B.A.M! - (((Buyouts, Acquisitions & Mergers)))

[buccaneer1961]

CTIX DD - A Primer updated
FOLLOW THE MONEY
Last Q 3/31/2012
10M preferred authorized, 0 issued
94M os
44M float
94k cash
7.2M total liabilities (2.6M payroll, $2,022,264 officer loan)

SO WHAT IS THE BIG DEAL?

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KevetrinTM a compound that activates p53 "Guardian Angel of the Human Genome". P53 activates proteins required to repair DNA.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.
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In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.
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Cellceutix consultant Dr. Sylvia Holden commented, "I have been researching new drugs for nearly 30 years. Cellceutix is now a true pioneer in oncology discovery with this very special compound, Kevetrin. The Mechanism of Action of Kevetrin™, impacting both wild and mutant types of p53 to induce apoptosis and cell cycle arrest through multiple pathways while being well-tolerated, is what sets it apart from other chemotherapies today. Rather than being a traditional drug that targets and attempts to seek and destroy cancer cells independently, Kevetrin™ revitalizes p53 so that the body's natural defense system eliminates the tumor on its own. As a stand-alone or combination front-line therapy, the magnitude of the potential of Kevetrin™ is simply unparalleled by anything that I have ever seen in the laboratory before."
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Pipeline, from website(updated)

Kevetrin Cancer Phase 1
Prurisol Psoriasis Phase 2/3 505(b)(2)
KM 391 Autism Preclinical
KM 227 Arthritis Preclinical
KM 278 Arthritis/Asthma Preclinical
KM 3174 Cancer Early R&D
KM 362 MS/ALS/Park Early R&D
KM 732 Hypertensive emergency Early R&D

*** Cellceutix filed Phase 1 for Kevetrin @ ClinicalTrials.gov.

THE SHORT VERSION:


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To determine the maximum tolerated dose (MTD) of Kevetrin.
To determine the dose limiting toxicities (DLT) of Kevetrin.
To establish a safe dose level of Kevetrin that can be used for future studies.

The secondary objectives are to determine the following:

The pharmacokinetics of Kevetrin in humans.
Observe for evidence of antitumor activity following administration of Kevetrin.
If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical/cellular effect.
If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.

"Throughout my career, I have evaluated and seen many new drug candidates go from start to finish through the regulatory pathway and I am extremely optimistic and excited about the potential of Kevetrin™ because of our data collected during extensive studies and the p53 connection as the Mechanism of Action. I'm not aware of any other anti-cancer compound at this stage of development that could have such a dramatic impact in the field of oncology. Dana-Farber is one of the few hospitals in the world that collects data 'mapping' the human genome as related to tumor profiling and the information that will be collected from our clinical trials of Kevetrin™ could prove an invaluable asset to those suffering from cancer and to Cellceutix." commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix.

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*** Kevetrin™ Phase 1

*** 8/6/2012 Dana-Farber Cancer Institute received Kevetrin™, the Company's flagship anti-cancer drug, for the commencement of hospital funded clinical trials.

*** 9/24/2012- Cellceutix expects the process of activation, recruitment, enrolling and first dosing to take approximately 3 weeks.

*Prurisol™ (psoriasis) the path to phase 2:

* 1/3/2012--The Company will be interacting with the FDA regarding obtaining 505(b)(2) designation for KM-133 (psoriasis) so it may be advanced immediately to Phase II clinical trials.

* 6/13/2012--Cellceutix is extremely pleased to announce that the FDA has informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™ (psoriasis)

* 7/16/2012--"We have conducted multiple meetings with companies to manufacture Prurisol™ and are aligning our strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible"

* 9/4/2012--"Cellceutrix announces the selection of Dr. Reddy's Laboratories Ltd., a New York Stock Exchange-listed company traded under the ticker "RDY," for the manufacturing of Prurisol™, the Company's new drug candidate for the treatment of psoriasis.

* Kevetrin™ Leukemia the path to Phase 1

* 9/10/2012--Cellceutix in discussions with top 10 European University wishing to fund clinical trials on Kevetrin™

http://www.cellceutix.com/