0001355250-12-000034.txt : 20120622 0001355250-12-000034.hdr.sgml : 20120622 20120622093300 ACCESSION NUMBER: 0001355250-12-000034 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20120621 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120622 DATE AS OF CHANGE: 20120622 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cellceutix CORP CENTRAL INDEX KEY: 0001355250 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 134303398 STATE OF INCORPORATION: NV FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52321 FILM NUMBER: 12921005 BUSINESS ADDRESS: STREET 1: 100 CUMMING CENTER STREET 2: SUITE 151-B CITY: BEVERLY STATE: MA ZIP: 01915 BUSINESS PHONE: (978)-633-3623 MAIL ADDRESS: STREET 1: 100 CUMMING CENTER STREET 2: SUITE 151-B CITY: BEVERLY STATE: MA ZIP: 01915 FORMER COMPANY: FORMER CONFORMED NAME: EconoShare, Inc. DATE OF NAME CHANGE: 20060306 8-K 1 form_8k.htm

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:  June 22, 2012

(Date of earliest event reported: June 21, 2012)

 

CELLCEUTIX CORPORATION

 

 

 

 

 

Nevada

 

30-0565645

 

 

 

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification Number)

 

 

100 Cumming Center, Suite 151-B

Beverly, MA  01915

 

 

 (Address of principal executive offices and zip code)

 

(978)-633-3623

(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):

 

o

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

 

o

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

 

o

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

 

o

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 8.01:  Other Events 

 

On June 22, 2012 the company announced that on June 21, 2012 the company was informed by the U.S. Food and Drug Administration (“FDA”)  that they have completed their review of the Company’s Investigational New Drug (IND) application for Kevetrin™, Cellceutix’s novel anti-cancer compound and advised Cellceutix that  “we have completed the review of your submission, and have concluded that you may proceed with the proposed study.”

As previously disclosed, the Phase 1 clinical trials are slated to be conducted at Harvard Cancer Centers’ Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.

Additionally, the Company has received notification yesterday from both the Institutional Review Board and the Scientific Review Committee at the hospital that the protocol for the clinical trial has been approved.

A copy of the press release is attached to this report as Exhibit 99-1.

 

 

Item 9.01:  Financial Statements and Exhibits.

 

Exhibits

99.1       Press Release 

 

Signature

   

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:  June 22,  2012

 

 

 

 

 

 

CELLCEUTIX CORPORATION

 

 

 

 

 

 

 

 

By:  

/s/ Leo Ehrlich

 

 

 

Chief Executive Officer

 

 

 

 

 

 

 

 

 EX-99.1 2 press_release.htm

 Exhibit 99-1  Press Release

Cellceutix Approved By FDA to Proceed with Clinical Trials on Novel Cancer Drug

BEVERLY, MA – June 22, 2012-- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has completed the review of the Company’s Investigational New Drug (IND) application for Kevetrin™, the Cellcetix’s novel anti-cancer compound, and has yesterday informed Cellceutix that “we have completed the review of your submission, and have concluded that you may proceed with the proposed study.”

As previously disclosed, the Phase 1 clinical trials are slated to be conducted at Harvard Cancer Centers’ Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.

Additionally, the Company has received notification yesterday from both the Institutional Review Board and the Scientific Review Committee at the hospital that the protocol for the clinical trial has been approved.

Further details on the commencement of the clinical trials will be provided to shareholders next week. 

To learn more about Kevetrin™ and the potent anti-cancer activity that it has demonstrated across multiple cancer lines, please visit: http://www.cellceutix.com/product-candidates/kevetrin-our-lead-compound.html

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.

 

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.

 

Cellceutix Corp.

Leo Ehrlich

(978) 236-8717

 

info@cellceutix.com