Cellceutix Corporation, a biopharmaceutical company focused on discovering small molecule drugs, has reported that the Site Initiation Visit (SIV) required for commencement of the company's phase I clinical trial for its novel anti-cancer drug, Kevetrin was completed at Harvard Cancer Centre.

The SIV provided researchers at the host hospitals, Harvard's Dana-Farber Cancer Center and partner Beth Israel Deaconess Hospital, with specific training on the protocol of the human trial to ensure a comprehensive knowledge of responsibilities. Cellceutix will be registering the trial at www.clinicaltrials.gov and expects patient enrollment to begin in August 2012.

As a completely new class of chemistry in medicine, Kevetrin has significant potential to be a major breakthrough in the treatment of cancers. 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 tumour suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.

In more than 50 per cent 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 tumours that contain inactivated p53, while a similar number have tumours 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.

Cellceutix is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. The company 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.