Dharma Therapeutics

Dharma in the News

July 2009

IONTOPHORETIC DRUG DELIVERY SYSTEM (IDDS) CONTAINING LIDOCAINE AND EPINEPHRINE IS EFFECTIVE IN REDUCING PAIN ASSOCIATED WITH INSERTION OF AN INTRAVENOUS CATHETER IN A PHASE 2 CLINICAL TRIAL

SEATTLE, WA – July 9, 2009 - Dharma Therapeutics, Inc., (“Dharma”) Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, has demonstrated safety and efficacy in a Phase 2 clinical trial.

About the Trial:

The trial conducted was a Phase 2, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and efficacy of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Eighty-nine (89) healthy volunteer subjects were treated at two clinical sites.  The trial included subjects representing a wide range of ages and ethnicity.  Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Active arm) or epinephrine alone (Placebo arm) at the site of insertion of an intravenous catheter. After placement of the intravenous catheter, subjects evaluated their pain using the Visual Analog pain Scale (VAS) scoring system and were asked if they would use the IDDS again. Safety of the treatment was also monitored during the trial.

Results:

In the Per-Protocol population (including subjects completing 8 minutes of treatment) the mean Visual Analog pain Scale (VAS) results recorded by the subject following the venipuncture procedure were 16.4 mm for the Active treatment versus 24.0 mm for the Placebo treatment (p=0.0235).  Therefore, the trial demonstrated statistically lower VAS scores for the Active group as compared to the Placebo group.  In addition, more than 80% of the Active group reported pain elimination and willingness to undergo IDDS treatment again.  The IDDS treatment was well tolerated, with no serious adverse event reported in any subject.

 “This represents a major advancement for Dharma and the Transcu Group” said Paul R. Sleath, President and CEO of Dharma Therapeutics.  “We are very excited about this product and the improvements over Dharma’s prototype evaluated in earlier clinical trials.  Our current design is very user friendly and can be manufactured cost efficiently at commercial scale.  We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product.”

Dharma has an end-of-phase 2 meeting scheduled with the Food and Drug Administration for this fall and plans to embark on pivotal Phase 3 trials in early 2010.

For further information, please contact:  Paul R. Sleath, President and CEO at psleath@dharmatherapeutics.com or by telephone at 206-330-2591.

 

May 2009

DHARMA THERAPEUTICS INITIATES PHASE 2B STUDY TO REDUCE PAIN ASSOCIATED WITH INSERTION OF AN INTRAVENOUS CATHETER

SEATTLE, WA -- May 18, 2009 - Dharma Therapeutics, Inc. ("Dharma"), Seattle, WA, a transdermal drug delivery company and wholly owned subsidiary of Transcu Ltd., Inc. ("Transcu"), Singapore, announced today that its active transdermal delivery technology, which delivers lidocaine and epinephrine through the skin via a small electric current, has entered Phase 2B clinical studies.

About the Trial:

The trial is a Phase 2B, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and effectiveness of the administration of lidocaine and epinephrine using Dharma's Iontophoretic Drug Delivery System (EDDS) to provide topical anesthesia in adults undergoing a venipuncture procedure.  Ninety (90) healthy adult volunteer subjects will be treated at two clinical sites.  Subjects will be randomized to receive and 8 minute administration of lidocaine plus ephinephrine (Treatment Arm) or ephinephrine alone (Placebo-Control Arm) in the posterior surface of the hand before insertion of an intravenous catheter into this site.  After placement onf the intravenous catheter, subjects will be asked to evaluate their pain using a standardized scoring system and will be asked if they would use the IDDS again.  Safety of the treatment will also be monitored.

"We anticipate that the results from this study will confirm the results of an earlier phase 2 study, that was conducted using and earlier prototype of our iontophoresis system," said Paul R. Sleath, Ph.D., President and CEO at Dharma.  "The product currently being evaluated has been re-designed to facilitate high volume, low cost manufacture and is also designed ot be user friendly."

 

November 2008

DHARMA’S PARENT COMPANY, TRANSCU, COMPLETES REVERSE TAKEOVER WITH ENG WAH

SINGAPORE – 14 November 2008 – Transcu Group Limited is pleased to announce that the reverse takeover (“RTO”) of Eng Wah Organisation Limited (“Eng Wah”) has been successfully completed today. The completion was made possible when the shareholders of Eng Wah voted favourably with overwhelming margin for the acquisition at Eng Wah's extraordinary general meeting (“EGM”) held on 7 November.

As completion of the RTO took place today, Eng Wah is renamed as Transcu Group Limited and its shares continue to be listed on the Singapore Exchange (“SGX”).

Our current operating entity, Transcu Ltd, is the wholly owned subsidiary of Transcu Group Limited. TTI ellebeau Inc. and Dharma Therapeutics Inc. continue to remain as the wholly owned subsidiaries of Transcu Ltd.

For further information, visit Transcu's website at: www.transcu.com.sg

 

March 2007

DHARMA THERAPEUTICS SHOWS IDDS IS EFFECTIVE IN REDUCING PAIN ASSOCIATED WITH INSERTION OF AN INTRAVENOUS CATHETER IN THEIR PHASE 2 CLINICAL TRIAL

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

SEATTLE, WA – March 20, 2007 - Dharma Therapeutics, Inc., (“Dharma”) Seattle, WA announced that its active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, was safe and effective in delivering topical anesthesia in 8 minutes.

About the Trial:

The trial was a Phase 2, double-blind, randomized, placebo-controlled, two-arm study evaluating the safety and effectiveness of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Seventy one (71) healthy volunteer subjects were treated at a single clinical site. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Treatment Arm) or epinephrine alone (Placebo-Control Arm) at the site of insertion of an intravenous catheter. After placement of the intravenous catheter, subjects evaluated their pain using the VAS scoring system and were asked if they would use the IDDS again. Investigators also evaluated the subjects’ level of pain and whether or not IDDS treatment was acceptable to the subjects. Safety of the treatment was also monitored.

Results:

Median VAS scores were reduced by 58%,. The majority of subjects in the Treatment Arm reported elimination of their pain, while only a minority of subjects in the Placebo-Control Arm reported pain elimination. Thirty four of thirty six subjects (94%) in the Treatment Arm reported that they would use the IDDS again compared to 21 out of 34 subjects (62%) in the Placebo-Control Arm (p = 0.001). In addition, investigators reported that 34 out of 36 subjects (94%) in the Treatment Arm found the IDDS treatment acceptable, which was significantly higher than the Placebo-Control Arm (p < 0.01The treatment was safe and well-tolerated with no significant adverse effects reported in any subject.

 

October 2006

RESULTS OF PHASE 1 CLINICAL TRIAL SHOW 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 24, 2006 Dharma Therapeutics, Inc., ("Dharma") Seattle, WA, announced today the successful completion of their first 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.

About the Trial:

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 as well as the duration of anesthesia.

Results:

In this clinical study sixty (60) subjects evaluated the level of pain they experienced during venipuncture. 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 significant less pain for those who used the IDDS device, as compared to the control arm.

The IDDS has an excellent safety profile. During the trial, no significant adverse events were recorded. The results of the trial and evidence show that administration of lidocaine and epinephrine is effective in reducing pain associated with a vascular access procedure for all dosing groups. Pain was eliminated using the IDDS and 80% of the subjects in the higher dosing groups would use the system again.

For more information about clinical trials please refer to http://www.clinicaltrials.gov