Cellceutix Corp (OTCMKTS:CTIX) continues to trade on the comeback trail since hitting a recent low of $1.32 after a SA hit piece came out titled ”Cellceutix: Empty Office, Unviable ‘Science’, Misleading Disclosures, 96% Downside” decimated the share price.
In recent news the Company said it is requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the advancement of the Company’s anti-cancer drug candidate Kevetrin for the treatment of pediatric retinoblastoma.
Retinoblastoma is the most common eye cancer affecting children usually before age 3. It is sight threatening and potentially fatal if not caught early. Occurrence is 250-300 cases per year in the U.S. The tumors arise from the retina, the light sensitive nerve tissue which lines the back of the eye. If caught early and treated it may spare the child from having the eye removed (enucleated) which occurs in late stages to prevent metastasis.
CTIX is one of those legendary stories that we love to report on; from pennies a share back in 2011 to recent highs near $5 CTIX has transformed itself as the top most traded stock on the entire bb’s.
It all comes back to Cellceutix chief scientific officer, Dr. Krishna Menon; the man is a real whiz; he played key roles in developing two blockbuster cancer drugs; Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s.
For CTIX he developed Kevetrin which just received Orphan Drug Designation for the treatment of ovarian cancer.. Kevetrin is successful in regulating the p53 pathway that has long been the holy grail of cancer research and big pharma. Industry leaders spent hundreds of millions of dollars trying to achieve what Dr. Krishna Menon has achieved with Kevetrin.
Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company located in Beverly, Massachusetts developing innovative therapies in oncology, dermatology and antimicrobial applications.
CTIX flagship is Brilacidin, a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the “front line” of defense in the human immune system and mange suggest Brilacidin could rival Cubist’s (NASDAQ:CBST) Daptomycin as the antibiotic of primary choice.
CTIX recently announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, the Company’s lead drug in a new class of antibiotics called defensin-mimetics, completed a Phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of daptomycin.
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The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
Among the benefits of QIDP is Fast Track and Priority Review status and a five-period of market exclusivity if approved. Cellceutix acquired Brilacidin last year when they purchased the assets of PolyMedix.
On May 13 CTIX announced financial results for the three months ended March 31, 2015. A detailed report of the third quarter fiscal 2015 has been filed in a Form 10-Q.
Highlights from the quarter ended March 2015 include:
— The start of the eleventh cohort of patients in the Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Patients in the completed tenth cohort were administered 450 mg/m2 of Kevetrin. We have found Kevetrin to be extremely well-tolerated, including in one patient who received their first treatment at 750 mg/m2 — the highest dose yet administered and is 75x the initial study dose. Maximum tolerated dose is yet to be determined.
— Manufacturing of additional quantities of Kevetrin, Brilacidin and Prurisol for planned clinical trials.
— The release of confidence interval statistics from the Company’s completed Phase 2b trial of Brilacidin, Cellceutix’s lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The confidence interval statistics reinforced previous data from the trial showing Brilacidin to be comparable to the blockbuster antibiotic daptomycin marketed by Cubist Pharmaceuticals under the brand name Cubicin.
— Development of formulations of Brilacidin and our “1807” antifungal compounds for otic (ear) infections. The compounds have been shipped to a leading university for ototoxicity testing.
— $30.0 million stock purchase agreement entered into with Aspire Capital.
— Applying to list Cellceutix common stock on the NASDAQ Capital Market.
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Currently trading at a $207 million market valuation CTIX is down a long way since its $4.93 highs on a well-planned and coordinated short attack on the Company. Up until recently CTIX was the darling of the bb’s running from pennies to $4.93 a share. They are currently fully funded with over $7 million in the treasury. The stock is just now coming into the price range where they will be noticed by the primary players of biotechnology who could be all over this one.We will be updating on CTIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CTIX.
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Disclosure: we hold no position in CTIX either long or short and we have not been compensated for this article.