Cellceutix Corp. announced today that they have reached agreements with PharPoint Reasearch and Medical Research Consulting Services for Phase 1 clinical trials of their lead compound, Kevetrin, which is being developed to target drug-resistant cancers. PharPoint will handle data management and statistical analysis while Medical Research will be responsible for clinical monitoring throughout the human trials.
Art Holmes, President of PharPoint, was quoted in the press release as stating, “We are pleased to have the opportunity to work with Cellceutix and to bring our skills to bear on the Kevetrin Phase 1 study,” Mr. Holmes continued, “From a corporate standpoint, it is exciting to be involved in the start of a promising clinical program, particularly in the field of oncology where there is an urgent need for new therapies.”
George Evans, Chief Executive Officer of Cellceutix, commented, “We were looking for elite partners that could provide world class service and with PharPoint and Medical Research Consulting Services we have come to terms with two of the best in the industry,” Mr. Evans continued, “These agreements are the next step in our mission to start the Phase 1 study of Kevetrin ASAP.”
In Mr. Evans quote, he touched on the “mission to start Phase 1.” Cellceutix has already conducted pre-IND (Investigational New Drug) meetings with the U.S. Food and Drug Administration (FDA). Other requirements to begin human trials are nearly completed with IND documentation for the FDA being prepared. Cellceutix has also been in discussions with a major cancer hospital to host the trials. Phase 1 human trials for Kevetrin appear to be approaching rapidly. During Phase 1 testing, a new pharmaceutical is assessed for safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of the drug.
Pre-clinical trials for Kevetrin have shown very promising data encouraging Cellceutix to further develop their novel compound. Cellceutix has presented data on several occasions at the American Association for Cancer Research (AACR) with the data receiving much attention from industry leaders in the development of completely unique compounds. The efficacy of Kevetrin in a mouse model of drug resistant lung cancer was shown to increase with increasing dose. The data presented at the AACR also shows that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance. More information about the results can be viewed on the Cellceutix web site at www.cellceutix.com.