Citius (CTXR) Reports FDA Response to Their Pre-IND Submission for Mino-Wrap and the News is Good
Good day everyone,
We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $1.14 per share
CTXR has breaking news about their Mino-Wrap product. Mino-Wrap is another product under license from the M.D. Anderson Cancer Center.
Breaking News (excerpted from the CTXR press release)
CTXR announced its receipt of a written response and guidance from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company’s Pre-Investigational New Drug (Pre-IND) consultation request for its Mino-Wrap briefing package.
The briefing package contained information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials. We include a link to the full press release.
This is good news for CTXR. Mino-Wrap is their product designed to treat infection, not uncommon is breast reconstruction procedures. The written response from the FDA places another of the CTXR product line into clinical trials. We placed a company description of the Mino-Wrap product and tissue expanders used in reconstructive breast surgery at the end of this newsletter.
Mino-Lok and Mino-Wrap, exclusively licensed products from the M.D. Anderson Cancer Center aren’t highly technical products, primarily proprietary combinations of existing compounds, but seem to be highly effective in the treatment of infections.
Now, when we consider the recent, and not so recent news about Mino-Lok and Candida Auris fungal infections, and now the advancing progress for Mino-Wrap, we can see that CTXR may be the company at the forefront of the battle against infections, both bacterial and fungal.
By our count, with success in fighting intravenous catheter infections with Mino-Lok, destroying Candida Auris infections with Mino-Lok, and beating infections in breast reconstruction with Mino-wrap:
The score is CTXR products 3 – infections 0
The success of the products coming out of CTXR is impressive. The M.D. Anderson licensed products, the mesenchymal stem cells therapy for ARDS licensed from Novellus Therapeutics, and their own Hydro-Lido product for the treatment of hemorrhoids, make CTXR a company that we cannot ignore.
We feel that the pipeline at CTXR could lead to a lucrative market rollout or a shareholder bonanza in the event of an exit to a larger pharma concern. Let’s not lose site of the fact that Mino-Lok, the company’s lead products is in a late-stage phase III clinical trial with a potential $1.8 billion worldwide market.
Even with the recent gains in the company share price, CTXR shares are still off 42% from their June high of $1.97/share.
About Mino-Wrap
Mino-Wrap is a novel approach to reducing post-operative infections associated with surgical implants. Mino-Wrap is a liquefying gel-based wrap containing minocycline and rifampin for reducing tissue expander (TE) infections following breast reconstructive surgeries. It is a laminate film comprised of porcine gelatin plasticized with glycerol. Mino-Wrap also contains the antibiotics minocycline and rifampin to reduce bacterial bioburden on implantable devices preventing colonization over a sustained period of time. In the setting of breast reconstruction, Mino-Wrap is designed to provide more durable antimicrobial protection of the implant-tissue interface than peri-operative irrigation with antibiotic solutions (the current standard of care). Both porcine gelatin (and collagen) as well as the combination of minocycline and rifampin have long histories of successful medical use in implantable devices in multiple anatomical settings.
About Tissue Expanders and Infection Risk
A common breast reconstruction technique is tissue expansion, which involves expansion of the breast skin and muscle using a temporary tissue expander. A tissue expander is an empty breast implant that is filled with normal saline over 6 to 8 weeks until it reaches the breast size that is desired. In this type of reconstruction, the surgeon will either make a pocket under a large muscle in the chest and place a tissue expander in that space or place the expander above the large muscle. About 4 to 8 weeks after the tissue expansion is finished, a second surgery is required to remove the tissue expander and insert the permanent breast implant. The patient receives either microvascular flap reconstruction, or the insertion of a permanent breast implant. Infection is one of the most common complications of tissue expanders and implants during breast reconstruction, with an infection rate ranging from 2.5 to 24 percent.
We believe the day is coming soon that CTXR reaches it’s true potential,
The Traders News Group
Original report 12-09-20 below
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Late-Stage Phase III Drug Could Save Thousands of Lives
Good morning everyone,
we are excited about the near-term prospects of this Biopharma stock.
We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $1.15 per share
Outstanding shares (est.) 55.48M
Float (est.) 39.36M
Insider ownership 39.08%
CTXR shares are just starting to trend. At Thanksgiving, the shares were trading at $.94/share. Why the uptick?
Their Mino-Lok product, for treatment of infected catheters with a $1.8 billion potential market is nearing the end of its Phase III trial.
The company just released information about expanded potential for Mino-Lok and new data for its iMSC therapy for ARDS
Shares are trading far below their June high of $1.97/share.
Big News and Potential catalyst for CTXR shares:
On Tuesday, CTXR announced interim data from a proof-of-concept large animal study of its proprietary induced mesenchymal stem cell (i-MSC) therapy for acute inflammatory respiratory conditions including COVID-19 related Acute Respiratory Distress Syndrome (ARDS).
The available results of i-MSC therapy in the study show improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury.
CTXR is developing the i-MSC therapy through its subsidiary, NoveCite and under license from Novellus Therapeutics. NoveCite has already filed a Pre-Investigational New Drug Application (Pre-IND) with the FDA and has received guidance on the requirements for the proposed trials.
Some of you may be thinking, “so what, we have a vaccine for covid-19, it’s going to go away, so why is this kind of therapy important?’
First, even before covid-19 the USA recorded 200,000 cases of ARDS annually, mainly from pneumonia. Second, we are only just beginning to understand the long-term impact of a covid-19 infection. We’ve all heard the term “long haulers”, folks that don’t recover from covid-19 in a couple weeks.
Consider these statements issued by the Mayo Clinic: “The type of pneumonia often associated with COVID-19 can cause long-standing damage to the tiny air sacs (alveoli) in the lungs. The resulting scar tissue can lead to long-term breathing problems.” and, “Many large medical centers are opening specialized clinics to provide care for people who have persistent symptoms or related illnesses after they recover from COVID-19.”
The reality is covid-19 has been infecting humans for 10 months and we have no idea what the long- term effects are. The development of i-MSC therapy at NoveCite is significant not only to potentially save lives, but the proprietary way they develop their i-MSCs, without continually harvesting stem cells sets them apart from the competition.
Many of our members know that we have been following CTXR for some time. We always like to point out that their lead product Mino-Lok was tested, in vitro, against 10 different strains of candida auris (c. auris) fungus and eradicated them all quickly. We first reported this to our members in May of 2019.
That in vitro result always stuck with us because it seemed to be a potential blockbuster application for the company’s lead product Mino-Lok, a late-stage Phase III drug candidate.
On November 30th, CTXR reported that a new study, utilizing their Mino-Lok drug combination showed positive results with these headlines: Mino-Lok superior to EDTA and Ethanol in eradicating most worrisome pathogen – Two strains of resistant Staphylococcus aureus tested – Study reinforces previous studies that all three components needed for some biofilm forming pathogens
Consider these facts from the CDC website:
It causes serious infections. C. auris can cause bloodstream infections and even death, particularly in hospital and nursing home patients with serious medical problems. More than 1 in 3 patients with invasive C. auris infection die.
It’s often resistant to medicines. Antifungal medicines commonly used to treat Candida infections often don’t work for Candida auris. Some C. auris infections have been resistant to all three types of antifungal medicines.
It’s becoming more common. Although C. auris was just discovered in 2009, it has spread quickly and caused infections in more than a dozen countries.
We continue to believe that Mino-Lok can be expanded beyond its Phase III testing for treatment of catheter-related bloodstream infections (CRBSIs), creating potential and additional verticals for the company.
As indicated in the chart, CTXR shares have blown past their 50 DMA and 200 DMA of $1.02 and $.95 respectively, in a bullish manner. The shares are leading their 20, 50, and 200 Simple Moving Averages indicating the shares are trending.
We will have an updated full report soon.
Stay tuned and stay informed,
The Traders News Group
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