UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report December 26, 2012
(Date of earliest event reported: December 19, 2012)
CELLCEUTIX CORPORATION
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| 30-0565645 |
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100 Cumming Center, Suite 151-B
Beverly, MA 01915
(Address of principal executive offices and zip code)
(978)-236-8717
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 3.02 Unregistered Sales of Equity Securities
On December 19, 2012 the Company issued 320,000 Class A common shares par value $.0001 to a consultant upon exercise of stock options granted to him pursuant to the Company’s 2009 and 2010 Equity Incentive Plans of which 80,000 were granted on March 2, 2009, exercisable at $0.14 per share; 200,000 were granted on February 8, 2011, exercisable at $0.20 per share; and 40,000 were granted on February 17, 2011 exercisable at $.20 per share. The Company received $59,200. The issuance was exempt from registration under Section 4(2) of the Securities Act.
On December 21, 2012 the Company issued 1,680,000 Class A common shares to a consultant upon exercise of Stock Options granted on December 29, 2010 under the Company’s 2010 Equity Incentive Plan and exercisable at $0.10 per share. The Company received $168,000. The issuance was exempt from registration under Section 4(2) of the Securities Act.
All of the options were granted at the prevailing market prices on the date of the grant
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
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| 99.1 | Press Release |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: December 26, 2012
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| By: | /s/ Leo Ehrlich |
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| Chief Executive Officer |
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Cellceutix Comments on New York Times Article Heralding p53 Drugs as the New Age in Cancer Research
BEVERLY, MA – December 24, 2012-- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, today provides commentary on a front page New York Times article published December 23, 2012 title, “Genetic Gamble; New Approaches to Fighting Cancer.”
The article, authored by Gina Kolata, discusses a seismic change in the direction that cancer research may undergo. Major pharmaceutical companies are striving to conduct clinical trials testing their drug candidates against a wide range of cancers, regardless of the tumor's origin. More succinctly, the article focuses on the key protein p53, often referred to as the “Guardian Angel Gene,” and initiatives by Merck & Co. (NYSE: MRK), Roche Holding Ltd. (OTCQX: RHHBY), and Sanofi SA (NYSE: SNY) in “racing to develop their own versions of a drug they hope will restore a mechanism that normally makes badly damaged cells self-destruct and could potentially be used against half of all cancers.”
“I am pleased to see such a high profile article being written on the game changing impact that a p53 drug can have on treating cancers,” said Leo Ehrlich, Chief Executive Officer of Cellceutix. “While I am disappointed that Cellceutix was not mentioned in the article, I understand that the article was likely written before Cellceutix’s clinical trials began.
The facts are while other compounds mentioned are not yet ready for clinical trials, or in clinical trials, our flagship p53 compound, Kevetrin is currently in phase 1 trials ongoing at Harvard’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. I believe that a discerning examination of the article and publicly available information shows that we are not only ahead of these larger companies, but we have a better mechanism which is more likely to function against most cancers. Our research to date shows that Kevetrin affects both wild and mutant types of p53, a claim that to the best of our understanding, the other companies cannot make. It is true that Roche has had Nutlins in clinical trials for years, but has faced ongoing challenges. Our data shows that Kevetrin is non-genotoxic, meaning that it does not damage surrounding normal DNA.”
“As we stated in a press release on April 25, 2011 discussing our poster presentation at last year’s annual meeting of the American Association for Cancer Research, Kevetrin was a standout then amongst any other p53 drug in development,” added Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Nothing has fundamentally changed since that day. In fact, the additional laboratory data that we have collected on Kevetrin, reinforces the novel drug’s ability to re-activate p53 to its role as a potent anti-proliferative and pro-apoptotic protein and holds a great deal of promise as a new therapeutic for treating cancer including some of the most difficult to treat types of the disease. The New York Times may have overlooked Cellceutix and Kevetrin, but the organizations that are contacting us to host and sponsor clinical trials certainly have not.”
About Kevetrin™
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
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.
The clinical trial titled, "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.
INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
info@cellceutix.com