FDA gives nod for Cellceutix (OTCBB:CTIX) psoriasis drug

Atlanta, GA 6/15/12 (StreetBeat) -- Cellceutix Corporation (OTCBB:CTIX), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, reported Wednesday that it has participated in a meeting with the U.S. Food and Drug Administration ("FDA") pertaining to the Company's psoriasis compound, Prurisol™. As previously disclosed on April 16, 2012, the Company had requested the meeting for guidance on its initiatives to seek a section 505(b)(2) designation for Prurisol™, which would allow the Company to forgo early-stage trials and advance Prurisol™ into latter-stage clinical trials.

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™.

"It was a very productive meeting with the FDA providing us with valuable advice about advancing Prurisol™ down the regulatory pathway," commented Cellceutix CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance. The recent activity of Steifel Labs, a GlaxoSmithKline company, spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica demonstrates how valuable and in high demand new dermatological drugs are right now. This is a very exciting time for Cellceutix and its shareholders as we transition from pre-clinical to clinical with drugs that have incredible potential."

Cellceutix has previously disclosed images of mice treated with Prurisol™ demonstrating its effectiveness as compared to methotrexate, a standard care treatment for psoriasis today.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Syracuse Basketball Icon Jim Boeheim Joins Cellceutix (OTCBB: CTIX) to Fight Cancer

Palm Beach, FL 5/7/12 (StreetBeat) -- 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.

Coach Boeheim has earned icon status in the world of basketball. Coaching on the sidelines of the Carrier Dome court that is now named after him, Boeheim has an 890–305 (.745) overall record; ranking him second in wins among active Division I coaches and third all-time in college basketball. Syracuse has nine Big East regular season championships, five Big East Tournament championships and 28 trips into the NCAA Tournament, including four Final Four appearances with a NCAA championship in 2003. Boeheim has earned bronze and gold medals for his role as assistant coach in the 1990 FIBA World Championship, the 2006 FIBA World Championship, the 2008 Summer Olympics and the 2010 FIBA World Championships in Turkey. This summer, he will be once again be filling the position in the latest edition of the “Dream Team” during the Olympics in London, England.In September 2005, Boeheim was inducted into the Basketball Hall of Fame.

Boeheim’s list of basketball accolades are only paralleled by his philanthropic efforts in the field of cancer. Surviving his own battle with prostate cancer, Boeheim now heads the Jim and Juli Boeheim Foundation and has become a major advocate for Coaches vs. Cancer, the Children’s Miracle Network, the Make-A-Wish Foundation, Easter Seals, the Special Olympics and more. His dedication to Coaches vs. Cancer, a non-profit collaboration between the National Association of Basketball Coaches and the American Cancer Society, has helped raise $4.5 million for the American Cancer Society’s Central New York chapter over the past 12 years.

“After speaking with Cellceutix about their planned clinical trial plans at Harvard’s Dana-Farber Cancer Institute and learning about the p53 connection with Kevetrin™ as a completely new class of chemistry in medicine, I was compelled to support their efforts,” said Jim Boeheim. “I am genuinely excited to begin this new challenge to bring an underdog to a championship.”

“We are thrilled to have Coach Boeheim joining our own version of a ‘Dream Team’,” commented Cellceutix CEO Leo Ehrlich. “His efforts both on and off the court epitomize a true champion, and that’s exactly what we want to surround ourselves with. Coach’s relationships in the cancer industry and tireless work ethic will help spread the important message about the potential of Kevetrin™ to medical experts and members of the public whose lives could be changed for the better as the compoundenters into clinical trials.”

The Cellceutix Team:

Advisor Paul Marks, MD, is the former President and Chief Executive Officer of Memorial Sloan-Kettering Cancer Center and current President Emeritus and Member of the Sloan-Kettering Institute (MSKCC). Across 19 years as President and CEO at MSKCC, Dr. Marks made major contributions in developing new and more potent chemotherapy and chemoprevention agents which led to the “Paul Marks Prize for Cancer Research” being established at MSKCC as an award to honor young investigators for promising cancer research.

Advisor Dr. Emil Frei III, MD, is one of the world's leading oncologists and a pioneer of chemotherapy. Dr. Frei has served as Chief of Medicine at National Cancer Institute and Director and Physician-in-Chief at the Dana-Farber Cancer Institute. He continues today as Physician-in-Chief, Emeritus, at Dana-Farber. Dr. Frei and his colleague Dr. Freireich established drug trials in children with leukemia using intermittent combinations of up to four drugs, each of which targeted a different pathway in the cell’s physiology. The treatment strategy significantly increased the survival rate for childhood leukemia and other types of cancer. In addition, they worked together to modernize chemotherapy trials by defining remission, organizing multi-patient treatment programs, and devising the concept of double-blind studies

Advisor Dr. Samuel Danishefsky is internationally recognized as a leading chemist in cancer research. A Sterling Professor of Chemistry at Yale University, Dr. Danishefsky currently serves as Director and Chairman of the Laboratory for Cancer Research Bioorganic Chemistry at Memorial Sloan-Kettering Cancer Center.

Advisor Dr. Paul Ginsburg received his Ph.D. in Chemistry from the City University of New York and his law degree from Columbia University where he was a Harlan Fiske Stone Scholar. Dr. Ginsburg retired from Pfizer Inc., where he served as Head of the New York Patent Department and worked on patent matters relating to several blockbuster products, including Viagra and Chantix.

Dr. Krishna Menon is a founder and Chief Scientific Officer of Cellceutix. Dr. Menon has nearly 30 years in drug development for academia and industry, including his position as Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly, where he played a key role in lead selection and pre-clinical development of blockbuster cancer drugs Gemzar and Alimta which earned him a President's Recognition Award from Eli Lilly.

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

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FDA Schedules Meeting With Cellceutix (OTCBB: CTIX) on New Psoriasis Drug

Shawshank, VA 4/17/12 (StreetBeat) -- Cellceutix Corporation (OTCBB: CTIX), a biopharmaceutical company developing small molecule drugs to treat severe medical conditions including drug-resistant cancers, announced today that it has received a response from the Food and Drug Administration("FDA") related to its pre-IND submission and meeting request on Prurisol™ (also known as KM-133), the Company's compound in development as a novel treatment for psoriasis. The FDA has confirmed mid-June 2012 for a pre-IND meeting focused on Prurisol™ to offer guidance on the Cellceutix initiatives to advance development of this new drug for treating psoriasis. In March 2012, Cellceutix submitted documentation in support of a meeting with the FDA for guidance to attain approval for a section 505(b)(2) designation for Prurisol™ from the FDA, allowing its proposed clinical trials to begin in advanced stages.

"This is another milestone in the advancement of Prurisol™ as we are hopeful that we will be able to take it directly into a Phase 2/3 clinical trial based on its active moiety already being approved by the FDA," said Cellceutix Chief Executive Officer Leo Ehrlich. "The market potential for an effectivepsoriasis treatment that outperforms today's therapies is significant and could possibly generate billions of dollars annually. Big pharma had seen the pictures that we had posted on our website and requested data. That resulted in the signing of Non-Disclosure Agreements related to Prurisol™ with some of the world's largest pharmaceutical companies. The meeting with the FDA is now a critical step for Cellceutix to advance this drug to clinical trials with the goal of bringing this drug to market."

Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, added, "For most developmental companies, Prurisol™ would be a lead drug candidate based on its composition, the strong research data that we have collected and the great need for a new drug for psoriasis. Our research of human xenografts in mouse models shows the type of stark differences in treatment with Prurisol™ as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin™, which has attracted so much attention by showing it can re-activate p53 to destroy cancer cells, has greater market potential, Prurisol should not be underestimated as in preclinical studies it too has shown significant qualities that can make it an important drug for Cellceutix. Cellceutix is in a very fortunate position now with two breakthrough drugs in the regulatory process. By advancing Prurisol™ to this stage, we are increasing our leverage in the industry as we continue to strive to make Cellceutix the most exciting pharmaceutical company today."

Cellceutix has previously disclosed images of mice treated with Prurisol™ demonstrating its effectiveness as compared to methotrexate, a standard care treatment for psoriasis today. More information on Prurisol and those images can be found at: http://www.cellceutix.com/product-candidates/km-133---psoriasis-compound.html.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Cellceutix (OTCBB: CTIX) in collaboration with Beth Israel Deaconess Medical Center

Shawshank, Va 3/20/12 (StreetBeat) -- Cellceutix Corporation (OTCBB: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to announce that it has entered into an agreement with Beth Israel Deaconess Medical Center, a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin™. The Medical Center wishes to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy.

The collaborative studies are completely independent from the planned clinical trials for Kevetrin™ that will be conducted at these cancer centers and sponsored by Cellceutix.

"It is quite a milestone accomplishment to have major universities and hospitals beginning to study our compound," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "Other parties and grants will cover the cost of the study. There are many benefits to working with a member of the premier university hospital in the world. Beth Israel Deaconess Medical Center will be researching Kevetrin™ for indications in addition to those which we will be studying in our company-sponsored clinical trials. If they collect promising data in their research of Kevetrin™ in melanoma and renal cell carcinoma, additional grant and government funding may become available to further study these separate indications, saving us substantial time and money towards the end goal of commercialization."

The p53 signaling pathway is a crucial regulator of cell cycle and apoptosis. Remarkably, p53 signaling pathway is defective in most, if not all, human tumors. Extensive pre-clinical research on Kevetrin™ has resulted in a compilation of promising data showing a wide therapeutic index through the re-activation of p53. In most melanoma and renal carcinoma (RCC) tumor cells the p53 gene is fundamentally intact, therefore it is possible to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in treatment of these malignancies. An agent that activates p53 function in mitochondria (e.g., Kevetrin™) might be particularly effective in the treatment of RCC and melanoma. In this regard, Cellceutix formed a collaborative agreement with Beth Israel Deaconess Medical Center for combination studies with multikinase inhibitors, under development from a large pharmaceutical manufacturer, which activate pro-apoptotic activity by translocation of p53 in mitochondria and inducing apoptosis. This study will provide vital insight to exploit the nuclear and/or mitochondrial pro-apoptotic function by Kevetrin in combination with other multikinase inhibitors in treatment of these malignancies.

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

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Cellceutix (OTCBB: CTIX) Pens Agreement with Beth Israel Deaconess

Tallahassee, FL 3/19/12 (StreetBeat) -- 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.

Disclosure reasons prevent Cellceutix from revealing many of the “behind the scenes” activities that are building a solid backdrop for a drug that is apparently garnering a lot of attention from major pharmaceutical companies and medical centers. In a press release last year, the company disclosed that it had signed a CDA with one of the world’s largest pharmaceutical companies regarding Kevetrin™, which is a very rare occurrence for a drug so early in development. Even rarer is the fact that Dana-Farber, the exalted cancer research center, will be hosting the clinical trials for Kevetrin™. Our research came-up empty trying to find another company with a market cap as small as Cellceutix that ever had Dana-Farber host a clinical trial. Trials are generally reserved for major pharma.

Today, Cellceutix released news that it has signed a collaboration agreement with Beth Israel Deaconess Medical Center, a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin™. The Medical Center wishes to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy.

The collaborative studies are completely independent from the planned clinical trials for Kevetrin™ that will be conducted at these cancer centers and sponsored by Cellceutix.

"It is quite a milestone accomplishment to have major universities and hospitals beginning to study our compound," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "Other parties and grants will cover the cost of the study. There are many benefits to working with a member of the premier university hospital in the world. Beth Israel Deaconess Medical Center will be researching Kevetrin™ for indications in addition to those which we will be studying in our company-sponsored clinical trials. If they collect promising data in their research of Kevetrin™ in melanoma and renal cell carcinoma, additional grant and government funding may become available to further study these separate indications, saving us substantial time and money towards the end goal of commercialization."

Putting together the pieces of the puzzle is creating an image of a company with enormous potential that is trading at 50 cents.

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Cellceutix (OTCBB: CTIX) Files Pre-IND Documentation to FDA for New Psoriasis Drug

ShawShank, VA March 13,2012 (StreetBeat) -- Cellceutix Corporation (OTC.BB: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to report that it has filed a pre-IND submission with the U.S. Food and Drug Administration (FDA) on Prurisol™ (also termed "KM-133"), the Company's drug in development as a novel treatment for psoriasis. The Company's submission provides information to the FDA on Prurisol supporting a pre-IND meeting.

Cellceutix is requesting the meeting for guidance to attain approval for a section 505(b)(2) designation for Prurisol from the FDA, allowing its proposed clinical trials to begin in advanced stages. The ultimate goal of the meeting is to gain a full understanding of the studies required to support a New Drug Application (NDA) filing for Prurisol. According to 505(b)(2) guidelines, reliance is placed upon the FDA's findings for a previously approved drug; allowing for a NDA approval to be received for a novel drug with a sponsor forgoing a portion of clinical trials and without a "right of reference" from the original drug maker.

"Prurisol is an ester of a FDA-approved drug that is used for different indications today," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol's eligibility for 'Fast Track' review, a designation that will further expedite our efforts to bring Prurisol to market."

Cellceutix has previously disclosed images of mice treated with Prurisol demonstrating its effectiveness as compared to methotrexate, a standard care treatment for psoriasis today.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Cellceutix Corp. (CTIX) Stock Chart Analysis

News hit today about filing of its Investigational New Drug application with the FDA. Coupling that with a support level at 30 cents and indicators that are at points for movement, and the CTIX chart is hitting the watchlist for potential price action.

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Cellceutix (CTIX) Technical Stock Chart Video

The Cellceutix stock chart has set a solid support in the area of 32 - 33 cents as the MACD is trending back towards zero. The RSI are testing pushing through 50 which is showing that momentum is trying to enter the chart. Technical traders will be watching now for upward pressure to challenge resistance at $0.48.

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Planned Clinical Trials at Dana-Farber/Harvard University Cancer Center a Big Deal for Little Cellceutix (OTCQB:CTIX)

Cellceutix Corporation (OTCQB:CTIX) disclosed that it has signed a laboratory agreement with Dana-Farber Cancer Institute, Harvard University’s cancer hospital, for its planned Phase I clinical trial for Kevetrin™, Cellceutix’s novel cancer compound for the treatment of drug-resistant cancers. While entering clinical trials is a milestone event for any biotechnology firm, having the trial at the world’s number one cancer research center speaks volumes for the potential of Cellceutix and Kevetrin™. DF/HCC, is afforded the ability to be extremely selective as to which drugs in development it will devote its resources and they do not seem to pick a small drug maker very often.

Of course, there are a whole host of big pharma that have conducted, or are conducting, clinical trials at DF/HCC including the likes of Pfizer, Inc. (NYSE:PFE), Astrazeneca PLC (NYSE:AZN) and Eli Lilly & Co. (NYSE:LLY), but small caps are few and far between. Although they may exist, no Over the Counter or OTCQB-listed companies were found, further showcasing the extreme rarity of Dana-Farber/Harvard Cancer Center agreeing to host a clinical trial of a small, pre-clinical company.

While a trial at DF/HCC, by no means implies impending achievements or drug approval by the Food and Drug Administration, some major drugs have come through the cancer center and have led to great successes for companies. Millenium Pharmaceuticals researched bortezomib (Velcade®) at Dana-Farber as an indication for multiple myeloma. Velcade® received FDA clearance in only seven years after initial synthesis even with early-stage trials moving notably slow as the drug moved through three different companies at first. Millenium was bought by Takeda Pharmaceutical Company (TSE:4502) in April 2008 for nearly $9 billion with Velcade® as its flagship product which is still undergoing research at Dana-Farber for different indications.

It is an arduous endeavor to seek approval for clinical trials at the world’s elite cancer center as each and every component of the initial review process can be painstakingly slow as a result of required procedural assessments. One can only imagine the number of committees that review the application. Unlike other hospitals which may provide a more expeditious service, the recognition and expertise that accompanies an outfit like Dana-Farber/Harvard Cancer Center showing a desire to research a particular drug is well worth the patience.

Having clinical trials hosted at DF/HCC should place Cellceutix at the forefront of developmental biotechs of all sizes, regardless of exchange listing; especially those in Phase I and a good portion of those in Phase II at lesser-known cancer centers. While no hospital ensures a positive outcome to clinicals, it could be discerned that odds are increased due to the selective nature of compounds that are permitted to enter trials at DF/HCC. Moreover, due to Kevetrin™ targeting drug-resistant cancers, Cellceutix will be researching their drug on terminal cancer patients (their ideal candidate) which raises the bar during Phase I as not only will the primary endpoint of safety be evaluated, but the possibility of efficacy being shown is a reality of the trials. Any sign of efficacy for a completely novel compound significantly increases the odds of expeditious development designations from the FDA.

Novel drugs are a hot commodity for any indication at the moment. Pharmasset, Inc. (NASDAQ:VRUS) is developing PSI-7977 as a treatment for Hepatitis C and posting strong results. The data has helped drive shares of VRUS northward by more than 250 percent so far this year to the $80 range (which would actually be $160 per share except for a 2 for 1 forward split in August). Split-adjusted shares were as low as $3.81 for VRUS just 2-1/2 years ago. Only in Phase II with its drug, Pharmasset boasts a nearly $6 billion market cap and serves as a solid reminder to followers of Cellceutix (with its current $32 million market cap and $0.37 per share price tag) as to what can happen in the mid-term with a potent drug candidate.

Cellceutix and Kevetrin™ have apparently impressed Dana-Farber/Harvard Cancer Center and its associates. Moreover, Cellceutix has Dr. Krishna Menon at the research helm as Chief Scientific Officer. Dr. Menon knows a bit about developing successful drugs from his time as a lead researcher at Eli Lilly where he won a President’s Award for his work in the development of multi-billion dollar cancer drugs Gemzar and Alimta. In June of this year, commenting on the robust pre-clinical research the has been generated studying Kevetrin™ on many different strains of cancer including breast, colon, lung, pancreatic and leukemia, Dr. Menon stated in a Cellceutix press release, “In all my years as a researcher, I have never seen anything like Kevetrin™.” That’s a strong statement and certainly food for thought about where Cellceutix could be in the near future.

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