News: Enrollment Approximately 50 Percent Co
Post# of 72440
Posted On: 09/30/2015 9:11:44 AM
News:
Enrollment Approximately 50 Percent Complete in Cellceutix Phase 2 Clinical Trial of Prurisol for Chronic Plaque Psoriasis
BEVERLY, MA–(Marketwired – Sept 30, 2015) – Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, today announces that the Company’s Phase 2 clinical trial of the oral drug candidate Prurisol for psoriasis has now enrolled approximately 50 percent of the planned number of patients. The trial was designed to enroll 100 patients with active mild to moderate chronic plaque psoriasis. Enrollment is expected to be completed by the end of 2015.
The randomized, double-blind study consists of four arms, with the three active arms receiving different dosing levels of oral Prurisol daily and the fourth arm receiving only placebo daily. The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of psoriasis lesions over a period of up to 84 days. More information on the trial is available on the clinicaltrials.gov website at: https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1.
There is an unmet medical need for an effective oral treatment for plaque psoriasis as an alternative to biologic therapies, which currently dominate the market. Cellceutix is very pleased with the steady pace of enrollment in the eight weeks since the trial commenced. To date, no serious adverse events have been reported.
Separately, Cellceutix would like to inform shareholders that approximately 30 pounds of the active pharmaceutical ingredient (API) in Brilacidin has been manufactured. The API will soon begin formulation for use in the planned clinical trials of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and other indications.
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
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.
Enrollment Approximately 50 Percent Complete in Cellceutix Phase 2 Clinical Trial of Prurisol for Chronic Plaque Psoriasis
BEVERLY, MA–(Marketwired – Sept 30, 2015) – Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, today announces that the Company’s Phase 2 clinical trial of the oral drug candidate Prurisol for psoriasis has now enrolled approximately 50 percent of the planned number of patients. The trial was designed to enroll 100 patients with active mild to moderate chronic plaque psoriasis. Enrollment is expected to be completed by the end of 2015. The randomized, double-blind study consists of four arms, with the three active arms receiving different dosing levels of oral Prurisol daily and the fourth arm receiving only placebo daily. The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of psoriasis lesions over a period of up to 84 days. More information on the trial is available on the clinicaltrials.gov website at: https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1.
There is an unmet medical need for an effective oral treatment for plaque psoriasis as an alternative to biologic therapies, which currently dominate the market. Cellceutix is very pleased with the steady pace of enrollment in the eight weeks since the trial commenced. To date, no serious adverse events have been reported.
Separately, Cellceutix would like to inform shareholders that approximately 30 pounds of the active pharmaceutical ingredient (API) in Brilacidin has been manufactured. The API will soon begin formulation for use in the planned clinical trials of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and other indications.
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
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.
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