For decades, humanity has fought the war against cancer with a shared common purpose and a mutual hope for victory over an advanced and constantly evolving enemy. This battle has played out in laboratories, research centers, and hospitals across the globe. In this time there have been a staggering number of lives lost, survivors wounded, thousands of hours of clinical research completed, and a jaw dropping amount of money spent in advancing towards the ultimate end game of eradicating this powerful and undiscriminating evil.
With all of the vast resources, both human and financial, that have been deployed in this ever evolving battle, in some respects the world of oncology is still in its infancy. To continue the military metaphor, many of today's common cancer drugs are the equivalent of an old but reliable warplane dropping a big bomb into a crowded battlefield in the hopes that the bad guys are wiped out, while knowing full well that there will be significant collateral damage along the way.
This orthodoxy has been reluctantly accepted by the medical world as a necessity in the battle against such a difficult to eradicate opponent. In this high stakes battle that sadly often comes down to life and death, desperate times often call for desperate measures in the noble pursuit of fighting off an aggressive and unrelenting enemy. However, there is now a new hope. We live at a time when a powerful and innovative new weapon is about to be deployed, one that could fundamentally and permanently change the way this battle is fought.
The next generation of cancer treatment has arrived.
Enter Cellceutix Corporation (CTIX.OB) and its revolutionary and truly unique cancer drug, Kevetrin.
What Microsoft (MSFT) and Apple (AAPL) have done to help make generational advances in the world of computing and technology, Cellceutix will do to make generational advances in the world of oncology and medicine. We are all about to become witnesses to the birth of a new era in cancer treatment, an era giving cancer sufferers a very powerful and different, but also much more humane option in the treatment of their disease. Kevetrin is simply unrivaled in the innovative and comprehensive way in which it takes the fight to cancer cells.
Where today's accepted cancer treatments are analogous to that old warplane dropping a bomb to level a crowded battlefield, Kevetrin calls off the sometimes effective but quite damaging chemotherapy and radiation bombs. Instead it deploys the best equipped and most powerful specialized cancer fighters we have within all of us. These protectors send a very precise and strategic offensive right to the heart of the enemy.
First and foremost, it is important to understand that Kevetrin is made up from a class of chemistry that has never before been used in oncology. Let me emphasize that again, although the class of drug and base molecule have been around for some time, this type of medicine has never been used before in humans and oncological applications.
There are many effective chemotherapies in existence today, but the majority of these approaches evolved from other existing treatments. It is an important distinction to make that Kevetrin is a drug that is revolutionary; it brings the fight to cancer in a very novel and powerful way. It's an entirely new and unique approach in how to treat cancer. This is not your father's old cancer treatment.
Secondly, unlike nearly every other therapy in oncology, this is a drug that is non-genotoxic - a hugely important characteristic. Kevetrin empowers your body to go after the genetic bad guys (cancerous cells), and not attack the good guys. (healthy DNA) This is a huge step forward beyond the "bombing the battlefield" approach that most current chemotherapy and radiation treatments employ. In fact, the level of precision within how Kevetrin directs your body to find and attack cancer cells is something that researchers have been striving to accomplish unsuccessfully with cancer treatments for decades.
And last, but certainly not least, is the "mechanism of action" of the drug or how it actually works. The brilliance of Kevetrin's genetic structure lies in its ability to repair and reactivate one very powerful and multifaceted gene, the "Guardian Angel" P53 gene. The P53 gene is one that has been studied and followed by researchers for decades. This gene is often called "The Guardian Angel of The Human Genome," due to the wide ranging and critical role it plays in keeping your body cancer free. So what exactly is this "Guardian Angel" protecting, and how does it all tie together with how Kevetrin works?
To start, it is important to understand what this P53 "Guardian Angel" gene does for all of us. There are within all of us genetic battles raging at varying levels of intensity, and subsequently having varying levels of consequences. Cancer, described in its simplest terms, is basically a good and healthy cell mutated and gone out of control. But what happens when a good cell starts to go corrupt? This is where the critically important P53 gene comes into play.
Think of your "Guardian Angel" P53 gene as your body's own ultimate protector and your best and final line of defense against cancerous cells. This highly skilled special forces troop sees that a cell is going bad and immediately engages these bad cells and in theory does one of the following actions:
1. It fights the bad cell, and defeats it by essentially reprogramming it and telling it to commit cellular suicide (cell apoptosis) so it can no longer do harm to your good cells.
2. It recognizes that this bad cell was once good, and it fixes the bad part of the cell by re-activating the P53 gene inside it to make it healthy and good once again.
Obviously our "Guardian Angel" is a smart and capable protector of our healthy DNA. The question then becomes - if we have this protector working inside us on our behalf, how do so many of us still end up getting cancer? Well, the harsh reality is that as powerful as the P53 gene is, this battle hardened warrior is sometimes outnumbered and outsmarted by a smart and rapidly evolving enemy. After many hard fought genetic battles, cancer often starts spreading when the bad cells finally start to overtake and disable your best and strongest fighters, your P53 gene. The bad guys storm, overrun, and disable your protectors, leaving cancerous cells to spread and corrupt more good guys to join their ranks. And as we all know, the unforgiving reality here is that if the bad guys continue to spread and overtake more and more good cells, it is only a matter of time until more battles are lost, and the war within us reaches a sad and final conclusion.
This is where Kevetrin comes in, and why it is so revolutionary when compared to any other cancer drugs. Keep in mind that once your P53 Guardian Angel gene is overrun and disabled by the bad guys, the most common and standard way today to fight this invasion is to send in those old warplanes I talked about earlier. Dropping big chemotherapy and radiation bombs on the battlefield is far from a perfect answer. We know those big bombs are going to unintentionally get some of our good guys, but the hope is we hit the bad guys hard enough to wipe them out and win the battle for us.
And when we consider how brutal and chaotic a current chemotherapy treatment can physically and emotionally be on a patient, it really brings the uniqueness and potency of Kevetrin to light. Kevetrin essentially functions by going into your body with a repair crew, instead of a bomb. Think of Kevetrin as the medic brought onto the battlefield with the special and unique ability to reactivate and reawaken your disabled P53 Guardian so it can finish the fight. Instead of calling in the heavy air strikes, we reinvigorate, repair, and return our body's best and most powerful cancer fighters right back into the thick of the battle. Kevetrin gives your body a much needed genetic "tune up," to change the momentum of the fight once again.
Kevetrin's ability to safely activate the "Guardian Angel" P53 gene and do so without harming surrounding healthy DNA is considered by many of the world's leading oncologists to be the "Holy Grail" of cancer research. This is a breakthrough that the world of oncology has been trying to reach for decades, spending many millions of dollars and countless lab hours of research in the process. The concept of using your body's own best defender to fight cancer is a compelling and exciting capability. This approach is a much more refined and smarter way to fight this war. If we have smartphones and smart cars to improve our day to day lives through technology, then why not have a smart chemotherapy to improve us at a much more important genetic level through oncology?
Suffice to say, the potential here is enormous, with expectations high, and the possible long-term implications even more profound. With this anticipation comes the credibility and confidence that can only come from associations, partnerships, and collaborations that have been built over a lifetime of hard and diligent work. The man behind Kevetrin, Dr. Krishna Menon, has a sterling reputation and a track record of successes that are paralleled only by some of the best and brightest minds in oncology.
Steve Jobs brought to Apple what Dr. Menon brings to Cellceutix - a rare talent for identifying and refining technologies that can change the world. This talented individual has already proven himself many times in his field, most notably with his work in helping identify and develop two current cancer drugs which have already generated billions in revenue, Gemzar and Alimta. This work helped earn him the prestigious President's Recognition Award during his time as a lead researcher at Eli Lilly (LLY), an accolade that's set against the broader backdrop of a very distinguished career in oncology spanning decades. If the painting of the Sistine Chapel was Michaelangelo's masterpiece, then Kevetrin is Dr. Menon's oncological equivalent. This masterpiece will prove to be his ultimate career accomplishment. It will leave an enduring legacy and write a permanent and riveting chapter in the history books of oncology.
Recognizing the doctor's talents and the potential of Kevetrin, Cellceutix has assembled a team of scientific advisors that are truly the best of the best in the world of oncology.
Dr. Emil Frei III (Sadly, it was just very recently announced that Dr. Frei passed away at the age of 89. Humanity has lost a true hero, as this man's brilliant body of work has saved and will continue to save and improve the lives of millions. - TP)
Dr. Paul Marks
Dr. Samuel Danishefsky
Dr. Paul Ginsburg
A quick and simple Google (GOOG) search on these individuals will give one a quick appreciation of the incredible team that's been assembled. Also, a quick visit to the Cellceutix team page provides all relevant info on Dr. Menon and Cellceutix's advisors. This team believes in Kevetrin and what it could mean for millions of cancer sufferers worldwide. When a small company like Cellceutix can claim that Dr Emil Frei, a man who is commonly referred to as "Father of the Cure for Childhood Leukemia," was a part of their team - that speaks for itself. Having these distinguished and brilliant individuals on your advisory team is like having Michael Jordan, Larry Bird, Kobe Bryant, and Magic Johnson on your NBA dream team.
Beyond that, consider this statement about Kevetrin from Dr Frei himself:
"What Cellceutix is doing with Kevetrin can lead to a groundbreaking moment in the world of oncology. In my career, including my tenure as Chief of Medicine at National Cancer Institute, I have seen countless companies throughout the world striving to bridge the gap between damaged or mutated p53 and carcinomas with little to no success. p53 can hold a vital key to the next generation of chemotherapy. Cellceutix's discovery of Kevetrin, which has been shown to reactivate p53 in a non-genotoxic manner, is a very promising advance in the fight against cancer."
A man with the reputation, decades of experience, and depth of knowledge of Dr. Emil Frei would not make a statement like this unless he truly believes in the science behind Kevetrin. And when Dr. Frei speaks, the world on oncology listens. There is simply no questioning of the credibility and accomplishments of a man who many view as the greatest and most accomplished oncologist of all time. His support, along with the rest of the scientific "dream team," validates Kevetrin's blockbuster potential in the fight against cancer.
So where does Kevetrin stand today? When will it be proven? How fast can it possibly come to market? The short answers are that it's in the best of hands, and the validation that it works in humans is coming soon, and with it the potential for very rapid acceleration to FDA approval. Currently, Kevetrin is underway with a Phase 1 human trial at arguably the world's most prestigious and highly respected cancer research center - Harvard's Dana Farber Cancer Research Institute.
A few key points important to note here:
1. Cellceutix is the smallest company ever to have convinced Dana Farber to agree to conduct a trial on their behalf. The big name institutional credibility speaks for itself. Having Dana Farber agree to host a trial for your cancer drug is a huge accomplishment in itself. If you think it's hard for your kid to get into Harvard for a college education, try getting your new drug accepted by Harvard's Dana Farber for clinical trials. The competition is fierce among companies seeking to have their drugs tested at Dana Farber, to say the least.
2. Although this is a phase I trial, there are secondary outcomes written into the trial protocol that would normally be incorporated in phase II testing. Most phase I trials simply test for how safe a drug is to try on humans. Kevetrin's trial will also include secondary goals that can clearly showcase just how effective this new drug can be. This is important since Kevetrin is being tested with patients that have very late stage and otherwise treatment resistant cancers. These folks oftentimes have no other hope, so Kevetrin showing effectiveness with these patients will be breaking entirely new ground for oncological treatments.
3. Not to be lost in the mammoth potential of Kevetrin itself, it is important to understand that this clinical trial will also have broader implications for the future of clinical trials in general. This will come through the validation and confirmation of the P21 biomarker as a very early stage tool used to confirm P53 activation through a drug that is non-genotoxic. Using biomarkers to tell researchers very early on in a trial if a drug is positively impacting the body can lead to much more effective later phase trials with a much higher probability of success. This is the very tip of the spear in showing how future trials will be run and analyzed, a generational advancement on the clinical trial front, which is ironic and fitting given that Kevetrin itself is a generational advancement for cancer therapy.
Consider this brief chronological summary of the current clinical trial protocol, and the specific data that will be extracted from the trial:
(from the clinicaltrials.gov website)
PHASE 1 TRIAL SUMMARY:
Primary Outcome Measures:
Dose Limiting Toxicities of Kevetrin. [Time Frame: up to 4 weeks]
Maximum Tolerated Dose of Kevetrin [Time Frame: up to 6 months]
Secondary Outcome Measures:
Pharmacokinetic Profile of Kevetrin [Time Frame: Day 1 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion]
Changes in the biomarker p21 in peripheral blood lymphocytes [Time Frame: baseline and 7 hours]
Changes in the biomarker p21 in peripheral blood lymphocytes [Time Frame: baseline and 24 hours]
Pharmacokinetic Profile of Kevetrin [Time Frame: Day 15 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion]
Decrease in serum tumor marker [Time Frame: baseline and 1 month]
Change in tumor size [Time Frame: baseline and 2 months]
Decrease in serum tumor marker [Time Frame: baseline and 2 months]
Decrease in serum tumor marker [Time Frame: baseline and 3 months]
Change in tumor size [Time Frame: baseline and 4 months]
Decrease in serum tumor marker [Time Frame: baseline and 4 months]
Decrease in serum tumor marker [Time Frame: baseline and 5 months]
Change in tumor size [Time Frame: baseline and 6 months]
Decrease in serum tumor marker [Time Frame: baseline and 6 months]
A careful review of the milestones throughout this Phase I trial clearly shows that although demonstrating safety in humans is the primary concern as always, there are several very important biomarker, serum tumor marker, and change in tumor size readings and scans that will be taking place over the course of the trial that can demonstrate clear signs of effectiveness and efficacy.
From a broader clinical trial advancement standpoint, biomarker confirmation will give powerful and cutting edge information to Cellceutix to present to the FDA in the efforts to rapidly accelerate Kevetrin forward through the clinical trial process as quickly as possible. Historically, one of the toughest aspects of bringing a great new treatment to patients has been the long and drawn out process of clinical trials and the bureaucracy associated with it. However, the FDA recently announced an exciting new option for companies like Cellceutix with cutting edge treatments. The FDA's recent implementation of "Breakthrough Therapy" designation for cutting edge treatments represents a generational jump forward in how rapidly a drug can be brought to the market.
For example, Pharmacyclics (PCYC) recent announcement that the company received approval for Breakthrough Therapy Designation of one of their drugs currently in clinical trials for leukemia had an immediate impact on their projected timeframe for achieving regulatory approval. Also as a result, happy shareholders certainly didn't complain about the instantly soaring share price that came with the announcement.
This hot off the press "Breakthrough Therapy" Designation can have a big impact on cutting down the total time and number of trials it takes to prove a new drug and get it to sick patients. Signed into law by President Obama in July of 2012, this law can be a game changer for companies with treatments for life threatening illnesses or ailments. The full text of the law can be found here (Breakthrough Therapy info is located in Section 902):
Also, consider the following link to the FDA website which lists all the specific drugs the FDA has already approved that have identified confirmed biomarkers for each drug.
If we connect all the dots here, it is easy to see the connections between good data and use of biomarkers, being granted Breakthrough Therapy Designation, and what it means for achieving final FDA approval much more quickly. Clearly, the FDA is looking for these genetic data points from companies trying to make a case that will justify getting a Breakthrough Therapy Designation and all of the important benefits that come along with it.
When considering all of these regulatory improvements, it is very encouraging to consider recent statements made by Cellceutix regarding their outlook on the prospect of Kevetrin achieving this rapid FDA acceleration. Based off of this recent company press release, the company anticipates taking full advantage of this new law to help propel Kevetrin forward towards market penetration.
Here is the most relevant excerpt when considering the potential for Kevetrin to achieve this breakthrough status:
"While our Phase 1 clinical trial is ongoing, we are planning for future trials that are aimed directly at the latest initiatives of the Food and Drug Administration to expedite development of 'breakthrough' technologies to commercialization," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "The data from the studies affirm that Kevetrin may be useful in a new tumor type, in addition to the other indications that we are studying. Kevetrin has delivered robust results against all indications tested to date. Cellceutix's strategy is to have multiple trials ongoing against multiple cancer types concurrently. We are conducting testing against several more cancers to delineate the quickest path to market to build corporate and shareholder value."
Such a clear show of confidence and stating plans to take advantage of these latest regulatory improvements once again shows that Kevetrin is positioning itself at the front lines as a new generation of cancer treatment. Using a Breakthrough Therapy Designation to expedite Kevetrin's pathway to FDA approval is like using an F16 fighter instead of a bicycle to travel from LA to NYC.
However, even with a powerful and promising new drug being tested in a cutting edge clinical trial that's designed to take advantage of the latest regulatory changes speeding along drug development, the bottom line is Kevetrin has to work and it has to work well. This raises the question, just how powerful and effective is that P53 Guardian Angel when it is put to work at fighting cancer for us? What type of evidence do we have of just how well we can possibly expect it to take the fight to the enemy in human beings in clinical trials?
The answers to those questions took years of meticulous and time consuming pre-clinical testing and research to acquire. Dr. Menon, realizing the staggering potential of Kevetrin early on, knew he had to build a bulletproof case for Kevetrin through extensive pre-clinical research and confirmation in order to have a chance to test Kevetrin at the world class research institution it deserved. Here Dr. Menon and his team at KARD Scientific were in their element, and went to work on making the case that ultimately convinced Harvard's Dana Farber to accept Kevetrin for the human testing that is underway right now. A brief summary of the results of these years of research tell a compelling story: using Kevetrin to activate our body's P53 fighter shows impressive or even plain jaw dropping results against every cancer line tested.
The importance of that last sentence can't be overstated: Kevetrin is not just some specialized cancer drug that works against one type of cancer, it has delivered results against every type of cancer it has been put up against. Drugs with this type of across the board potency have a much greater chance of successfully translating the same results into humans when compared with drugs that may target a very specific molecular target or single type of cancer. Kevetrin has the potential to be an "All in One" cancer therapy.
Taken from the Cellceutix website, here is a very brief but telling summary of preclinical results for Kevetrin:
- Lung Cancer: An average of 72% tumor growth delay and 81% tumor volume reduction tested against two cell lines of multi-drug resistant cancers
- Lung Cancer: An average of 149% tumor growth delay and 94% of tumor volume reduction tested against another cell line of multi drug resistant cancers
- Breast Cancer: An average of more than 100% tumor growth delay and more than 90% tumor volume reduction tested against two cell lines of multi-drug resistant cancers
- Breast Cancer: Tumor volume reduction of 72% and tumor growth delay of 52% tested against a taxane-resistant cell line of cancer
- Colon Cancer: Tumor growth delay of 43% tested against drug resistant cell line of cancer
- Colon Cancer: Kevetrin was studied in two experiments alone and in combination with 5-FU against the HT-29 cell line of colon cancer. Kevetrin alone demonstrated average tumor growth delay of 43% compared to controls. 5-FU alone showed an average tumor growth delay of 20%. The combination of Kevetrin and 5-FU resulted in an average tumor growth delay of 97%.
- Head and Neck Cancer: An average tumor growth delay of 45% compared to controls from Kevetrin alone, similar to radiation alone. When administered in conjunction with radiation, Kevetrin showed an average tumor growth delay of 116%.
- Breast Cancer: Demonstrated tumor growth delay of 90% compared to controls
- Prostate Cancer: An average tumor growth delay of 54% compared to controls
- Retinoblastoma (a very rare and extremely difficult to treat cancer of the eye): Significantly reduced the tumor volume by more than half in the subcutaneous tumor model and showed a significant improvement in the clarity of the eye in mice treated with Kevetrin.
Some very impressive results, to say the least. A much more detailed review of the data is available on the Cellceutix Kevetrin page.
Another important and positive impact of Kevetrin is the fact that your P53 fighter also helps to "soften" or weaken the bad guys so that they are that much more easily defeated by a combination of treatments if needed in extreme cases. This important attribute means that for very advanced and late stage patients with a very aggressive disease, a 1-2 punch of Kevetrin along with an existing treatment can really bring a fierce and sustained attack against aggressive cancers. Kevetrin effectively has the potential to "supercharge" existing treatments, a characteristic that has to be extremely attractive for big pharma. The Pfizers (PFE), Roches (OTC:RHHBY), Astra Zenecas (AZN) and all the other big pharmaceutical companies across the globe could be well served to have Kevetrin as the backbone and core of their cancer treatment portfolio.
The potential these combination therapies have with Kevetrin are currently being validated and tested in multiple studies and trials across the globe. Kevetrin is currently being studied in combination with Pfizer drugs for melanoma and renal cancers at Beth Israel Deaconess Research Hospital. Currently, that research is going through lab testing and the results so far have been very promising. It is entirely possible that this research may lead to yet another clinical trial that would be paid for by funding from the hospital's own sources. Here is a link to the original announcement on these studies from the company website.
Also, yet another compelling recent announcement by Cellceutix holds great promise for yet another clinical trial to be conducted by another world renowned cancer research institution. This trial will be free of charge to Cellceutix aside from the company providing the drug itself to the institution. The company announced the following in a company press release, which can be found on the company's website here.
Here is the relevant excerpt from that lengthy and informative Press Release:
"We disclosed in an 8-K filing with the Security and Exchange Commission on December 27 that the Company has recently been approached by one of the world's most prominent cancer centers (the "Cancer Center"), located in the Southwest United States. The organization is interested in conducting and sponsoring studies on Kevetrin at their facilities. As stated in the regulatory filing, no assurances are made or implied that an agreement will be executed, but we are optimistic that the relationship will move forward early in 2013. We have now signed a Non-Disclosure Agreement with the Cancer Center and are quickly moving forward with a Material Transfer Agreement. Further details will be provided as permitted, but we are free to say that the Cancer Center is interested in the possibility of Kevetrin as a potential therapy for myeloma. Just like the other institutions, they will perform their own preclinical testing of Kevetrin."
My own speculation here is that this is no other than the prestigious MD Anderson Cancer Center located in Houston or Phoenix. My logic here is simply that MD Anderson is without a doubt "one of the world's most prominent cancer centers (the "Cancer Center"), located in the Southwest United States" as mentioned in the company press release. Ironically a quick visit to the MD Anderson website home page shows the institution by the name of "MD Anderson Cancer Center." This is an obvious match which was described and worded in the company Press Release, with the only omission being the actual institution's name itself. Finally, Dr Emil Frei's previous position of Associate Scientific Director at MD Anderson certainly could have played a key role in laying the groundwork for discussions about this trial.
And finally, although Kevetrin has generated a flurry of research and interest from top tier research institutions domestically, Kevetrin's reach does not stop at American borders. Also taking notice of the possibility of another blockbuster combination therapy, one of the most well known and reputable research institutions in Europe recently agreed to conduct yet another clinical trial that will be no cost to Cellceutix, other than providing Kevetrin. The following company Press Release provides details on this trial and its goals.
Kevetrin combined with Cytarabine makes for an exciting trial, as I believe this very potent 1-2 punch has the potential to crush Leukemia.
Apparently, the researchers at The University of Bologna see the same possibility given that they will be funding this trial for Cellceutix.
With all of the studies and trials taking place or set to take place in the near future, it is at times difficult to fully appreciate the extent to which Kevetrin has already begun to securely embed itself in the fiber of the oncological industry. The ever growing and impressive portfolio of clinical studies and trials taking place with Kevetrin hold the potential to validate this drug for treatment of several types of the most common cancers found in humans today. With that validation comes the potential for enormous revenue that could range from multibillion dollar to just plain staggering amounts.
It is no secret in the biotech industry today that many of the world's largest pharmaceutical companies are coming up on what is often referred to "patent cliff." If sequestration took the US economy off of a "fiscal cliff," the biotech industry is rapidly approaching a similar "patent cliff" of sorts that will also have potentially huge financial implications. This will impact many pharmaceutical giants that stand to lose billions in annual revenue from expired drug patents.
This "patent cliff" has helped fuel big pharma to spend big money to buy out and swoop up the most promising treatments being developed by smaller and lesser known companies. This aggressive "outsourcing" by large pharmas for new drugs to absorb and add in to their pipeline could prove to be a very rewarding strategy for Cellceutix shareholders and a big pharmaceutical company alike.
Not to be lost in the recent flurry of activity and news surrounding Kevetrin, I believe one of the most interesting announcements that the company has made to date occurred in March 2011:
Cellceutix Corporation (OTC:CTIX) today disclosed that it has entered into a Confidential Disclosure Agreement (CDA) pertaining to its anti-cancer drug, Kevetrin™, with one of the world's largest pharmaceutical companies.
Cellceutix CEO, Leo Ehrlich , commented, "It's relatively uncommon for big pharma to be signing a CDA on a compound before clinical trials are underway. The process begins with Cellceutix providing non-confidential information to the other party. If after review of the materials the interest remains high, they will request to enter into a CDA. We are glad that their interpretation of the Kevetrin™ studies was sufficient to warrant entering into a CDA with Cellceutix." Mr. Ehrlich continued, "Signing a CDA does not mean a licensing deal or other transaction is imminent and makes no assumptions that it ever will. But, conversely, a deal won't ever happen without first signing a CDA. At Cellceutix, we are focused on moving our compounds toward clinical trials and maximizing shareholders' value. This agreement is one more step in that process."
This groundwork could prove to be very important, as it gives this big pharma a closer look at Kevetrin and raw data from the trial. Combined with an FDA Breakthrough Therapy Designation, this would make for a compelling case for this company to make a potential buyout offer for the drug at the right time. So who is the most likely candidate to move aggressively and make a play to own Kevetrin?
In my opinion, because of the compelling case built for Kevetrin thus far and the human trial data that is soon to come, I consider Pfizer to be the clear cut front runner in a buyout scenario. Once there is adequate trial data to serve as a call to action for big pharma, this could happen quickly and dramatically, given the potential value of Kevetrin. However, even with Pfizer's deep pockets, one cannot rule out GlaxoSmithKline (GSK), Celgene (CELG) or a few others large players. All of these companies to a certain degree are in the same boat, and any one of them could move aggressively to own what will prove to be the next generation in cancer treatment.
In today's e-trading environment of information over-saturation and internet over-hype, I do genuinely believe Cellceutix offers investors a legitimately unique opportunity for a life changing return on investment. Of course, a company in Phase 1 trials should always be viewed as a high-risk investment. But for even the most skeptical investor, I do think that an objective analysis and thorough investigation of Cellceutix and the potential of Kevetrin will reveal a once in a lifetime investment opportunity.
This is of course without even considering or taking into account the 7 other compounds working their way through different stages of the R&D process at Cellceutix. With a very promising autism compound, as well as a psoriasis compound in Prurisol set to start mid stage trials within the next few months, the current stock price of roughly 1.60 for CTIX is in my opinion the best bang for the buck potential in the market today.
The rewards from Kevetrin's success for CTIX shareholders would be life changing. Much more importantly, the rewards from Kevetrin's success for those suffering from this horrific disease would not only be life changing, but potentially life saving.