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The clinical trial will be conducted by using the drug once a week or once a month for patients with type2 diabetes.
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It will be conducted at approximately 150 centers in 10 countries starting in late September… it also seeks to find out effect on obesity control.
SEOUL, Korea I October 15, 2013 I Hanmi Pharmaceutical (KSE: 128940) will launch multinational phase IIb clinical studies on its biologic drug for diabetes, LAPS-Exendin4, aiming at administering once a week or once a month.
The company said on October 10 that the phase II clinical studies on LAPS-Exendin4, which involve approximately 700 patients with type 2 diabetes or obesity, will be conducted at about 150 centers in a dozen different countries, including the United States, Europe and Korea, starting in late September this year.
The phase II clinical trials are designed to assess safety and efficacy of LAPS-Exendin4 by administering it once a week or once a month, while determining its dose in phase III clinical studies. The clinical studies are also designed to find out whether it is effective for controlling obesity.
Executive Director Kang Ja-hoon, Clinical Study Team at Hanmi Pharmaceutical said, “Comparing to other GLP-1 class diabetic treatments that are already developed or are in development, LAPS-Exendin4 is expected to show the most excellent outcomes in lowering blood glucose and sustaining efficacy.” “The company will exert effort to successfully enter into phase III clinical study based on results of these clinical trials that are designed to comprehensively identify efficacies and safety of once a week or once a month administration as well as obesity control,” added she.
Meanwhile, Hanmi Pharmaceutical has demonstrated LAPS-Exendin4’s safety and efficacy through its phase I clinical study conducted in Korea and separate phase II clinical studies conducted in the United States and Europe.
Clinical studies on LAPS-Exendin4 conducted thus far showed that it provides the longest duration of effect (half life is longer than 150 hours on average) compared to other treatments for patients with type 2 diabetes. And it lowered HbA1c to less than target level in more than 60% of subjects, proving potentiality as an innovative GLP-1 class new drug for diabetes.
Note: LAPS-Exendin4 is a GLP-1 class drug for treating type 2 diabetes that accelerates secretion of insulin when glucose level is elevated. As a new biologic drug combined with LAPSCOVERY, the proprietary technology of Hanmi Pharmaceutical, that can drastically prolong duration of drug effect, its administration interval is extended to up to once a month.
Hanmi Pharmaceutical Co., Ltd.
Established in 1973, Hanmi Pharmaceuticals (KSE: 128940) now is one of the top 5 pharmaceutical companies in Korea, and has been the most R&D focused company with the highest R&D investment for several years. Hanmi Pharm also has worldwide offices in major countries such as China, Japan, Europe, U.S etc. More detail about the company, visit http://www.hanmipharm.com.
SOURCE: Hanmi Pharmaceutical Co
Post Views: 281
-
The clinical trial will be conducted by using the drug once a week or once a month for patients with type2 diabetes.
-
It will be conducted at approximately 150 centers in 10 countries starting in late September… it also seeks to find out effect on obesity control.
SEOUL, Korea I October 15, 2013 I Hanmi Pharmaceutical (KSE: 128940) will launch multinational phase IIb clinical studies on its biologic drug for diabetes, LAPS-Exendin4, aiming at administering once a week or once a month.
The company said on October 10 that the phase II clinical studies on LAPS-Exendin4, which involve approximately 700 patients with type 2 diabetes or obesity, will be conducted at about 150 centers in a dozen different countries, including the United States, Europe and Korea, starting in late September this year.
The phase II clinical trials are designed to assess safety and efficacy of LAPS-Exendin4 by administering it once a week or once a month, while determining its dose in phase III clinical studies. The clinical studies are also designed to find out whether it is effective for controlling obesity.
Executive Director Kang Ja-hoon, Clinical Study Team at Hanmi Pharmaceutical said, “Comparing to other GLP-1 class diabetic treatments that are already developed or are in development, LAPS-Exendin4 is expected to show the most excellent outcomes in lowering blood glucose and sustaining efficacy.” “The company will exert effort to successfully enter into phase III clinical study based on results of these clinical trials that are designed to comprehensively identify efficacies and safety of once a week or once a month administration as well as obesity control,” added she.
Meanwhile, Hanmi Pharmaceutical has demonstrated LAPS-Exendin4’s safety and efficacy through its phase I clinical study conducted in Korea and separate phase II clinical studies conducted in the United States and Europe.
Clinical studies on LAPS-Exendin4 conducted thus far showed that it provides the longest duration of effect (half life is longer than 150 hours on average) compared to other treatments for patients with type 2 diabetes. And it lowered HbA1c to less than target level in more than 60% of subjects, proving potentiality as an innovative GLP-1 class new drug for diabetes.
Note: LAPS-Exendin4 is a GLP-1 class drug for treating type 2 diabetes that accelerates secretion of insulin when glucose level is elevated. As a new biologic drug combined with LAPSCOVERY, the proprietary technology of Hanmi Pharmaceutical, that can drastically prolong duration of drug effect, its administration interval is extended to up to once a month.
Hanmi Pharmaceutical Co., Ltd.
Established in 1973, Hanmi Pharmaceuticals (KSE: 128940) now is one of the top 5 pharmaceutical companies in Korea, and has been the most R&D focused company with the highest R&D investment for several years. Hanmi Pharm also has worldwide offices in major countries such as China, Japan, Europe, U.S etc. More detail about the company, visit http://www.hanmipharm.com.
SOURCE: Hanmi Pharmaceutical Co
Post Views: 281
