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Nasdaq Profile (CTXR) Trends Green Early On Big Breaking P3 News, Read Immediately
Maxim Group - $4.00 Price Target
December 6th
Good Morning,
Huge news this morning for CTXR has this Nasdaq past champ trending green early.
Check it out here:
Citius Pharmaceuticals Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK for the Treatment of Cutaneous T-Cell Lymphoma
Topline study results expected in the first half of 2022
Biologics License Application (BLA) filing anticipated in the second half of 2022
CRANFORD, N.J., Dec. 6, 2021 /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 announced that it has completed patient enrollment in its Pivotal Phase 3 trial of I/ONTAK, an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The treatment phase for the study has been completed with topline results expected in the first half of 2022 and a biologics license application (BLA) expected to be filed with the U.S. Food and Dr-ug Administration (FDA) in the second half of 2022.
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Read the full article here.
Now, this news only dropped minutes ago, so as it continues to circulate this AM it could draw some serious buzz to CTXR.
With topline study results due in the 1st half of 2022, CTXR could be headed for some major Wall Street attention.
And as I mentioned in my report, CTXR has several oversold leaning technicals.
Could today's news help provide a spark for CTXR to go on a healthy reversal?
If you haven't yet, read my initial report below and get CTXR back on your radar. (Remember, this is a former triple-digit champ).
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Let's get it kicked up a notch...
I've been following a specific Nasdaq idea closely in recent weeks.
As multiple potential catalysts have started to appear, I think it would be a good time to get this company on your radar.
Oh. And did I say it was a past champ?
Wait. A triple-digit past champ?
That's right. I brought this profile to your attention earlier this year and watched as it made an approximate 100%+ move.
And now, it could be gearing up to go again based on several potential catalysts I've uncovered.
So, for December 6th, there is one Nasdaq idea to watch closely:
*Citius Pharmaceuticals, Inc. (CTXR)*
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care.
Now, pay close attention...
I brought this profile to your attention back on the morning of April 19th. That day, CTXR opened at $1.99. Fast-forward to June 22nd and CTXR had raced to a high of $4.56.
Wowzers.
With that $2.00+ move, CTXR crushed a chart blazing run of approximately 129%.
Now, here's where things get interesting...
CTXR And Its 2 "De-Risked" Phase 3 Lead Assets
Antibiotic lock therapy for salvaging catheters that cause bloodstream infections
Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.
Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. Mino-Lok® is being developed to address the complications, discomfort and cost of CVC removal and replacement. There are currently no FDA-approved products to salvage infected CVCs.
Program Highlights
- Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs
- A multicenter Phase 3 pivotal superiority trial is currently underway.
- Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036
- Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center
How it works
Mino-Lok® contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok® is used in two-hour locking cycles, allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.
CTXR Lead Asset #2
I/ONTAK (E7777). Citius’ other lead asset, I/ONTAK, is an IL-2 recombinant fusion protein for the treatment of advanced or refractory CTCL. As was the case with the old ONTAK, I/ONTAK binds to IL-2 receptors to deliver the diphtheria toxin into tumor cells expressing the CD25 high affinity receptor. Diphtheria toxin is an exotoxin, the pathogenic bacterium Corynebacterium diphtheriae known to cause diphtheria. Unlike the old ONTAK, I/ONTAK is a purified reformulation that removed the manufacturing contaminant, thus resolving the misfolded protein issue. I/ONTAK maintains the same amino acid sequence of ONTAK but features markedly improved purity and 1.5x-2x greater bioactivity; all while maintaining the safety and efficacy profile of ONTAK that physicians viewed favorably.
Mechanism of Action. Much like the old ONTAK, I/ONTAK is a fusion protein designed to direct the cytocidal action of diphtheria toxin to cells that express the IL-2 receptor. After binding to the IL-2 receptor on the tumor cell surface, I/ONTAK is internalized by receptormediated endocytosis. The fusion protein is subsequently cleaved, releasing diphtheria toxin from the IL-2 fragment, in turn inhibiting protein synthesis and causing cell death.
Clinical Development. Two clinical studies for I/ONTAK(E7777) have been completed, both in Japan. A Phase 1 study in N= 13 patients with relapsed of refractory CTCL and PTCL evaluated doses of 6, 12, and 9g/kg/day IV on 5 consecutive days per 21-day cycle. The maximum tolerated and recommended dose of E7777 was 9mcg/kg/d IV for five consecutive days per 21-day cycle. Overall, safety was well tolerated. The next study completed was a multi-center, open-label, single-arm Phase 2 study for relapsed of refractory CTC and PTCL. N= 19 in CTCL patients and N=17 in PTCL patients. The efficacy of the drug was evaluated in N=36 of patients with CTCL or PTCL, and safety was evaluated in N=37 patients. E7777 was administered 9mcg/kg/d IV for 5 consecutive days for a 21-day cycle of up to 8 cycles. The study achieved the primary endpoint with ORR of 31.6% (n=19) for CTCL, and ORR of 41.2% (n=17) for PTCL. The most common adverse events (AEs) were increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), hypoalbuminemia, lymphopenia, and pyrexia.
Phase 3 Trial Design. The trial design is multicenter, open-label single-arm study in patients with relapsed or refractory CTCL. The lead in study, N= 21 patients found optimal dosing to be 9mcg/kg/d administered intravenously. Data from the lead in were encouraging, with an objective response rate (ORR) of 38% in the ITT population. Given the previous data from the old ONTAK and E7777 in Japan, which have demonstrated response rates of mid-high 30% and a favorable safety profile, we consider the trial to be de-risked and see favorable odds of success for the primary endpoint of ORR. The primary end point for the pivot is ORR. The trial initiated in 2Q16 and is expected to report top-line data in 1H22.
More key details and sources here.
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And with these two potential lead assets nearing possible commercialization, CTXR may not fly under Wall Street's radar for much longer.
