal superiority trial as planned with no modifications or safety concerns,
- Citius expects to complete the Mino-Lok® trial by the end of 2021 or early 2022, subject to continued easing of COVID-19 restrictions in the U.S.,
- Citius plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022 following completion of its Phase 3 Mino-Lok® trial, and
- Subsequent to March 31, 2021, Citius issued 11.2 million shares of Citius common stock upon the exercise of warrants, for aggregate proceeds of $16.9 million during the quarter and a total of $127.6 million in financing activities during the first half of 2021.
“On July 1, 2021, we reported that the independent Data Monitoring Committee (DMC), following its third interim review, recommended