Navigation Links
TWi Biotechnology Successfully Completes Patient Recruitment for Phase IIb Trial of AC-201 for the Treatment of Type II Diabetes
Date:9/7/2011

TAIPEI, Taiwan, Sept. 7, 2011 /PRNewswire-Asia/ -- TWi Biotechnology, Inc. announces the successful patient recruitment for the multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of AC-201 for the treatment of Type II Diabetes. A combined 240 patients from 13 US sites plus 8 Taiwan sites have been enrolled to the trial. With six-month treatment and one-month follow-up, completion of the trial data analysis is expected in the early second quarter of 2012. The trial's primary endpoint is defined as the change in glycated hemoglobin A1c (HbA1c) from baseline compared to placebo after twenty-four weeks of treatment. In addition, the study is powered to demonstrate additional benefits by monitoring various secondary endpoints including change in lipid profile, change in body weight, change in blood pressure and change in beta-cell function. Meanwhile, by measuring various biomarkers such as interleukin-1Beta, interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-Alpha, high-sensitivity C-reactive protein, plasminogen activator inhibitor-1, transforming growth factor-Beta, and adiponectin, the company is able to stratify different patient groups in terms of clinical response, so as to develop personalized, preventive or therapeutic strategies.

"Through careful planning and execution, we are pleased with the efficient manner in which the twenty-one clinical sites, thirteen in US and eight in Taiwan, have enrolled 240 patients in the phase IIb study within 5 months since its inception, which is 4-month ahead of the expected schedule," stated Dr. M. Sherry Ku, President & CSO of TWi Biotech. "During the previous Phase IIa study, those patients with inadequate blood glucose control by multiple drug combinations of currently available oral anti-diabetic drugs were treated with AC-201 as an add-on therapy. The Phase IIa proof-of-concept study showed a mean reduction of 0.63% for HbA1c (N=56, p<0.05) at the end of 24 weeks treatment period, which is very promising and encouraging. With the positive Phase IIa data and successful completion of enrollment of Phase IIb trial, we are confident that this study shall keep us on track of our projected development timeline for AC-201 and we believe AC-201 will be the first-in-class oral small molecule IL-1Beta inhibitor for treating Type II Diabetes to reach the market. For the future development strategy, we are planning to collaborate with a global partner developing AC-201 as an add-on therapy for the treatment of Type II Diabetes and explore the additional benefits of AC-201 in helping diabetic patients such as protection of kidney function and prevent further cardiovascular events that are major complications for diabetic patients."

About AC-201

AC-201 is the only orally available small molecule modulating the cytokine synthesis of IL-1Beta and in post-transcription and post-translation stage. Reduction of IL-1Beta has been demonstrated to be effective in treating a variety of inflammatory diseases including Arthritis, Diabetic Nephropathy (DN) and Diabetic Mellitus (DM).

About TWi Biotechnology
TWi Biotechnology, Inc. (www.twipharma.com) is a leading biopharmaceutical company based in Taipei, Taiwan. The company is specializing in in-licensing and developing innovative new drugs for unmet medical needs. With the solid experience in regulatory affairs and clinical development, the company can expedite the development process of drug candidates for worldwide market. The company is building its product pipeline through in-licensing of late pre-clinical stage drug candidates from renowned pharmaceutical companies and research/academic institutions. The company has three active therapeutic candidates to treat Type II Diabetes complications, retinopathy cancer and dermatology diseases.


'/>"/>
SOURCE TWi Biotechnology, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Industrial Biotechnology China News 1108
2. Amarantus BioSciences and Generex Biotechnology Collaborate on Cell Therapy for Late Stage Diabetes
3. Summer Street Research Announces Expansion of Research Team with the Addition of Ling Wang, CFA, Senior Biotechnology Analyst
4. Industrial Biotechnology China News 1106
5. Reportlinker Adds White Biotechnology
6. New Jersey Targets Life-Sciences Investors at Worlds Largest Biotechnology Event
7. Reportlinker Adds India Biotechnology in India Industry
8. MKM Partners Hires Biotechnology/Specialty Pharmaceuticals Analyst
9. Reportlinker Adds Industrial Biotechnology China News 1105 - Annual Subscription
10. Reportlinker Adds Future of White Biotechnology in China
11. Asmacure Ltee Appoints Pharmaceutical and Biotechnology Industry Veteran Martin Driscoll as CEO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... ... 2016 , ... PharmApprove announced today the hiring ... for Rare Disorders (NORD). Dorman will lead PharmApprove efforts to work with patients, ... drug regulatory review process. , “Adding Diane Dorman is just the latest in ...
(Date:2/9/2016)... Three-Year Initiative Supports Next Generation of Medical Geneticists and  ... Experiences SHPG ) ... of children born with rare diseases, as well as the future ... a new initiative designed to positively affect the lives of children ... disease care. --> To mark the company,s founding 30 ...
(Date:2/8/2016)... 8, 2016 Should antibiotic bone cement products ... to prevent infection after standard total hip or knee ... ECRI Institute have been fielding a lot lately. ... Bottom Line?" --> "Antibiotic Bone ... --> While there isn,t a simple ...
(Date:2/8/2016)... ... February 08, 2016 , ... Thomas J. Todorow has joined ... President for Corporate Services and the Chief Financial Officer at The Children’s Hospital ... Treasury, Managed Care Contracting, Supply Chain, and Investments. , Prior to joining CHOP ...
Breaking Biology Technology:
(Date:1/20/2016)... Jan. 20, 2016   MedNet Solutions , an ... spectrum of clinical research, is pleased to announce the ... achievements are the result of the company,s laser focus ... eClinical , it,s comprehensive, easy-to-use and highly affordable ... --> Key MedNet growth achievements in 2015 include: ...
(Date:1/18/2016)... , Jan. 18, 2016  Extenua Inc., ... that simplifies the use and access of ubiquitous ... go-to-market partnership with American Cyber.  ... extensive experience leading transformational C4ISR and Cyber initiatives ... integrating the latest proven technology solutions," said ...
(Date:1/13/2016)... ALBANY, New York , January 13, 2016 /PRNewswire/ ... Transparency Market Research has published a new market report ... Share, Growth, Trends, and Forecast, 2015 - 2023. According to ... mn in 2014 and is anticipated to reach US$1,625.8 ... from 2015 to 2023. In terms of volume, the ...
Breaking Biology News(10 mins):