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
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, dermal patch and a direct current power source with lidocaine and epinephrine (IDDS)
SEATTLE, WA – March 20, 2007 - Dharma Therapeutics, Inc., (“Dharma”) Seattle, WA, a transdermal drug delivery company and wholly owned subsidiary of Transcu Ltd., Inc. (“Transcu”), Singapore 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 ranging in age from 18 to 57 years old 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 into the posterior surface of the subject’s hand. 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%, a highly significant reduction in perceived pain (p ≤ 0.01). 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 (p < 0.05). 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 < 0.01). Following treatment with placebo, 44% of subjects reported moderate to severe pain (VAS score ≥ 30) while only 8% of the subjects in the Treatment Arm reported moderate pain. The treatment was safe and well-tolerated with no significant adverse effects reported in any subject. Further, the iontophoresis procedure was successfully completed in all subjects in the Treatment Arm.
“We are very encouraged and pleased that we have been able to confirm the results of our Phase 1 clinical study that was completed in September 2006. In our current Phase 2 trial we have demonstrated in a randomized placebo controlled study that brief treatment with the IDDS is capable of providing significant pain relief to subjects undergoing intravenous catheterization” said Darrick A. Carter, Ph.D., Vice President of Research and Development at Dharma. “Moreover, nearly all subjects were reported to find the IDDS acceptable treatment demonstrating not only its therapeutic effects, but overall acceptability for administrating topical anesthesia. Given these results, we are intensifying and expanding our development efforts to study the potential clinical efficacy of the IDDS in other applications. We plan to rapidly initiate a clinical trial evaluating the IDDS to provide local anesthesia for patients undergoing dermatological procedures and development for Phase 3 pivotal studies is underway.”
Transcu is a biotech company focused on drug delivery using its IDDS technology. Transcu conducts research in Tokyo, Japan and at its subsidiary, Dharma in Seattle, WA. For further information, visit Dharma’s website at: www.dharmatherapeutics.com
If you have any questions please contact Paul Sleath, Ph.D. at 206-330-2591 or at info@dharmatherapeutics.com.
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, a transdermal drug delivery company and wholly owned subsidiary of Transcu Ltd. ("Transcu"), Singapore 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 as well as the duration of anesthesia.
In this clinical study sixty (60) subjects evaluated the level of pain they experienced during venipuncture by rating their pain from 0 (no pain) to 10 (maximum pain imaginable). 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. 3.3 % of the subjects (2 of 60) had mild adverse reactions and 1.7 % of the subjects (1 of 60) reported a moderate adverse reaction to treatment with the system.
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.
"The completion of our first Phase 1 clinical trial in the U.S. for the Transcu/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."
Lifetree Clinical Research® in Salt Lake City , UT conducted the Phase 1 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 info rmation, visit their website at: www.lifetreeresearch.com
International Regulatory Consultants, L.C. ("IRC") a full service regulatory consultancy and specialty clinical research organization (CRO) also based in Salt Lake City , UT conducted this Phase 1 study. IRC is a full service CRO specializing in unique clinical studies. IRC offers global clinical development support for Phase 1-3 clinical programs. For further info rmation, visit their website at: www.irclc.com .
Transcu is a biotechnology company focused on drug delivery using its IDDS technology. Transcu conducts research in Tokyo, Japan and at its subsidiary, Dharma Therapeutics, Inc. in Seattle , WA. For further information, visit their website at: http://www.transcu.com/
If you have any questions please contact Paul Sleath, Ph.D. at 206-330-2591 or at info@dharmatherapeutics.com