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Cellceutix Reports 24 Core Phase 2b Clinical Trial Sites for Oral Prurisol Treatment of Moderate-To-Severe Psoriasis Initiated and Open for Screening
BEVERLY, Mass., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that 24 of the 25 (all US based) core Phase 2b clinical trial sites for oral Prurisol in the treatment of moderate-to-severe psoriasis have now been initiated and are open for screening, with the last site anticipated to follow later this week. The availability of the additional sites beyond those that have already begun to treat active study participants is expected to greatly facilitate timely completion of full enrollment.
This Phase 2b study increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization, respectively). The trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment duration is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment.
Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI). Multiple secondary endpoints will also be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic. Interim analysis of 6-week data with readout is anticipated in 2Q2017, with full study top-line results in 3Q2017.
“We are very excited to have already completed a successful Phase 2a trial with very encouraging results and now look to this Phase 2b trial to set the stage for what we believe will be anchoring data to guide our Phase 3 psoriasis program,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.
Cellceutix believes now is an opportune time to be developing an oral treatment for moderate-to-severe plaque psoriasis. Currently approved treatment options are limited, with many of them not easily administered and often associated with undesirable side effects. The dermatology space has become extremely active recently with multiple large licensing deals and acquisitions speaking both to the market need in the therapy area and a growing demand among Big Pharma to fill their drug development pipelines. Above all, Cellceutix remains committed to improving the lives of patients.
Cellceutix will be presenting a corporate overview at the upcoming 2017 Biotech Showcase in San Francisco. The senior management team will be available to participate in one‐on‐one meetings at select times on January 9th and 10th. Conference attendees who are interested in scheduling a meeting are encouraged to sign up through the conference's portal, link provided below, or by emailing Cellceutix at conference@cellceutix.com.
2017 Biotech Showcase:
https://ebdgroup.knect365.com/biotech-showcase/
Alerts:
Sign-up for Cellceutix email alerts is available at:
http://www.cellceutix.com/email-alerts
About Prurisol
Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis. Cellceutix has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and efficacious in the highest dosing arm (200 mg) across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early (by week two) dose-dependent response that improved as treatment duration increased was observed. Cellceutix has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens, 300 mg and 400 mg, respectively.
Details on the ongoing Phase 2b clinical trial for oral Prurisol in the treatment of moderate-to-severe psoriasis can be found at:
https://clinicaltrials.gov/ct2/show/NCT02949388
About Psoriasis
Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities. Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
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 multiple diseases. Cellceutix believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is preparing for a Phase 2 study. 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 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first cohort of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). 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 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements 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.
Cellceutix Reports 24 Core Phase 2b Clinical Trial Sites for Oral Prurisol Treatment of Moderate-To-Severe Psoriasis Initiated and Open for Screening
BEVERLY, Mass., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that 24 of the 25 (all US based) core Phase 2b clinical trial sites for oral Prurisol in the treatment of moderate-to-severe psoriasis have now been initiated and are open for screening, with the last site anticipated to follow later this week. The availability of the additional sites beyond those that have already begun to treat active study participants is expected to greatly facilitate timely completion of full enrollment.
This Phase 2b study increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization, respectively). The trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment duration is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment.
Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI). Multiple secondary endpoints will also be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic. Interim analysis of 6-week data with readout is anticipated in 2Q2017, with full study top-line results in 3Q2017.
“We are very excited to have already completed a successful Phase 2a trial with very encouraging results and now look to this Phase 2b trial to set the stage for what we believe will be anchoring data to guide our Phase 3 psoriasis program,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.
Cellceutix believes now is an opportune time to be developing an oral treatment for moderate-to-severe plaque psoriasis. Currently approved treatment options are limited, with many of them not easily administered and often associated with undesirable side effects. The dermatology space has become extremely active recently with multiple large licensing deals and acquisitions speaking both to the market need in the therapy area and a growing demand among Big Pharma to fill their drug development pipelines. Above all, Cellceutix remains committed to improving the lives of patients.
Cellceutix will be presenting a corporate overview at the upcoming 2017 Biotech Showcase in San Francisco. The senior management team will be available to participate in one‐on‐one meetings at select times on January 9th and 10th. Conference attendees who are interested in scheduling a meeting are encouraged to sign up through the conference's portal, link provided below, or by emailing Cellceutix at conference@cellceutix.com.
2017 Biotech Showcase:
https://ebdgroup.knect365.com/biotech-showcase/
Alerts:
Sign-up for Cellceutix email alerts is available at:
http://www.cellceutix.com/email-alerts
About Prurisol
Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis. Cellceutix has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and efficacious in the highest dosing arm (200 mg) across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early (by week two) dose-dependent response that improved as treatment duration increased was observed. Cellceutix has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens, 300 mg and 400 mg, respectively.
Details on the ongoing Phase 2b clinical trial for oral Prurisol in the treatment of moderate-to-severe psoriasis can be found at:
https://clinicaltrials.gov/ct2/show/NCT02949388
About Psoriasis
Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities. Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
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 multiple diseases. Cellceutix believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is preparing for a Phase 2 study. 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 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first cohort of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). 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 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements 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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