04/05/2007
BASEL, Switzerland and TRENTON, New Jersey, May 4 /PRNewswire/ --
- Trial Convincingly Proves Functionality in Humans of CTI's
Programmable, Pulsatile, Passive Transdermal Drug Delivery Device -
ChronoDose(TM)
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."
ABOUT CHRONO THERAPEUTICS INC.
-- Chrono Therapeutics Inc. (CTI) was founded in late 2003 to become the
global leader in Chrono-Pharmacologically based prescription and OTC
drug delivery.
-- Today CTI is a specialty pharmaceutical company that developing,
manufacturing and commercializing Chrono-Pharmacologically based drug
products.
-- CTI has created and patented the world's first automated and
programmable, passive transdermal drug delivery device-ChronoDose(TM)
-- ChronoDose
-- Dramatically improves therapies
-- Significantly decreases symptoms and side effects
-- Ensures less built-up tolerance to the drug
PATIENT NON-COMPLIANCE
Annually, over 20% of hospital admissions result from patient
non-compliance, costing the healthcare industry over US$100 billion/year.
ChronoDose(TM) offers a revolutionary step forward in guaranteed patient
compliance, especially for the elderly, hospitalized, or the mentally ill.
Contact:
Chrono Therapeutics Inc.
Guy DiPierro, President and Chief Executive Officer
Phone: +1-609-838-2572
Email: Info@ChronoDose.com
Website: ChronoDose.com
Web site: http://www.chronodose.com
Chrono Therapeutics Inc.
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