Overview

Cellceutix Pharmaceuticals, Inc. is an emerging bio-pharmaceutical company in the business of developing small molecule therapies in areas of unmet medical need. The Company's primary efforts are in cancer and inflammatory disease. What differentiates this company from others involved in cancer drug development is their lead product, Kevetrin, which has been shown in cell and animal models to be highly effective in treating drug-resistant cancers. The Company has recently announced some exciting results in animal models of multi-drug resistant lung and breast cancer. Cellceutix is located outside of Boston, Massachusetts. The senior management of Cellceutix is composed of people with long experience in researching, developing and marketing innovative pharmaceutical products.

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Investment Highlights

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Profile

Cellceutix is an emerging bio-pharmaceutical company in the business of developing small-molecule therapies in areas of unmet medical needs. It owns the rights to seven drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-133, which it is developing for psoriasis.

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.

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.

The Company announced in May of 2009, that it had filed a U.S. patent application covering pharmaceutical formulations of a compound referred to as Kevetrin and many novel compounds having similar structures to Kevetrin. These structures cover a large number of compounds that Cellceutix can look at as possible drug development candidates. The application covers the use of Kevetrin and the other compounds in various areas, including cancers. Cellceutix plans to file in other countries within a year of the U.S. filing.

The compounds covered by this patent application are structurally very different from anti-cancer agents currently on the market. It took the Company longer than expected to file this patent application due to the additional compounds that presented themselves as Kevetrin related structures. The result is a patent with new and expanded claims that will provide a strong intellectual property base for Kevetrin and a large portfolio of possible compounds for future development.

Kevetrin has been performing exceptionally during animal trials. The Company 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.

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.

Experience at the top is key for medical Companies, and Cellceutix has a CEO that has more than 25 years experience in the Pharmaceutical industry. He worked in a number of positions for Pfizer Inc., one of the largest pharmaceutical giants in the world. 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. To read the full bio on the the full managment team, scroll lower to the management section of this profile.

In the above press release, the Company compared their results with results for Taxol and Cisplatin. Taxol is made and marketed by Bristol-Myers Squibb Company (NYSE:BMY). The Company is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceutical and nutritional products. Bristol-Myers is a Fortune 500 Company (#129 in 2007 list) with over 35,000 employees worldwide.

Cisplatin, on the other hand,  is a chemotherapy drug which is used to treat cancers including: sarcoma, small cell lung cancer, germ cell tumors, lymphoma, and ovarian cancer. Cisplatin is off-patent. That means no company has the exclusive right to its manufacture and any credible drug company can make it (subject to government-approved safety regulations.) Bristol-Myers Squibb settled with the Federal Trade Commission in 2003 over charges it engaged in anti-competitive practices to keep the price of cisplatin high.

Having a junior medical Company that owns the patent and rights to a cancer drug that has performed better in animal tests than a Fortune 500 pharmaceutical Company's Cancer drug, should in its own right, raise some eyebrows. Medical buyouts are not uncommon, in fact, a major buyout occurred just last year involving cancer drugs.

In October of 2008, ImClone Systems Inc. received a takeover offer from a large pharmaceutical company, Eli Lilly, valued at over $6 Billion. The cancer drug ImClone is known for, is Erbitux--a product that it markets in partnership with Bristol. ImClone also has a promising cancer drug candidate that's either a follow-up to or potential competitor for Erbitux.

With Cancer still one of the deadliest worldwide diseases, plenty of money and resources are given to try and provide treatments and cures. A small cap medical Company that holds lots of promise, and will no doubt capture the attention of many large pharmaceutical Companies is Cellceutix Corp. (OTCBB:CTIX). The positive results of their lead cancer drug, Kevetrin, along with their very experienced management team, were more than enough reason for AllPennyStocks.com to take a closer look at the Company and spotlight it to their investors.

The stock has been on a bit of a run-up over the last month as investors find out about this emerging medical Company. With tonight's important press release, investors are encouraged to watch the trading in this Company over the next week as Cellceutix continues to turn heads with its impressive lead cancer drug.

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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

Cellceutix Meets With One of the World's Largest Pharmaceutical Companies At Partnering Meeting
GlobeNewswire (Wed, Sep 23)

 

Cellceutix's Kevetrin(TM) Demonstrates Significant Delay of Tumor Growth in Drug Resistant Breast Cancer
GlobeNewswire (Mon, Sep 21)

 

Cellceutix Announces Acquisition of New Compound With High Blood Pressure Lowering Properties
GlobeNewswire (Tue, Aug 25)

Cellceutix Signs Agreement for Kevetrin(tm) API
GlobeNewswire (Mon, Aug 17)

Cellceutix's Cancer Drug Shows No Significant Indications of Toxicity
GlobeNewswire (Wed, Jul 22)

Cellceutix Announces Dr. Samuel Danishefsky Joins Its Scientific Advisory Board
GlobeNewswire (Tue, Jul 14)

Cellceutix Announces Kevetrin(tm) Animal Model Testing Success Against Multi-Drug Resistant Lung Cancer Cell Lines
GlobeNewswire (Mon, Jul 13)

Cellceutix Announces Dr. Emil Frei to be On Its Scientific Advisory Board Through June 30, 2010
GlobeNewswire (Tue, Jun 30)
 

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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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