Cellceutix Corporation reported that its flagship cancer compound, Kevetrin, has demonstrated potent anti-tumour activity in the treatment of leukaemia cells in a haematopoietic xenograft tumour 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 honoured 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 leukaemia. 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 leukaemia 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 Tumour Cell Line Screen showed that Kevetrin was effective in killing leukaemia cells in vitro. Accordingly, the activity of Kevetrin was evaluated in nude mice bearing established human chronic myelogenous leukaemia tumours, K-562. After administration of 200 mg/kg every other day per week for 3 weeks, Kevetrin significantly reduced the average tumour volume by 84% (day 24, p< 0.01). Tumours 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 Tumour Growth Delay of 110%. In addition, after Kevetrin treatment, the tumours 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-tumour activity compared to historical data with standard leukaemia chemotherapies, Vincristine or Daunorubicin, in a human xenograft model, e.g., Vincristine (0.2 mg/kg every other day for 1 week) reduced tumour volumes by 55% and Daunorubicn (1 mg/kg every other day for 2 weeks) reduced tumour volume by 30% in the MOLM-13 acute myeloid leukaemia 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 US 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.