AML p53 Activity “Kevetrin: Preclinical Study of a New Compound in Acute Myeloid Leukemia”

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

GlobeNewswire•May 30, 2017


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/2017/22nd/180680/roberta.napolitano.kevetrin.preclinical.study.of.a.new.compound.in.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/

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Hate to burst your bubble their francis but p53 mutation is such a small subset in AML. So this will be another second line/third line crap drug that might be a fit for 5-10% of AML pts. and with modest results at best with a high price tag. Yeah....looking for needles in haystacks. And you though Del 5q MDS was hard.

This company does not have anything to fill huge gap Revlimid will leave when it loses exclusivity in less than 3 years. Remember, it is 60+% of the company's revenue. You think this AML turd will fill that void? Are you familiar with how tiny the AML market really is? Are you familiar with all the new therapies that are coming for AML? This will be another turd they will try to polish.