Safflower-Produced Insulin Nears Human Clinical Trials in US
August 1, 2008| |
SemBioSys Genetics Inc. recently announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). An IND is necessary for a new drug's early preclinical development. "All of our studies to date confirm that our safflower-produced insulin is equivalent to pharmaceutical-grade human insulin. We met our internal schedule to submit the IND and we are on track to begin human clinical trials in the fourth quarter of 2008 as planned," said Andrew Baum, president and chief executive officer of SemBioSys.
The company also intends to submit a Clinical Trial Application (CTA) to the appropriate European authorities later this quarter. Assuming approval of the CTA, SemBioSys plans to conduct a Phase I/II trial in the UK.
To read more, visit http://micro.newswire.ca/release.cgi?rkey=1607298075&view=36078-0&Start=0.
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