Cellceutix Advancing Treatment for Hidradenitis Suppurativa, Pre-IND Meeting Request to Food and Drug Administration
Marketwired
BEVERLY, MA--(Marketwired - Mar 16, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to inform shareholders that further to the Company's press release on March 2, 2015, Cellceutix is this week submitting a request with the U.S. Food and Drug Administration for a pre-Investigational New Drug (IND) meeting to initiate a clinical study for one of the Company's Host Defense Proteins (HDPs) for the treatment of hidradenitis suppurativa (HS).
Hidradenitis suppurativa (also known as acne inversa) is a chronic and debilitating inflammatory skin disease characterized by recurrent abscesses and formation of sinus tracts, typically where skin rubs together, such as the armpits, groin, between the buttocks and under the breasts. Although the first published case was 176 years ago, the etiology of HS, which causes significant physical and psychosocial distress to both men and women, remains largely understood with no cure and only limited effective treatment options. Reports of prevalence range widely from approximately one-half a percent up to approximately four percent of the general population.
"Our team continues to analyze very promising data on our HDP mimetic for HS and we are excited to be moving ahead with this indication," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "HS presents in many different forms and it is unclear the exact role of bacteria in the pathogenesis of HS, but a number of hard-to-treat bacteria species (i.e. Staphylococcus, Streptococcus, enterobacteriaceae) are commonly isolated in HS lesions, many of which our novel HDPs have been shown to be active against. We look forward to a meeting with the FDA in preparation for an IND filing and clinical study to treat this condition that plagues so many people."
In other corporate developments, Cellceutix is also pleased to inform shareholders that Nasdaq has responded to the Company with a "request for additional information" regarding Cellceutix's application to be listed on the Nasdaq exchange. Cellceutix executives and legal counsel are preparing the requisite information as requested as part of the move to uplist to Nasdaq.
With respect to the Phase 1 clinical trial of Kevetrin for solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the third and final patient in the tenth cohort is now enrolled and being treated with 450 mg/m2. Two patients have completed the dosing protocol with no serious adverse events reported to date. Further, samples have been taken from these subjects and sent to the laboratory for analysis of increased levels of the protein p21, a key biomarker for activity of p53, a protein often referred to as the "Guardian Angel of the Human Genome" because of its role as a master cell regulator and tumor suppressor.
"We are exhilarated for our company and shareholders as the ball is now rolling with respect to our move to Nasdaq. Our team is eagerly putting together the requested information to respond as quickly as possible," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "As far as the Kevetrin trial, we believed that the severe weather conditions recently in the Boston area would have a more profound impact on treating patients. We are very happy to be advised that two patients have completed the treatment per protocol and the final patient in the cohort has been enrolled. We are aiming for a major breakthrough to treat certain types of cancer and greatly look forward to data on the p21 biomarker for patients treated at these higher dosing levels, which we are hopeful will support earlier data from the trial showing that increasing levels of p21 are dose dependent."
Elsewhere in the pipeline, Cellceutix is also now engaged in scaling up the manufacturing of its lead Gram-negative compound for treating Klebsiella species and Escherichia coli (E. coli). Grant money studies are ongoing and data is expected in approximately one month, which will be used for planning clinical research. To expedite the Company's Gram-negative program, Cellceutix is improving the manufacturing process of this very unique HDP mimetic.
Cellceutix intends to provide shareholders with a comprehensive update on all clinical trials and development of compounds in the pipeline following the end of the quarter.
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 will soon begin 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 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 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.
