BEVERLY, MA--(Marketwired - February 24, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the Company has concluded negotiations with formulation developers and selected Dr. Reddy's Custom Pharmaceutical Services (CPS), part of the Pharmaceutical Services and Active Ingredients (PSAI) business unit of Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's"), a New York Stock Exchange-listed company traded under the ticker "RDY", for the formulation of the Company's defensin mimetic drug Brilacidin for use in ophthalmic and otitis infections.
Laboratory research on Brilacidin conducted at the Charles T. Campbell Ophthalmic Microbiology Laboratory demonstrated the safety, tolerability and broad activity of Brilacidin against drug-sensitive and drug-resistant clinical isolate strains of ocular infections. Additional research by Contract Research Organization Iris Pharma showed that Brilacidin has a high residence time on the surface of the eye with negligible systemic exposure, suggesting that Brilacidin has the potential to treat ophthalmic infections, such as conjunctivitis and keratitis, with a limited dosing regimen.
Cellceutix is pleased to report that in an ongoing study, Brilacidin has shown excellent results in preliminary testing of middle ear (otitis media) infection. In the study done in the Chinchilla Model of Otitis Media, Brilacidin drastically reduced the number of bacterial counts of Streptococcus pneumonia in the middle ear and had no toxic effect. Chinchilla otitis models are an excellent indicator if the drug will work in humans. We are waiting for additional pathology results and additional testing is planned. Once all data is confirmed, Cellceutix will publish the results.
Acute otitis media is one of the most common pediatric illnesses and also a leading cause of conductive hearing loss. About 2.2 million cases of otitis media with ear effusion occur annually in United States. Over seven hundred million (700,000,000) cases of acute otitis media occur worldwide each year.
Ear infection joins the growing list of indications of treatment of disease in which Brilacidin has potent efficacy.
"We are presently in a Phase 2b trial with Brilacidin for serious skin infections. Additional laboratory studies on Brilacidin have been ongoing and I am pleased to say we are more impressed than ever on the drug's potential. Due to the unique properties of Brilacidin as a defensin mimetic and a possible one-time or even a three-day drug treatment to patients, we see an FDA approved Brilacidin for ABSSSI having the potential to knock off the present market leader who is presently generating approximately $1,000,000,000 in yearly sales. Expanding our Brilacidin franchise as a potential new therapy for eye and inner ear infections is a very important project for us as we view the aggregate market potential for these indications as very significant," comments Leo Ehrlich, Chief Executive Officer at Cellceutix. "After undertaking an intense due diligence process to identify the best formulator for the job, Dr. Reddy's was the clear choice as they have shown a deep understanding of what we want to accomplish. Their recent acquisition of OctoPlus in the Netherlands was a big addition to their already highly talented team as OctoPlus specializes in complex formulations. We are extremely optimistic about Brilacidin for ophthalmic and ocular indications based upon research to date and look forward to having this potentially game-changing drug in more clinical trials."
Commenting on this development, Dr. R Ananthanarayanan, President, PSAI Business, Dr. Reddy's said, "Dr. Reddy's CPS has extensive knowledge in manufacturing and formulating anti-infective therapeutics. We are already working with Cellceutix on the manufacturing of Prurisol™ and are excited to work with them on the development of Brilacidin. Our expertise in both APIs and formulation development will assist Cellceutix in the clinical progression of Brilacidin."
About Dr. Reddy's
Dr. Reddy's Laboratories Ltd. "NYSE: RDY" is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses -- Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products -- Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to www.drreddys.com.
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 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 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, has begun a Phase 2b trial in February 2014 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 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
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.