Cellceutix Announces Database Lock in Phase 1 Tria
Post# of 72440
Posted On: 06/06/2016 7:47:07 AM
Cellceutix Announces Database Lock in Phase 1 Trial of Kevetrin, a Promising New Cancer Treatment That Activates p53
BEVERLY, MA--(Marketwired - June 06, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the study database from the Phase 1 trial of Kevetrin (thioureidobutyronitrile) for advanced solid tumors will be "soft locked" this week. These locked results are the final protocol requirement for the study of Kevetrin in its next clinical trial and will be added to the already prepared documentation for submission to the U.S. Food and Drug Administration ("FDA" in support of the planned Phase 1b/2 trial of Kevetrin in ovarian cancer patients with resistance to platinum-based therapies. Cellceutix is developing Kevetrin under an Orphan Drug designation from the FDA.
The first-in-human clinical trial evaluating the safety and pharmacokinetics of Kevetrin was conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The study enrolled a total of 48 patients, who had failed previous therapies, with various types of advanced solid tumors, including 11 patients with advanced ovarian cancer. A dose-escalation design was used with patients enrolled in 11 cohorts with the maximum dose administered at 750 mg/m2. Kevetrin was shown to be safe and well-tolerated, with no dose-limiting toxicities occurring among patients who received even the highest dose of Kevetrin.
Kevetrin has a unique multimodal mechanism of action. The drug enhances the activity of p53, a key tumor suppressor protein often referred to as the "Guardian Angel" gene, in both wild type and mutant p53-expressing tumors. In the majority of advanced ovarian cancer patients, p53 is inactive because of genetic mutations. In the completed trial, the hospital measured p53 activity by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. Samples were collected from patients at 7 and 24 hours after the initiation of the first Kevetrin infusion.
Preliminary data has been very encouraging. As previously released, regardless of tumor type, a total of 27 of 40 evaluable patients (67.5%) had an increase in p21 expression relative to pre-treatment levels. For patients with the greatest increases at either 7 hours or 24 hours, the mean percent increase at 7 hours (10 patients) was 38.5% (median 22%) and at 24 hours (17 patients) the mean percent increase was 24.5% (median 17%). For those patients who received Kevetrin at doses of ≤ 165 mg/m2, the mean percent increase was 21.7% (n=11). And for patients who received Kevetrin at doses ranging from 215 mg/m2 to 750 mg/m2, the mean percent increase was 35.2% (n=17). Concerning ovarian cancer in particular, analyses showed increased p21 expression in 8 of 11 (73%) patients.
The above data confirm the ability of Kevetrin to activate p53. The trial also validates the short half-life of Kevetrin in plasma. In an earlier February 2016 meeting with the FDA, the FDA agreed that a regimen of multiple doses each week is an appropriate approach. In the Phase 1 trial, patients received Kevetrin only once a week. In the planned Phase 1b/2 ovarian cancer trial, Cellceutix intends to treat patients three times weekly, with the expectation that multiple doses will enhance p53 activity and, thus, result in a corresponding improvement in therapeutic benefit. Patients will receive Kevetrin in combination with a currently approved chemotherapy (doxorubicin), as related laboratory studies produced extremely encouraging data-results that the Company hopes will continue to translate in the clinic.
"This data lock is exactly what we've been waiting for," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "It has been a long road, but we enrolled more patients and completed more cohorts than anyone originally expected. Underscoring this success was the strong safety profile and promising pharmacokinetic activity exhibited by Kevetrin in its first human trial. That leading scientists monitoring the study, as well as other clinical professionals both within the academic community and pharmaceutical industry, continue to want to learn more about our lead oncology drug also speaks to its potential."
Leo Ehrlich continued: "Cellceutix certainly has diversified its pipeline over the years, but I joined this company with the intent of finding a new cancer drug after losing both my parents to the disease. Cellceutix, to date, has a perfect record of achieving success in all its clinical trials, meeting each trial's primary endpoint. We attribute this to the rigorous study of our drugs in the laboratory setting before entering clinical trials. I'm thrilled to be moving forward with what I believe can truly become a breakthrough therapy in cancer treatment. And I am confident that by leaving the academic setting, Kevetrin's potential in treating various cancers will be realized much more quickly."
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
Alerts:
Sign-up for Cellceutix email alerts is available at
http://cellceutix.com/email-alerts/ - sthash.CRfqSmmY.k6MzKBo8.dpbs
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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer 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 anti-psoriasis drug Prurisol completed 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. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.
BEVERLY, MA--(Marketwired - June 06, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"
, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the study database from the Phase 1 trial of Kevetrin (thioureidobutyronitrile) for advanced solid tumors will be "soft locked" this week. These locked results are the final protocol requirement for the study of Kevetrin in its next clinical trial and will be added to the already prepared documentation for submission to the U.S. Food and Drug Administration ("FDA" in support of the planned Phase 1b/2 trial of Kevetrin in ovarian cancer patients with resistance to platinum-based therapies. Cellceutix is developing Kevetrin under an Orphan Drug designation from the FDA. The first-in-human clinical trial evaluating the safety and pharmacokinetics of Kevetrin was conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The study enrolled a total of 48 patients, who had failed previous therapies, with various types of advanced solid tumors, including 11 patients with advanced ovarian cancer. A dose-escalation design was used with patients enrolled in 11 cohorts with the maximum dose administered at 750 mg/m2. Kevetrin was shown to be safe and well-tolerated, with no dose-limiting toxicities occurring among patients who received even the highest dose of Kevetrin.
Kevetrin has a unique multimodal mechanism of action. The drug enhances the activity of p53, a key tumor suppressor protein often referred to as the "Guardian Angel" gene, in both wild type and mutant p53-expressing tumors. In the majority of advanced ovarian cancer patients, p53 is inactive because of genetic mutations. In the completed trial, the hospital measured p53 activity by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. Samples were collected from patients at 7 and 24 hours after the initiation of the first Kevetrin infusion.
Preliminary data has been very encouraging. As previously released, regardless of tumor type, a total of 27 of 40 evaluable patients (67.5%) had an increase in p21 expression relative to pre-treatment levels. For patients with the greatest increases at either 7 hours or 24 hours, the mean percent increase at 7 hours (10 patients) was 38.5% (median 22%) and at 24 hours (17 patients) the mean percent increase was 24.5% (median 17%). For those patients who received Kevetrin at doses of ≤ 165 mg/m2, the mean percent increase was 21.7% (n=11). And for patients who received Kevetrin at doses ranging from 215 mg/m2 to 750 mg/m2, the mean percent increase was 35.2% (n=17). Concerning ovarian cancer in particular, analyses showed increased p21 expression in 8 of 11 (73%) patients.
The above data confirm the ability of Kevetrin to activate p53. The trial also validates the short half-life of Kevetrin in plasma. In an earlier February 2016 meeting with the FDA, the FDA agreed that a regimen of multiple doses each week is an appropriate approach. In the Phase 1 trial, patients received Kevetrin only once a week. In the planned Phase 1b/2 ovarian cancer trial, Cellceutix intends to treat patients three times weekly, with the expectation that multiple doses will enhance p53 activity and, thus, result in a corresponding improvement in therapeutic benefit. Patients will receive Kevetrin in combination with a currently approved chemotherapy (doxorubicin), as related laboratory studies produced extremely encouraging data-results that the Company hopes will continue to translate in the clinic.
"This data lock is exactly what we've been waiting for," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "It has been a long road, but we enrolled more patients and completed more cohorts than anyone originally expected. Underscoring this success was the strong safety profile and promising pharmacokinetic activity exhibited by Kevetrin in its first human trial. That leading scientists monitoring the study, as well as other clinical professionals both within the academic community and pharmaceutical industry, continue to want to learn more about our lead oncology drug also speaks to its potential."
Leo Ehrlich continued: "Cellceutix certainly has diversified its pipeline over the years, but I joined this company with the intent of finding a new cancer drug after losing both my parents to the disease. Cellceutix, to date, has a perfect record of achieving success in all its clinical trials, meeting each trial's primary endpoint. We attribute this to the rigorous study of our drugs in the laboratory setting before entering clinical trials. I'm thrilled to be moving forward with what I believe can truly become a breakthrough therapy in cancer treatment. And I am confident that by leaving the academic setting, Kevetrin's potential in treating various cancers will be realized much more quickly."
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
Alerts:
Sign-up for Cellceutix email alerts is available at
http://cellceutix.com/email-alerts/ - sthash.CRfqSmmY.k6MzKBo8.dpbs
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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer 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 anti-psoriasis drug Prurisol completed 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. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.
(1)
(0)Innovation Pharmaceuticals Inc (IPIX) Stock Research Links
If you try to defend yourself against lies of the board moderators your post will be deleted. Just like the board they claim to be better than!!! Watch who you trust especially the "long term investors" that support the real attackers!
Scroll down for more posts ▼