Overview

Cellceutix Corporation is a preclinical cancer, autism and anti-inflammatory drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin™, which it is developing as a treatment for drug-resistant cancers, and KM-391, which it is developing for the treatment of autism.

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Investment Highlights

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Profile

The biotechnology industry is one of the most lucrative of all industries because of the unique potential to generate billions of dollars annually with the success of one drug. Understand that there is always the primary intention of developing compounds to provide new treatments for diseases that have areas of unmet need for the good of the species, but business is still business and revenues certainly have their place in the overall perspective of things. Investors in biotechnology generally follow a couple methods in selecting a company with tremendous upside. One of the primary strategies is investing in a company involved in HOT areas of research. A second method is to invest in a niche company with an orphan or completely novel drug that, if successful, is protected from competition for several years. Success in these in either one of these areas will ensure the company and the investor a faster return and greatly increase the likelihood of a larger financial windfall for all involved.

This brings us to one of the hottest areas in biotechnology at this time: autism. Autism Spectrum Disorder is the single fastest growing developmental disease in the world today with 10 - 17 % annual growth rate. 1% of the United States population, ages 3 to 17, is afflicted with autism spectrum disorder and more children will be diagnosed with autism this year than with AIDS, diabetes & cancer combined. Even with these stunning facts, there is NO drug available on the market today that approaches the core issues of autism. There are many drugs that are manufactured to treat the symptoms that result from having autism, Ritalin for example, but none that address the core issues of the autistic brain. Presently, there is one drug approved by the FDA for use, the antipsychotic, Risperidone, produced by Johnson & Johnson which has been approved for use in infantile autism. Risperidone has not been without its critics, though, as many question the use of the antipsychotic medication with autistic infants. With President Obama recently earmarking $1 billion for studies extending through 2018, biotechnology companies have recently begun a push to develop compounds seeing both the great financial and humanitarian benefits that can result with the successful development of a compound for autism.

From an investor’s standpoint, the two golden rules above describe why finding companies that are vying for position in this area can yield great long-term rewards. The research and development in order to bring one of these drugs to market is still several years away, but some ground-level entries should be considered. There are only limited choices presently as to pharmas that are pulling ahead of the pack in autism drug research and only ONE that is developing a 100% novel compound.

Novartis (NYSE: NVS), the German biotech giant, recently announced that they are conducting research on a compound that they believe can benefit several areas of illness including Fragile X Syndrome and autism. While the studies have been small in scale, the results were promising. In the article released by www.theautismnews.com in April, Dr. Mark C. Fishman, president of the Novartis Institutes for BioMedical Research stated, “We have been reluctant to make this public because we still need to do more experiments, do them correctly and in a bigger way,” Dr. Fishman continued, “But our group feels pretty good about the data.” The compound that Novartis is researching for autism is an existing compound that they believe can possibly be re-applied as a treatment for autism.

Pfizer, Inc. (NYSE: PFE), the largest drug manufacturer in the world, assembled a 14-member autism research team in 2009. While Pfizer has not disclosed much about their research, they seem to be searching for general biological components of the autistic brain to direct their focus. Issues with neurotransmitters, more specifically the overabundance of neural connections, may be a key in addressing core issues of autism and may hold a key to a treatment. "We've always been interested in this area but we didn't have the targets," said Martin Mackay, Pfizer's president of global research and development, in an interview. Mr. Mackay followed up with, "Now we do."

Cellceutix Corporation (OTCBB: CTIX) is the dark horse investment candidate as they continue developments of KM-391, their compound for the treatment of autism. With a research team led by Dr. Krishna Menon, who was a Presidential Award Winner and key researcher for the blockbuster drugs Alimta and Gemzar during his time at Eli Lilly (NYSE: LLY), Cellceutix is developing a novel compound to address the core issues or autism. In a recent press release regarding their preclinical studies, Dr. Menon stated, “I am very encouraged by the research results that we are achieving with KM-391 and its development potential as a treatment for autism. In our testing, we have simulated specific characteristics of an autistic brain and behavioral symptoms that result from them. KM-391 has been shown to significantly improve both the physical conditions in the brain and behaviors resulting in our animal models.”

Cellceutix is particularly attractive due to several factors. For starters, they are the only company with a completely novel compound, not a derivative of another or a re-application of an existing. Second, the stock price is only at $.45 currently as they are still “sliding under the radar” while Novartis and Pfizer are trading at $49 and $16, respectively. The potential gains from successful bringing KM-391 to market are astounding. Finally, Big Pharma has been historically lacking in research capacities while continually looking to acquire smaller biotechnology companies with promising compounds, such as Cellceutix. History may very well repeat itself in the not too distant future.

Autism research and treatment, is not the only thing that makes Cellceutix attractive. The Company's flagship product, Kevetrin™, is being developed to treat cancers that are resistant to standard treatments. Kevetrin is rapidly approaching Phase 1 human trials with a target date set for the fourth quarter of this year. All required FDA pre-clinical research has been completed with the final data being formally prepared for the IND filing. While most cancer treatments today are derivatives of other compounds, Kevetrin is a completely novel compound. Multidrug resistance, the principal mechanism by which strains of cancer develop resistance to chemotherapy drugs, is a major factor in the failure of many forms of chemotherapy today and represents a huge need for novel cancer treatments.

Kevetrin has been extensively studied in animal models of lung, breast, and colon cancers, targeting carcinoma strains that have proven resistant to standard therapies available on the market today with the results showing greater tumor growth delay than present therapies and strong efficacy in animal models with increasing dosages. The impressive data obtained during pre-clinical research has investors excited about human trials as a history has shown that successful drug for the treatment of specific lines of cancer can result in billions of dollars in revenues.

Kevetrin, is a small molecule compound proprietary to the Company. Its structure is distinct from other anti-cancer agents currently on the market. Kevetrin was discovered by the Company's founder, Dr. Krishna Menon, and has been studied extensively (in vitro and in vivo) demonstrating potent anti-cancer activity against various cancer cell lines. Kevetrin's recent success in a series of animal model experiments with drug-resistant cancer cell lines has galvanized the Company to focus on Kevetrin's development potential in this area.

The Company further proved the benefits of Kevetrin when they announced that they had successfully completed animal model tests on a taxane-resistant, estrogen receptor-negative breast cancer human cell line, MDA-MB-435s, using its proprietary pharmaceutical compound Kevetrin™. Tumor volume was reduced by 74% and tumor growth was delayed by more than 62% compared to controls. In addition, both the tumor volume reduction and the tumor growth delay were greater with Kevetrin than with paclitaxel (Taxol) (p<0.01) or with cisplatin (p<0.01). The experiment was repeated in order to increase the level of confidence in the results, though cisplatin was not included in the repeat experiment. The results in the repeated experiment were similar to that in the initial test.

"In in-vivo testing Kevetrin continues to demonstrate consistent success in fighting drug resistant cancers, the leading cause of chemotherapy failure" said Mr. George Evans, CEO of the Company. Mr. Evans continued: “We are optimistic that Kevetrin will continue to progress on the developmental pathway as a treatment for these very difficult cancers.”

This is very significant news, as it not only shows that Kevetrin is beneficial in various types of cancers, but also that it has been studied against several drug-resistant cancer cell lines. One of the main causes of failure in the treatment of cancer is the development of drug resistance by the cancer cells. Since Kevetrin's structure is distinct from other anti-cancer agents currently on the market, in laboratory tests, it has been able to overcome that major hurdle.

Cellceutix's business strategy is well-described by their company slogan “Compounds for Cures.” Cellceutix has kept a “low profile” while developing their novel compounds, but the Company name is spreading quickly through the industry and investors are taking notice. Led by a team of pioneers in the industry with over 100 years’ experience while holding high level executive and research positions with companies such as industry giants Pfizer and Eli Lilly, the Cellceutix team has unparalleled leadership and research experience. The team united with the specific goal of duplicating the incredible results that they achieved for other companies for the shareholders of Cellceutix.

Cellceutix has everything going for them, but they are still significantly under the radar of most investors. The stock has been trading in a range between $0.30 and $0.60 for the better part of the last 9 months or so with a current price at around $0.45. Looking at the stock from a technical perspective, the first thing the charts are signalling is the tightening of the bollinger bands, on little volume. This is a good sign as it indicates that the stock has no significant buying or selling pressure. With any important corporate release and some new buying interest, CTIX could make a run upwards with just a little bit of extra liquidity.

We have also prepared a video chart evaluating CTIX, which discusses support and resistance levels as well as what to look for going forward with the stock price. The major support level for this stock seems to be the $0.30 level, so setting stop losses in that area would be strongly encouraged. There are a few resistance points to look for with CTIX, and the video chart will discuss all of the levels in more detail. Investors are encouraged to view the video chart for CTIX by clicking here. Remember, these are only our interpretations of CTIX`s stock chart, and in the case of the video chart, 123LearnToTrade.com's interpretation, and as always, we encourage all investors to do their own due diligence and consult with a financial advisor prior to making any investment decisions.

There are other technical indicators signalling the possibility of further upward movement, however with the low liquidity it is difficult to truly evaluate this stock from a technical perspective, so with such strong fundamentals, technical analysis should be put in the passenger seat for this Company's stock.

Cellceutix Corp. (OTCBB:CTIX) is definitely a Company worth exploring more. It may not be an overnight winner, but is laying the groundwork for a long and prosperous corporate future as it holds key patents and the rights to several drug compounds that would make most Fortune 500 medical companies jealous. The Company's lead drug, Kevetrin™, is in development as a treatment for drug-resistant cancers, and KM-391, which it is developing for the treatment of autism are among the most prominent developments from the Company, and with medical mergers and acquisitions commonplace, it is a Company that may be on the radar screens of bigger fish in the medical pond. CTIX's impressive management team certainly has the experience and contacts to move this Company forward in a prosperous fashion. For these reasons and more, AllPennyStocks.com decided to spotlight Cellceutix Corp. (OTCBB:CTIX) as their latest U.S. Company Spotlight and encourages investors to do their own due diligence on this rapidly growing junior biotech Company.

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Kevetrin - Lead Product

Excellent results in animal model experiments in drug-resistant cancers

Kevetrin, the Company's lead product candidate, is a small molecule compound proprietary to the Company. Its structure is distinct from other anti-cancer agents currently on the market. Kevetrin was discovered by the Company's founder, Dr. Krishna Menon, and has been studied extensively (in vitro and in vivo) demonstrating potent anti-cancer activity against various cancer cell lines. Kevetrin's recent success in a series of animal model experiments with drug-resistant cancer cell lines, has galvanized the Company to focus on Kevetrin's development potential in this area. Kevetrin's primary mechanism of action is as an AKT inhibitor but it also acts as an alkylating agent and LTB4 inhibitor with anti-angiogenic properties.

Some highlights of the studies conducted to date include:

• Small molecule drug that is structurally different from anti-cancer agents currently on the market
• Primary mechanism of action is AKT inhibition
• Potent in vitro cytotoxicity against a panel of human tumor cell lines
• Demonstrated success in more than 5,000 small animal tests, achieving significant delays in tumor growth compared to controls in breast, prostate and colon cancer tumors.
• In animal tests of a head and neck cancer cell line, delay in tumor growth was significantly increased by 14 days with Kevetrin alone (about the same as with radiation alone) but when Kevetrin was administered in conjunction with radiation, tumor growth delay increased by 36 days, more than two-fold compared to controls
• In small animal tests, Kevetrin was well tolerated.

The Company is now conducting additional studies to allow them to request permission from the FDA to begin studies in humans.

Chemistry

Kevetrin is a small molecule that is different in structure from all currently marketed cancer drugs. It is water-soluble and simple to synthesize from commercially available starting materials. The Company expects that it will initially be administered as an intravenous (IV) product.

Patent Protection

Cellceutix filed a patent application covering Kevetrin in May, 2009. The patent application claims pharmaceutical formulations of Kevetrin in addition to novel compounds having similar structures to Kevetrin that may have potential as drug development candidates. The application also covers the use of Kevetrin and the other compounds in various disease states, including cancers. Cellceutix plans to file patent applications in other countries within a year of the U.S. filing.

Drug-Resistant Cancer Cell Lines

One of the main causes of failure in the treatment of cancer is the development of drug resistance by the cancer cells. Kevetrin has been studied against several drug-resistant cancer cell lines.

Lung Cancer

Kevetrin has been studied in animal models using a number of drug-resistant cell lines. Kevetrin was studied in two cell lines of multi-drug resistant lung cancer. In two studies with the A549 cell line, Kevetrin showed average tumor growth delay of 72% and average tumor volume reduction of 81% compared to controls. Both tumor growth delay and tumor volume reduction were also significantly greater with Kevetrin than with paclitaxel (Taxol) (p<0.001).

In two studies with the NCI-H1975 cell line of multi-drug resistant lung cancer, Kevetrin showed average tumor growth delay of 149% and tumor volume reduction of 94% compared to controls. Both tumor growth delay and tumor volume reduction were greater with Kevetrin than with paclitaxel (p<0.001).

Other Cancer Cell Lines:

Head and Neck Cancer

Kevetrin was studied in multiple experiments alone and in conjunction with radiation against the SCC-15 cell line of head and neck cancer. Kevetrin alone showed an average tumor growth delay of 45% compared to controls, similar to radiation alone. When administered in conjunction with radiation, Kevetrin showed an average tumor growth delay of 116%.

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%.

Breast Cancer

In a study with the MDA-MB-231 breast cancer cell line, Kevetrin demonstrated tumor growth delay of 90% compared to controls.

Prostate Cancer

Kevetrin was studied against the PC-3 cell line of prostate cancer. In two studies, Kevetrin demonstrated an average tumor growth delay of 54% compared to controls, while cisplatin showed and average tumor growth delay of 49%.

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Recent News and Press Releases

Kevetrin Demonstrates Significant Results in the Treatment of Multi-Drug Resistant Cancer Cells
Marketwire (Mon, Jun 21)

New Autism Drug Research by Cellceutix on Compound KM-391 Results in Significant Behavioral Changes; Chief Scientific Officer Sees Potential for Company to Emerge as Industry Leader as Pharmas Strive for Revolutionary Autism Treatments
Marketwire (Mon, Jun 14)

Cellceutix Responds to Public Support by Expediting Autism Studies; Completes Two Required Safety Pharmacology Studies for Its Cancer Compound
Marketwire (Mon, Jun 7)

Cellceutix CFO Discusses Autism Drug, Kevetrin(TM) and Company Progressions With CEOCFO Interviews and News
Marketwire (Thu, Jun 3)

Cellceutix Signs Agreements for Kevetrin(TM) Phase 1 Support; Company Continues to Advance Kevetrin Toward Human Studies Targeting Drug Resistant Cancers
Marketwire (Mon, May 24)

Cellceutix Files Foreign Patent Application in PCT and Other Key Countries for Its Flagship Cancer Compound
Marketwire (Tue, May 18)

Recent Announcements Suggest Cellceutix Is Well Positioned With Autism Compound; Pfizer and Novartis Announcements Indicate Interest in Autism by Major Companies
Marketwire (Wed, May 12)

Cellceutix Presents Poster Session at AACR; Important New Data on Kevetrin(TM) in Resistant Lung Cancer Model Show Dose Response; No Tumor Cell Resistance With Second Cycle
Marketwire (Wed, Apr 21)
 

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Management

Chief Executive Officer, Chairman of the Board of Directors- George W. Evans, JD, MBA;

George Evans has more than 25 years experience in the Pharmaceutical industry. He worked in a number of positions for Pfizer Inc, ending his career there as General Counsel for Pfizer's worldwide prescription drug unit, and a member of the unit's leadership team. During his time at Pfizer Mr. Evans gained experience in all aspects of the pharmaceutical business, from early stage research to end-of-life-cycle strategies. Mr. Evans also played a key part in negotiating several major transactions for Pfizer. In addition to his direct business experience, Mr. Evans has a wealth of experience in building and integrating organizations while maintaining the highest levels of performance. Mr. Evans was a member of the Editorial Advisory Board and the Finance Committee of the Food and Drug Law Institute and a member of the Board of the City Bar Fund. He is a graduate of Williams College and Columbia University's Law and Business schools.

President, Chief Scientific Officer, Board of Directors - Dr. Krishna Menon

RCM, PhD, VMD - Dr. Krishna Menon has more than 35 years in drug development for academia and industry. Originally trained as a veterinary surgeon, Menon began his career as Chief Government Veterinarian for a major Parish in Jamaica. He segued to a three-year stint as Director of Agriculture for the Cayman Islands, in the British Caribbean and, in 1982, moved to the Dana Farber Cancer Research Institute, where he worked under the direction of Dr. Emil Frei. Two years later, he earned his PhD in Pharmacology from Harvard University. Menon's PhD work focused on anti-folate therapy of various cancers. Menon was a Research Scientist at Dana Farber from 1985 to 1990 and Senior Research Scientist, In Vivo Research (Cancer), at Bayer Pharmaceuticals (Miles Laboratories) from 1991 to 1993. After a year operating his own veterinary oncology and drug development consultancy practice, Menon was tapped Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly (1995-2001), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta which in 2006 had over 2.1 billion dollars ($2,100,000,000) in sales, and is a co-developer of another seven compounds currently in late-stage clinical development. In 1999, Lilly honored Menon with the President's Recognition Award, an award not bestowed annually but rather on only special occasions.


Chief Financial Officer, Board of Directors- Leo Ehrlich, CPA

Served as Chief Financial Officer (CFO) of Cellceutix Pharma since inception in June 2007. Following the acquisition, he was appointed CFO and a director. Mr. Ehrlich was also founder of Nanoviricides, Inc. (OTCBB:NNVC). That Company started with limited trading volume and a very small market cap and has a present market cap of over $100 million dollars. Mr. Ehrlich is a Certified Public Accountant and received his BBA from Bernard Baruch College of the City University of New York.

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Contact

Cellceutix Corp.
100 Cumming Center, Suite 151-B
Beverly, MA 01915

Phone: 978-633-3623
Fax: 978-921-6564
Email: info@cellceutix.com

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FORWARD LOOKING STATEMENTS

This report includes forward-looking statements that reflect Cellceutix Corp. current expectations about its future results, performance, prospects and opportunities. Cellceutix Corp. has tried to identify these forward-looking statements by using words and phrases such as "may," "will," "expects," "anticipates," "believes," "intends," "estimates," "plan," "should," "typical," "preliminary," "we are confident" or similar expressions. These forward-looking statements are based on information currently available and are subject to a number of risks, uncertainties and other factors that could cause Cellceutix Corp.'s actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. These risks, uncertainties and other factors include, without limitation, the Company's growth expectations and ongoing funding requirements, and specifically, the Company's growth prospects with scalable customers, and those outlined above. Other risks include the Company's limited operating history, the Company's history of operating losses, consumers' acceptance, the Company's use of licensed technologies, risk of increased competition, the potential need for additional financing, the terms and conditions of any financing that is consummated, the limited trading market for the Company's securities, the possible volatility of the Company's stock price, the concentration of ownership, and the potential fluctuation in the Company's operating results.

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Disclaimer

AllPennyStocks.com feature stock reports are intended to be stock ideas, NOT recommendations. Please do your own research before investing. It is crucial that you at least look at current SEC filings and read the latest press releases. Information contained in this report was extracted from current documents filed with the SEC, the company web site and other publicly available sources deemed reliable. For more information see our disclaimer section, a link of which can be found on our web site. This document contains forward-looking statements, particularly as related to the business plans of the Company, within the meaning of Section 27A of the Securities Act of 1933 and Sections 21E of the Securities Exchange Act of 1934, and are subject to the safe harbor created by these sections. Actual results may differ materially from the Company's expectations and estimates. This is an advertisement for Cellceutix Corp. The purpose of this advertisement, like any advertising, is to provide coverage and awareness for the company. The information provided in this advertisement is not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to law or regulation or which would subject us to any registration requirement within such jurisdiction or country.

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