Articles

PRESS RELEASE
FOR IMMEDIATE RELEASE

CONTACT:

Darrick A. Carter, Ph.D.

Dharma Therapeutics, Inc.

Vice President, Research and Development

206-330-2599

RESULTS OF PHASE 1 CLINICAL TRIAL
SHOWS EXCELLENT SAFETY PROFILE FOR IDDS

Iontophoretic Drug Delivery System, dermal patch and a direct current power source with lidocaine and epinephrine (IDDS)            

SEATTLE, WA – October 5, 2006   Transcutaneous Technologies Inc. ("TTI”), Tokyo, Japan, a transdermal drug delivery company and its wholly owned subsidiary Dharma Therapeutics, Inc. ("Dharma”) Seattle, WA, announced today the successful completion of their first human Phase 1 clinical trial using an active transdermal delivery technology known as iontophoresis, which administers lidocaine and epinephrine through the skin via a mild electric current..

The trial evaluated the safety of the iontophoretic drug delivery system, dermal patch and a direct current power source with lidocaine and epinephrine ("IDDS”) at three dosage levels (as determined by the designed time of administration) to induce dermal anesthesia during a vascular access procedure (I.V. catheter insertion/venipuncture) in adult volunteers.  A subset of the study was included to determine if lidocaine levels in plasma were detectable by standard clinical laboratory methods.

In this clinical study sixty (60) subjects evaluated the level of pain they experienced during venipuncture using an established pain assessment tool, the Visual Analogue Scale (VAS) (e.g.0 = no pain, 10 = maximum pain) method. Evaluations were performed immediately following venipuncture in the untreated control arm and following intravenous I.V. catheter insertion in the treated arm after IDDS patch removal. Pain score evaluations from both scales resulted in statistically significantly less pain for those who used the IDDS device, as compared to the control arm.

The results of the trial and evidence showed that administration of lidocaine and epinephrine was effective in reducing pain associated with a vascular access procedure for all dosing groups.  Pain was eliminated using IDDS and 80% of the subjects in the higher dosing groups would use the system again.

There were no significant adverse events. Adverse events were either systemic or local.

Lifetree Clinical Research, LLC in Salt Lake City, UT conducted the Phase I clinical trial under an IND filed with the Food and Drug Administration (FDA), Division of Anesthesia, Analgesia and Rheumatology Products, Office of Drug Evaluation, Center for Drug Evaluations and Research ("CDER”).  Lifetree Clinical Research has earned a reputation for providing clinical trial support and management in the area of pain management.  For further information, visit their website at: www.lifetreeresearch.com

International Regulatory Consultants, LLC ("IRC”) a clinical research organization (CRO) also based in Salt Lake City, UT conducted this Phase 1 study. IRC is a full service CRO.  IRC offers global clinical development support for Phase 1-3 clinical programs. For further information, visit their website at: www.irc.com.

 "The completion of our first Phase 1 clinical trial in the U.S. for the TTI/Dharma IDDS represents a significant milestone.” stated Steven G. Reed, Ph.D., President of Dharma. "It is an important step forward, and we believe our support for this technology will help advance needle-free drug delivery systems. We are pleased to see increasing evidence of our IDDS's excellent safety profile.

TTI is a biotechnology company focused on drug delivery using its IDDS technology. TTI conducts research at its headquarters in Tokyo, Japan, and at its subsidiary, Dharma in Seattle, WA website. For further information, visit their website at: www.dharmatherpeutics.com

If you have any questions please contact Darrick A. Carter, Ph.D. at 206-330-2599.