Dynavax Technologies Corporation (DVAX) announced that it completed the planned enrolment in the ongoing clinical trial, HBV-23, on experimental hepatitis B vaccine, Heplisav-B.
We note that in Apr 2014, Dynavax commenced HBV-23 on Heplisav. HBV-23 is a large safety and immunogenicity study, which is designed to address the complete response letter (CRL) issued by the FDA in Feb 2013.
The FDA asked for additional safety data in its meeting with the company to discuss the CRL issued in 2013.
This study will provide an adequate safety database to support licensure. The phase III study will evaluate the overall safety and immunogenicity of Heplisav as compared to GlaxoSmithKline’s (GSK) Engerix-B in patients aged 18 to 70 years.
The study will also evaluate the immunogenicity of Heplisav-B in patients who did not respond well to currently approved Hepatitis B vaccines. Dynavax enrolled more than 8,250 adults for the study at 40 sites in the U.S.
The subjects enrolled for the study were randomized in a 2:1 ratio to receive either a two-dose series of Heplisav-B or a three-dose series of the control vaccine, Engerix-B. The safety follow-up will continue for 12 months following each subject's second vaccination. The study visits will be completed by Oct 2015.
Presently, Dynavax does not have any marketed product in its portfolio. Hence, we expect investor focus to remain on Heplisav-B.
Dynavax carries a Zacks Rank #3 (Hold). Some better-ranked stock in the health care sector includes Jazz Pharmaceuticals (JAZZ) and Pacira Pharmaceuticals (PCRX). Both carry a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment