Understanding the ancient Chinese innovation of deep drilling and elaborate mining methods, helps hard money-oriented precious metal investors to comprehend why Medieval rulers considered salt "white gold." The Romans used salt cakes as currency, and in some European realms salt was traded ounce-for-ounce for gold. Imagine in today's terms, if one were to prove up a proven and probable 100 million ounce salt mine within a 100 million share company. If salt were again valued as it was historically, consider what value those shares might reflect. I will begin low at a $100.00 a share. I believe that a type of engineered patented pharmaceutical salt owned by Cellceutix (OTCQB:CTIX) could very well be a class of salt that will soon have a value per ounce similar to that of Gold. Recent blockbuster oncolytic drugs are expensive.
However, as evidenced by a trip to the grocery store, increasingly efficient technology and labor has brought substantially higher quantities of salt to the surface. As the quantity of salt has increased, its price per ounce has plummeted. Nevertheless, salt continues to contribute to the well being of humans. Certainly we would rather that salt be plentiful and cheap, as over precious and rare-as-gold. In the world of the investor, imagine buying salt and watching it turn into gold. Cellceutix currently trades as if Kevetrin is far closer to salt, than it is gold. Brilacidin in stage 2b is the primary catalyst for Cellceutix' near term stock appreciation. However, in my opinion Brilacidin only sets the stage for an elegant eclipse as Kevetrin's destiny manifests as the winner of "The Amazing P53 and P21 Race." If and when this happens, I believe that it will be what former FDA Deputy Commissioner Scott Gottlieb, might term a third step forward in "The War against Cancer."
We commonly associate salt with the melting of ice on our country roads and city streets, or as a flavor-enhancing agent for our favorite dish. Table salt is just sodium chloride, and the truth is salt, as a chemical type, is part of an expansive category. Some salts taste sweet, others are bitter or salty. Many violate all of our common intuitions about how a salt should look and feel. These chemical salts are used in the production of antifreeze, cleaning fluids, dyes, glass, paper, plastics, pesticides, pottery and soap. For several years, a unique salt has been used to activate the immune systems of laboratory animals both to kill and heal cancer cells. It has also been working inside of humans for over 20 months.
Isothiourea Nitrile: A Salt Worth Gold
It was the Philosopher Schopenhauer, who said "Talent hits a target no one else can hit; genius hits a target no one else can see." Dr. Krishna Menon, an oncolytic pharmaceutical inventor, studied the medicinal properties of an isothiourea nitrile derivative-a salt. In late 2010, Dr. Menon was the first scientist to study the compound, develop parameters of pharmacological application, and broadly patent them. Cellceutix, which owns Dr. Menon's isothiourea nitrile patent, has taken on the corporate task of commercializing Kevetrin. Dr Menon retired from Eli Lilly (NYSE: LLY) and has since developed Kevetrin. Dr. Menon appears to be paving the way for his induction into the Biotechnology Hall of Fame, as well as The National Inventors Hall of Fame. According to Leo Ehrich, CEO of Celleutix, there are conservatively over 30,000 pharmaceutical compounds that could be claimed and developed within Dr. Menon's Kevetrin patent. Dr. Menon's actions have already qualified him for the proverbial Schopenhauer's genius award! In 5,000 animal preclinical studies, plus 8 cohorts of FDA 1 clinical trails, Kevetrin has indicated the ability to activate the P53 ,P21 and MDM2 within the genome system, potentially causing a broad variety of cancer cells to either heal or commit suicide (apoptosis) with no damage to healthy tissue surrounding the cancer. Now in FDA 1, Dr. Menon proclaims that "Kevetrin is behaving as expected."
Kevetrin's Validation For The Prudent Skeptic:
Currently, Kevetrin has three clinical trials in various stages. On March 19, 2014, it was announced that patients in the FDA 1 trial were progressing, with data indicating that safety and therapeutic effectiveness are yet promising features to be determined. As the European FDA Blood Cancer study for the third quarter 2014 comes into focus, along with further clinical work at Beth Israel, both will be advantaged to begin at the MTD or maximum therapeutic dosage. The University of Bologna will be cocktail-conjugating Kevetrin with Cytarabine, beginning at or close to MTD, this will provide much more opportunity to measure Kevetrin's therapeutic effectiveness. Kevetrin has already been cocktailed with Pfizer's (NYSE: PFE) FDA-approved Sunitinib. The results were outstanding and Harvard's Beth Israel has applied for a research excellence grant to continue the study. If the Dana Farber FDA 1 cohorts continue as very safe with evident therapeutic value, and subsequently be added to more substantial results from the hematological trial at Bologna, the convergence of these two streams of data will impress both the health science and regulatory communities. Due to the fact that the hematological trial has yet to begin, and the research excellence grant has yet to awarded, we are probably looking at mid to late 2015 for this data synergy.
For the prudent skeptic, Kevetrin's clinical data has proceeded to double due diligence and soon it will be quadruple. We now have a small biotech company with an early stage pharmaceutical compound that is embraced by scientists at Harvard's Beth Israel and combined with FDA approved compounds from the likes of Pfizer. The University of Bologna and a European pharmaceutical company will begin a FDA/Health EU phase 1b-2 study of blood cancers in the fourth quarter of 2014. Added to the second and third is number four- MD Anderson, who is speculated to be the research glove covering Amgen's (NASDAQ:AMGN) hand. Note that almost all other Kevetrin clinical research outside of FDA 1 at Dana Farber is paid for by other medical science entities. These most accretive imputations coupled with the breadth of early stage validation, is to my knowledge without parallel in modern oncology. Please comment if you know more than I.
Connecting The Kevetrin Dots To Roche
How many micro cap biotechnology companies succeed at developing an entire new scientific platform that majors like the 257 billion cap Roche (OTC: OTCQX:RHHBY) tried their high-dollar best to do and to put it gently are yet trying (page 4 of the hyperlinked Green Barron article)? Roche scientists made the tremendous discovery of cis imidazolines (nutlins). Roche's Nutlin discovery and work to activate the P53 between 2002 and 2011, is amply cited on the web. Roche's previous work validates much of what we now know about Kevetrin. However, its obvious that Roche is still searching to find the vehicle to translate their scientific success into a compound that would clinically activate the P53 and P21 to produce the oncolytic value without extreme toxicity. Imagine the interest that Roche scientists have regarding Dr. Menon's Kevetrin patent. What about the move that Harvard's Beth Israel made to place their behemoth 195 billion capitalization Pfizer, at the front of the Big Pharma line to evaluate Kevetrin, with Pfizer's FDA approved multikinase inhibitors for solid tumors? The clairvoyant Beth Israel initiative began while Kevetrin was yet a preclinical compound. This is validation in spades.
Roche is the European pharma most interested in nutlins and P53. Interestingly enough, Roche's interest in nutlins also extended into Hematologic Cancer, and that's the interest of the unidentified European pharmaceutical that will work with Bologna, in a Kevetrin FDA 1b-2A trial. Hematologic cancers are dreaded diseases. So desperate is medical science to find therapeutics, in the past to date Arsenic has been used to combat Leukemia. All other matters equal in the battle between Roche and Pfizer, the company that owns the vast majority of Kevetrin, will in my opinion have a major edge in the cancer, as well as other disease areas where P53 and P21 enhancement is therapeutic. It is possible that Kevetrin could be a therapeutic used against benign tumors in humans, and also in animals. Speculatively, I predict that after Kevetrin is approved for Human oncolytic utilization that it will likely enter both human benign tumor and veterinary markets (NYSE:ZTS).
My Scotland Yard surmise is that Roche wanted to equalize the Harvard/Pfizer position by coupling Kevetrin with an EU University. The parameters that support my suspicion about Roche is their little talked about acquisition of Arius in 2008, where they purchased not only an oncolytic therapeutic but also snapped up an entire technological platform that provided a 400 compound potential for their pipeline. Roche gobbled Arius up for less than 250 million. Shortly thereafter in 2009, Roche completed the acquisition of 44 billion dollar Genentech, which included their oncolytic compound Herceptin, which comes off patent in 2014.
For approximately a year, Roche displayed substantial interest in Bioasis' Transcend Technology (OTCQB:OTCQB:BIOAF) that promises to overcome the blood-brain barrier for breast cancer that often metastases to the brain. Roche evidently wanted to find a technological platform that would allow a cancer drug like Herceptin, to be used in smaller less toxic doses for breast to brain cancer. CNS central nervous system drugs typically require multiples of the normal drug dosage because of the blood brain barrier. Some of Bioasis' shareholders were speculating on the stockhouse bull board, that Roche was going cut licensing a deal with Bioasis, or perhaps gobble the entire company up. Perhaps a partial reason for the delay was Roche's knowledge of none to minimally toxic Kevetrin. Note that around the same time that Roche passed on Transcend, that Cellceutix released Kevetrin brain cancer data. Should Kevetrin arrive at MTD with very low toxicity, then logically there might be less need for Bioasis' Transcend Technology to aid should Kevetrin be found to be highly effective in brain cancer. As I understand Kevetrin, it promises oncolytic potential that may well exceed Herceptin and Transcend combined. It might also eclipse and surpass Galena's (NASDAQ:GALE) Neuvax with Roche's Herceptin. After 8 FDA cohorts, it appears as though Kevetrin may be associated with some mild side effects, but that must be viewed in relation to the type of patients that it has been tested in, stage 4 cancer patients. Since I mentioned Bioasis, I must finish by saying that they have secured a deal with Med Immune, a subsidiary of the much coveted Astra Zeneca (NYSE:AZT). Note Bioasis potential for reducing the amount while increasing the effectiveness of Central Nervous System therapeutics. It has vast application and tremendous potential. If Pfizer wants to obtain something that will get AstraZeneca's attention, they should accumulate a large share position in Bioasis.
Kevetrin Is Unique
There is a material difference in a substantial company like Galena paying the bill for FDA trials using their compound Neuvax with Herceptin, versus Kevetrin being invited with almost all expenses paid by Beth Israel, Bologna and MD Anderson. Among developmental Cancer therapies the vote is in and Kevetrin appears to be the most sought after compound. There can only be one self evident reason for the prior fact. In three out of four current Kevetrin studies other medical science entities are paying for the Kevetrin FDA clinicals or research. There is something about Kevetrin that compels major pharma and universities to fork over millions of dollars to place it in actual straddle clinicals and FDA 1b to 2A trials. Have there been any recent early clinical stage pharmaceutical compounds that you can say the same about? The question is germane, I want to know if there is another oncolytic clinical trial compound with as many major health science validators funding it, as Kevetrin?
Read the Kevetrin patent, and you will find that it includes a host of other potential disease applications. The clinical evidence indicates that Kevetrin has unique and unrivaled ability to activate the P53, P21 and MDM2, of the genome system. If this continues in human trials, both Roche, Pfizer and many others will do anything in their reasonable power to participate in Kevetrin.
In ancient Hebrew literature, salt was used as a symbol of the redemptive concern of the Lord for people. Salt was to be used in all Israelite animal sacrifices. It is intriguing that a reconstituted chemical salt might contain a major therapeutic that could significantly impact the treatment of not only cancer, but many other diseases that plague humanity with suffering, grief and morbidity (Num 18:19). Salt contributes to joy, happiness and life. My belief is that Kevetrin is the salt that will turn into proverbial gold! As the data builds, it will probably have high impact in early 2015. Until that time Cellceutix shareholders are focused upon Brilacidin, which I believe will provide ample reason for the shares to move up to new highs from the current $1.71.
Kevetrin may soon compete for a substantial portion of Andrew Baum's 35 billion dollar a year immune system activating cancer therapeutic market. Mr Baum is the leading Health Science analyst, with the largest forecast for immune system activating cancer drugs. At this time it does not appear as though Mr Baum, is making statements as to which drug that he thinks is the lead and most effective. However, Mr Hirschler, who quotes Baum, has mentioned other blue chip pharmaceutical companies who's immune system activating drugs have thus far produced substantial side effects while consciously ignoring Kevetrin, which is behaving safely in FDA trails. Thus far Mr Hirschler, appears to be willfully making the same myopic mistake as Gina Kolata, did in a similar New York Times article regarding the same subject. This article invites Mr Andrew Baum, Mr Ben Hirschler, Ms Kolata, and Mr Paul Howard to be comprehensive in their scientific coverage of immune system activating oncolytic compounds. This should also include Inovio (NYSE:INO). As far as I can see the four authorities mentioned as most influential, are in my opinion totally ignoring the safest and most powerful FDA clinical compounds for cancer fighting immune system activation. If so, this is unconscionable.
Cellceutix with 3 compounds in FDA trials, is now in a time event science driven corridor that will obviously create a catalyst for a major move up or down, that will happen in the next 8 months. As of March 31,2014 the company reported approximately 5.1 million dollars in cash, and it's trailing cash burn is approximately $430,000 a month. Cellceutix will need to raise more money and therefore dilute it shares further within 8 months. Apparently the private placement funding is having a depressing impact upon the companies share price. A Brilacidin licensing with a major, or spin off of the PolyMedix assets which includes 9 drugs, is needed to prevent substantial further dilution of Cellceutix shares. I believe that a PolyMedix spin off would be IPO capitalized above 250 million dollars and could be initially listed on NASDAQ with Cellceutix retaining 40% of the new company, plus a material cash infusion. Such a move by the company would cause Cellceutix shares to respond very positively. Yes, I am saying that the Brilacidin and the PolyMedix assets are worth more all by themselves than Cellceutix current 182 million dollar cap. I believe that without the PolyMedix assets, Cellceutix currently trades in a reasonably undervalued range. Therefore, Cellceutix in my opinion is very undervalued.
A major licensing agreement for Brilacidin could occur in the last quarter of 2014 or the first quarter of 2015, thereby providing all the financing that the company would need for the foreseeable 2015. If such should happen then the share price should reflect both relief and also substantial long term promise. While the risk of investment principal is obvious, I believe that the time event data issuing from Brilacidin and Kevetrin FDA trials provides more promise than risk and that a sustainable Cellceutix share price rise to $3.25 or more over the next 8 months is possible.
If anyone wants to take this blog article, reformulate and edit it. You may resubmit it to Seeking Alpha in your account listing yourself primary and regarding me as a research contributor. Ella Ruth