Osaka-based AnGes will end a major international Phase III study on peripheral artery diseases gene therapy candidate AMG0001--Collategene (beperminogene perplasmid)--citing high costs as it refocuses on a narrower effort with a revised endpoint of ulcer and pain-at-rest improvement.
The company said it now needs to work with U.S. study sites versed in critical limb ischemia (CLI) to aid patient recruitment for the new effort, AnGes said in a release, adding it is also in talks with the U.S. FDA on trial outlines. Shares listed on the Tokyo Mothers market fell sharply on the news, ending Friday, June 24, at ¥348--compared to ¥467 on June 20.
"This plan is intended to reduce costs and to ensure that the timing of our original plan for submission is maintained," the release said, adding the amended effort would not affect the development of HGF Plasmid in Japan, which is separate from the global study.
“The termination of the ongoing Phase III study is a difficult but necessary decision made to accelerate the global development of HGF Plasmid and to minimize the development costs and timelines," Ei Yamada, president and CEO of the company, said in a statement.
AnGes reported a loss of ¥4.14 billion ($39.6 million) in the financial year ended March 31 and said the impact of the halt was still being assessed.
In February of last year, AnGes announced a partnership with Mitsubishi Tanabe Pharma to market Collategene in Japan, ending ties with Daiichi Sankyo. Mitsubishi Tanabe held exclusive marketing rights in the U.S. in 2012.
Collategene was filed for approval in Japan in 2008 for CLI, but the application was withdrawn in 2010.
The large-scale pivotal trial of around 500 patients started in October 2014 in the U.S. and Europe.
- here's the release