Cellceutix Corporation, a clinical stage biopharmaceutical company, will soon be commencing a clinical study for its anti-psoriasis drug Prurisol. The company has completed and submitted all regulatory documents necessary for the clinical study and anticipates receiving the regulatory documents this week allowing for the importation of Prurisol into Europe to begin the clinical study.
“We are pleased to inform shareholders that we have now completed the regulatory matters necessary for a clinical study of Prurisol and that we have been notified by our contract manufacturer, Dr Reddy’s Laboratories (RDY), that Prurisol is ready for shipping to the clinical site,” Leo Ehrlich, CEO at Cellceutix stated. “We are planning to have the drug shipped in August and the trial to commence shortly thereafter. The clinical site has been notified to begin patient recruitment. We are optimistic about the potential for Prurisol to reproduce the laboratory results which showed the drug to effectively eliminate all signs of psoriasis.”
In other news, Cellceutix’s clinical trial of its anti-cancer drug Kevetrin is progressing and is presently in the dose escalation phase as maximum tolerated dose (MTD) has not yet been reached. The testing for p21, a biomarker study at the Harvard Cancer Centre lab has not yet begun. Dr Krishna Menon, Cellceutix’s chief scientific officer commented, “We understand that there were internal priorities at the lab and because these are very sophisticated and complex tests, the process can be detailed and somewhat time consuming. We are hopeful that these important biomarker studies will soon be processed and when they are, we will share those results.”
“Due to the Company’s strong financial backing from our $10 million equity line from Aspire Capital, and further progress in our clinical trials, we are intending to move to a senior exchange,” commented Leo Ehrlich, CEO. “Over the coming weeks we will be interviewing for the positions of independent directors to meet the requirements for an uplisting which we hope will increase liquidity and unlock inherent value in our stock. We will be presenting at the Rodman and Renshaw Annual Global Investment Conference in September where we will discuss in detail the Company’s progress, growth objectives and plans for 2013- 2014.”
As a completely new class of chemistry in medicine, Kevetrin has significant potential to be a major breakthrough in the treatment of solid tumours. 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 per cent of all human carcinomas, p53 is limited in its anti-tumour 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.