OUR NEW PROFILE IS: NASDAQ: CTXR
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Hello Everyone,
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
CRANFORD, N.J., Sept. 7, 2021 /PRNewswire via COMTEX/ — CRANFORD, N.J., Sept. 7, 2021 /PRNewswire/ — Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR) today announced that it has entered into a definitive agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) (NYSE: RDY) to acquire its exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. E7777, an engineered IL-2-diphtheria toxin fusion protein, is an improved formulation of oncology agent, ONTAK®, which was previously approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with persistent or recurrent CTCL. The last patient in a Pivotal trial of E7777 has been enrolled, and a biologics license application (BLA) for E7777’s first indication in CTCL is expected to be filed with the FDA by the end of 2022.
Under the terms of this agreement, Citius will acquire Dr. Reddy’s exclusive license of E7777 from Eisai Co., Ltd. (“Eisai”) and other related assets owned by Dr. Reddy’s. Citius’s exclusive license rights include rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Additionally, Citius will retain an option on the right to develop and market the product in India. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia. Dr. Reddy’s will receive a $40 million upfront payment and is entitled to up to $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets, up to $70 million in development milestones for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales. Eisai is to receive a $6 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds. Eisai will be responsible for completing the current CTCL clinical trial, and chemistry, manufacturing and controls (CMC) activities through the filing of a BLA for E7777 with the U.S. Food and Drug Administration (FDA). Citius will be responsible for development costs associated with potential additional indications. As of June 30, 2021, Citius had $115.7million in cash and cash equivalents on its balance sheet and plans to fund the upfront payments for the transaction with cash on hand.
“We are expanding our late-stage pipeline with E7777, a novel formulation of a well-known and previously FDA-approved immunotherapy for the treatment of CTCL, a rare and debilitating cancer that reduces a patient’s quality of life. The addition of E7777 will allow us to accelerate serving cancer patients with critical unmet needs and provide us with a substantial near-term revenue opportunity in CTCL. There are approximately 3,000 new cases of CTCL diagnosed in the U.S. annually, resulting in approximately 30,000 to 40,000 patients suffering from CTCL at any given time. The addressable population for E7777 will be later stage, relapsed and refractory patients who require systemic therapy. We estimate that this could be approximately 30% of the CTCL population. We also believe E7777 may support substantially greater upside potential in PTCL and intend to explore additional immuno-oncology indications,” stated Myron Holubiak, President and Chief Executive Officer of Citius.
“As an oncologist who treated CTCL patients with ONTAK®, I appreciate the great need for effective therapies for CTCL patients as the disease progresses. Due to variable response rates and limited benefits of alternative therapies, we believe many patients with relapsed or refractory CTCL will have an option to be prescribed E7777, if approved, at some point during treatment of their disease. Given E7777’s improved purity compared to ONTAK®, unique mechanism of action, and the well-known safety and efficacy profile of denileukin diftitox, this new biologic could offer CTCL patients and their physicians an important and effective tool with which to manage this incurable disease. We are excited by its potential as a treatment for CTCL patients for whom first-line therapies have not worked. We also believe it may address the needs of larger populations and plan to explore its potential in additional clinical indications in PTCL and immuno-oncology. We look forward to the planned completion of the Pivotal Phase 3 trial and submission of the BLA next year,” added Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius.
“This opportunity is consistent with our strategy of investing in assets that have differentiated upside potential and unique commercial advantages. With its substantially completed development work and purified formulation, now is an ideal time to add this near BLA-ready and, we believe, de-risked asset to the Citius pipeline. If approved, we intend to leverage the planned commercial infrastructure being developed for Mino-Lok® to launch E7777, providing Citius with potentially two marketed products in 2024. Our strong balance sheet will enable us to complete the transaction and, based on our current projections, continue to advance our other pipeline programs without requiring additional financing at this time,” concluded Mr. Holubiak.
About E7777
E7777 is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. E7777, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK®. ONTAK® was marketed in the U.S. from 2008 to 2014, when it was voluntarily withdrawn from the market to enable manufacturing improvements. These improvements resulted in E7777, which maintains the same amino acid sequence but features improved purity and bioactivity. E7777 has received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to E7777 for the treatment of PTCL and CTCL, respectively, making it eligible for seven years of market exclusivity post-approval.
A global, multicenter, open-label, single-arm Pivotal study of E7777 in participants with recurrent or persistent CTCL (NCT01871727) is underway. The last patient has been recruited; top line results are anticipated in the first half of 2022. A BLA for E7777 is expected to be filed with the FDA by the end of 2022.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sezary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and has usually spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple systemic agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no cure for advanced CTCL. Approximately 3,000 new cases are reported in the United States every year, with an estimated 30,000 – 40,000 individuals living with the disease.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is an aggressive and uncommon type of NHL that develops in mature white blood cells called T-cells and natural killer (NK) cells. The most common subtypes of PTCL are peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), anaplastic large-cell lymphoma (ALCL), adult T-cell leukemia/lymphoma (ATLL) and angioimmunoblastic T-cell lymphoma (AITL). Often discovered once the disease has progressed, symptoms include swelling and lumps in the lymph nodes, fever, night sweats and weight loss. Prognosis is good for ALK-positive anaplastic large cell lymphoma which tends to affect adults aged between 20 and 30. However, treatment of other subtypes of PTCL is difficult and associated with poor prognoses, as it often affects older adults in their 60s with comorbidities. Relapse is common and advances in treatment options have been slow. PTCL is a rare disease with a significant unmet medical need.
CTXR PIPELINE: FOUR ACTIVE PROGRAMS
MINO-LOK®
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.
Program Highlights
- 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.
HALO-LIDO
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.
Program Highlights
- 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.
Program Highlights
- 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….
Mino-Wrap
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.
Program Highlights
- 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
continuing the Phase 3 trial for Mino-Lok® without modification. This recommendation affirms that there is an important efficacy signal that merits moving forward with the trial, there are no safety concerns to warrant halting the trial, and that the full data set upon trial completion may support statistically significant superiority. Whether Mino-Lok® demonstrates statistical superiority will only be known to us once the trial is finished and the data is unblinded. We view the recommendation of the DMC as a strong positive signal, and remain fully committed to completing the trial in a timely manner,” stated Myron Holubiak, President and Chief Executive Officer of Citius.
“Mino-Lok® trial patients represent an extremely ill population, which is challenging to enroll under the best of circumstances. Like many clinical trials conducted during the pandemic, the timeline for our study has been impacted by COVID-19. It has taken longer than anticipated to enroll patients due to restrictions established at our trial sites during the height of the pandemic. These restrictions, in place for close to half of the duration of our trial, reflect a series of challenges including: site closures, limited site and patient access, reallocation of resources away from clinical trials to COVID-patient treatment, modifications to catheter infection treatment protocols, and lengthy approval time to qualify new study sites, resulting in fewer monthly patient screenings compared to pre-pandemic levels. The ability of sites to ramp back up for the Mino-Lok® trial depends largely on how these varied and complex factors are addressed. Several institutions have resumed our trial, and provided that COVID restrictions continue to ease and are not reinstated, we believe it would be possible for our trial sites to complete enrollment in the Mino-Lok® study as early as the end of the year. That would put us on target to submit an NDA in 2022,” added Mr. Holubiak.
“We intend to aggressively pursue all options to expedite completion of the Mino-Lok® trial. During the first half of 2021, we raised more than $127 million, of which approximately $17 million was from warrants exercised since March 31, 2021. We intend to leverage these resources to accelerate our outreach efforts to advance the trial. Moreover, we believe we are well capitalized to advance Mino-Lok® beyond trial completion, and will engage closely with the FDA in the coming months to do so. Concurrently, we are actively advancing three additional first-and-only or novel pipeline products as outlined in our updated corporate presentation published on our website this morning. With a late-stage product candidate moving toward completion of its Phase 3 trial, depth in our pipeline, and the financial resources to execute our near-term strategy, we believe Citius is better positioned than ever before to deliver long-term value to shareholders,” concluded Mr. Holubiak.
About Mino-Lok®
Citius is developing Mino-Lok®, an antibiotic lock solution to treat patients with catheter-related blood stream infections that was licensed from The University of Texas MD Anderson Cancer Center. Citius believes Mino-Lok® provides a superior alternative to removing and replacing a central venous catheter (CVC), leading to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok® would be the first-and-only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
The Mino-Lok® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Approximately 144 subjects diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study are to be randomized in a 1:1 ratio to receive either Mino-Lok® therapy or standard of care antibiotic lock therapy.
Subjects in the Mino-Lok® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
Three planned interim analyses were performed as defined by the study protocol. The primary role of the independent DMC, defined in the DMC charter, is to safeguard the interests of study participants, assess the safety of the treatment, and monitor the overall conduct of the study. In order to ensure the protection of patients enrolled in the trial and to assure the timely and efficient completion of the study, each DMC recommendation is bound by strict parameters outlined in the DMC charter. A recommendation to continue the trial as planned indicates that the data reviewed by the DMC, at this juncture, is within the statistical boundaries determined by Citius in order to complete the trial with the protocol-defined sample size and power to achieve the primary endpoint.
Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial
– Independent Data Monitoring Committee (DMC) to review Mino-Lok® safety, superiority, and futility data at upcoming meeting scheduled for June 29, 2021-
CRANFORD, N.J., June 8, 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 announced that the next planned interim analysis in its Phase 3 trial of Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related blood stream infections (CRBSIs/CLABSIs) has been scheduled for the end of June 2021. In accordance with the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority and futility.
“We look forward to feedback from the DMC following their review of the trial data,” stated Myron Holubiak, President and Chief Executive Officer of Citius.
According to the Mino-Lok® Phase 3 study protocol, the DMC is responsible for conducting interim analyses when 40%, 50% and 65% of the total number of anticipated events have been observed. The first two interim analyses were conducted by the DMC in 2019 and 2020, respectively. The next interim analysis meeting of the DMC will be held on June 29, 2021. At that time, the DMC will review unblinded study data and subsequently provide written recommendations to Citius within five business days.
The Mino-Lok® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Approximately 144 subjects diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok® therapy or standard of care antibiotic lock therapy. To date, the Company has achieved more than 80% of the expected enrollment.
Subjects in the Mino-Lok® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
CATALYSTS
- Diversified pipeline of potential first-in-class products with multiple near-term staged catalysts
- Attractive multi-billion-dollar opportunities in adjunctive cancer care, infectious disease and gastrointestinal disease
- Strong research partnerships to advance the pipeline
- Robust balance sheet to support pipeline development and invest in long-term growth
- Seasoned leadership with successful execution-focused track record
Citius is guided by three principles in our mission to deliver best-in-class therapies for patients with critical unmet needs.
- Advance therapies with unique commercial advantages
- Invest in assets with differentiated upside potential
- Create long-term sustainable value for shareholder
TRIALS
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
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
Treating CLABSI: A Clinical and Economic Challenge
Unnecessary Removal of Central Venous Catheters in Cancer Patients with Bloodstream Infections: Impact on Symptom Burden
Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep
Mino-Lok®
Phase 3 TrialBased 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 TrialCitius 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 ResultsMino-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)
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
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
NEWS
MANAGEMENT
Leonard MazurExecutive Chairman, Director
Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding and building multiple healthcare companies, and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is also the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC, a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008, and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical companies. From 2005 to 2012, Mr. Mazur co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC, a specialty pharmaceutical company producing prescription dermatological drugs. Earlier, he was the founder and Chief Executive Officer of Genesis Pharmaceuticals, Inc., a dermatological products company that marketed its products through dermatologists’ offices and co-promoted products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company. Mr. Mazur has extensive sales, marketing and business development experience from previous tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc., Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc.
Mr. Mazur is a member of the Board of Trustees of Manor College, and is a recipient of the Ellis Island Medal of Honor. Mr. Mazur received both his BA and MBA from Temple University, and served in the U.S. Marine Corps Reserves.
Myron HolubiakPresident and Chief Executive Officer, Director
Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. From 1998 to 2001, Mr. Holubiak served as President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company. As President of Roche, Mr. Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. During his 19-year tenure at Roche Labs, Mr. Holubiak also held multiple sales and marketing roles. Prior to Roche, Mr. Holubiak founded Emron, Inc., a health economics and managed care consulting company, and helped establish the Academy of Managed Care Pharmacy (AMCP). From 2012 to 2016, Mr. Holubiak served as Chairman of the Board of Bioscrip, Inc., a national home infusion company. Since 2010, Mr. Holubiak has served as a member of the Board of Directors of Assembly Biosciences, Inc. and its predecessor, Ventrus Biosciences, Inc., and is a trustee of the Academy of Managed Care Pharmacy Foundation.
Mr. Holubiak received a BS in molecular biology and biophysics from the University of Pittsburgh. He received advanced business training from Harvard Business School and the University of London, as well as advanced training in health economics from the University of York’s Centre for Health Economics.
Jaime BartushakChief Financial Officer
Mr. Bartushak is an experienced finance and operations professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business development, M&A, restructuring, capital formation, and strategic planning expertise. Mr. Bartushak is a founder of Leonard-Meron Biosciences, and, as CFO, was instrumental in obtaining initial investment capital for its start-up in 2014. Earlier, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., and before that, he led the financial efforts for the successful sale of Triax Pharmaceuticals to PreCision Dermatology.
Mr. Bartushak holds a Master of Science and BS from the New Jersey Institute of Technology.
Myron S. Czuczman, MDChief Medical Officer and EVP
Dr. Czuczman is an experienced physician-scientist, academic oncologist, and pharma executive with decades of experience in strategic design, implementation, and oversight for the global development of novel therapeutics for hematologic malignancies. Dr. Czuczman joined Citius from Celgene where he was Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL. In this role, Dr. Czuczman managed a global team of physicians and scientists responsible for cross-functional development of compounds from proof-of-principle to worldwide registration. Prior to his career in pharma, Dr. Czuczman practiced medicine for over two decades at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma Service and head of the Lymphoma Translational Research Laboratory. In addition to his extensive publications record, membership and leadership roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr. Czuczman also attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center.
Dr. Czuczman received his medical degree from the Pennsylvania State University College of Medicine after graduating magna cum laude in biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.
Gary F. TalaricoEVP, Operations
Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently, he was a founder, partner and Executive Vice President of Leonard-Meron Biosciences, Inc.; he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talarico was a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included tenures as Vice President of Sales for Medicis Pharmaceutical Corporation at its start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.
Jay WadekarSVP, Business Strategy
Mr. Wadekar has been associated with Citius since its inception. Prior to Citius, he lead the clinical program at Ischemix, Inc., a company developing novel therapies for cardiovascular conditions. Mr. Wadekar has more than thirty years of experience in areas of finance, corporate strategy, sales and senior leadership in the healthcare field. Mr. Wadekar has held numerous executive level positions throughout his career in biotechnology and pharmaceutical industries including Chairman and CEO of Able Laboratories, Inc. Most recently he served as a strategic advisor to Camber Pharmaceuticals, Inc. where he was instrumental in building the executive team and establishing Camber’s Sales Operations systems.
Alan Lader, PhDVP, Clinical Operations
Dr. Lader has served as VP, Clinical Operations since March 2016. Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr. Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital, where he taught Integrated Human Physiology, and was Principal Investigator for NIH-funded studies in mechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer-reviewed journals, and has presented more than 20 abstracts at scientific meetings. He received his PhD from the University of South Carolina School of Medicine. He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University.
Ilanit AllenVP, Investor Relations
Ms. Allen has more than 20 years of experience in corporate communications, investor relations, strategy and investment banking. Since 2014, Ms. Allen has provided investor relations counsel to more than two dozen private and public life science companies. Previously, she advised executives across a broad spectrum of industries and growth stages, including technology startups and Fortune 500 financial institutions. Ilanit began her career as an investment banking analyst at SG Cowen with a focus on mergers and acquisitions. Ms. Allen holds an MBA from Harvard Business School, a Bachelor of Science degree in Finance from The Wharton School, and a Bachelor of Arts degree in International Relations from the University of Pennsylvania.
Sincerely,