US Patent Granted To Chrono Therapeutics Inc. For Its Chrono-Pharmacological Drug Delivery Systems And Applications.
Patent Protection extends at least to 2025
Release Date: 6/2/2010
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Chrono Therapeutics Inc. receives notification from the European Patent Office that an additional key patent for CHRONODOSE™ has been granted. This new patent grant affirms the novelty of CTI’s technology and believes it will considerably reduce any potential risk to the CTI group.
Chrono Therapeutics Inc. is featured in Transdermal Magazine.
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Human Clinical Trials
CTI has recently completed a successful human clinical trial for its first drug product
CTI is in advanced stage clinical-stage development for its initial drug product. The market for this drug product is estimated to soon exceed $5 billion. We first conducted initial preliminary human trials for this lead drug product at the University of Basel and the Basel Hospital.
After obtaining successful preliminary human data, CTI conducted a complete human clinical trial in 2007 at the University Hospital Basel, Switzerland, Division of Clinical Pharmacology and Toxicology.
The final report containg this data was carefully reviewed by world leading physicians, clinical pharmacologists, and specialists in specific therapeutic areas. By all accounts, this human data was outstanding. Our drug product had a high degree of accuracy and reproducibility.
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™ 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 was utilized. Local and systemic tolerability of the model drug after its transdermal administration was better than planned.
We are currently planning our second human clinical trial on the same compound. We are also planning our preliminary human tests on our second drug product.