Feb 04 NR
Initial phase 2 test results summary and next steps
In this repeated dose study, groups of three males and three females were dosed with either 50 mg/kg, 250 mg/kg or 1,000 mg/kg of Zen's patent-pending biocidal compound once per day for seven days.
Zen's patent-pending biocidal compound was administered orally close to the throat area of the rats daily for sev days at dose levels of 50 mg/kg, 250 mg/kg or 1,000 mg/kg. Based on the clinical observations, food consumption, body weights, blood clinical pathology and postmortem examination, there were no test article-related findings of concern in any of the dose levels evaluated in this study. Tissues from the main organs are now being prepared for histopathology examination and these results will be included with the final report.
Pending final histopathology results, the company is preparing to initiate a pivotal 14-day repeated dose toxicity safety study that will be conducted at Nucro Technics Laboratories in accordance with good laboratory practice regulation to support phase 1 human clinical trials.
Mar 03 NR
Repeated Dose Toxicity Study
Testing was conducted by Nucro-Technics - a fully accredited Pharmaceutical Contract Research Organization that is a partner to pharmaceutical companies located worldwide. Nucro-Technics is inspected by and in compliance with the US Food and Drug Administration and Health Canada.
Results Overview: (histopathology results)
No significant abnormal clinical observations were noted during the 7-day repeated dose studyNo findings in blood clinical pathology that could be attributed to the dosingNo significant or clinically relevant alterations in absolute organ weights, organ/body weight, or organ/brain weight ratiosNo abnormal findings from histopathology attributed to the dosingAnalysis of all generated data indicated that ZEN's compound was well tolerated following a 7-day repeated oral dose administration
Based on these encouraging results, ZEN will now initiate a 14-day repeated dose toxicity safety preclinical study that will be conducted by Nucro-Technics in accordance with Good Laboratory Practice regulations to support Phase 1 human clinical trials.
No one confused here! WhelanBay
So, in two months from today you should get a histopathic result report itemizing the findings of the 14 day trial on the MICE. Then you make formal application (if a 30 day trial is not needed) to HC which is an entirely different submission because it outlines how the user intends on running his PH1,2,3 human trials, thats at least another 60-120 days to prepare that submission.
Then you have to recruit candidates and start PH1 human trials. |
