Cellceutix to Request Meeting With FDA for Phase 2
Post# of 72447
Posted On: 10/26/2015 7:49:21 AM
Cellceutix to Request Meeting With FDA for Phase 2 Ovarian Cancer Study; Company's First-in-Human Study Defines the Pharmacokinetic Profile of Kevetrin
MARKET WIRE 6:40 AM ET 10/26/2015
BEVERLY, MA -- (Marketwired) -- 10/26/15 -- Cellceutix Corporation(CTIX) (the "Company" ), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the Kevetrin trial for advanced solid tumors is providing important data on the pharmacokinetic (PK) profiles of the drug when administered in single doses over a wide range of concentrations and over differing durations of the intravenous infusion. This dose-ranging trial is near completion. We have collected enough data for planning Phase 2 trials. This data is being used to design the Kevetrin dosing regimen for the planned studies in patients with advanced ovarian carcinoma. The FDA meeting request is planned to be submitted this week.
To date, PK profiles found that the plasma half-life of Kevetrin is relatively short, supporting the projected administration of multiple infusions each week in the next study. The half-lives after the first dose and after the sixth dose do not differ appreciably.
Longer durations of Kevetrin infusion have shown prolonged exposure to the drug. Prolonged exposure and high area-under-the-curve (AUC) may be desirable in therapy of solid tumors especially with Kevetrin since activation of cell death signaling requires multiple gene synthesis and the phase or phases of the tumor cell cycle most susceptible to the effect(s) of Kevetrin is not known.
The Company has now gathered very valuable information from the Kevetrin Phase 1 study for planning mid-stage trials of Kevetrin. The PK data are reinforcing the Company's belief that with its short half-life, Kevetrin may provide an even greater therapeutic benefit with multiple weekly treatments. Since Kevetrin acts through transcription factor p53 and regulates many pro-apoptotic genes, the sustained exposure of Kevetrin is required to activate the apoptotic pathways in tumors. Cellceutix's(CTIX) goal is for the patient to have prolonged exposure to Kevetrin by dosing multiple times so that the tumor with different stages of mutations get ample time to activate the cell death signaling. As we have stated, we are now turning our attention to advance evaluation of Kevetrin in a Phase 2 study in patients with ovarian carcinoma for which Kevetrin was granted an orphan drug designation earlier this year. To help patients and develop the best medicines is why we the employees, with support from our shareholders, work so tirelessly at Cellceutix(CTIX). We acknowledge the support and assistance of the Phase 1 trial's investigators at Dana Farber and Beth Israel Deaconess, including the pharmacokinetic laboratory, for lending their expertise in the development of our novel compound.
*NOTE: I added the bold type
MARKET WIRE 6:40 AM ET 10/26/2015
BEVERLY, MA -- (Marketwired) -- 10/26/15 -- Cellceutix Corporation(CTIX) (the "Company" ), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the Kevetrin trial for advanced solid tumors is providing important data on the pharmacokinetic (PK) profiles of the drug when administered in single doses over a wide range of concentrations and over differing durations of the intravenous infusion. This dose-ranging trial is near completion. We have collected enough data for planning Phase 2 trials. This data is being used to design the Kevetrin dosing regimen for the planned studies in patients with advanced ovarian carcinoma. The FDA meeting request is planned to be submitted this week.
To date, PK profiles found that the plasma half-life of Kevetrin is relatively short, supporting the projected administration of multiple infusions each week in the next study. The half-lives after the first dose and after the sixth dose do not differ appreciably.
Longer durations of Kevetrin infusion have shown prolonged exposure to the drug. Prolonged exposure and high area-under-the-curve (AUC) may be desirable in therapy of solid tumors especially with Kevetrin since activation of cell death signaling requires multiple gene synthesis and the phase or phases of the tumor cell cycle most susceptible to the effect(s) of Kevetrin is not known.
The Company has now gathered very valuable information from the Kevetrin Phase 1 study for planning mid-stage trials of Kevetrin. The PK data are reinforcing the Company's belief that with its short half-life, Kevetrin may provide an even greater therapeutic benefit with multiple weekly treatments. Since Kevetrin acts through transcription factor p53 and regulates many pro-apoptotic genes, the sustained exposure of Kevetrin is required to activate the apoptotic pathways in tumors. Cellceutix's(CTIX) goal is for the patient to have prolonged exposure to Kevetrin by dosing multiple times so that the tumor with different stages of mutations get ample time to activate the cell death signaling. As we have stated, we are now turning our attention to advance evaluation of Kevetrin in a Phase 2 study in patients with ovarian carcinoma for which Kevetrin was granted an orphan drug designation earlier this year. To help patients and develop the best medicines is why we the employees, with support from our shareholders, work so tirelessly at Cellceutix(CTIX). We acknowledge the support and assistance of the Phase 1 trial's investigators at Dana Farber and Beth Israel Deaconess, including the pharmacokinetic laboratory, for lending their expertise in the development of our novel compound.
*NOTE: I added the bold type
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