CTXR - Citius Pharmaceuticals - Gute Pipeline plus Corona Phantasie (Seite 2)
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CitiusPharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submission
Wed, April 6, 2022, 5:50 PM
In this article:
CTXR
-1.60%
CRANFORD, N.J., April 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products in oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies, today reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK®, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.
Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)
Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)
"We are encouraged by the results of the study, which we believe are clinically meaningful, and are hopeful that I/ONTAK will be an important treatment option for patients with persistent or recurrent CTCL. There is no single standard of care for this orphan disease. We believe the full body of data from this and prior studies will support a successful reintroduction of denileukin diftitox to the market. We are eager to move forward with a BLA submission for the treatment of CTCL later this year. This important milestone brings Citius one step closer to launching its first commercial product next year, if approved by the FDA," stated Myron Holubiak, Chief Executive Officer of Citius.
"The topline results demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control without cumulative toxicity. I/ONTAK has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination of immunosuppressive Tregs within the tumor microenvironment. The topline data further demonstrate that I/ONTAK has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies. If approved, we believe this biologic with its observed efficacy and safety data, and which is already approved for CTCL and peripheral T-cell lymphoma (PTCL) patients in Japan, would arm oncologists in the U.S. with an important additional treatment option for this devastating orphan disease," added Dr. Myron Czuczman, Chief Medical Officer of Citius.
About I/ONTAK Pivotal Phase 3 Study 302 (E7777-G000-302)
Study (E7777-G000-302) is a pivotal, multicenter, open-label, single-arm study of I/ONTAK (E7777) in subjects with persistent or recurrent CTCL (NCT01871727). All subjects were diagnosed with Mycosis Fungoides or Sézary Syndrome, with tumors assessed as positive for expression of the CD25 subunit of the IL-2 receptor.
The study was conducted in two parts with an initial Lead-In Study to determine the optimal dose of I/ONTAK, followed by the Main Study. The Lead-In study was completed with 21 subjects treated at doses of 6 to 15 µg/kg/day. Final data collection for the Lead-In Study occurred in August 2015. The Protocol Steering Committee selected a dose of 9 μg/kg/day to be used for the Main Study. A total of 91 subjects with Stage I-IV CTCL were enrolled in the Main Study. Study participants were administered 9 μg/kg/day of I/ONTAK (E7777) by intravenous infusion over 60 minutes (+/-10 minutes) on 5 consecutive days per cycle every 21 days.
A total of 71 subjects with Stage I-III persistent or recurrent CTCL from the Lead-In and Main Studies were assessed for efficacy with 69 subjects included in the Primary Efficacy Analysis Set. Study 302 was completed in December 2021.
Summary of Topline Efficacy and Safety Data
The primary outcome measure of Study 302 is the Objective Response Rate (ORR) based on the Global Response Score (GRS) (Olsen, JCO 2011). ORR is defined as the proportion of subjects with a significant reduction in tumor size that can be classified as achieving either a partial response (PR) or a complete response (CR).
According to the trial protocol, the treatment would be considered efficacious and demonstrate clinical benefit if the lower limit of the 2-sided 95% exact confidence interval (CI) of the observed ORR exceeds 25.0%, as determined by the Independent Review Committee (IRC);
In this study, the IRC determined the study achieved an ORR of 36.2%, 95% confidence interval (25.0%, 48.7%) (25 patients out of 69);
An Investigator Efficacy Analysis determined that the study achieved an ORR of 42.3%, 95% confidence interval (30.6%, 54.6%) (30 patients out of 71);
The FDA recently provided additional written comments indicating that their efficacy evaluation will be based on study results showing the lower limit of a 95% confidence interval to exceed a clinically relevant response rate (determined during BLA review) which may be supported with data from from the prior ONTAK study that led to ONTAK's intial approval. In our trial ORR will need to be supported by adequate magnitude of duration of response and an acceptable risk/benefit ratio;
Overall rates of adverse events and serious adverse events were consistent with published data of previously approved ONTAK. Most common adverse events included: nausea, fatigue, increased alanine aminotransferase, chills and peripheral oedema. No new safety concerns were identified.
The study evaluated additional secondary and exploratory endpoints that include progression free survival, duration of response, time to response, skin response, duration of skin response, time to skin response, ORR (Prince, JCO 2010) and safety.
These results reflect preliminary topline data and are subject to further analysis. These data as well as full detailed results will be presented at upcoming scientific conferences and submitted for publication.
Selected Preliminary Efficacy Data Table
Independent (IRC) Stage I-III
Primary Efficacy Analysis Set1
(n=69*)
Investigator Stage I-III
Efficacy Analysis Set2
(n=71)
Objective Response Rate (ORR)
(Complete Response + Partial Response), n (%)
25 (36.2)
30 (42.3)
95% CI
(25.0, 48.7)
(30.6, 54.6)
Duration of Response (months)
Subjects with Objective Response (n)
25
30
Median observed DOR (months)
6.5
5.7
Range (Min, Max)
(3.0+, 23.5+)
(0.7+, 26.1+)
Time to Response (months)
Subjects with Objective Response (n)
25
30
Median
1.41
1.41
Clinical Benefit Rate, n (%)
(CR + PR + Durable Stable Disease)
34 (49.3)
38 (53.5)
95% CI
(37.0, 61.6)
(41.3, 65.5)
Independent Review Committee assessment of the Primary Efficacy Analysis Set which included 69 Stage I-III CTCL subjects from the Lead-In Study and the Main Study who received a dose of 9 ug/kg/day of study drug. *Two subjects included in the Investigator Efficacy Analysis Set were considered by the IRC to have Stage IV CTCL and excluded from the Primary Efficacy Analysis Set. This dataset matches the patient population used for the ONTAK indication.
Investigator Efficacy Analysis Set: All subjects considered by the Investigators to have Stage I-III CTCL who received study drug at 9 μg/kg dose in Lead-In and Main Study (n=71)
About I/ONTAK
I/ONTAK 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. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively, making it potentially eligible for seven years of market exclusivity post-approval for each indication.
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 Sézary 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 potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant can 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 curative therapy 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.
Wed, April 6, 2022, 5:50 PM
In this article:
CTXR
-1.60%
CRANFORD, N.J., April 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products in oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies, today reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK®, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.
Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)
Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)
"We are encouraged by the results of the study, which we believe are clinically meaningful, and are hopeful that I/ONTAK will be an important treatment option for patients with persistent or recurrent CTCL. There is no single standard of care for this orphan disease. We believe the full body of data from this and prior studies will support a successful reintroduction of denileukin diftitox to the market. We are eager to move forward with a BLA submission for the treatment of CTCL later this year. This important milestone brings Citius one step closer to launching its first commercial product next year, if approved by the FDA," stated Myron Holubiak, Chief Executive Officer of Citius.
"The topline results demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control without cumulative toxicity. I/ONTAK has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination of immunosuppressive Tregs within the tumor microenvironment. The topline data further demonstrate that I/ONTAK has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies. If approved, we believe this biologic with its observed efficacy and safety data, and which is already approved for CTCL and peripheral T-cell lymphoma (PTCL) patients in Japan, would arm oncologists in the U.S. with an important additional treatment option for this devastating orphan disease," added Dr. Myron Czuczman, Chief Medical Officer of Citius.
About I/ONTAK Pivotal Phase 3 Study 302 (E7777-G000-302)
Study (E7777-G000-302) is a pivotal, multicenter, open-label, single-arm study of I/ONTAK (E7777) in subjects with persistent or recurrent CTCL (NCT01871727). All subjects were diagnosed with Mycosis Fungoides or Sézary Syndrome, with tumors assessed as positive for expression of the CD25 subunit of the IL-2 receptor.
The study was conducted in two parts with an initial Lead-In Study to determine the optimal dose of I/ONTAK, followed by the Main Study. The Lead-In study was completed with 21 subjects treated at doses of 6 to 15 µg/kg/day. Final data collection for the Lead-In Study occurred in August 2015. The Protocol Steering Committee selected a dose of 9 μg/kg/day to be used for the Main Study. A total of 91 subjects with Stage I-IV CTCL were enrolled in the Main Study. Study participants were administered 9 μg/kg/day of I/ONTAK (E7777) by intravenous infusion over 60 minutes (+/-10 minutes) on 5 consecutive days per cycle every 21 days.
A total of 71 subjects with Stage I-III persistent or recurrent CTCL from the Lead-In and Main Studies were assessed for efficacy with 69 subjects included in the Primary Efficacy Analysis Set. Study 302 was completed in December 2021.
Summary of Topline Efficacy and Safety Data
The primary outcome measure of Study 302 is the Objective Response Rate (ORR) based on the Global Response Score (GRS) (Olsen, JCO 2011). ORR is defined as the proportion of subjects with a significant reduction in tumor size that can be classified as achieving either a partial response (PR) or a complete response (CR).
According to the trial protocol, the treatment would be considered efficacious and demonstrate clinical benefit if the lower limit of the 2-sided 95% exact confidence interval (CI) of the observed ORR exceeds 25.0%, as determined by the Independent Review Committee (IRC);
In this study, the IRC determined the study achieved an ORR of 36.2%, 95% confidence interval (25.0%, 48.7%) (25 patients out of 69);
An Investigator Efficacy Analysis determined that the study achieved an ORR of 42.3%, 95% confidence interval (30.6%, 54.6%) (30 patients out of 71);
The FDA recently provided additional written comments indicating that their efficacy evaluation will be based on study results showing the lower limit of a 95% confidence interval to exceed a clinically relevant response rate (determined during BLA review) which may be supported with data from from the prior ONTAK study that led to ONTAK's intial approval. In our trial ORR will need to be supported by adequate magnitude of duration of response and an acceptable risk/benefit ratio;
Overall rates of adverse events and serious adverse events were consistent with published data of previously approved ONTAK. Most common adverse events included: nausea, fatigue, increased alanine aminotransferase, chills and peripheral oedema. No new safety concerns were identified.
The study evaluated additional secondary and exploratory endpoints that include progression free survival, duration of response, time to response, skin response, duration of skin response, time to skin response, ORR (Prince, JCO 2010) and safety.
These results reflect preliminary topline data and are subject to further analysis. These data as well as full detailed results will be presented at upcoming scientific conferences and submitted for publication.
Selected Preliminary Efficacy Data Table
Independent (IRC) Stage I-III
Primary Efficacy Analysis Set1
(n=69*)
Investigator Stage I-III
Efficacy Analysis Set2
(n=71)
Objective Response Rate (ORR)
(Complete Response + Partial Response), n (%)
25 (36.2)
30 (42.3)
95% CI
(25.0, 48.7)
(30.6, 54.6)
Duration of Response (months)
Subjects with Objective Response (n)
25
30
Median observed DOR (months)
6.5
5.7
Range (Min, Max)
(3.0+, 23.5+)
(0.7+, 26.1+)
Time to Response (months)
Subjects with Objective Response (n)
25
30
Median
1.41
1.41
Clinical Benefit Rate, n (%)
(CR + PR + Durable Stable Disease)
34 (49.3)
38 (53.5)
95% CI
(37.0, 61.6)
(41.3, 65.5)
Independent Review Committee assessment of the Primary Efficacy Analysis Set which included 69 Stage I-III CTCL subjects from the Lead-In Study and the Main Study who received a dose of 9 ug/kg/day of study drug. *Two subjects included in the Investigator Efficacy Analysis Set were considered by the IRC to have Stage IV CTCL and excluded from the Primary Efficacy Analysis Set. This dataset matches the patient population used for the ONTAK indication.
Investigator Efficacy Analysis Set: All subjects considered by the Investigators to have Stage I-III CTCL who received study drug at 9 μg/kg dose in Lead-In and Main Study (n=71)
About I/ONTAK
I/ONTAK 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. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively, making it potentially eligible for seven years of market exclusivity post-approval for each indication.
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 Sézary 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 potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant can 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 curative therapy 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.
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2022 Financial Results and Provides Business Update
Fri, February 11, 2022, 4:30 AM
In this article:
CTXR
+5.84%
Explore the topics mentioned in this article
Strong balance sheet with $65.4 million in cash and cash equivalents as of December 31, 2021 and no debt
Topline results of Pivotal Phase 3 trial in cancer immunotherapy I/ONTAK for the treatment of cutaneous T-cell lymphoma expected 1H 2022; BLA submission planned for 2H 2022
Mino-Lok® Phase 3 trial progressed despite Covid-19-related recruitment challenges
CRANFORD, N.J., Feb. 10, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today reported business and financial results for the first fiscal quarter of 2022 ended December 31, 2021.
Fiscal Q1 2022 Business Highlights and Subsequent Developments
Pivotal Phase 3 trial of I/ONTAK (E7777) completed in December 2021 with topline results anticipated in the first half of 2022 and a biologics license application (BLA) submission planned in the second half of 2022;
Mino-Lok® Phase 3 trial completion anticipated in 2022; and,
Regulatory, manufacturing, clinical and commercial capabilities expanded to support late-stage pipeline with the addition of seasoned executives with extensive pharmaceutical industry experience:
Financial Highlights
Cash and cash equivalents of $65.4 million as of December 31, 2021;
R&D expenses were $5.5 million for the first quarter ended December 31, 2021, compared to $6.2 million for the first quarter ended December 31, 2020;
G&A expenses were $2.9 million for the first quarter ended December 31, 2021, compared to $1.7 million for the first quarter ended December 31, 2020;
Stock-based compensation expense was $0.9 million for the first quarter ended December 31, 2021, compared to $0.3 million for the first quarter ended December 31, 2020; and,
Net loss was $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the first quarter ended December 31, 2020.
"We anticipate 2022 will be a year of important catalysts for Citius. The timeline for the I/ONTAK program remains on track, with topline results anticipated in the first half of 2022, followed by a planned BLA filing in the second half of the year. Moreover, the FDA confirmed that no pediatric study will be required for I/ONTAK, further de-risking this asset," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.
"Covid-19 continues to pose a challenge to the Mino-Lok® Phase 3 trial. We remain committed to completing the trial this year and believe we are well-positioned to continue our efforts as Covid-19 infections and hospitalizations subside, restrictions are lifted and the overall environment for clinical trials improves. These efforts include active engagement with our existing sites, and evaluation of additional trial sites. We continue to believe that there is a significant unmet medical need to salvage catheters so that critically ill patients need not undergo the painful and costly removal and replacement of a central venous line. Our primary focus remains to execute a plan that ensures we have a robust dataset that maximizes the potential success of Mino-Lok®," added Mr. Holubiak.
"To further support the launch of our two late-stage product candidates, I/ONTAK and Mino-Lok®, if approved, and to advance our other pipeline programs, we have added several key regulatory, clinical, commercial and manufacturing industry veterans to our team. Their expertise will help propel our activities to bring these important products to market, and our strong balance sheet continues to support these efforts. We look forward to sharing our value-creating milestones with our stakeholders in the coming months," concluded Mr. Holubiak.
Key Recent Hires
Catherine Kessler, MS – EVP, Regulatory Affairs
Ms. Kessler is a well-respected biotech executive with more than 25 years of experience in the pharmaceutical industry, including 20 years of experience in regulatory affairs and 16 years of expertise in managing regulatory affairs and operations activities supporting early and late-stage product development in multiple therapeutic areas. She has prepared regulatory submissions for the US FDA, EMEA and other regulatory authorities for investigational drugs. Catherine's deep expertise in developing regulatory paths to market for unique investigational products, engaging health authorities through complex stages of clinical development, tactical aspects of regulatory applications, and efficient resourcing of application-related activities will allow her to successfully chart the regulatory paths for each of the pipeline programs at Citius.
Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls
Mr. Creighton is a senior regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products. He joined Citius from Clinipace Worldwide, a leading global contract research organization. As head of global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU.
Kevin Carey – VP, Program Management
Mr. Carey is a seasoned pharmaceutical executive with more than 20 years of experience in complex global pharmaceutical project management, and more than 10 years of experience in combination drug/device development. Kevin has managed all phases of the pharmaceutical drug development lifecycle including discovery and development, preclinical research, clinical research, and FDA drug review and approval, including seven NDA submissions and approvals throughout his career. Mr. Carey joined Citius from Dr. Reddy's Laboratories where he was a Senior Director and head of the Program and Alliance Management Office, and was integral to the I/ONTAK (E7777) program.
Preeti Singh, MD – Medical Director
Dr. Singh is an accomplished clinical strategy and development leader with more than a decade of experience in drug development from proof-of-concept studies to Phase 3 trials and life cycle management in the areas of oncology, dermatology, neurology, and pediatric and adult gastroenterology. She brings diverse and well-rounded experience in medical affairs, drug commercialization and strategy, with extensive knowledge of new drug approval and regulatory compliance, to the newly formed role at Citius. Dr. Singh joined Citius from Dr. Reddy's Laboratories where she was the Subject Matter Expert on I/ONTAK (E7777).
FIRST QUARTER ENDED DECEMBER 31, 2021 Financial Results:
Liquidity
As of December 31, 2021, the Company had $65.4 million in cash and cash equivalents and no debt.
As of December 31, 2021, the Company had 146,012,169 common shares issued and outstanding.
The Company estimates that its available cash resources will be sufficient to fund its operations through March 2023.
Research and Development (R&D) Expenses
R&D expenses were $5.5 million for the fiscal quarter ended December 31, 2021, compared to $6.2 million for the fiscal quarter ended December 31, 2020. The decrease of $0.7 million is primarily due to a $4.8 million decrease in research and development expenses related to our proposed novel cellular therapy for ARDS offset by increases in R&D expenses related to I/ONTAK, Mino-Lok®, Halo-Lido and Mino-Wrap. During the three months ended December 31, 2020, we expensed a $5,000,000 license fee paid to Novellus.
We expect that research and development expenses will increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok® and I/ONTAK, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.
General and Administrative (G&A) Expenses
G&A expenses were $2.9 million for the fiscal quarter ended December 31, 2021, compared to $1.7 million for the fiscal quarter ended December 31, 2020. The increase of $1.2 million is primarily due to costs associated with additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.
Stock-based Compensation Expense
For the fiscal quarter ended December 31, 2021, stock-based compensation expense was $0.9 million as compared to $0.3 million for the prior year period. The increase primarily reflects expenses related to new grants made by Citius to employees, directors and consultants.
Net loss
Net loss was $9.2 million, or ($0.06) per share for the fiscal quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the fiscal quarter ended December 31, 2020. The increase in net loss is primarily due an increase in general and administrative expenses.
Fri, February 11, 2022, 4:30 AM
In this article:
CTXR
+5.84%
Explore the topics mentioned in this article
Strong balance sheet with $65.4 million in cash and cash equivalents as of December 31, 2021 and no debt
Topline results of Pivotal Phase 3 trial in cancer immunotherapy I/ONTAK for the treatment of cutaneous T-cell lymphoma expected 1H 2022; BLA submission planned for 2H 2022
Mino-Lok® Phase 3 trial progressed despite Covid-19-related recruitment challenges
CRANFORD, N.J., Feb. 10, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, today reported business and financial results for the first fiscal quarter of 2022 ended December 31, 2021.
Fiscal Q1 2022 Business Highlights and Subsequent Developments
Pivotal Phase 3 trial of I/ONTAK (E7777) completed in December 2021 with topline results anticipated in the first half of 2022 and a biologics license application (BLA) submission planned in the second half of 2022;
Mino-Lok® Phase 3 trial completion anticipated in 2022; and,
Regulatory, manufacturing, clinical and commercial capabilities expanded to support late-stage pipeline with the addition of seasoned executives with extensive pharmaceutical industry experience:
Financial Highlights
Cash and cash equivalents of $65.4 million as of December 31, 2021;
R&D expenses were $5.5 million for the first quarter ended December 31, 2021, compared to $6.2 million for the first quarter ended December 31, 2020;
G&A expenses were $2.9 million for the first quarter ended December 31, 2021, compared to $1.7 million for the first quarter ended December 31, 2020;
Stock-based compensation expense was $0.9 million for the first quarter ended December 31, 2021, compared to $0.3 million for the first quarter ended December 31, 2020; and,
Net loss was $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the first quarter ended December 31, 2020.
"We anticipate 2022 will be a year of important catalysts for Citius. The timeline for the I/ONTAK program remains on track, with topline results anticipated in the first half of 2022, followed by a planned BLA filing in the second half of the year. Moreover, the FDA confirmed that no pediatric study will be required for I/ONTAK, further de-risking this asset," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.
"Covid-19 continues to pose a challenge to the Mino-Lok® Phase 3 trial. We remain committed to completing the trial this year and believe we are well-positioned to continue our efforts as Covid-19 infections and hospitalizations subside, restrictions are lifted and the overall environment for clinical trials improves. These efforts include active engagement with our existing sites, and evaluation of additional trial sites. We continue to believe that there is a significant unmet medical need to salvage catheters so that critically ill patients need not undergo the painful and costly removal and replacement of a central venous line. Our primary focus remains to execute a plan that ensures we have a robust dataset that maximizes the potential success of Mino-Lok®," added Mr. Holubiak.
"To further support the launch of our two late-stage product candidates, I/ONTAK and Mino-Lok®, if approved, and to advance our other pipeline programs, we have added several key regulatory, clinical, commercial and manufacturing industry veterans to our team. Their expertise will help propel our activities to bring these important products to market, and our strong balance sheet continues to support these efforts. We look forward to sharing our value-creating milestones with our stakeholders in the coming months," concluded Mr. Holubiak.
Key Recent Hires
Catherine Kessler, MS – EVP, Regulatory Affairs
Ms. Kessler is a well-respected biotech executive with more than 25 years of experience in the pharmaceutical industry, including 20 years of experience in regulatory affairs and 16 years of expertise in managing regulatory affairs and operations activities supporting early and late-stage product development in multiple therapeutic areas. She has prepared regulatory submissions for the US FDA, EMEA and other regulatory authorities for investigational drugs. Catherine's deep expertise in developing regulatory paths to market for unique investigational products, engaging health authorities through complex stages of clinical development, tactical aspects of regulatory applications, and efficient resourcing of application-related activities will allow her to successfully chart the regulatory paths for each of the pipeline programs at Citius.
Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls
Mr. Creighton is a senior regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products. He joined Citius from Clinipace Worldwide, a leading global contract research organization. As head of global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU.
Kevin Carey – VP, Program Management
Mr. Carey is a seasoned pharmaceutical executive with more than 20 years of experience in complex global pharmaceutical project management, and more than 10 years of experience in combination drug/device development. Kevin has managed all phases of the pharmaceutical drug development lifecycle including discovery and development, preclinical research, clinical research, and FDA drug review and approval, including seven NDA submissions and approvals throughout his career. Mr. Carey joined Citius from Dr. Reddy's Laboratories where he was a Senior Director and head of the Program and Alliance Management Office, and was integral to the I/ONTAK (E7777) program.
Preeti Singh, MD – Medical Director
Dr. Singh is an accomplished clinical strategy and development leader with more than a decade of experience in drug development from proof-of-concept studies to Phase 3 trials and life cycle management in the areas of oncology, dermatology, neurology, and pediatric and adult gastroenterology. She brings diverse and well-rounded experience in medical affairs, drug commercialization and strategy, with extensive knowledge of new drug approval and regulatory compliance, to the newly formed role at Citius. Dr. Singh joined Citius from Dr. Reddy's Laboratories where she was the Subject Matter Expert on I/ONTAK (E7777).
FIRST QUARTER ENDED DECEMBER 31, 2021 Financial Results:
Liquidity
As of December 31, 2021, the Company had $65.4 million in cash and cash equivalents and no debt.
As of December 31, 2021, the Company had 146,012,169 common shares issued and outstanding.
The Company estimates that its available cash resources will be sufficient to fund its operations through March 2023.
Research and Development (R&D) Expenses
R&D expenses were $5.5 million for the fiscal quarter ended December 31, 2021, compared to $6.2 million for the fiscal quarter ended December 31, 2020. The decrease of $0.7 million is primarily due to a $4.8 million decrease in research and development expenses related to our proposed novel cellular therapy for ARDS offset by increases in R&D expenses related to I/ONTAK, Mino-Lok®, Halo-Lido and Mino-Wrap. During the three months ended December 31, 2020, we expensed a $5,000,000 license fee paid to Novellus.
We expect that research and development expenses will increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok® and I/ONTAK, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.
General and Administrative (G&A) Expenses
G&A expenses were $2.9 million for the fiscal quarter ended December 31, 2021, compared to $1.7 million for the fiscal quarter ended December 31, 2020. The increase of $1.2 million is primarily due to costs associated with additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.
Stock-based Compensation Expense
For the fiscal quarter ended December 31, 2021, stock-based compensation expense was $0.9 million as compared to $0.3 million for the prior year period. The increase primarily reflects expenses related to new grants made by Citius to employees, directors and consultants.
Net loss
Net loss was $9.2 million, or ($0.06) per share for the fiscal quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the fiscal quarter ended December 31, 2020. The increase in net loss is primarily due an increase in general and administrative expenses.
Antwort auf Beitrag Nr.: 70.500.464 von iknowtheway am 13.01.22 20:31:54Schade, ich kaufe momentan wieder, Zeit muss man natuerlich mitbringen, sehe das Niveau aber momentan wieder als guenstig an, Danke Dir.
Antwort auf Beitrag Nr.: 70.498.535 von ooy am 13.01.22 18:19:18Bin schon etwas länger nicht mehr dabei. Die Aktie ist auch nicht oben auf meiner wachtlist. Was mir auffällt ist, das der Mino-lok trial nun schon eine ganze Weile dauert. Mögliche positive Mino-Lok news waren damals der Hauptgrund meines Investments.
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Antwort auf Beitrag Nr.: 68.663.776 von iknowtheway am 01.07.21 15:53:45Bis Du noch dabei?
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Danke...
Warum dieser Citius-Analyst der Ansicht ist, dass die Aktien von Biopharma 375 % Aufwärtspotenzial bieten
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr.
Benzinga
·
10.09.2021, 16:21:14 Uhr
Haftungsausschluss: Dieser Artikel stellt nur die persönliche Meinung des Autors dar und stellt keine ...
Hör dir die Nachrichten an
Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr. Reddy's Laboratories Ltd (NYSE:RDY) zum Erwerb seiner exklusiven Lizenz von E7777 bekannt, einer onkologischen Immuntherapie im Spätstadium zur Behandlung des kutanen T-Zell-Lymphoms , eine seltene Form des Non-Hodgkin-Lymphoms.
Der Citius-Analyst: Jason Kolbert, Analyst von Dawson James Securities, behielt ein Kaufrating für die Citius-Aktie bei und erhöhte das Kursziel von 8 auf 10 US-Dollar.
Die Citius-These: E7777, deren Übernahme Citius zugestimmt hat, wurde kürzlich in Japan zugelassen und verfolgt in den USA einen ähnlichen Weg, sagte Analyst Kolbert in einer Mitteilung.
E7777 ist eine verbesserte Formulierung des onkologischen Wirkstoffs ONTAK, der zuvor von der Food and Drug Administration für die Behandlung von Patienten mit persistierendem oder rezidivierendem CTCL zugelassen wurde, stellte der Analyst fest.
Verwandter Link: Der tägliche Biotech-Puls: Apellis sinkt bei Daten, Endo glänzt bei der Beilegung von Opioid-Rechtsstreitigkeiten, T2 Biosystems steigt bei der Mutantenerkennungsfähigkeit des COVID-Tests
Die aktuelle Phase-3-Studie in den USA ist dem Analysten zufolge eine Brückenstudie zur Validierung einer Herstellungsänderung, Dosisbestätigung und Wirksamkeit bei CTCL-Patienten. Angesichts der Tatsache, dass der Prüfgegenstand eine verwaiste Indikation aufweist, ist die Preisgestaltung wahrscheinlich zu hoch, sagte der Analyst.
Der letzte Patient in eine zulassungsrelevante Studie mit E7777 wurde aufgenommen und ein Zulassungsantrag für Biologika für die erste Indikation bei CTCL wird voraussichtlich bis Ende 2022 bei der FDA eingereicht, sagte Kolbert.
Citius zahlte 40 Millionen US-Dollar im Voraus und hat eine Verpflichtung für Meilensteine in Höhe von 40 Millionen US-Dollar und möglicherweise eine Lizenzgebühr von 10 %, schätzt der Analyst. Zusätzliche Zahlungen für andere Indikationen und bescheidene Gebühren an Eisai Co., Ltd. (OTC: ESALY) seien fällig, fügte er hinzu.
ET7777 hat eine jährliche Chance von 100 bis 200 Millionen US-Dollar, sagte der Analyst. Der Analyst sieht auch Synergien, da die Zielgruppe von MinoLok Patienten mit Dauerkathetern sind und ein bedeutendes Segment dieses Marktes Onkologiepatienten sind.
"Klinische Daten von E7777 deuten auf eine ORR (Overall Response Rate) von 40% hin, und die Aufsichtsbehörden glauben, dass dies die Zulassung unterstützt, insbesondere in Verbindung mit einem gutartigen Nebenwirkungsprofil im Vergleich zu anderen verwendeten Wirkstoffen (Off-Label)," sagte Dawson James.
Citius Price Action: Am Freitagmorgen fielen die Citius-Aktien um 0,64% auf 2,09 USD.
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr.
Benzinga
·
10.09.2021, 16:21:14 Uhr
Haftungsausschluss: Dieser Artikel stellt nur die persönliche Meinung des Autors dar und stellt keine ...
Hör dir die Nachrichten an
Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr. Reddy's Laboratories Ltd (NYSE:RDY) zum Erwerb seiner exklusiven Lizenz von E7777 bekannt, einer onkologischen Immuntherapie im Spätstadium zur Behandlung des kutanen T-Zell-Lymphoms , eine seltene Form des Non-Hodgkin-Lymphoms.
Der Citius-Analyst: Jason Kolbert, Analyst von Dawson James Securities, behielt ein Kaufrating für die Citius-Aktie bei und erhöhte das Kursziel von 8 auf 10 US-Dollar.
Die Citius-These: E7777, deren Übernahme Citius zugestimmt hat, wurde kürzlich in Japan zugelassen und verfolgt in den USA einen ähnlichen Weg, sagte Analyst Kolbert in einer Mitteilung.
E7777 ist eine verbesserte Formulierung des onkologischen Wirkstoffs ONTAK, der zuvor von der Food and Drug Administration für die Behandlung von Patienten mit persistierendem oder rezidivierendem CTCL zugelassen wurde, stellte der Analyst fest.
Verwandter Link: Der tägliche Biotech-Puls: Apellis sinkt bei Daten, Endo glänzt bei der Beilegung von Opioid-Rechtsstreitigkeiten, T2 Biosystems steigt bei der Mutantenerkennungsfähigkeit des COVID-Tests
Die aktuelle Phase-3-Studie in den USA ist dem Analysten zufolge eine Brückenstudie zur Validierung einer Herstellungsänderung, Dosisbestätigung und Wirksamkeit bei CTCL-Patienten. Angesichts der Tatsache, dass der Prüfgegenstand eine verwaiste Indikation aufweist, ist die Preisgestaltung wahrscheinlich zu hoch, sagte der Analyst.
Der letzte Patient in eine zulassungsrelevante Studie mit E7777 wurde aufgenommen und ein Zulassungsantrag für Biologika für die erste Indikation bei CTCL wird voraussichtlich bis Ende 2022 bei der FDA eingereicht, sagte Kolbert.
Citius zahlte 40 Millionen US-Dollar im Voraus und hat eine Verpflichtung für Meilensteine in Höhe von 40 Millionen US-Dollar und möglicherweise eine Lizenzgebühr von 10 %, schätzt der Analyst. Zusätzliche Zahlungen für andere Indikationen und bescheidene Gebühren an Eisai Co., Ltd. (OTC: ESALY) seien fällig, fügte er hinzu.
ET7777 hat eine jährliche Chance von 100 bis 200 Millionen US-Dollar, sagte der Analyst. Der Analyst sieht auch Synergien, da die Zielgruppe von MinoLok Patienten mit Dauerkathetern sind und ein bedeutendes Segment dieses Marktes Onkologiepatienten sind.
"Klinische Daten von E7777 deuten auf eine ORR (Overall Response Rate) von 40% hin, und die Aufsichtsbehörden glauben, dass dies die Zulassung unterstützt, insbesondere in Verbindung mit einem gutartigen Nebenwirkungsprofil im Vergleich zu anderen verwendeten Wirkstoffen (Off-Label)," sagte Dawson James.
Citius Price Action: Am Freitagmorgen fielen die Citius-Aktien um 0,64% auf 2,09 USD.
Citius Pharmaceuticals to Present at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15
Wed, September 8, 2021, 8:15 PM
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CTXR
+1.45%
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Citius to highlight addition of Phase 3 cancer immunotherapy to its late-stage pipeline
CRANFORD, N.J., Sept. 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 oncology, anti-infective products in adjunct cancer care, unique prescription products and stem cell therapies, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.
The presentation video will be available for viewing on demand starting at 7:00 am ET on Monday, September 13th. Investors may register for the conference at the event website. The archived webcast will be available for 90 days after the event and will be accessible on the Citius website.
Myron Holubiak, President and Chief Executive Officer of Citius, and Dr. Myron Czuczman, Chief Medical Officer of Citius, will discuss the Company's expanded pipeline and near-term catalysts
Wed, September 8, 2021, 8:15 PM
In this article:
CTXR
+1.45%
Explore the topics mentioned in this article
Citius to highlight addition of Phase 3 cancer immunotherapy to its late-stage pipeline
CRANFORD, N.J., Sept. 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 oncology, anti-infective products in adjunct cancer care, unique prescription products and stem cell therapies, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.
The presentation video will be available for viewing on demand starting at 7:00 am ET on Monday, September 13th. Investors may register for the conference at the event website. The archived webcast will be available for 90 days after the event and will be accessible on the Citius website.
Myron Holubiak, President and Chief Executive Officer of Citius, and Dr. Myron Czuczman, Chief Medical Officer of Citius, will discuss the Company's expanded pipeline and near-term catalysts
Citius (CTXR) Acquires Dr. Reddy's License for NHL Therapy
Zacks Equity Research
Wed, September 8, 2021, 10:34 PM
In this article:
ESALY
-4.39%
CTXR
+1.45%
IRWD
-0.08%
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Citius Pharmaceuticals, Inc. CTXR announced that it has acquired the exclusive in-license rights of Dr. Reddy’s Laboratories RDY for E7777 (denileukin diftitox). The candidate is an improved formulation of Ontak, which received FDA approval for the treatment of persistent or recurrent cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma (“NHL”).
Please note that Dr. Reddy’s had previously acquired global license rights (excluding Japan and Asia) from Eisai Co. ESALY to develop and commercialize E7777. The rights for Japan and Asia remain with Eisai.
Shares of Citius have rallied 107.8% so far this year against the industry’s 9.6% decline.
Zacks Investment Research
Zacks Investment Research
Image Source: Zacks Investment Research
Per the agreement terms, Dr. Reddy’s will receive an upfront payment of $40 million and is entitled to receive up to $40 million and $70 million in development milestones for CTCL and additional indications, respectively. In addition, Eisai is eligible 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.
The drug, which is currently being evaluated in a pivotal phase III study to treat persistent or recurrent CTCL, has completed patient enrolment in the study. Top-line data from this study is anticipated in the first half of 2022.
While Eisai will be responsible for completing the current CTCL study, Citius will be responsible for development costs associated with potential additional indications. The company expects to file a biologics license application for the drug to treat CTCL by 2022-end.
We inform investors that Ontak was marketed in the United States from 2008 until it was voluntarily withdrawn from the market in 2014 to enable manufacturing improvements.
The company is also planning to evaluate the drug in patients with peripheral T-cell lymphoma, another form of NHL, and other cancer indications.
Apart from E7777, Citius is also evaluating its lead pipeline candidate Mino-Lok in a pivotal phase III study for the treatment of patients with catheter-related bloodstream infections (“CRBSIs”). Mino-Lok has received Fast Track designation from the FDA for CRBSIs.
Zacks Equity Research
Wed, September 8, 2021, 10:34 PM
In this article:
ESALY
-4.39%
CTXR
+1.45%
IRWD
-0.08%
Explore the topics mentioned in this article
Citius Pharmaceuticals, Inc. CTXR announced that it has acquired the exclusive in-license rights of Dr. Reddy’s Laboratories RDY for E7777 (denileukin diftitox). The candidate is an improved formulation of Ontak, which received FDA approval for the treatment of persistent or recurrent cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma (“NHL”).
Please note that Dr. Reddy’s had previously acquired global license rights (excluding Japan and Asia) from Eisai Co. ESALY to develop and commercialize E7777. The rights for Japan and Asia remain with Eisai.
Shares of Citius have rallied 107.8% so far this year against the industry’s 9.6% decline.
Zacks Investment Research
Zacks Investment Research
Image Source: Zacks Investment Research
Per the agreement terms, Dr. Reddy’s will receive an upfront payment of $40 million and is entitled to receive up to $40 million and $70 million in development milestones for CTCL and additional indications, respectively. In addition, Eisai is eligible 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.
The drug, which is currently being evaluated in a pivotal phase III study to treat persistent or recurrent CTCL, has completed patient enrolment in the study. Top-line data from this study is anticipated in the first half of 2022.
While Eisai will be responsible for completing the current CTCL study, Citius will be responsible for development costs associated with potential additional indications. The company expects to file a biologics license application for the drug to treat CTCL by 2022-end.
We inform investors that Ontak was marketed in the United States from 2008 until it was voluntarily withdrawn from the market in 2014 to enable manufacturing improvements.
The company is also planning to evaluate the drug in patients with peripheral T-cell lymphoma, another form of NHL, and other cancer indications.
Apart from E7777, Citius is also evaluating its lead pipeline candidate Mino-Lok in a pivotal phase III study for the treatment of patients with catheter-related bloodstream infections (“CRBSIs”). Mino-Lok has received Fast Track designation from the FDA for CRBSIs.
Benzinga
Citius Pharmaceuticals Addresses Unmet Needs for Patients with CVCs
CTXR
+0.06%
Emily Cervone
Wed, August 4, 2021, 9:34 PM
In this article:
CTXR
+0.06%
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Kurse
View my watchlists
Image by falco from Pixabay
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.
Citius Pharmaceuticals Addresses Unmet Needs for Patients with CVCs
CTXR
+0.06%
Emily Cervone
Wed, August 4, 2021, 9:34 PM
In this article:
CTXR
+0.06%
My Watchlist
Kurse
View my watchlists
Image by falco from Pixabay
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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