SOURCE: Cellceutix

Cellceutix

December 01, 2015 10:31 ET

Cellceutix Receives Rare Pediatric Disease Designation From FDA for Kevetrin for the Treatment of Retinoblastoma

BEVERLY, MA--(Marketwired - December 01, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that on November 30, 2015 the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to Kevetrin for the treatment of retinoblastoma, a rare form of eye cancer that begins in the retina, the light sensitive nerve tissue that lines the back of the eye. Retinoblastoma is most generally found in children, usually before the age of three, and rarely found in adults. It is sight threatening and potentially fatal if not diagnosed early.

The rare pediatric disease designation supplements the Orphan Drug Designation granted by the FDA to Kevetrin for retinoblastoma, as announced on November 23, 2015.

The designation of Rare Pediatric Disease provides the opportunity to apply for participation in the FDA's Rare Pediatric Disease Priority Review Voucher Program. The program is intended to incentivize development of drugs for neglected diseases where no adequate therapies exist. Due to a provision triggered earlier this year, the voucher program will be up for review and reauthorization by Congress, as it is scheduled to end early in 2016. While the voucher program has wide support, there are no assurances to reauthorization in whole or changes that could be made.

"Receiving the Rare Pediatric Disease designation strengthens our portfolio and adds to our belief that Kevetrin has the potential to provide a meaningful therapeutic benefit to children and families affected by retinoblastoma, where enucleation (removal) of the eye is often the only solution," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We are putting plans in place to move ahead with this exciting project. We view the voucher program as very valuable in meeting areas of unmet medical need and certainly keep in mind the monetary component considering United Therapeutics recently agreed to sell its Rare Pediatric Disease Priority Review Voucher to a subsidiary of AbbVie for $350 million."

About Rare Pediatric Disease Designation
The FDA defines a "rare pediatric disease" as a disease that affects fewer than 200,000 individuals in the U.S. aged from birth to 18 years. Under the FDA's current Rare Pediatric Disease Priority Review Voucher Program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher which can be redeemed to receive a priority review of a subsequent marketing application for a different product. The Rare Pediatric Disease Priority Review Voucher may be sold or transferred by the recipient.

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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 antimicrobial 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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