BEVERLY, MA--(Marketwired - January 15, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, today provides shareholders with an update on the current status of the Company's compounds in development.
Kevetrin, anti-cancer compound in a Phase 1 clinical trial for solid tumors being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center:
To date, six cohorts have completed enrollment, with the sixth cohort receiving infusions at 110 mg/m2. Maximum Tolerated Dose ("MTD") has still not been reached. To date, one patient has competed 7 dosing cycles; 2 patients have completed 5 dosing cycles; 1 patient has completed 4 dosing cycles; 1 patient has completed 3 dosing cycles; 8 patients have completed 2 dosing cycles; and 7 patients have completed 1 dosing cycle. A dosing cycle is 28 days.
As disclosed in December (See press release dated December 9, 2013), the Company had filed an amendment with the U.S. Food and Drug Administration ("FDA") to modify the trial protocol to limit the dosing infusion timeframe to a maximum of six hours, versus the current protocol of 30 mg/m2 without a maximum infusion timeframe. As dosing continued to increase without yet reaching a MTD, the infusion duration became a concern as it could become quite lengthy. We are pleased to report that yesterday the FDA accepted our amendment. The FDA approval now allows for enrollment to begin of the seventh cohort under the amended protocol. The safety committee overseeing the trial has approved dosing to be increased to 165 mg/m2 with a 6-hour maximum infusion timeframe for the seventh cohort.
Cellceutix has been advised that requisite documentation is prepared for the planned Phase 1b/2 clinical trial of Kevetrin in combination with Cytarabine for Acute Myelogenous Leukemia to be sponsored by the University of Bologna in Italy, The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) and hosted at European clinical sites. We are now in the process of manufacturing a formulation of Kevetrin for this trial.
Prurisol, anti-psoriasis compound being developed under FDA guidance that a 505(b)(2) designation is an appropriate developmental pathway:
Recently, the Company submitted the application to the Institutional Review Board ("IRB") responsible for the planned Phase 1 clinical trial of Prurisol. Upon IRB approval, the Company will immediately file the Investigational New Drug ("IND") application with the FDA to initiate a brief Phase 1 crossover study to confirm that Prurisol converts into abacivir in the human body, as it has been shown to do in animal models. The Phase 1 trial is expected to take approximately 45 days to complete. Following successful completion of the crossover study, Cellceutix will move forward with initiation of a larger Phase 2/3 clinical trial under the pathway of a 505(b)(2), which permits research to immediately move to advanced stages because Prurisol is an ester of an drug already approved by the FDA. Dr. Reddy's Laboratories has already manufactured sufficient quantities of Prurisol for both the Phase 1 and Phase 2/3 trials.
Brilacidin, lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics:
- ABSSSI (Acute Bacterial Skin and Skin Structure Infections). On January 10, 2014, Cellceutix received IRB approval for a U.S.-based phase 2b clinical trial in ABSSSI. In this 200-patient study, three brilacidin dosing regimens (two single-dose regimens and one 3-day regimen) will be compared to a standard 7-day regimen of daptomycin. Site initiation visits are planned, after which enrollment will begin.
- Oral mucositis (OM): As disclosed in December (See press release dated December 20, 2013), the Company filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for its oral rinse formulation Brilacidin™-OM as a drug candidate for the prevention of radiation or chemotherapy-induced oral mucositis in patients with head and neck cancer. The company is awaiting a response from the Agency. The company is planning a U.S.-based Phase II trial of Brilacidin-OM for this indication and plans an IRB submission at the end of 1Q 2014.
- Ophthalmic infections: As disclosed in November (See press release dated November 4, 2013) 2013), the company has identified ocular infections, such as keratitis, as an area of unmet medical need and significant commercial potential, based on positive preclinical data supporting safety, antimicrobial efficacy, and prolonged residence time on the ocular surface with minimal systemic exposure. The Company has received proposals for the necessary formulation and will shortly select a manufacturer.
- Otitis media/externa: Preclinical studies in animals have begun and formulation development is in progress.
"We are extremely pleased with the advancements of Kevetrin, Brilacidin and Prurisol; their developments as a testament to the dedication and hard work of our team," comments Leo Ehrlich, Chief Executive Officer of Cellceutix. "Looking back at 2013, our Company has experienced tremendous growth, moving forward in clinical trials, adding very promising compounds to our portfolio with the acquisition of PolyMedix assets, doubling the size of our laboratory and strengthening our financial position. As satisfied as we are with the accomplishments of 2013, we have higher expectations for 2014 and again are striving to be an even better, more formidable company at this time next year."
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensing-mimetic compound has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is being readied for clinical trials at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is set to begin a Phase 2b trial in January 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. Cellceutix has formed research collaborations with world renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.