Cellceutix Reports Spleen Lesion 'Disappears' in Patient With Metastatic Stage 4 Ovarian Cancer in Clinical Trial of Anti-Cancer Drug Kevetrin - Seite 2

Additionally, the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial. Cellceutix interprets this recommendation as a very optimistic sign regarding anticipated outcomes for the trial and clinical advancement of Kevetrin.

"I can't overexpress the excitement at Cellceutix regarding Kevetrin or the significance of a metastatic lesion disappearing in a late-stage ovarian cancer patient," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We don't know of any other company, regardless of specialization, albeit small molecule, immunotherapy or other, that has published an effect like that in such a hard-to-treat disease like metastatic ovarian cancer during a Phase 1 safety trial. The idea that a stage 4 ovarian cancer patient's disease was clinically stabilized, although her CA-125 count was increased in the third month, is remarkable. The patients in our trial are incredibly sick, have often run the gamut of approved treatments and subject to constant therapy modification to address the greatest area of need at the given moment. That's an everyday practice in oncology, especially when a drug regimen, such as the strict protocol with the Kevetrin trial where dosing levels and intervals absolutely cannot be changed. We are not privy to the minutiae underscoring any physician's decisions in a trial, but we interpret the stabilization of the cancer as allotting the physician an opportunity to modify treatment to improve the patient's quality of life, an opportunity that potentially may have not been there without Kevetrin. With that in mind, we are analyzing the collective preliminary data from the trial to date showing a strong safety profile for Kevetrin, an effect on p53 and data seeming to indicate that ovarian, pancreatic and other FDA designated orphan cancers would be ideal mid-stage clinical trial targets as we plan to move forward. Considering what has been shown recently in the Kevetrin trial and the recently completed Phase 2b trial of Brilacidin for ABSSSI, we believe that we have an incredibly strong franchise headlined by one of the most promising cancer drugs and one of the best antibiotics in development today."