Citius Pharmaceuticals (CTXR) Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK for the Treatment of Cutaneous T-Cell Lymphoma

Citius Pharmaceuticals (CTXR) Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK for the Treatment of Cutaneous T-Cell Lymphoma
Citius Pharmaceuticals (CTXR) Completes Enrollment in the Pivotal Phase 3 Study of its Cancer Immunotherapy I/ONTAK for the Treatment of Cutaneous T-Cell Lymphoma

Good day everyone,

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) is a late-stage biopharmaceutical company with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies.

Current price $1.60/share (+6.5% at 10:00 a.m. EST 12-6-21)

After closing last Friday’s session at $1.51/share, CTXR shares opened today’s session at $1.5587. Trading volume in the first 30 minutes has been 842K shares.

Today CTXR announced that it has completed patient enrollment in its Pivotal Phase 3 trial of I/ONTAK. A total of 70 patients were enrolled in the main part of the I/ONTAK Phase 3 study, a multicenter, open-label, single-arm Pivotal study of I/ONTAK in participants with recurrent or persistent CTCL.

Positive efficacy data from an initial 21-subject lead-in study supported proceeding with the main study with an optimal dose level of 9 micrograms per kilogram (mcg/kg) of I/ONTAK. Subjects were administered I/ONTAK by intravenous infusion over 60 minutes (+/-10 minutes) on 5 consecutive days per cycle every 21 days.

I/ONTAK, is a purified version of denileukin diftitox, and a reformulation of previously FDA-approved oncology treatment ONTAK®. ONTAK® was marketed in the U.S. from 2008 to 2014, when it was voluntarily withdrawn from the market to enable manufacturing improvements. These improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity.

I want to mention a couple things about CTXR that I like:

As of June 30th, the company had $115M in cash which I find extraordinary for a company with a $220M market cap. That level of cash could be sufficient to bring both Mino-Lok® and I/ONTAK to commercialization without further dilution.

Secondly, Leonard Mazur, Executive Chairman, Director, and Myron Holubiak, President and CEO, have invested $26.5M of their own money into CTXR shares. I think that goes beyond “skin in the game” and indicates a high level of confidence from these two biopharma industry veterans.

The Traders News Group
original report below


Citius Pharmaceutical (CTXR) Has Two Products in Late Stage Phase Three Clinical Trials Concluding with Interim Catalyst Potential

Hello and welcome to all our new members,

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) is a late-stage biopharmaceutical company with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies.

Current price $1.51/share (at market close 12-3-21)

We have covered CTXR on several occasions and now we want to update you on two of the company’s products, both in late-stage Phase 3 clinical trials and close to a conclusion.

Mino-Lok® is a compound developed to treat catheter-related bloodstream infection (CRBSI). The company is developing this product under license from the M.D. Anderson Cancer Center.

Mino-Lok® is only therapy under FDA investigation to salvage infected CVCs. In a Phase 2b trial, Mino-Lok® demonstrated a 100% efficacy rate in salvaging colonized CVCs; with no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced, the current SOC. Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036.

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.

The Moni-Lok phase 3 study is ongoing and will evaluate 144 CBSI events. The primary endpoint is superiority in time to catheter failure, and previous futility analyses found superior efficacy at 50% and 65% of events. Though COVID-19 has delayed results, as the recent Delta surge has subsided, topline data is on track for the first half of 2022 with an NDA by the end of 2022. With QIDP designation, a 6-month review time is expected.

I/ONTAK (fka E7777) is being developed to treat cutaneous T-cell lymphoma (CTCL). Earlier this year, CTXR Bought Dr. Reddy’s (RDY) exclusive license rights to E7777, an improved formulation of previously FDA-approved ONTAK®; the exclusive license is with Eisai Co. Ltd. I/ONTAK is a reformulation of a previously FDA approved IL-2 targeting drug, removing the manufacturing issues that caused the original to be pulled from the market, thereby de-risking development.

I/ONTAK is currently approved and marketed in Japan where E7777 was approved in for the treatment of CTCL and PTCL in 2021 The drug is currently in an ongoing phase three pivotal study for CTCL that has completed enrollment and is expected to readout in the first half of 2022, with a BLA by the end of 2022. When approved, the BLA will provide regulatory exclusivity for 12 years.

Amongst the potential near term catalysts for I/ONTAK and Mino-Lok® are the topline data readouts. Those data could be released in a couple of months, but the timeline could also be just weeks. I would be remiss by not mentioning the potential for interest in these two products from an outside source.

The three analysts covering CTXR all have a “buy rating and two of them have issued a consensus target price of $5.00/share. The shares of CTXR have already shown they react well to new milestone/catalyst events (hitting $4.56/share in June of this year. Given the timeline for Mino-Lok and I/ONTAK detailed above, we see plenty of potential catalysts in the near term.

The Traders News Group
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