SemBioSys to proceed with Phase I/II study
Добавлено: 18.09.2008, 11:50
Sep 17, 2008 (Datamonitor via COMTEX) -- SMBGF | Quote | Chart | News | PowerRating -- SemBioSys Genetics has announced that it is eligible to proceed with its planned Phase I/II human clinical trial of plant-produced insulin now that the 30-day review period of its investigational new drug application has passed.
SemBioSys submitted the application in July 2008 to the FDA, which has now completed its review of the file. SemBioSys intends to conduct the Phase I/II insulin trial in Europe.
SemBioSys plans to initiate a Phase I/II human trial of its safflower- produced insulin in the UK during the fourth quarter of 2008. Prior to proceeding with the trial, the company must await clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
SemBioSys's planned Phase I/II human clinical trial is designed to enroll up to 30 healthy volunteers in a three-arm study to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products.
Separately, the FDA has advised SemBioSys that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) approval process.
Andrew Baum, president and CEO of SemBioSys, said: "The purpose of filing an investigational new drug application in the US, even though we intend to conduct the trial in Europe, is to ensure that we can pursue US and European regulatory approval of our plant-produced insulin contemporaneously.
"Conducting the planned insulin trial in Europe allows us to establish the bioequivalence of our safflower-produced insulin to commercially available insulin products from both the US and Europe in a single trial."
SemBioSys submitted the application in July 2008 to the FDA, which has now completed its review of the file. SemBioSys intends to conduct the Phase I/II insulin trial in Europe.
SemBioSys plans to initiate a Phase I/II human trial of its safflower- produced insulin in the UK during the fourth quarter of 2008. Prior to proceeding with the trial, the company must await clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
SemBioSys's planned Phase I/II human clinical trial is designed to enroll up to 30 healthy volunteers in a three-arm study to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products.
Separately, the FDA has advised SemBioSys that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) approval process.
Andrew Baum, president and CEO of SemBioSys, said: "The purpose of filing an investigational new drug application in the US, even though we intend to conduct the trial in Europe, is to ensure that we can pursue US and European regulatory approval of our plant-produced insulin contemporaneously.
"Conducting the planned insulin trial in Europe allows us to establish the bioequivalence of our safflower-produced insulin to commercially available insulin products from both the US and Europe in a single trial."