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Cellceutix Anti-Cancer Drug Candidate’s p53 Activity in Acute Myeloid Leukemia to be Presented by Independent Researchers at the 2017 European Hematology Association Annual Meeting
BEVERLY, Mass., May 30, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), is pleased to share further data supporting the p53 mechanism of action of Kevetrin and its treatment potential in Acute Myeloid Leukemia (AML) at the 2017 European Hematology Association (EHA) Annual Meeting to be held June 22-25, in Madrid, Spain.
Poster Title: “Kevetrin: Preclinical Study of a New Compound in Acute Myeloid Leukemia”
http://learningcenter.ehaweb.org/eha/2017/22n...acute.html
The poster presentation includes pre-clinical results from two cell lines (KASUMI-1, mutant p53; and MOLM-13, wild type) treated with Kevetrin. The analysis indicates that Kevetrin exposure induces cell cycle arrest, reduces mitochondrial membrane potential, and increases Caspase-3 in cleaved form—features that contribute to apoptotic cell death. In the p53-mutated (KASUMI-1) cell line, a marked p53 down-regulation was observed along with reduced expression of p21 and PUMA, which are p53 targets. The MOLM-13 cell line showed a marked p53 reduction, and marked up-regulation of p21, whereas PUMA protein was highly down-regulated suggesting a p53-independent mechanism of action.
The researchers’ conclusion:
Our results suggest Kevetrin is a promising new drug in AML patients treatment, both in wild type and, even more, in TP53 mutated tumors, through different molecular mechanisms, giving more therapeutic alternatives in the treatment of this disease.
“We are extremely pleased to see these pre-clinical results of Kevetrin in AML, particularly as the work was initiated independently by academic researchers intrigued by our novel compound,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “The findings bolster ongoing research, such as investigations regarding Kevetrin in Ovarian Cancer presented at the 2017 AACR meeting, further informing how Kevetrin modulates p53. Given dysfunctional p53 is implicated in at least one-half of all cancers, Kevetrin has the potential to become a truly special anti-cancer drug.”
In a completed Phase 1 trial in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Centers, Kevetrin was well-tolerated, with minimal adverse effects. A Phase 2a trial in Ovarian Cancer is currently ongoing, in which similar analyses of pathway modulations by Kevetrin are being explored directly using tumor biopsies before and after treatment. Running in parallel, Cellceutix continues to make strides toward developing Kevetrin as an oral formulation.
About Kevetrin
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) for 3 weeks and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and up to a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
Learn more here:
http://www.cellceutix.com/kevetrin-1/
Alerts
Sign-up for Cellceutix email alerts is available at:
www.cellceutix.com/email-alerts
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 has commenced 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. 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 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; interim results have shown a marked reduction in the incidence of severe oral mucositis (WHO Grade ≥ 3). Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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 two cohorts 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 Anti-Cancer Drug Candidate’s p53 Activity in Acute Myeloid Leukemia to be Presented by Independent Researchers at the 2017 European Hematology Association Annual Meeting
BEVERLY, Mass., May 30, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), is pleased to share further data supporting the p53 mechanism of action of Kevetrin and its treatment potential in Acute Myeloid Leukemia (AML) at the 2017 European Hematology Association (EHA) Annual Meeting to be held June 22-25, in Madrid, Spain.
Poster Title: “Kevetrin: Preclinical Study of a New Compound in Acute Myeloid Leukemia”
http://learningcenter.ehaweb.org/eha/2017/22n...acute.html
The poster presentation includes pre-clinical results from two cell lines (KASUMI-1, mutant p53; and MOLM-13, wild type) treated with Kevetrin. The analysis indicates that Kevetrin exposure induces cell cycle arrest, reduces mitochondrial membrane potential, and increases Caspase-3 in cleaved form—features that contribute to apoptotic cell death. In the p53-mutated (KASUMI-1) cell line, a marked p53 down-regulation was observed along with reduced expression of p21 and PUMA, which are p53 targets. The MOLM-13 cell line showed a marked p53 reduction, and marked up-regulation of p21, whereas PUMA protein was highly down-regulated suggesting a p53-independent mechanism of action.
The researchers’ conclusion:
Our results suggest Kevetrin is a promising new drug in AML patients treatment, both in wild type and, even more, in TP53 mutated tumors, through different molecular mechanisms, giving more therapeutic alternatives in the treatment of this disease.
“We are extremely pleased to see these pre-clinical results of Kevetrin in AML, particularly as the work was initiated independently by academic researchers intrigued by our novel compound,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “The findings bolster ongoing research, such as investigations regarding Kevetrin in Ovarian Cancer presented at the 2017 AACR meeting, further informing how Kevetrin modulates p53. Given dysfunctional p53 is implicated in at least one-half of all cancers, Kevetrin has the potential to become a truly special anti-cancer drug.”
In a completed Phase 1 trial in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Centers, Kevetrin was well-tolerated, with minimal adverse effects. A Phase 2a trial in Ovarian Cancer is currently ongoing, in which similar analyses of pathway modulations by Kevetrin are being explored directly using tumor biopsies before and after treatment. Running in parallel, Cellceutix continues to make strides toward developing Kevetrin as an oral formulation.
About Kevetrin
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) for 3 weeks and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and up to a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
Learn more here:
http://www.cellceutix.com/kevetrin-1/
Alerts
Sign-up for Cellceutix email alerts is available at:
www.cellceutix.com/email-alerts
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 has commenced 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. 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 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; interim results have shown a marked reduction in the incidence of severe oral mucositis (WHO Grade ≥ 3). Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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 two cohorts 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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