BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Cellceutix Files Investigational New Drug Application (IND) With FDA, Clinical Trials Planned at Dana-Farber Cancer Institute/Harvard Cancer Center


11/7/2011 7:56:56 AM

BEVERLY, MA--(Marketwire - November 07, 2011) - Cellceutix Corporation (OTCBB: CTIX) ("the Company"), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to report that the Company has filed its Investigational New Drug (IND) application for Kevetrin™, a novel anti-cancer drug, with the U.S. Food and Drug Administration (FDA). The Company must now wait 30 calendar days before initiating the clinical trial. During this time, the FDA reviews the data in the IND and determines the conditions under which human trials can commence.

The Phase I trial is planned to take place at Dana-Farber Cancer Institute and its partner hospitals including Beth Israel Deaconess Medical Center. The clinical trial will test Kevetrin™ against a variety of different cancer types in patients with advanced-stage cancers. Primary endpoints for the study will be safety, tolerable dosing levels and establishing the dose for a future Phase II clinical trial.

Cellceutix is focused on developing Kevetrin™ as a new class of chemotherapy for treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53, and that Kevetrin strongly induced apoptosis, 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. It is often referred to as the "Guardian Angel of the Human Genome."

"The filing of the IND represents a historic day for Cellceutix and its shareholders. We cannot possibly express how pleased we are to be making the shift to a clinical stage company," stated Leo Ehrlich, CEO of Cellceutix.

About Dana-Farber/Harvard Cancer Center
More information on Dana-Farber/Harvard Cancer Center can be found at http://www.dfhcc.harvard.edu/

About Cellceutix

Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. 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.


Contact:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
Email Contact



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES