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FDA to Expedite the Drug Approval Process for Breakthroughs FDA to Expedite the Drug Approval Process for Breakthroughs(0)

An article released yesterday by Reuters titled, “U.S. may speed approval of ‘breakthrough’ drugs” could prove extremely valuable for biotechs of all sizes.  According to the article,

Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

U.S. drug regulators would be able to label such treatments ‘breakthrough’ therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA ‘must-pass’ funding bill currently working its way through Congress and set to be passed by the end of the summer.



Smaller companies like Cellceutix Corporation (OTCBB: CTIX) will be closely watching for the proposal to become law as it could expedite the development of its anti-cancer drug Kevetrin™, a completely new class of chemistry that lab studies showed to reactivate p53, a critical regulator of the cell cycle that is damaged or malfunctioning in the vast majority of cancers.  Given its uniqueness and promising pre-clinical data, the drug certainly has the potential to qualify as a “breakthrough.”  Clinical trials should be starting in the next couple months at Harvard’s Dana-Farber Cancer Institute, which is a milestone that investors have been waiting for as Cellceutix looks to leap to the forefront of cancer researchers.

Cellceutix (CTIX) Stock Quote and News:







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Jim Boeheim and Cellceutix Team to Fight Cancer Jim Boeheim and Cellceutix Team to Fight Cancer(0)

Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company developing a novel drug to treat cancers and cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers),is pleased to announce that Syracuse University’s legendary men’s basketball coach Jim Boeheim has joined Cellceutix as an advisor to the Company. Read More

Cellceutix Novel Anti-Cancer Compound Kevetrin Presented at AACR Annual Meeting Cellceutix Novel Anti-Cancer Compound Kevetrin Presented at AACR Annual Meeting(0)

Company on Schedule for Filing Amended IND -

Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a biopharmaceutical company developing small molecule drugs to treat severe medical conditions, including drug-resistant cancers, is pleased to provide shareholders an update on developments with its novel anti-cancer compound Kevetrin™. Read More

Sunshine Biopharma Shares Jump on Multi-Drug Resistant Breast Cancer Presentation News Sunshine Biopharma Shares Jump on Multi-Drug Resistant Breast Cancer Presentation News(0)

With the backdrop of news on Monday that Sunshine Biopharma, Inc. (OTCBB:SBFM) will be presenting new scientific data at the American Association for Cancer Research Meeting in Chicago, IL (to be held on March 31 – April 4, 2012), shares of the junior biotech surged a cool 100% to close Monday’s trading at 50 cents each. Read More

Cellceutix Pens Agreement for Cancer Drug with Beth Israel Deaconess Cellceutix Pens Agreement for Cancer Drug with Beth Israel Deaconess(0)

Cellceutix Corporation (OTCBB:CTIX) continues to align itself with the biggest names in oncology research in the world.  This truly sets the company apart from most of it developmental peers, regardless of exchange-listing or size.  The company has released news recently about FDA document submissions seeking guidance on 505(b)(2) clearance for its psoriasis drug (which has provider stellar pre-clinical data) in addition to the clinical trials for its flagship cancer drug, Kevetrin™, which should be starting at Dana-Farber in the coming months. Read More

Cellceutix Featured on Front Page of Boston Business Journal Cellceutix Featured on Front Page of Boston Business Journal(0)

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 announce that it was featured Friday, January 20th on the front page of the Boston Business Journal print edition. Owned by American City Business Journals, the Boston Business Journal is available in both print and online versions and reaches hundreds of thousands of subscribers each month. Read More

FDA Gives Provectus Guidance for Phase 3 Cancer Research FDA Gives Provectus Guidance for Phase 3 Cancer Research(0)

Heading down the path in search of a Special Protocol Assessment (SPA) from the Food and Drug Administration, Provectus Pharmaceuticals (OTCBB:PVCT), a biotech specialized in developing oncology and dermatology therapies, has received guidance from the FDA to submit its Phase 3 protocol for review.  After several Read More

Another Cancer Research Breakthrough for Cellceutix Another Cancer Research Breakthrough for Cellceutix(0)

Cellceutix Corporation (OTCBB:CTIX) has regularly reported significant breakthroughs in cancer research through studies of Kevetrin, the company’s novel cancer drug in development. Amazing data has been collected by Cellceutix researchers testing Kevetrin against many cancer lines, including head & neck, prostate, lung, colon, pancreatic and leukemia. Defining the Method of Action (MOA), first the p53 connection was discovered (potentially the “Holy Grail” for anticancer drugs), then the impact Kevetrin seems to have on the retinoblastoma protein. Read More

Cellceutix Plans Clinical Trials for Psoriasis and Cancer Drugs in 2012 Cellceutix Plans Clinical Trials for Psoriasis and Cancer Drugs in 2012(0)

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 provide corporate updates on Kevetrin™, its novel drug in development for drug-resistant cancers, and KM-133, its compound being developed as a revolutionary psoriasis indication. Read More

Avastin Ousted by FDA for Breast Cancer, Sunshine Biopharma Gears-Up for Clinicals Avastin Ousted by FDA for Breast Cancer, Sunshine Biopharma Gears-Up for Clinicals(0)

It was only about a week ago that the U.S. Food and Drug Administration revoked the approval of Avastin® (bevacizumab) as a treatment for breast cancer.  This is not the end of the world for the Genentech, who was acquired by the Roche Holdings (OTCQX:RHHBY) for $46.8 billion in March of 2009, drug as it still retained its indications for colon, kidney, lung and brain cancer.  The revocation did, however, increase awareness for other breast cancer treatment candidates coming down the pipeline. Read More



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Dana-Farber to Host Cellceutix Trials

Cellceutix Corporation (CTIX)
Cellceutix Corporation has filed its Investigational New Drug application with the FDA. Dana-Farber and Beth Israel Deaconess Medical Center will be hosting the clinical trials for Kevetrin, Cellceutix's novel cancer drug. Read more news and get a stock quote.

Diabetes Rate Growing Exponentially

According to the International Diabetes Federation, more than 500 million people will be diagnosed with diabetes in the next two decades, a more than 50 percent increase from today. Technologies are available presently to help manage the frequency, complications and costs associated with diabetes. Read the complete article to learn more.

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