Cellceutix Discovers Drug Activates 'Guardian Angel p53' in Fight Against Leukemia
BEVERLY, Mass., March 7, 2011 /PRNewswire/ -- Cellceutix Corporation (OTCQB: CTIX) today reported that its flagship cancer compound, Kevetrin™, has demonstrated potent anti-tumor activity in the treatment of leukemia cells in a hematopoietic xenograft tumor model. The activity, once again, is attributed to the reactivation of p53, the "Guardian Angel" protein, which Cellceutix announced last week as a major breakthrough in cancer research.
The data was presented to Cellceutix Scientific Advisor, Emil Frei III, MD, who is Physician-in-Chief emeritus at Harvard University's world renowned Dana-Farber Cancer Institute and Distinguished Professor of Medicine at Harvard Medical School. Dr. Frei was honored by the American Association for Cancer Research with its inaugural lifetime achievement award for revolutionizing chemotherapy and his role in developing the first treatment leading to the complete cure for childhood leukemia. After reviewing the most recent data on Kevetrin's method of action regarding leukemia, Dr. Frei commented, "The p53 mechanism of Kevetrin as a possible new therapy for leukemia is very exciting and holds significant promise. After Dr. Menon's years of hard work, I am impressed with the progress of this novel compound. I look forward to the commencement of human trials and the realization of Kevetrin's potential as a new therapy for a wide array of cancers."
Data from the NCI-60 DTP Human Tumor Cell Line Screen showed that Kevetrin was effective in killing leukemia cells in vitro. Accordingly, the activity of Kevetrin was evaluated in nude mice bearing established human chronic myelogenous leukemia tumors, K-562. After administration of 200 mg/kg every other day per week for 3 weeks, Kevetrin significantly reduced the average tumor volume by 84% (day 24, p< 0.01). Tumors in mice treated with Kevetrin took a median of 32 days to reach 1000 mm3 in volume whereas control mice took only 15 days, resulting in a Tumor Growth Delay of 110%. In addition, after Kevetrin treatment, the tumors in 14% of the mice completely regressed for a period of 3 weeks. This was achieved with no significant weight loss in the animals. This represents more potent anti-tumor activity compared to historical data with standard leukemia chemotherapies, Vincristine or Daunorubicin, in a human xenograft model, e.g., Vincristine (0.2 mg/kg every other day for 1 week) reduced tumor volumes by 55% and Daunorubicn (1 mg/kg every other day for 2 weeks) reduced tumor volume by 30% in the MOLM-13 acute myeloid leukemia xenograft model (Yang 2007 Blood 110:2034).
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented, "Kevetrin continues to exceed our original expectations as a possible new cancer therapy. Dr. Frei is amongst the most elite cancer researchers in the history of the disease. For Kevetrin to impress him is really saying something about the possibilities of this novel compound."
Cellceutix has been notified by its formulation vendor that production is scheduled to begin this week to produce Kevetrin in the dosage form for planned clinical trials. The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in May 2011, with human trials to begin thereafter.
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, for the treatment of psoriasis, and KM-391, for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
This Press Release contains forward-looking statements that are based on our current expectations, beliefs and assumptions about the industry and markets in which Cellceutix Corporation operates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Cellceutix's actual results to be materially different from any future results expressed or implied by these statements. Actual results may differ materially from what is expressed in these statements, and no assurance can be given that Cellceutix can successfully implement its core business strategy and improve future earnings.
The factors that may cause Cellceutix's actual results to differ from its forward-looking statements include: Cellceutix's current critical need for additional cash to sustain existing operations and meet ongoing existing obligations and capital requirements; Cellceutix's ability to implement its new product development and commercialization, enter into clinical trials, expand the intellectual property portfolio, and receive regulatory approvals in a timely and cost-effective manner. All forward-looking statements are also expressly qualified in their entirety by the cautionary statements included in Cellceutix's SEC filings, including its quarterly reports on Form 10-Q and its annual report on Form 10-K.
Kevetrin, KM133, and KM-391 have not been studied in humans at this time. The Company's positive results in animal studies do not necessarily guarantee success in humans, though they may form the basis for beginning Phase 1 trials.
SOURCE Cellceutix Corporation
Posted: March 2011