CTXR - Citius Pharmaceuticals - Gute Pipeline plus Corona Phantasie
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ISIN: US17322U2078 · WKN: A2DXS0 · Symbol: 47N
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Mino-Lok® Phase 3 trial expanded to include sites outside the U.S.; trial enrollment expected to be completed by end of 2022
Topline results of Phase 3 trial in cancer immunotherapy I/ONTAK consistent with prior formulation; BLA submission on track for 2H 2022
$55.8 million in cash and cash equivalents as of March 31, 2022 and no debt
CRANFORD, N.J., May 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today reported business and financial results for the second fiscal quarter of 2022 ended March 31, 2022.
Fiscal Q2 2022 Business Highlights and Subsequent Developments
Engaged global clinical research organization (CRO) to expand Mino-Lok® Phase 3 trial to include additional trial sites outside the U.S.;
Reported topline results of Phase 3 trial of I/ONTAK (E7777) with no new safety signals and consistent with prior formulation (ONTAK); biologics license application (BLA) submission on track for the second half of 2022; and,
Initiated Halo-Lido Phase 2b trial with first patient dosed in April 2022 and anticipated enrollment completion by end of 2022.
Financial Highlights
Cash and cash equivalents of $55.8 million as of March 31, 2022;
R&D expenses were $3.5 million and $8.9 million for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the three and six months ended March 31, 2021, respectively;
G&A expenses were $3.1 million and $6.0 million for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $ 4.0 million for the three and six months ended March 31, 2021, respectively;
Stock-based compensation expense was $1.0 million and $1.9 million for the three and six months ended March 31, 2022, respectively, compared to $0.3 million and $0.6 million for the three and six months ended March 31, 2021, respectively; and,
Net loss was $7.6 million and $16.8 million, or ($0.05) and ($0.11) per share for the three and six months ended March 31, 2022, respectively, compared to a net loss of $4.1 million and $12.3 million, or ($0.04) and ($0.16) per share for the three and six months ended March 31, 2021, respectively.
"We continue to make significant progress with our three clinical development programs. To date in 2022, we actively engaged with our U.S. Mino-Lok trial sites to drive increased enrollment as COVID-19 infections waned, engaged an additional CRO to expand Mino-Lok patient recruitment to sites outside the U.S., announced topline results for the Phase 3 trial of I/ONTAK that were consistent with the prior FDA-approved formulation (ONTAK), and initiated a Phase 2b study of Halo-Lido for patients suffering from hemorrhoids. Moreover, we expect additional important catalysts from these programs in the second half of the calendar year as we remain on track with a BLA submission for I/ONTAK in the second half of 2022, and expect to complete enrollment in the Mino-Lok and Halo-Lido trials by the end of the year," stated Leonard Mazur, Chairman and CEO of Citius.
"Covid-19 remains an enduring challenge worldwide. Although our Mino-Lok trial has been impacted, we are actively engaging with existing sites to drive enrollment during periods of waning infection, and expanding recruitment sites outside the U.S. to mitigate the risk of future Covid-19 waves. Our aim is to achieve the events required to complete the Mino-Lok trial this year," added Mr. Mazur.
"The Citius balance sheet remains healthy with $55.8 million in cash available to execute our near-term plans. As stewards of Citius shareholders' capital, we focus on creating long-term value in the business and will continue to evaluate all strategic and financial options available to us. These may include non-equity financing, out-licensing agreements, asset sales or other strategic arrangements that would support the commercialization of our two late-Phase 3 assets," concluded Mr. Mazur.
SECOND QUARTER ENDED MARCH 31, 2022 Financial Results:
Liquidity
As of March 31, 2022, the Company had $55.8 million in cash and cash equivalents and no debt.
As of March 31, 2022, the Company had 146,129,630 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 $3.5 million and $8.9 million for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the comparable periods ended March 31, 2021. The increase during the quarter is primarily due to additional R&D expenses related to I/ONTAK which Citius in-licensed in September 2021, and start-up costs associated with the Halo-Lido Phase 2b trial, offset by decreases in Mino-Lok® R&D expenses.
During the six months ended March 31, 2022, ARDS-related R&D expenses decreased by $4.7 million compared to $5.3 million during the prior year period. R&D expense for the six months ended March 31, 2021 reflected a $5.0 million 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 $3.1 million and $6.0 million for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $4.0 million for the comparable periods ended March 31, 2021. The increase is primarily due to additional compensation costs for new employees, increased investor relations costs and additional insurance expense. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the fiscal quarter ended March 31, 2022, stock-based compensation expense was $1.0 million as compared to $0.3 million for the prior year period. For the six months ended March 31, 2022, stock-based compensation expense was $1.9 million as compared to $0.6 million for the six months ended March 31, 2021. The increase primarily reflects expenses related to new grants made by Citius to employees (including new hires), directors and consultants.
Net loss
Net loss was $7.6 million, or ($0.05) per share for the three months ended March 31, 2022, compared to a net loss of $4.1 million, or ($0.04) per share for the three months ended March 31, 2021.
Net loss was $16.0 million, or ($0.11) per share for the six months ended March 31, 2022, compared to a net loss of $12.2 million, or ($0.16) for the six months ended March 31, 2021.
The increase in net loss is primarily due to an increase in research and development and general and administrative expenses.
Topline results of Phase 3 trial in cancer immunotherapy I/ONTAK consistent with prior formulation; BLA submission on track for 2H 2022
$55.8 million in cash and cash equivalents as of March 31, 2022 and no debt
CRANFORD, N.J., May 12, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today reported business and financial results for the second fiscal quarter of 2022 ended March 31, 2022.
Fiscal Q2 2022 Business Highlights and Subsequent Developments
Engaged global clinical research organization (CRO) to expand Mino-Lok® Phase 3 trial to include additional trial sites outside the U.S.;
Reported topline results of Phase 3 trial of I/ONTAK (E7777) with no new safety signals and consistent with prior formulation (ONTAK); biologics license application (BLA) submission on track for the second half of 2022; and,
Initiated Halo-Lido Phase 2b trial with first patient dosed in April 2022 and anticipated enrollment completion by end of 2022.
Financial Highlights
Cash and cash equivalents of $55.8 million as of March 31, 2022;
R&D expenses were $3.5 million and $8.9 million for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the three and six months ended March 31, 2021, respectively;
G&A expenses were $3.1 million and $6.0 million for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $ 4.0 million for the three and six months ended March 31, 2021, respectively;
Stock-based compensation expense was $1.0 million and $1.9 million for the three and six months ended March 31, 2022, respectively, compared to $0.3 million and $0.6 million for the three and six months ended March 31, 2021, respectively; and,
Net loss was $7.6 million and $16.8 million, or ($0.05) and ($0.11) per share for the three and six months ended March 31, 2022, respectively, compared to a net loss of $4.1 million and $12.3 million, or ($0.04) and ($0.16) per share for the three and six months ended March 31, 2021, respectively.
"We continue to make significant progress with our three clinical development programs. To date in 2022, we actively engaged with our U.S. Mino-Lok trial sites to drive increased enrollment as COVID-19 infections waned, engaged an additional CRO to expand Mino-Lok patient recruitment to sites outside the U.S., announced topline results for the Phase 3 trial of I/ONTAK that were consistent with the prior FDA-approved formulation (ONTAK), and initiated a Phase 2b study of Halo-Lido for patients suffering from hemorrhoids. Moreover, we expect additional important catalysts from these programs in the second half of the calendar year as we remain on track with a BLA submission for I/ONTAK in the second half of 2022, and expect to complete enrollment in the Mino-Lok and Halo-Lido trials by the end of the year," stated Leonard Mazur, Chairman and CEO of Citius.
"Covid-19 remains an enduring challenge worldwide. Although our Mino-Lok trial has been impacted, we are actively engaging with existing sites to drive enrollment during periods of waning infection, and expanding recruitment sites outside the U.S. to mitigate the risk of future Covid-19 waves. Our aim is to achieve the events required to complete the Mino-Lok trial this year," added Mr. Mazur.
"The Citius balance sheet remains healthy with $55.8 million in cash available to execute our near-term plans. As stewards of Citius shareholders' capital, we focus on creating long-term value in the business and will continue to evaluate all strategic and financial options available to us. These may include non-equity financing, out-licensing agreements, asset sales or other strategic arrangements that would support the commercialization of our two late-Phase 3 assets," concluded Mr. Mazur.
SECOND QUARTER ENDED MARCH 31, 2022 Financial Results:
Liquidity
As of March 31, 2022, the Company had $55.8 million in cash and cash equivalents and no debt.
As of March 31, 2022, the Company had 146,129,630 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 $3.5 million and $8.9 million for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the comparable periods ended March 31, 2021. The increase during the quarter is primarily due to additional R&D expenses related to I/ONTAK which Citius in-licensed in September 2021, and start-up costs associated with the Halo-Lido Phase 2b trial, offset by decreases in Mino-Lok® R&D expenses.
During the six months ended March 31, 2022, ARDS-related R&D expenses decreased by $4.7 million compared to $5.3 million during the prior year period. R&D expense for the six months ended March 31, 2021 reflected a $5.0 million 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 $3.1 million and $6.0 million for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $4.0 million for the comparable periods ended March 31, 2021. The increase is primarily due to additional compensation costs for new employees, increased investor relations costs and additional insurance expense. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the fiscal quarter ended March 31, 2022, stock-based compensation expense was $1.0 million as compared to $0.3 million for the prior year period. For the six months ended March 31, 2022, stock-based compensation expense was $1.9 million as compared to $0.6 million for the six months ended March 31, 2021. The increase primarily reflects expenses related to new grants made by Citius to employees (including new hires), directors and consultants.
Net loss
Net loss was $7.6 million, or ($0.05) per share for the three months ended March 31, 2022, compared to a net loss of $4.1 million, or ($0.04) per share for the three months ended March 31, 2021.
Net loss was $16.0 million, or ($0.11) per share for the six months ended March 31, 2022, compared to a net loss of $12.2 million, or ($0.16) for the six months ended March 31, 2021.
The increase in net loss is primarily due to an increase in research and development and general and administrative expenses.
Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally
Fri, May 6, 2022, 8:37 PM
In this article:
CTXR
+6.86%
Additional sites to support trial completion by end of 2022
CRANFORD, N.J. , May 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has selected Biorasi, LLC ("Biorasi"), a global clinical research organization (CRO), to help expand the Company's Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).
"Citius is pleased to collaborate with Biorasi to expand the Mino-Lok trial to include international clinical sites, as originally planned. This complements efforts underway in the U.S. by our lead CRO, Medpace, to drive recruitment. We paused our ex-U.S. strategy as COVID-19 spread across the globe and hospitals halted non-COVID trials. With the COVID-19 pandemic receding, we believe there is now an opportunity to access additional sites and plan to leverage Biorasi's track record of quickly ramping up sites around the world to recruit clinical trial subjects outside the U.S. CRBSIs remain a critical unmet need globally with millions of patients requiring sterile central venous catheters to receive life-saving therapies," stated Leonard Mazur, Chairman and CEO of Citius.
"We are committed to continuing to recruit patients until we reach the minimum required trial events, as per FDA guidance and outlined in our trial protocol to achieve statistically significant results. This will enable us to optimize the potential of a successful New Drug Application (NDA) submission. We believe our efforts to establish trial sites outside the U.S., combined with our ongoing initiatives, which have driven a recent increase in study enrollment at our U.S. sites, will assist us in reaching the necessary events to complete the trial by the end of this year," added Mazur.
Fri, May 6, 2022, 8:37 PM
In this article:
CTXR
+6.86%
Additional sites to support trial completion by end of 2022
CRANFORD, N.J. , May 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has selected Biorasi, LLC ("Biorasi"), a global clinical research organization (CRO), to help expand the Company's Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).
"Citius is pleased to collaborate with Biorasi to expand the Mino-Lok trial to include international clinical sites, as originally planned. This complements efforts underway in the U.S. by our lead CRO, Medpace, to drive recruitment. We paused our ex-U.S. strategy as COVID-19 spread across the globe and hospitals halted non-COVID trials. With the COVID-19 pandemic receding, we believe there is now an opportunity to access additional sites and plan to leverage Biorasi's track record of quickly ramping up sites around the world to recruit clinical trial subjects outside the U.S. CRBSIs remain a critical unmet need globally with millions of patients requiring sterile central venous catheters to receive life-saving therapies," stated Leonard Mazur, Chairman and CEO of Citius.
"We are committed to continuing to recruit patients until we reach the minimum required trial events, as per FDA guidance and outlined in our trial protocol to achieve statistically significant results. This will enable us to optimize the potential of a successful New Drug Application (NDA) submission. We believe our efforts to establish trial sites outside the U.S., combined with our ongoing initiatives, which have driven a recent increase in study enrollment at our U.S. sites, will assist us in reaching the necessary events to complete the trial by the end of this year," added Mazur.
Citius Pharmaceuticals, Inc. Provides Business Update, Highlights Upcoming Milestones
Tue, May 3, 2022, 9:06 PM·6 min read
In this article:
CTXR
+6.33%
CRANFORD, N.J., May 3, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today provided a business update for the first quarter ended March 31, 2022 and reported on recent corporate developments and upcoming milestones.
Recent Highlights and Upcoming Milestones
Citius anticipates filing a biologics license application (BLA) for I/ONTAK® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;
Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;
Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;
Phase 3 Mino-Lok® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;
Mino-Lok Phase 3 trial completion anticipated by end of 2022; and,
Pre-clinical development ongoing for Citius' Mino-Wrap and induced mesenchymal stem cell programs.
"2022 is a year of important catalysts for Citius as we continue to make progress on multiple fronts. We recently released topline results for I/ONTAK which were consistent with the prior FDA-approved and marketed formulation of denileukin diftitox (ONTAK). In preparation for a planned BLA submission in the second half of 2022, we are marshalling the necessary manufacturing and commercial resources to support the application, and ultimately a successful launch," stated Leonard Mazur, Chairman and CEO of Citius.
"Our Mino-Lok program continues to advance in accordance with the recommendations of the independent data monitoring committee, which advised us to continue with the trial as planned, following each of its three data reviews. We remain encouraged by the positive signal conveyed by the DMC guidance to proceed. Coupled with the recent ramp up in patient recruitment following an easing of COVID-related hospital restrictions, we believe our efforts to increase engagement with existing trial sites and to onboard additional sites will continue to drive trial enrollment and enable us to achieve the necessary trial events to support statistically significant results," added Mazur.
"In April, we initiated our Phase 2b Halo-Lido trial for the treatment of hemorrhoids. By the end of 2022, we expect to complete trial enrollment. A data readout will follow upon validation and analysis of the information provided in the electronic patient reported outcome tool (ePRO) designed with guidance from the FDA. The results will be used to design the Phase 3 trial. As this product would ultimately be marketed directly to consumers, rather than to targeted physician and hospital groups like our other pipeline candidates, we will evaluate alternatives to optimize the value of this asset as we advance the program. Citius considers all strategic alternatives to maximize the value of our portfolio, individually and collectively, on an ongoing basis. We believe we remain well capitalized to advance our programs through multiple catalysts this year, and we plan to continue building long-term value in the business by focusing on execution," concluded Mr. Mazur.
2022 Achieved and Anticipated Catalysts
Report Topline results of I/ONTAK Phase 3 trial (April 2022)
Initiate Halo-Lido Phase 2b trial (April 2022)
Submit I/ONTAK BLA application (2H 2022)
Complete enrollment in Mino-Lok Phase 3 trial (end of 2022)
Complete enrollment in Halo-Lido Phase 2b trial (end of 2022)
Tue, May 3, 2022, 9:06 PM·6 min read
In this article:
CTXR
+6.33%
CRANFORD, N.J., May 3, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today provided a business update for the first quarter ended March 31, 2022 and reported on recent corporate developments and upcoming milestones.
Recent Highlights and Upcoming Milestones
Citius anticipates filing a biologics license application (BLA) for I/ONTAK® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;
Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;
Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;
Phase 3 Mino-Lok® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;
Mino-Lok Phase 3 trial completion anticipated by end of 2022; and,
Pre-clinical development ongoing for Citius' Mino-Wrap and induced mesenchymal stem cell programs.
"2022 is a year of important catalysts for Citius as we continue to make progress on multiple fronts. We recently released topline results for I/ONTAK which were consistent with the prior FDA-approved and marketed formulation of denileukin diftitox (ONTAK). In preparation for a planned BLA submission in the second half of 2022, we are marshalling the necessary manufacturing and commercial resources to support the application, and ultimately a successful launch," stated Leonard Mazur, Chairman and CEO of Citius.
"Our Mino-Lok program continues to advance in accordance with the recommendations of the independent data monitoring committee, which advised us to continue with the trial as planned, following each of its three data reviews. We remain encouraged by the positive signal conveyed by the DMC guidance to proceed. Coupled with the recent ramp up in patient recruitment following an easing of COVID-related hospital restrictions, we believe our efforts to increase engagement with existing trial sites and to onboard additional sites will continue to drive trial enrollment and enable us to achieve the necessary trial events to support statistically significant results," added Mazur.
"In April, we initiated our Phase 2b Halo-Lido trial for the treatment of hemorrhoids. By the end of 2022, we expect to complete trial enrollment. A data readout will follow upon validation and analysis of the information provided in the electronic patient reported outcome tool (ePRO) designed with guidance from the FDA. The results will be used to design the Phase 3 trial. As this product would ultimately be marketed directly to consumers, rather than to targeted physician and hospital groups like our other pipeline candidates, we will evaluate alternatives to optimize the value of this asset as we advance the program. Citius considers all strategic alternatives to maximize the value of our portfolio, individually and collectively, on an ongoing basis. We believe we remain well capitalized to advance our programs through multiple catalysts this year, and we plan to continue building long-term value in the business by focusing on execution," concluded Mr. Mazur.
2022 Achieved and Anticipated Catalysts
Report Topline results of I/ONTAK Phase 3 trial (April 2022)
Initiate Halo-Lido Phase 2b trial (April 2022)
Submit I/ONTAK BLA application (2H 2022)
Complete enrollment in Mino-Lok Phase 3 trial (end of 2022)
Complete enrollment in Halo-Lido Phase 2b trial (end of 2022)
Citius Pharmaceuticals Enrolls First Patient in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids
Tue, April 26, 2022, 7:30 PM
In this article:
CTXR
-9.17%
Primary endpoint is the reduction in hemorrhoidal symptoms
CRANFORD, N.J., April 26, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the first patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids. If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.
The Phase 2b study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. Five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids will be dosed. Approximately 60 patients per cohort are expected to be enrolled, for a total of 300 patients.
The key objective of the study is to evaluate the ability of the formulations used in each cohort to provide relief for patients with acute flare ups. The study will evaluate reduction in hemorrhoidal symptoms (including: pain, burning, itching, and swelling) following treatment and is expected to provide the foundation for development of the Phase 3 study. The FDA has guided Citius in developing a Patient Reported Outcome (ePRO) instrument which patients will use to record and report important safety and efficacy data in real time. The instrument has been adapted for use on an electronic platform and will be loaded on patients' hand-held smart devices. The study will also be used to validate the ePRO. Results of this trial are expected in the second half of 2023.
"We are pleased to have initiated the Halo-Lido study and expect to complete enrollment later this year. Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from hemorrhoid discomfort each year. If approved, Halo-Lido would be the first prescription product indicated for the treatment of hemorrhoids. As such, we believe there is a substantial worldwide market opportunity for this drug candidate. Assuming study results are positive, and in order to realize the full potential of Halo-Lido, we intend to seek strategic or financial partners for this asset at the appropriate time," stated Leonard Mazur, Executive Chairman of Citius.
Tue, April 26, 2022, 7:30 PM
In this article:
CTXR
-9.17%
Primary endpoint is the reduction in hemorrhoidal symptoms
CRANFORD, N.J., April 26, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the first patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids. If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.
The Phase 2b study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. Five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids will be dosed. Approximately 60 patients per cohort are expected to be enrolled, for a total of 300 patients.
The key objective of the study is to evaluate the ability of the formulations used in each cohort to provide relief for patients with acute flare ups. The study will evaluate reduction in hemorrhoidal symptoms (including: pain, burning, itching, and swelling) following treatment and is expected to provide the foundation for development of the Phase 3 study. The FDA has guided Citius in developing a Patient Reported Outcome (ePRO) instrument which patients will use to record and report important safety and efficacy data in real time. The instrument has been adapted for use on an electronic platform and will be loaded on patients' hand-held smart devices. The study will also be used to validate the ePRO. Results of this trial are expected in the second half of 2023.
"We are pleased to have initiated the Halo-Lido study and expect to complete enrollment later this year. Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from hemorrhoid discomfort each year. If approved, Halo-Lido would be the first prescription product indicated for the treatment of hemorrhoids. As such, we believe there is a substantial worldwide market opportunity for this drug candidate. Assuming study results are positive, and in order to realize the full potential of Halo-Lido, we intend to seek strategic or financial partners for this asset at the appropriate time," stated Leonard Mazur, Executive Chairman of Citius.
Trading Spotlight
Antwort auf Beitrag Nr.: 71.397.050 von iknowtheway am 21.04.22 17:56:21...und die Meldung vom 6.4.? Total verpufft, aber so ein Absturz, schon krass...
Antwort auf Beitrag Nr.: 71.396.810 von ooy am 21.04.22 17:37:46Der Mino-Lok Trial läuft wohl noch mindestens bis Ende 2022. Ich glaube es gab kürzlich eine Präsentation wo dies erwähnt wurde...
Das Haar scheint leider laenger zu sein, aber warum??
Findet Jemand das Haar in der Suppe??
Vielen Dank...
Ich hatte lange auf so eine Meldung gewartet.
Vielen Dank...
Ich hatte lange auf so eine Meldung gewartet.
Antwort auf Beitrag Nr.: 71.296.698 von ooy am 06.04.22 16:20:17Jetzt schon 10% minus...
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