Cox Report on CTIX Must-Own Small Biotech Sto

Cox Report on CTIX


Must-Own Small Biotech Stock #5: Cellceutix Corporation (CTIX)
Existing antibacterials do two things to fight bacterial infections. First, they identify some molecule on the microorganism’s surface and bind to it. Once attached, they transport a drug into the bacterium to interfere with some critical part of its biological processes.
Bacteria, in turn, develop resistances by changing the molecules being targeted by antibiotics so that the drugs can’t recognize or bind to their targets. They can also evolve their “efflux pumps” to expel the antibiotic drugs.
Due to these abilities, the uninformed tend to view bacteria as nearly invincible—the inevitable winners in the war between humans and disease-causing organisms. The obvious problem with this view is that we live in a world filled with bacteria.
So the questions we should be asking are:
• Why aren’t we all suffering from massive infections?
• How do we swim through this ocean of bacteria, many seemingly intent on killing us, without succumbing?
These questions led to a new type of antibiotic based on the antimicrobial defenses we are born with.
These natural biological antibiotics called defensins are found throughout the animal kingdom, including in insects. Structurally, defensins are peptides, short amino acid chains with an electrostatic charge. (Larger amino acid chains, by the way, are called proteins.)
Defensins lock onto bacteria and other microorganisms, including fungi and some viruses, and effectively perforate their outer membranes. For targeted microbes, this attachment is the hug of death—the resultant “leaks” disrupt their vital functions.
Bacteria can’t develop resistance to defensins, because unlike conventional antibiotics, which must penetrate bacterial cell walls, defensins act directly on the surface membrane.
To escape the defensins, bacteria would have to evolve entirely new outer membrane characteristics,
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which is nearly inconceivable for these simple organisms.
Defensins are found in and on many human body parts, including the skin, tongue, cornea, salivary glands, kidneys, esophagus, and lungs. They form the protective barrier that prevents infection by ubiquitous bacteria. Only when this barrier is broken, infections can occur.
Throughout the course of human evolution, our defensins have been protecting us by killing harmful bacteria. Therefore, given what we know about the ability of bacteria to adapt to and survive antibiotics, it is enlightening to realize that they have never developed resistances to our defensins.
University of Pennsylvania scientists set their sights on creating a small-molecule drug mimicking the critical parts of our bodies’ defensins to produce cheap, easily manufactured mimetics that kill grampositive and gram-negative bacteria by puncturing their outer membranes.
Preclinical experiments indicate that bacteria can never develop resistance to these defensin mimetics. This new category of antibiotics is probably the last that will ever need to be developed, and Cellceutix owns the rights to it.
This is one of the best opportunities among small biotech companies.
Reason #1: “Irresistible” Antibiotics
If Cellceutix’s crown jewel is an entirely new class of antibiotics known as defensin mimetics, then its lead drug candidate, brilacidin, is king.
Cubist Pharmaceuticals’ drug daptomycin, marketed under the brand name Cubicin, currently owns the market that brilacidin addresses.
“Dapto,” as it’s often called, is a blockbuster drug used as a last line of defense for serious bacterial infections, especially those caused by drug-resistant bacteria. It’s used only rarely, in less than 10% of severe bacterial infections, but it’s expensive and thus accounts for over 80% of antibiotic revenues. Total revenues for Cubist approach a billion dollars per year.
Existing drugs like dapto need to be taken for multiple days, which is less than optimal, for several reasons.
First of all, it’s costly, because multiple doses raise the cost of treatment. The raw cost of the drug is high already; now add to that fees for medical personnel to administer each IV-infused dose.
An effective single-dose antibiotic would have huge pharmaco-economic implications, drastically reducing institutional overhead. In the current confused medical environment, anything that lowers
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clinic and hospital costs without sacrificing healthcare quality will be welcomed with enthusiasm.
Second, there is the issue of patient compliance. When a patient fails to finish a complete regimen of antibiotic therapy, it often allows the strongest bacteria to survive. Given the massive number of bacteria involved in an infection and the high frequency of mutation, noncompliance can create highly resistant and lethal strains.
Scientists duplicate this process purposely in so-called serial passage studies to test bacteria’s ability to develop resistance. In brilacidin studies using Staphylococcus aureus, they’ve found no sign of developing resistance.
This is where you cue the trumpets.
Much of the media’s panic about the bacterial apocalypse is the result of the emergence of strains resistant to daptomycin, caused by noncompliant dosing. I’m convinced that brilacidin’s defensin-based mechanism of action makes resistance unlikely if not impossible, but to play it completely safe, a singledose therapy would remove the possibility of noncompliance.
Though scientifically I consider this a redundant benefit, the truth is that it will be a huge marketing advantage, because the medical industry is conditioned to avoid noncompliance.
For all these reasons, a single-dose antibiotic would be a game changer, and a lot of people in the industry know it.
Given the enormous size of the antibiotic market, a successful Phase 3 clinical trial could make a lot of people very wealthy. It would not, however, be the end of the story.
Reason #2: The Enormous Brilacidin Pipeline
If brilacidin is approved by the FDA, it smooths the path for multiple forms of the drug, aimed at other types of infections, including respiratory, blood, bone, and joint conditions, diabetic ulcer, and STDs.
Synthetic defensins also promote healthy immune functions. To emphasize that point, let me tell you about oral mucositis.
Oral mucositis is not caused by bacteria. Rather, it is the ulceration and inflammation of the mouth and tongue that afflicts about 40% of chemotherapy recipients. The rate doubles among those treated with both chemo and radiation for head or neck cancer.
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The stresses of chemotherapy and radiation are particularly hard on the fragile protective barrier cells in the mouth. Oral mucositis increases the risk of septicemia (aka blood poisoning) by a factor of four and can prevent talking, eating, or drinking. It is so painful that many cancer patients reject treatment altogether.
The only approved therapy, Kepivance, costs almost $10,000 per cycle but is rarely used because of its very narrowly defined label. Total additional costs for treating severe oral mucositis are probably well in excess of $20,000 per patient, including extended hospitalization.
Cellceutix has a topical-rinse version of brilacidin diluted in saline solution, called Brilacidin-OM. In animal tests, the incidence of oral mucositis was cut from 42.7% to 2–4%. In treated animals, the duration of the condition was reduced by 90%.
Simply rinsing the mouth three times a day with Brilacidin-OM should effectively treat oral mucositis in humans, though we’ll need clinical trials to prove it. Very little of the drug would be expected to enter the system, so side effects would be minimal or nonexistent. It may even be possible to piggyback Brilacidin-OM on brilacidin’s safety data, allowing the company to go straight to Phase 2 trials.
Other barrier function disorders that might be treated with some version of brilacidin include inflammatory bowel disease, irritable bowel syndrome, proctitis, periodontitis, atopic dermatitis, diabetic ulcers, acne, and keratitis of the eye.
Further investigation is required, but brilacidin could also be useful in the treatment of cystic fibrosis, asthma, chronic bronchitis, otitis, and sinusitis.
Given what we know about the natural effects of defensins on microorganisms, brilacidin is an
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extremely promising treatment for fungal, viral, and even parasitic diseases such as malaria. And Cellceutix has various other defensin compounds that may be even more effective in these areas.
Reason #3: Covering Everything from Psoriasis to Cancer Cures
Source: http://cellceutix.com/wp-content/uploads/2012...ine-21.jpg
Cellceutix’ defensin mimetics are not the only disruptive, breakthrough drug candidates in its pipeline.
The company already has an extremely exciting and novel cancer drug known as Kevetrin. It activates the P53 gene pathway, which is always deactivated in cancers.
P53 is often called the “guardian angel gene.” Formerly known as TP53, this gene encodes the cancer
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suppressing transcription factor p53. Its discovery was a major scientific event, and the journal Science named p53 “Molecule of the Year” in 1993.
P53 activates gene-repair processes when a cell’s DNA is damaged. If the genetic damage is too great to repair, p53 triggers apoptosis (cell suicide) and stops the mutations that can transform normal cells into cancer cells.
P53 can fix nearly every gene but one—itself. This is why we find that cancers shut down or block p53 activity.
Discovered by Cellceutix cofounder Dr. Krishna Menon, Kevetrin is a pharmaceutical-grade salt of a molecule belonging to a class of organosulfur compounds known as thiourea. Commonly used in industrial chemical processes, these compounds had never been investigated as potential drugs.
Cellceutix also has a promising psoriasis drug that reduces PRINS (psoriasis-associate RNA induced by stress). Known as Prurisol, it is an ester of an approved drug, Ziagen, which has been used in humans millions of times.
Because the hysteria over antibiotic resistance continues to grow, just brilacidin alone could be a gamechanger for the company. Add the numerous backup drug candidates to reduce downside risk, the company is a compelling investment, with outstanding upside.
Buy Cellceutix Corporation (CTIX) at the market price.