Delay recommended for bluebird's HGB-208 pediatric study

US clinical-stage biotech company bluebird bio (Nasdaq: BLUE) says it has completed the National Institutes of Health (NIH) Recombinant DNA Advisory Committee’s (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio’s LentiGlobin BB305 product candidate in beta-thalassemia major.

The RAC recommendation was to delay initiation of the study in the USA for one to two years. This recommendation has no effect on the HGB-207 protocol plan, the company noted.

“We appreciate the recommendations from the RAC members regarding the HGB-208 pediatric study protocol,” said David Davidson, chief medical officer. “We will take the RAC feedback on the timing of initiating HGB-208 under advisement as we advance the clinical development of our LentiGlobin BB305 product candidate for patients with beta-thalassemia major. The HGB-207 trial protocol did not require further review by the RAC, and we will continue to work closely with the regulatory authorities and our clinical study sites to pursue appropriate accelerated regulatory approval pathways in the US and the EU,” Dr Davidson added.