Biotech Breakout Citius Pharmaceuticals’ (NSDQ: CTXR) Phase 3 Results Could Transform the $3.5 Billion Fight Against this Deadly Affliction … and that’s Just the Beginning …
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Non-Hodgkin’s Lymphoma is one of the deadliest forms of cancer.
Targeting your body’s germ-fighting immune system, it invades your body’s lymph nodes. Left unchecked, it can kill more than 1-in-3 of those diagnosed, with over a half-million new cases each year.
But one company could be set to change all that …
Flying well under the radar, Citius Pharmaceuticals (NSDQ: CTXR) has quietly acquired the rights to the experimental compound “E-7777,” a direct improvement to a previously FDA-approved medication that directly attacks infected cancer cells inside the human body.
And this new cancer-fighting remedy could be mere months away from its own approval.
If and when it hits the market, this new treatment could provide a whole new proven alternative to the harsh side effects of chemotherapy or aggressive radiation treatment.
Directly targeting and attacking infected cells, E-7777 could transform the $3.5 Billion market for Non-Hodgkin’s Lymphoma treatment.
The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline …
April 26, 2022
Primary endpoint is the reduction in hemorrhoidal symptoms
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.
May 3, 2022
Recent Highlights and Upcoming Milestones
Citius Pharmaceuticals United States NASDAQ: (CTXR) is what’s called a “late-stage biopharmaceutical” company, where a highly-experienced management team purchases rights to the most promising new therapies and then either brings them to market or licenses rights to bigger pharma companies like Pfizer or Johnson & Johnson.
It should go without saying that “late-stage” development is the most difficult, most expensive part of the process for any new kind of treatment. Because even after years of investment, research and development, some 2 out of 5 drugs still fail to secure final FDA approval.
But with a “Dream Team” of top industry insiders, Citius is turning the odds in their favor—with two treatments now in Phase 3, and both looking like they will pass.
In addition to E-7777, it’s currently advancing three proprietary product candidates in total:(12)
We’re going to focus primarily on Mino-Lok here, since it’s Citius Pharmaceuticals’ most promising (and most immediate) potential revenue source …
Mino-Lok is an antibiotic designed to treat patients with catheter-related bloodstream infections (CRBSIs). At present, these infections are treated by removing the catheter and prescribing antibiotics.
This is a costly medical process with potential complications. In fact, studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.4
Mino-Lok allows doctors to treat the infection without needing to remove the catheter, avoiding both costs and complications. It’s a simple, prescription solution to another $3.5 Billion problem.
Currently, in Phase 3 pivotal trials, it could be approved in a matter of months …
According to CEO Myron Holubiak:14
“Data from the Mino-Lok® (M-L) Phase 3 program was reviewed by our independent Data Monitoring Committee (DMC) for safety and efficacy and found to be progressing as planned with no recommended changes to trial design.”
Mino-Lok has reportedly performed well to date:18
Citius’ Mino-Wrap could help reduce post-operative infections associated with surgical implants. Its gel-containing film is used primarily to wrap the tissue expander used in breast reconstructive surgeries.
As also noted by CEO Holubiak:14
“We believe that this serious condition impacts about 100,000 women in the U.S. and many more in the rest of the world. Mino-Wrap is a bio-absorbable, antimicrobial semi-solid film that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical infections. Once implanted, Mino-Wrap slowly dissolves in situ for a specified period of time, providing extended protection against infection.”
Shockingly, there are no FDA-approved prescription products for hemorrhoids at the moment.16
However, that could soon change with Citius’ halobetasol and lidocaine formulations.
Hemorrhoids are an uncomfortable and often recurring condition. However, despite the numerous prescription and over-the-counter (OTC) products commonly used to treat hemorrhoids, none possess the necessary safety and efficacy data generated from rigorously conducted clinical trials.
Citius believes its halobetasol-lidocaine product could one day become that go-to treatment for physicians wanting to provide patients with a therapy demonstrating safety and efficacy.16
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• There are about three million cases of Acute Respiratory Distress Syndrome (ARDS) globally, with approximately 200,000 instances just in the U.S.17
• The health crisis significantly added to the amount of ARDS cases, with death rates among patients on ventilators as high as 50%.17
• Worse, at the moment, there are no approved treatments for ARDS.17
According to Citius CEO Holubiak:
“Currently, there is no FDA-approved drug therapy for ARDS. We plan to submit an IND to the FDA and initiate our Phase 1 study by the end of the second quarter of 2022. Our first-in-human clinical trial is entitled “i-MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [the health predicament]: i-MARCO.” Following the completion of a multi-center Phase 1 pilot study, we would expect to proceed on to a double-blinded, randomized Phase 2/3 trial to demonstrate the safety, efficacy, and multimodal healing capabilities of our i-MSCs in patients with moderate to severe ARDS due to [the health predicament].”14
• Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS)
• i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process
• No FDA-approved treatment for ARDS exists today
• Preclinical activities are underway
As you’ve seen today, some of the treatments in Citius Pharmaceuticals’ portfolio go far beyond the definition of “Cutting Edge” …
Mino-Lock could potentially erase the need to operate on those suffering from Catheter-Related Bloodstream Infections (CRBIs), revolutionizing treatment of a $1.5 Billion medical problem overnight. E-7777 could offer a powerful new alternative to those suffering from Non-Hodgkin’s Lymphoma.
Combined with a full pipeline of other treatments, Citius Pharmaceuticals could be sitting on top of $5.5 Billion in cumulative pharmaceutical market disruption…
With over 5 years of “cash runway” left to complete critical Research & Development, along with the outrageous profit potential if even one of these treatments makes it to market, Citius Pharmaceuticals (NSDQ:CTXR) is a company that should definitely be on your radar.
Source 1: https://www.prnewswire.com/news-releases/citius-receives-positive-fda-feedback-on-its-submitted-plan-to-study-catheter-compatibility-for-mino-lok-therapy-301069349.html
Source 2: https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-highlight-its-phase-3-clinical-trial-product-mino-lok-at-benzinga-biotech-small-cap-conference-on-march-25-301253709.html
Source 3: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093967/
Source 4: https://www.citiuspharma.com/opportunity/crbsis/
Source 5: https://www.everydayhealth.com/things-your-doctor-wont-tell-about-hospital-infections/
Source 6: https://www.gurufocus.com/news/697235/citius-announces-united-states-patent-trademark-office-registered-the-companys-minolok-trademark
Source 7: https://www.citiuspharma.com/mino-lok/
Source 8: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
Source 9: https://www.citiuspharma.com/mino-wrap/
Source 10: https://stockcharts.com/h-sc/ui?s=ctxr
Source 11: https://www.barchart.com/stocks/quotes/CTXR/opinion
Source 12: https://www.citiuspharma.com
Source 13: https://d1io3yog0oux5.cloudfront.net/_335875ea4142d81b5406df99d97e4cdf/citiuspharma/db/249/1064/pdf/3.19.2021.WEB.Presentation_Final.pdf
Source 14: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
Source 15: https://www.citiuspharma.com/mino-wrap/
Source 16: https://www.citiuspharma.com/halo-lido/
Source 17: https://ir.citiuspharma.com/press-releases/detail/122/citius-pharmaceuticals-signs-an-exclusive-worldwide
Source 18: https://citiuspharma.com/pipeline/mino-lok/default.aspx
Source 19: https://citiuspharma.com/pipeline/mino-wrap/default.aspx
Source 20: https://www.citiuspharma.com/halo-lido/#:~:text=There%20are%20no%20FDA%2Dapproved,hemorrhoids%20in%20the%20United%20States
Source 21: https://citiuspharma.com/pipeline/stem-cell-platform/default.aspx
Source 22: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/statistics#:~:text=The%20overall%205%2Dyear%20survival,survival%20rate%20is%20around%2063%25.
Source 23: https://pubmed.ncbi.nlm.nih.gov/30895415/
Source 24: https://www.nuventra.com/resources/blog/why-do-clinical-trials-fail/#:~:text=This%20means%20that%20around%202,3%20fail%20to%20reach%20approval.
Source 25: https://www.google.com/search?rlz=1C1CHBF_enUS977US977&q=NASDAQ:+CTXR&stick=H4sIAAAAAAAAAONgecRowS3w8sc9YSn9SWtOXmPU5OIKzsgvd80rySypFJLmYoOyBKX4uXj10_UNDZOSzSxLDLIzeBax8vg5Brs4BlopOIdEBAEAzts1gUwAAAA&sa=X&ved=2ahUKEwi9i77gz8r0AhV1SzABHY-TBrkQsRV6BAg0EAM&biw=1536&bih=792&dpr=1.25
Source 26: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals/news/we-think-citius-pharmaceuticals-nasdaqctxr-can-afford-to-dri-1
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