Oct. 17, 2011, 6:30 a.m. EDT
Cellceutix Updates Shareholders; Answers Questions About Clinical Trials for Novel Cancer Drug
BEVERLY, MA, Oct 17, 2011 (MARKETWIRE via COMTEX) — Cellceutix Corporation (otcqb:CTIX) (pinksheets:CTIX) (“the Company”), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to provide shareholders with the following update. The Company’s accomplishments in cancer have garnered much attention with many questions being asked of its management and consultants to the Company. As Cellceutix just filed its annual 10K filing with the SEC, the Company felt it’s the opportune time to answer some of the most frequently asked questions.
Q. What is so unique about your drug Kevetrin?
Kevetrin(TM), is a novel chemistry never before used in medicine. In a prepared regulatory letter we state, “Our pre-clinical studies support the application of Kevetrin as an effective and well-tolerated anti-cancer agent in the clinic, while being non-genotoxic. Kevetrin’s unique mechanism of action comes from its ability to activate both wild type and mutant p53 in both a transcriptional dependent and independent manner. Compounds currently under development that target p53 are effective in only a subset of cancer patients. Kevetrin’s effect on multiple pathways and large therapeutic index due to its low toxicity and potent anti-tumor activity make it an ideal candidate for clinical development. Therefore, we anticipate Kevetrin will positively impact patients with refractory solid tumors.”
Q. Why has it taken so long?
It has taken a significant amount of time, even longer than we had originally expected, but what was unforeseeable was the lengthy review process at the world’s leading cancer research center. It is an arduous task, to say the least. Understand that it is representatives from member hospitals that will be involved in the clinical trials that must review the data and agree to host the human trials. They are very thorough in their due diligence and selective as to which companies and compounds they will research. We could have gone with many different, less prestigious hospitals, but given that our research has shown that Kevetrin holds unparalleled potential, we wanted to go with the absolute best and we feel that the extra time was well-warranted.
Q. You have mentioned “world’s leading cancer research center” and phrases of that nature on several occasions. Why are you not using the name of the hospital?
We cannot use the names without requesting consent from the hospital/university cancer center for each occurrence. Because it can take time to get the proper approvals, it makes complete sense to simply refer to them in a different manner. Those who have been following our story know that we recently signed a contract and know that they are at the pinnacle of cancer research worldwide.
Q. Would you say that it is uncommon for a research center of this magnitude to agree to host clinical trials for such a small company as Cellceutix?
We absolutely would. This is a very difficult process for even the largest of companies. The key reason why the hospital chose Kevetrin for clinical trials among the many requests it gets is due to Kevetrin’s unique method of action, p53, also known as the “guardian angel gene.” So, yes, we would certainly say that it is extremely rare and speaks volumes about the quality of not only Kevetrin as a potential ground-breaking cancer therapy, but Cellceutix as a company.
Q. Patient recruitment often delays trials. Will there be enough patients for a timely trial?
The research center is the largest comprehensive cancer center in the world. Our planned Phase 1 trial will include three of the member hospitals. Considering the Phase 1 will be for patients with solid tumors, we have been told there is no reason to foresee any difficulty in conducting a timely trial.
Q. There are thousands of drugs in development for cancer. Why do you feel that Kevetrin has such a strong chance of success in clinical trials?
Many of the drugs being developed by small and large companies are variations of existing compounds already being used in cancer treatments. They are tested alone or in combination with an approved drug and they hope to show better results. They often fail to meet FDA approval because they are too toxic or don’t show enough improvement over existing treatments.
First off, Kevetrin activates both wild and mutant p53 while being non-genotoxic. Those two factors alone set Kevetrin apart from nearly every cancer drug out there today. Pre-clinical data has shown stellar results in tumor growth delay and reductions in tumor volume in breast cancer, lung cancer, prostate cancer, head and neck cancer, leukemia and other cancers. When conducting pre-clinical research, compounds are tested against many different strains of cancer to determine which it could be most effective against. In many cases, a drug shows little activity against different tumors, but this is not the case with Kevetrin. It is a robust compound and showing activity in every tumor line tested and, even more importantly, very strong results against cancers that are resistant to all other drugs available today. Additionally, when a drug shows this sort of activity across a wide sampling of tumor lines in animals, it greatly increases the odds of efficacy in humans. It is for these reasons that Dr. Menon, our Chief Scientific Officer, is so excited about Kevetrin. Dr. Menon, the inventor of Kevetrin, is considered an expert in reviewing animal data and is often consulted by small and large pharma corporations and universities. Never before has he seen a drug as robust as Kevetrin against cancers. He believes that Kevetrin is outperforming other drugs he had worked on at similar points in development, which eventually became multi-billion dollar blockbusters.
Q. Will you begin your clinical trials with a Phase 1 or combination Phase 1/2?
A lot of thought has gone into this strategy. Early on, before we realized the potential of our compound across so many cancers, we were planning a Phase 1/2 targeting cancers of the head and neck. However, as we started seeing results against drug-resistant cancers, we realized that we had a drug far better than we could have ever dreamed. Thereafter, we learned of its p53 activity which became a game changer. The strategy then became to begin with a Phase 1 against solid tumors. Continuing with this strategy, and subject to FDA approvals, we plan that at the conclusion of the Phase 1 to choose a cancer for fast track with a Phase 2/3 application. In addition, the strategy would be to select another cancer which would qualify as an orphan drug for Phase 2/3 studies. We believe this is the right strategy based on pre-clinical studies showing the range of Kevetrin’s “p53″ mechanism of action.
Q. Do you compare yourself to Pharmasset (symbol “VRUS”)?
We get asked this a lot since a write-up compared Cellceutix to Pharmasset. Pharmasset is a clinical stage company with a share price of approximately $80, a market cap of six billion dollars, trades an average of one million shares daily and is targeting hepatitis C. They are now in clinical trials and have a unique drug that could eventually be the standard of care for this disease. While it may not be an “apples to apples” comparison at this moment, we have an extremely unique compound addressing a much larger market, cancer. We are transitioning to become a clinical stage company. If “p53″ is activated in our planned clinical trials and we achieve results similar to what we’ve seen in preclinical studies, we definitely feel at some point it could warrant comparisons.
Q. Do you anticipate a licensing or partnering deal with another pharma?
Of course we have no way of gauging the seriousness in our compound by other pharmas. However, we can say that we are in communication with many of the world’s largest pharmaceutical companies. Our strategy has always been to take Kevetrin in to clinical trials before seeking any deal. The pharmas have asked us to keep an open line of communication and be updated during the planned clinical trial.
Q. When do you expect to begin the trials?
The lengthy process of finalizing the hosting hospital and the IND filing are nearly behind us, so we expect the trials to begin early 2012.
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, for the treatment of psoriasis, and KM-391, for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com .
This Press Release contains forward-looking statements that are based on our current expectations, beliefs and assumptions about the industry and markets in which Cellceutix Corporation operates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Cellceutix’s actual results to be materially different from any future results expressed or implied by these statements. Actual results may differ materially from what is expressed in these statements, and no assurance can be given that Cellceutix can successfully implement its core business strategy and improve future earnings.
The factors that may cause Cellceutix’s actual results to differ from its forward-looking statements include: Cellceutix’s current critical need for additional cash to sustain existing operations and meet ongoing existing obligations and capital requirements; Cellceutix’s ability to implement its new product development and commercialization, enter into clinical trials, expand the intellectual property portfolio, and receive regulatory approvals in a timely and cost-effective manner. All forward-looking statements are also expressly qualified in their entirety by the cautionary statements included in Cellceutix’s SEC filings, including its quarterly reports on Form 10-Q and its annual report on Form 10-K.
Kevetrin, KM-133, and KM-391 have not been studied in humans at this time. The Company’s positive results in animal studies do not necessarily guarantee success in humans, though they may form the basis for beginning Phase 1 trials.