SOURCE: Cellceutix

September 09, 2014 15:00 ET

Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis

Dosing Increases Approximately 65% in Cancer Drug Trial

BEVERLY, MA--(Marketwired - Sep 9, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce this update on its recently completed Phase 2b study of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections ("ABSSSI").

The study was a 215-patient blinded trial with four treatment arms and approximately 50-55 patients per arm. Three of the arms evaluated Brilacidin, two single-dose arms and one 3-day regimen, and the fourth arm was daptomycin of once per day for seven days. Daptomycin for injection is marketed by Cubist Pharmaceuticals under the brand name Cubicin® and generated approximately $447 million in sales in the first half of 2014.

The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to -- if not higher than -- cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design.

Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.

"We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections."

Cellceutix is also pleased to announce the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to commence a Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis.

Oral mucositis is a common and often debilitating inflammation and ulceration in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy that affects nearly half a million people each year. Laboratory studies of Brilacidin-OM have demonstrated antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin-OM as an oral rinse that significantly reduced the duration of oral mucositis by 90 percent or more. There are currently no FDA-approved preventative or therapeutic drugs to treat oral mucositis induced by a broad spectrum of cancer therapies.

"Oral mucositis is an extremely painful condition that often goes overlooked and unpublicized as a side effect for treating hundreds of thousands of cancer patients," commented Leo Ehrlich Chief Executive Officer of Cellceutix. "There is a tremendous market opportunity to treat this condition as it pertains to cancer, as well as in the emerging field of stem cell transplantation. We have a great deal of confidence in initiating this Phase 2 trial and hope this will lead to a drug that offers oral mucositis patients a viable treatment for their discomfort."

Regarding Kevetrin, Cellceutix's lead anti-cancer compound in a dose escalation Phase 1 clinical trial, no drug-related serious adverse events or significant laboratory changes were reported in the eighth cohort in which patients were treated with 215 mg/m2 of Kevetrin. The safety committee yesterday determined that the next 9th cohort may be treated with 350 mg/m2. Patient dosing is scheduled to begin this week.

About Cellceutix:

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 has submitted an IND to the FDA for its planned Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin 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 has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed enrollment in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than most currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). 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.

Forward-Looking Statements

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.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email Contact