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Cellceutix Expedites Phase 2 Trial of Brilacidin-OM For Oral Mucositis

July 21, 2016

BEVERLY, MA --(Marketwired - July 21, 2016) - Cellceutix Corporation, (CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis (OM), a serious and debilitating complication of radiation and chemotherapy for head and neck cancer.

Cellceutix has recently retained several experienced OM consultants and embarked on a rapid expansion of the study with a goal of completing its study enrollment on an expedited basis. The Company also has been advised that a competing OM trial, which announced recently that it is being discontinued, has resulted in the availability of a large number of clinical sites, that are being considered to participate in the Cellceutix trial. Cellceutix expansion of the study assures that it will be working with sites and investigators possessing a keen understanding of the unique challenges of OM trials and a proven track record of reliable patient recruitment and retention.

"Cellceutix is committed to completing its ongoing study of Brilacidin-OM for the benefit of patients at risk for developing oral mucositis and we are optimistic that the promising preclinical results from an established and predictive laboratory animal model will be replicated in this study," commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. "While we can never predict with certainty what will happen when we transition from the laboratory to the clinic, we certainly can take steps to expedite the clinical trial process and maximize the probability of success. We are pleased to have engaged groups with proven track records to get us to the finish line in an efficient and capable manner."

As disclosed on Monday, July 18, 2016, Cellceutix received positive feedback from the first patient treated in a Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). While this commentary was only for one patient, it is relevant to Cellceutix management and shareholders, as OM, UP and UPS are all conditions where inflammation plays a significant role. The open-label design of the P-o-C trial, compared to the double-blind design of the OM trial, was the first opportunity for Cellceutix to know with certainty that the subject was treated with Brilacidin. Albeit very early feedback, the Company views the positive feedback as supportive of the anti-inflammatory properties demonstrated in the preclinical research of Brilacidin and the potential for these properties to help patients with OM.

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Posted by
DaubersUP Thursday, 07/21/16 08:55:09 AM
Re: DaubersUP post# 155474
Post # of 155487

July 11th this was announced:
ROCKVILLE, Md., July 11, 2016 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global biopharmaceutical company, today announced the decision to discontinue the development of cobiprostone based on the results of a prespecified futility analysis of the Phase 2a study of an oral spray formulation of cobiprostone for the prevention of oral mucositis in patients that are undergoing radio chemotherapy for head and neck cancer. The futility analysis indicated that the clinical benefit of cobiprostone was insufficient to support continuation of the study. There were no safety concerns identified and cobiprostone demonstrated a well-tolerated safety profile consistent with earlier Phase 1 studies.

"Based on these results, we have decided to terminate the ongoing oral mucositis study and discontinue further development of cobiprostone,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “We will continue to focus on our life cycle management programs for lubiprostone, our partnership with Cancer Prevention Pharmaceuticals for its Phase 3 compound in the orphan indication familial adenomatous polyposis, and continuing to build a development pipeline through business development."