Trials

A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma Learn more

Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI Learn more

Antimicrobial Catheter Lock Solution for the Treatment of Central Line Associated Bloodstream Infection (CLABSI) Learn more

Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI (MLK) Learn more

Publications

Mino-Lok Phase 2b Study Results Publication

Successful Salvage of Central Venous Catheters in Patients with Catheter-Related or Central Line-Associated Bloodstream Infections by Using a Catheter Lock Solution Consisting of Minocycline, EDTA, and 25% Ethanol

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Treating CLABSI Clinical and Economic Considerations

Treating CLABSI: A Clinical and Economic Challenge

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Treating CLABSI Clinical and Economic Challenges

Unnecessary Removal of Central Venous Catheters in Cancer Patients with Bloodstream Infections: Impact on Symptom Burden

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Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep

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I/ONTAK

Phase 3 Trial

A global, multicenter, open label single arm pivotal clinical trial for the treatment of patients with persistent or recurrent CTCL was initiated in 2013 and completed in December 2021. Inclusion criteria for the study were to evaluate patients in advanced stage CTCL (Mycosis Fungoides or Sézary Syndrome), who received at least one prior CTCL therapy.

The pivotal trial was divided into two phases, a lead-in phase with 21 subjects that evaluated dose finding, pharmacokinetics and immunogenicity, as well as assessing the Objective Response Rate (the “ORR”). An ORR is defined as a complete and partial response.

The second phase to the pivotal trial was a 70-patient study administered at the 9 mcg/kg/dose rate for 5 consecutive days in 21-day cycles, The inclusion criteria was identical to the lead-in study and the primary objective was to evaluate the ORR.

The topline results of the study are consistent with the prior formulation. No new safety signals were identified.

Investigator Initiated Trials

A Phase 1 trial has been initiated at the University of Minnesota, Masonic Cancer Center. This study is a single-arm non-randomized trial which has an estimated enrollment of 20 participants who will be administered denileukin diftitox prior to tisagenlecleucel Chimeric Antigen Receptor (CAR-T) therapy. The Phase 1 study consists of two components:  dose finding to establish a maximum tolerated dose (MTD) of denileukin diftitox in  combination  with  CART-T  therapy,  and a small extension component to provide an estimate of efficacy at that MTD. (Title: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL). IND #153242)

A second Phase 1 Study is planned at the University of Pittsburgh Medical Center, Hillman Cancer Center.  This study will investigate the safety and efficacy of a combined regimen of pembrolizumab with T-regulatory cell depletion and denileukin diftitox in patients diagnosed with recurrent or metastatic solid tumors in the second line setting. (Title: The efficacy of T-regulatory cell depletion with E7777 combined with immune checkpoint inhibitor, pembrolizumab, in recurrent or metastatic solid tumors: Phase I/II Study. IND #157242)

Mino-Lok®
 
Phase 3 Trial

Based on Phase 2b results, Citius Pharmaceuticals believes that Mino-Lok® is highly effective in salvaging infected indwelling catheters and is well-tolerated, making Mino-Lok® therapy an attractive alternative to removing and replacing a CVC.

  • To evaluate the efficacy of Mino-Lok® along with standard of care (SOC) systemic antibiotics for salvaging the central venous catheter (CVC) in subjects with catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI)
  • To evaluate the safety of Mino-Lok® in subjects with CRBSI/CLABSI

 

Phase 2b Trial

Citius Pharmaceuticals completed a Phase 2b study in December 2014. There were 90 patients in the study, with 30 patients in the active arm and 60 patients in a matched cohort for comparison. All patients were receiving treatment at The University of Texas MD Anderson Cancer Center for hematologic or solid tumor cancers.

Outstanding Comparative Results

Mino-Lok® salvaged 100% of CVCs, helping to cure all of the bacterias with no serious adverse events, compared to an 18% serious adverse event rate in the matched cohort where patients had the infected CVCs removed and replaced with a new CVC. The published manuscript can be downloaded here.

* One polymicrobial patient had a Gram+ and a Gram– organism cultured
** Six patients had more than one complication
*** All 3 CVCs were removed within 1 month.

Halo-Lido

Phase 2a Study*

In a randomized, double-blind study, 210 patients with Grade I and II hemorrhoids were treated twice daily for 14 days. Patients received either a placebo or one of six active drug treatments, with two concentrations each of hydrocortisone, lidocaine, or a hydrocortisone-lidocaine combination. Patients kept a diary of their symptoms.

Additionally, there were four physician assessments, during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids, such as bleeding, pruritus, overall pain and discomfort, and time to the onset of symptom relief.

Level Improvement Global Severity

Within the first few days of treatment, the highest concentration of the hydrocortisone lidocaine combination was directionally superior to the placebo as measured by the number of subjects experiencing a minimum of two levels improvement from baseline according to the GSDS scale. This study was not powered to obtain statistical significance; however, the data suggest that the combination product may also perform better than hydrocortisone or lidocaine alone.

Pruritus (Severe Itching)

clinical Trails

The hydrocortisone-lidocaine combination seemed to achieve 88.9% greater relief of pruritus at Day 2 as compared to any of its components alone.

Pain and Discomfort

clinical Trails

The hydrocortisone-lidocaine combination seemed to achieve 85.7% greater relief of pain and discomfort at Day 2 as compared to any of its components alone.

* Study was not powered to show statistical significance; its purpose was to inform future study designs.

CITI-001 (Hydro-Lido) was the first steroid-anesthetic combination product tested in a clinical trial for symptomatic relief of hemorrhoids. The new formulation, CITI-002, combines lidocaine with the higher-potency corticosteroid for symptomatic relief of the pain and discomfort of hemorrhoids. This change should improve the efficacy further while also providing faster onset of relief. While not used in combination in currently marketed products, the proposed corticosteroid is included as an FDA-approved topical product to treat a variety of dermatological disorders.

Stem Cell Platform

Citius is conducting a proof-of-concept study to test the safety and efficacy of a novel potent iPSC induced MSCs ( i-MSCs) in a clinically relevant sheep model of sepsis-induced ARDS. Interim results show that animals receiving i-MSCs demonstrated clear improvement over control animals with improved oxygenation, less systemic shock and reduced lung vascular injury.

While the interim results of the study have shown that use of i-MSCs is safe and effective in ameliorating severity of sepsis-induced acute lung injury, further studies of increasing sample sizes are warranted. Data from this sheep ARDS study will inform the design and dosing of planned future human clinical trials in ARDS using these i-MSCs.

Interim results of i-MSCs in the proof-of-concept study:

  • Displayed characteristics of donor MSCs by differentiating to adipocytes, osteoblasts and chondrocytes
  • Population doubling was ~4-fold higher vs. that of bone marrow-derived MSCs
  • Improved oxygenation and prevented onset of ARDS
  • Reduced pulmonary microvascular hyperpermeability to water and protein and ameliorated severity of pulmonary edema
  • Reduced fluid requirement
  • Reduced vasopressor requirement to maintain arterial blood pressure
  • Significantly improved bacterial clearance
  • Had no hemodynamic adverse effects
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