I will guarantee a partnership in 2017. You heard it here first.
Another strong year and only 2mil increase in shares with 6.3 mil cash on hand. Great work by Management to get through another trial and show success without diluting shareholders.
May 5th - OS - 122,540,536 (5.3 mil cash on hand)
Sept 13th - OS - 124,608,756 (6.3 mil cash on hand)
What are you talking about - very little K info in 10-K:
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Kevetrin
Kevetrin, our anti-cancer drug candidate, has completed a Phase 1 study at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center (“BIDMC”). The clinical trial evaluated the safety and potential efficacy of Kevetrin in patients with advanced-stage solid tumors of various types. The primary endpoints for the study were safety, determining the maximum tolerated dose, and establishing the dose for future Phase 2 clinical trials.
Exposure to Kevetrin as measured by plasma concentrations have been achieved which are greater than concentrations shown to induce apoptosis in non-clinical studies. While the trial is primarily to evaluate safety of repeated cycles of Kevetrin, it is encouraging that some patients have had stabilization of tumor status during treatment. Further, Kevetrin appears to be having the expected effects on p53 in a number of the patients treated, as measured by increases in the levels of the downstream protein p21 biomarker.
The Phase 1 trial of Kevetrin trial yielded data validating the safety of Kevetrin and suggestive evidence of the potential clinical benefit of Kevetrin in patients who had relapsed after other cancer treatments. Because of the relatively short half-life of Kevetrin in plasma, it is the Company’s belief that administering Kevetrin multiple times per week may have an even greater clinical benefit in the planned Phase 2 trial in patients with ovarian cancer.
Pharmacokinetic profiles found that Kevetrin has a relatively short biological half-life (less than 2 hours) in plasma. Plasma half-life (T1/2) clearance (CL) and volume of distribution (Vd) suggest that drug elimination predominantly involves hepatic mechanisms and Kevetrin undergoes rapid extensive distribution from systemic circulation into tissues. Pharmacokinetic (PK) data, as measured by area under the curve (AUC) and maximum serum concentration (Cmax) levels, further revealed that Kevetrin exhibited a dose-dependent response, has as stated a relatively short half-life (approximately 2 hours) and clears the body within one day - on average between 8 and 10 hours - though the drug can remain in the body up to approximately 24 hours, depending upon individual patient variations.
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When the duration of the treatment of a disease is shorter than the therapeutic activity of drug, single doses are given. After a single dose IV infusion administration, plasma drug concentration levels rise above and then fall below the minimum effective concentration (MEC - the minimum plasma drug concentration required to produce a desired pharmacological effect in most patients) resulting in decline in therapeutic effect. To treat cancer, multiple IV infusion regimens are required to maintain the plasma drug levels above the MEC, but below the minimum toxic concentration to achieve optimal clinical effectiveness.
Ideally, a dosage regimen is established for each drug to provide the correct plasma level without excessive fluctuation and drug accumulation outside the therapeutic window. Kevetrin has less than a two-hour half-life. PK results indicate that, with the current dose regimen, Kevetrin is almost completely out of plasma within 24 hours. Therefore, little drug remains for any substantial period of time afterwards.
Based on these findings, we believe the impact of Kevetrin when administered to patients with repeated dosing (3 times per week), as planned in the upcoming ovarian cancer trial, will achieve fairly steady levels of Kevetrin above the MEC. The sustained activation/modulation of p53 will modulate multiple signaling pathways and should substantially increase its therapeutic efficacy. As noted above, Kevetrin is administered as an intravenous therapy (IV). The Company is now researching other formulations (e.g., oral).
In February 2016, Cellceutix met with FDA Division of Oncology Products 1 to discuss Kevetrin’s Phase 1 study data, as well as a proposed design for a planned Phase 2 trial in patients with ovarian cancer resistant to platinum-based therapy. The FDA was agreeable to Cellceutix’s plan to initiate such a trial, and based upon the data from the Phase 1 trial, that the administration of Kevetrin doses at three times per week would be acceptable.
Kevetrin was granted FDA Orphan Drug Designation for the treatment of ovarian cancer and pancreatic cancer.
Kevetrin was granted FDA Rare Disease Designation for Kevetrin for the treatment of pediatric retinoblastoma.
In 2012, we entered into an agreement with BIDMC, a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin. BIDMC wishes to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy. We anticipate engaging in advanced discussions with the hospital when we have more resources as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas.
After testing Kevetrin in preclinical studies, the University of Bologna in Italy (the "University") and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) approached us to test Kevetrin in a clinical trial against Acute Myelogenous Leukemia (AML). The study proposed is a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with AML. The protocol was submitted in May 2015 by the Principal Investigator to the institutional review committee. In October 2015, we were advised by the Principal Investigator that there are difficulties with the funding in Italy and he asked whether we would be interested in contributing financially to the study. We have requested budgets and timelines to help us with the decision making process as we are interested in engaging in clinical trials for the use of Kevetrin in leukemias. We intend to address this potential project once we are engaged in the ovarian cancer study and have available to us additional capital and resources.
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