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Citius Pharmaceuticals (NSDQ: CTXR) and MD Anderson Cancer Center

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Armed with new data today for its flagship candidate, and already well-connected to U.S. News & World Report's top-ranked cancer hospital, Citius Pharmaceuticals (NASDAQ: CTXR) is catching investors' attention this week.

If you're looking for growth opportunities in an overvalued and shaky stock market, consider alternatives that rarely get hyped on financial television.

Small-caps in the drug sector look particularly promising. The beleaguered biotechnology sector, which has endured political controversy amid charges of price gouging, is now on an upward trajectory. Companies with smaller valuations offer greater capital appreciation potential than their mega-cap peers.

But you must be selective.

One fast-rising biopharma company just scored a big win with today's 8am new announcement, and could be on the verge of a substantial move. Chances are, you've never heard of the company: Citius Pharmaceuticals (NSDQ: CTXR), which develops and markets therapeutic treatments. The New Jersey-based company focuses on adjunctive cancer care and critical care drug products. Citius is a hidden gem suitable for contrarians who are leery of the investment herd.

The company's flagship product now in the developmental pipeline is Mino-Lok, which has successfully completed Phase 2b clinical trials for the treatment of catheter related bloodstream infections.

These infections can be life threatening and have resisted treatment. Mino-Lok is currently advancing to Phase 3 clinical studies, for which Citius is recruiting sites in the U.S.

The company announced today that a recent international study at MD Anderson's sister institutions supported Mino Lok's Phase 2b results.

The study's results showed a 95% efficacy in salvaging infected catheters for Mino-Lok, as compared to 83% for the control.

Citius presented this international data on Mino-Lok at the ID Week Conference 2017, held October 4-8, in San Diego, California.

ID Week is an international forum for health and drug industry professionals of various specialties to exchange information.

The University of Texas MD Anderson Cancer Center in Houston focuses on cancer patient care, research, education and prevention.

MD Anderson is one of the largest cancer centers in the world and it's widely regarded as among the best. Over the years it has been consistently ranked #1 for cancer care in the United States by the prestigious U.S. News and World Report magazine.

A Billion-Dollar Market

The 44 patient study was conducted in Brazil, Lebanon, and Japan and showed Mino-Lok therapy was an effective intervention to salvage long-term, infected central venous catheters (CVCs) in catheter related bloodstream infections in patients who had cancer with limited vascular access.

Citius CEO, Mr. Myron Holubiak, commented:

"It is extremely reassuring to note that Mino-Lok is as useful in clinics outside of the U.S. as it is here in the number 1 rated cancer center. We are excited to advance this innovative product to a potentially greater than $1 billion marketplace worldwide. We are beginning our phase 3 trials here in the U.S., and look forward to introducing Mino-Lok throughout the world."

CEO Myron Holubiak previously served as president of Roche Laboratories.

Mino-Lok is designed to salvage central venous catheters (CVCs), preventing the need to remove and replace the catheter. As such, Mino-Lok would address widespread and unmet medical need.

Patients can die from complications caused by urinary catheters. Notably, it's common for patients to get urinary tract infections (UTIs) from catheters. Infections in patients recovering from total joint replacement surgeries can have deadly consequences. An infection caused by catheterization can make its way to the prosthesis. If the infection is sufficiently severe, the patient's prosthesis must be removed.

A hospital-acquired UTI often isn't easy to treat because the bacteria are more likely to be drug resistant. The patient may require strong antibiotics, which can pose their own set of risks.

Urethral injury is another common catheter risk, cause by physical trauma when the catheter is inserted forcefully or roughly. Urethral injury also can result in death.

Blood infection (or sepsis) is a complication of bladder catheterization. When bladder catheterization is combined with the need to use a larger catheter, damage to the lining of the bladder can occur.

Accodingly, it's quite clear that Mino-Lok meets a very real and growing need.

Citius also has a partnership and licensing agreement with Alpex Pharma to develop and commercialize orally disintegrating tablet formulations of drugs in the U.S., Canada, and Mexico.

These orally dispersible treatments, known as "fast melt tablets," are a hot area in drug development. The most common and preferred route of drug administration remains the oral route.

Tablets and capsules are the most popular solid dosage forms. However, many patients encounter difficulty in swallowing tablets and hard gelatin capsules. Medical care providers welcome any innovation that makes oral delivery faster and more efficient.

Citius also is developing a proprietary topical formulation of hydrocortisone and lidocaine to provide relief for hemorrhoids. This area actually constitutes a big growth opportunity: by age 50, about half of all adults must contend with the pain and discomfort of hemorrhoids.

The biotech sector is notoriously volatile; indebted players can crash and burn on the first whiff of bad news. But in return for shouldering extra risk, biotech investors face the potential for massive and often quick gains.

The political headwinds that had previously kept the sector in check are now dissipating, as cost controls and tougher regulations become less likely. Now's the time to scoop up appealing biotech stocks that investors aren't noticing.

In an overvalued market, the list of stocks that can confer outsized gains is getting smaller. These conditions add to the appeal of biotech "disruptors" such as Citius.

Unlike many debt-laden small-cap biotechs, Citius boasts a strong balance sheet, with a total debt-to-equity ratio (most recent quarter) of only 46.72. The company's market cap is $35.4 million.

If Mino-Lok survives the regulatory gauntlet, shares of CTXR should skyrocket. The results of the MD Anderson study bode well for the treatment's final approval.

As a flood of patent expirations continue to shake up the drug industry, the future winners will be those with the strongest drug development pipelines and the most innovative treatments. Citius is suitable for aggressive investors looking for a small-cap biotech that's set to take off.


This article was written by Luke Douglas for on .

This article published in collaboration with Scutify, the best app for traders and investors. Download the Scutify iOS App, the Scutify Android App or visit Scutify.com.

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