Cellceutix Announces A Study Planned At The University Of Bologna Titled “A Multi-Center, Open-Label, Phase Ib Study Of Kevetrin With Cytarabine In Patients With Acute Myelogenous Leukemia (AML)” ; U.S. Patent Issued for Kevetrin, Cellceutix’s p53 Anti-Cancer Compound
BEVERLY, MA – January 7, 2013– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to provide information on the planned upcoming European clinical trials for Kevetrin™, the Company’s flagship anti-cancer compound.
The clinical phase 1b trial is titled “A Multi-Center, Open-Label, Phase 1B Study of Kevetrin with Cytarabine in patients with Acute Myelogenous Leukemia (AML)”
The University of Bologna in Italy (the “University”) and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) are sponsoring the clinical trials. Cellceutix has been advised that the submission for approval for the clinical trials are on schedule and the trials are expected to begin during the first half of 2013.
“Kevetrin has garnered the attention of some of the world’s foremost authorities in oncology,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The University of Bologna has a distinguished history as a European leader in cancer research with a particular expertise in the field of hematological cancers. We could not be more pleased that this institution sees the potential for Kevetrin as a new drug candidate for AML and look we forward to building upon this special relationship with this esteemed institution.”
Cellceutix also announced today that the United States Patent and Trademark Office (USPTO) awarded the Company U.S. Patent No. 8,338,454 B2, titled “Nitrile Derivatives and their Pharmaceutical Use and Compositions.” The patent was issued on December 25, 2012.
The patent covers pharmaceutical compositions comprising Kevetrin™, the Company’s novel anti-cancer compound currently being evaluated in clinical trials against advanced solid tumors. The patent also covers related compounds and compositions.
Dr. Paul Ginsburg, a member of the Company’s Scientific Advisory Board, wrote the patent. Dr. Ginsburg has held senior legal positions at some of the world’s leading pharmaceutical companies, including Pfizer, Inc., Merck, and Schering-Plough. Dr. Ginsburg is perhaps most well-known as the author of the patent covering Schering-Plough’s hugely successful product Claritin. Dr. Ginsburg recently retired from Pfizer Inc., where he served as Head of the New York Patent Department and worked on patent matters relating to several blockbuster products, including Viagra, and represented Pfizer on the intellectual property committees of the National Association of Manufacturers, the Chemical Manufacturers Association and the Biotechnology Industry Organization.
Cellceutix’s intellectual property law firm, Ladas & Parry, prosecuted the above referenced patent.
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.
The clinical trial, titled “A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors,” is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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