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Successful Human Clinical Trial of Chrono Therapeutic's Drug/Device Combination Product - ChronoDose |
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04 May 2007 |
Trial Convincingly Proves Functionality in Humans of CTI's Programmable, Pulsatile, Passive Transdermal Drug Delivery Device - ChronoDose
BASEL, Switzerland and TRENTON, NJ, USA | May 3, 2007 | Chrono Therapeutics Inc. (CTI) announced today the successful completion of its first phase human clinical trial of its programmable, pulsatile, passive transdermal drug/device combination product: ChronoDose(TM). CTI intends to publish this clinical data in leading scientific and medical journals by year end.
CLINICAL STUDY DESIGN
The trial was conducted between February and April 2007 at the University Hospital Basel, Switzerland, Division of Clinical Pharmacology and Toxicology. Georgios Imanidis, PhD, of the University of Basel was the Principal Investigator on behalf of CTI.
This study was an open, randomized, three period, single-center, dose- escalation study. Thirty-six independent human transdermal tests were conducted on male volunteers using wristwatch-like ChronoDose(TM) devices. The trial successfully proved the efficacy of the device on human subjects using its model drug compound. The dose escalation trial showed statistically significant modulation and control of the dosing profiles. Using low, medium and high concentrations, for 16 hours, the model drug permeated each subject's skin on multiple occasions, resulting in clear and distinct peaks and troughs of therapeutically effective and well-targeted blood plasma concentration levels. A non-compartmental and compartmental model based analysis of pharmacokinetics will be utilized. Local and systemic tolerability of the model drug after its transdermal administration was better than planned.
Dr. Georgios Imanidis commented, "CTI has for the first time in transdermal drug delivery history successfully completed a significant human trial with a passive, automated and programmable multiple dosing transdermal device system. We are extremely pleased with the excellent results".
Guy DiPierro, CEO and President of CTI noted, "This solid and convincing clinical data along with initial human data generated last summer will help us to rapidly commercialize our initial drug product. We are particularly pleased that ChronoDose(TM) produced targeted blood plasma concentrations as accurately as it did and at the intended time periods."
SOURCE: Chrono Therapeutics Inc. |
