Wapner's Lament For Jobs:Entrance Of Kevetrin
Grieving over Steve Jobs, funneled through a scientific apparatus, can yield compelling actionable insight for biotechnology investors. Jessica Wapner grieved in such a manner in the October 2011 issue of Scientific American. She quoted Tim Birdsall, vice president of integrative medicine at the Cancer Treatment Centers Of America, relating Jobs' quest for a cure for his neuroendocrine pancreatic cancer, to the activation of the P53 and P21 in the human immune system. Approximately one year after Jessica's article, such a drug named Kevetrin, which promised to activate the P53 and P21 in the human body, began FDA 1 trials at Harvard's Dana Farber Cancer Center. Deborah Erickson of Elsevier Business Intelligence recorded the beginning of what promises to become the historical fulfillment of Wapner's lament.
Kevetrin 15 Months Later: Overwhelming Validation
Fifteen months after beginning FDA trials, some of the stage 4 cancer patients who received Kevetrin in early cohorts, are continuing in the trials. Inventor, Dr. Krishna Menon, commented that Kevetrin is "behaving as expected." As over the usual vertical narrative, when Dana Farber FDA data is paralleled with Beth Israel's renal cancer results, connecting the dots becomes mentally energizing. Kevetrin has received overwhelming early stage validation. It's owner Cellceutix (OTCQB:OTCQB:CTIX) stock price rocketed from 33 cents in October of 2011 to 1.88 cents in November of 2012. Harvard's Beth Israel has continued to gather the capital necessary to continue research with Pfizer's(NYSE:PFE) FDA approved cancer drugs. The University of Bologna is funding the FDA stage 1b/2 trial using Kevetrin in hematological cancer patients with a partner speculated to be Roche (OTC:OTCQX:RHHBY). MD Anderson is providing the financial support to use Kevetrin in clinicals involving lymphoma and multiple myeloma, and is also suspected to be the research glove covering Amgen's (NASDAQ:AMGN) commercial hands. It is noteworthy that MD Anderson has acquired or developed cancer diagnostics that are analytically P53-specific, raising the specter of personalized medicine for P53-activating therapeutics. Investors concerned with scientific advancement should mark and follow how Kevetrin develops as a theranostic. These collaborations will provide investors with science driven market chemistry to reignite Cellceutix shares which have been range bound from $1.88 to $2.42 for since November 2012, to the current time.
Kevetrin's Potential Risk And Reward: Watch Roche
The Kevetrin patent owned by Cellceutix (OTCQB:) is not just a single drug, it is a technological platform that contains the potential to produce 30,000 different therapeutic compounds. For an example of what can happen to a stock when a new drug encompasses the possibility of being a blockbuster therapeutic platform, look at (NASDAQ:ICPT) obeticholic acid, a drug utilized for primary biliary cirrhosis. For breast and prostate carcinomas, look at (NASDAQ:GALE) NeuVax. I temper all these examples by saying that after their big upward moves, investors who sold short have also been rewarded. There have been some who indicate that Cellceutix prospects have been grossly exaggerated and that persons like myself who own the common shares have believed an embellished story. They also point to the company's obvious need for more financial resources to conduct numerous trials and a stronger balance sheet to uplist to a major exchange. Investing in early stage biotechnology companies like Cellceutix does involve a high degree of risk and can result in the entire loss of your principal investment, however I believe that a major pharmaceutical will make an offer for licensing Kevetrin shortly after the Bologna trial or opt to take a 50% equity position in Cellceutix, similar to the manner of Roche's two stage takeover of Genentech. Mr Ehrlich has indicated that he believes Kevetrin's market potential is 10 billion annually. For approximately 15 years, Roche has spent a tremendous amount of money on P53, P21, MDM2, nutlins and theranostics. Allowing Kevetrin to leave their dominant grasp would jeopardize their leadership in oncology.
Kevetrin Possibilities In The Global Market
The 2013 global market for human cancer therapies is over 110 billion. Speculatively, I foresee post FDA- approved Kevetrin capturing 10 to 20% of the global cancer therapy market. To succinctly consider Kevetrin's possibilities for the veterinarian market for canines, felines and horses, it appears arguably accurate that if Cellceutix was offered a licensing fee to develop Kevetrin for canines, that it would supersede Zoetis' (NYSE:ZTS) cancer drug Palladia. Note the fundamental connection between Palladia with Pfizer's multikinase inhibitor. Although possible, it is unlikely in the near term.
Kevetrin Contrasted With Job's Woo Medicine
Steve Jobs was correct-"people do not know what they need until you show them." If Steve Jobs would have been offered Kevetrin, a non-toxic chemotherapy agent with negligible side effects (one that would have activated his own immune system to both heal and destroy his pancreatic cancer cells), I believe that it would have received his attention along with the "Woo Medicine", acupuncture, herbs, and juices that he first accepted as cancer treatment.
Comparing Job's With Buffett: Kevetrin Is Oncolytic Elegance
Jobs' cancer was discovered in early stages as was Warren Buffett's. However, Mr. Buffett chose the best innovation within conventional therapy, while Jobs sought innovation without the guidance of conventional science. The results are self evident. A non-toxic chemotherapy treatment would be a more desirable therapeutic for prostate cancer victims as over Mr. Buffett's 44 radiation treatments. Radiation does not claim to remove the underlying cause of prostate cancer, and if it was related to mutant P53, then it is very possible that it may reoccur. This also helps us understand why toxic chemotherapy is used before burning radiation or post surgery. From this context, we are able to understand the potential of Kevetrin's activation of P53, P21 and MDM2. Kevetrin has the potential to accomplish the end-point impacts of all three conventional modes of cancer treatment without their side effects. At minimum, it is logical to assume that properly functioning P53 and P21 provide a substantial defense against metastasis. When P53 is activated, it causes cancer cells to both heal and commit suicide. Kevetrin appears to be causing both. This therapeutic balance seems to contribute to the avoidance of tumor lysis, a serious side effect occurring when cancer cell contents are emptied into the blood stream too rapidly. It will continue to be heralded that Kevetrin has a swing-weight therapeutic balance, earning it the description of oncolytic elegance.
Kevetrin Versus Leukemia At Bologna
After considering that the FDA has approved arsenic for specific leukemia patients, one can believe that after a successful leukemia trial at Bologna, accelerated FDA approval for Kevetrin will be enhanced. Late this year toward the end of the Dana Farber trial, should the Bologna trial be well into its testing, the dual synergy of information could produce a corridor of legitimate expectancy that will move Cellceutix shares in a manner as they moved from October 26th, 2012 at .86 cents to $1.88 on December 21, 2012. At this time Cellceutix public float has increased by approximately 30% or 26 million shares since that period referred to. It will require very positive transitional news for the shares to double from current.
Kevetrin's Fulfills Roche's Dream: Offering Hope To The Hopeless
Kevetrin's therapeutic index is perhaps as broad as cancer type indexes. Roche realized this about P53 activation, and for almost a decade invested a substantial amount of its vast resources to develop a P53 and P21-activating therapeutic. Roche was able to cure cancer in rodents, but was unable to find the nuance necessary to make its compound safe in humans. In this important matter alone Kevetrin in FDA 1, is far ahead of where Roche left off. However, Kevetrin has plenty of wealthy partners and they all seem impressed and willing to pay the forward research bill. Cellceutix management appears to have visionary wisdom in planning to elevate Kevetrin by testing it with other FDA approved drugs like cytarabine. They also smartly focus on unmet needs by proposing to treat cancers like retinoblastoma for which there is no effective treatment. Viewing tragic pictures of this form of cancer affecting children often at age 2, it is reasonable that the FDA would move quickly to help these afflicted children. A restrained imagination could see St Jude Children's Research Hospital or The Jimmy Fund watching closely or participating in the retinoblastoma trial. Considering a successful Bologna trial and an outcome of safe and effective with retinoblastoma has caused me to conclude that Kevetrin will obtain FDA approval after the retinoblastoma trial.
Cellceutix: Brilacidin: Kevetrin's Pathway To Advancement
Cellceutix valuation will be further supported by two other potential blockbuster drugs, Brilacidin and Prurisol. Prior to the end of 2014, I predict that Cellceutix will sign one or two licensing agreements ( hyperlink paragraph 4)with mid-tier to major pharmaceuticals involving Brilacidin ( hyperlink paragraph 6 and 7). Since the company believe that Brilacidin is has the potential to generate billions annually these events will probably bring Cellceutix cash, milestone payments and an overriding royalty. A licensing deal could provide the company with the necessary cash and balance sheet asset to operate well into 2015, possibly up list to Nasdaq, and begin FDA trials for Prurisol. It is possible that we might see a 2015 foreign approval of Brilacidin for an emerging-market country like Vietnam, or India where Cellceutix CEO Mr. Ehrlich and Dr Menon have strong relationships. Pay attention as to how aggressively Dr. Reddy's Laboratories (NYSE:RDY) has been moving into the generic and clinical cancer market. Imagine the conjugation of a fleet of generic cancer drugs with a low dose of Kevetrin for non G7 countries, better known as E7. Dr Reddy's deal for stage 3, NeuVax was based upon them bearing research and development, along with milestones and royalties. However, without a favorably structured licensing deal, Cellceutix will face the prospect of substantial dilution in order to continue to develop Brilacidin or Prurisol. Kevetrin appears to have attracted enough interest that other entities would probably be willing to fund its research and development through to FDA approval, even if a bid for it does not materialize.
Thanks to Jessica Wapner for contributing to my discernment that Kevetrin makes Cellceutix a compelling investment. As data from each of the future hopeful epochs is released investors will probably respond with legitimate enthusiasm.
Disclosure: I am long CTIX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: I am long 10,000 shares