Dynavax Technologies Corp. (DVAX) has announced that it intends to present a detailed analysis of safety data on Heplisav, the company’s most advanced pipeline candidate.
Dynavax provided encouraging data on Heplisav’s safety profile. The company reported that the candidate’s safety profile was comparable to that of GlaxoSmithKline’s (GSK) Engerix-B. Moreover, no difference was observed in autoimmune adverse events or laboratory markers of autoimmunity in patients receiving Heplisav and Engerix-B.
Dynavax will present the data on Heplisav at the Drug Information Association’s (DIA) Third Oligonucleotides-based Therapeutics Conference. The safety data was originally prepared for submission to the US Food and Drug Administration (FDA) as part of extensive documentation that formed the basis upon which Heplisav’s clinical development was allowed to resume in late 2009.
Heplisav, an investigational adult hepatitis B vaccine, is being developed for large, high-value populations that are less responsive to currently available vaccines. This includes people with chronic kidney disease.
The candidate is currently in two phase III studies. One of them is a large-scale study, designed to enroll 2,000 patients in Canada and the United States. Out of the 2,000 patients, 1,600 will be treated with Heplisav, while the remaining patients will receive Engerix-B. The large-scale study intends to show that Dynavax’s HBV vaccine is just as effective as Engerix-B eight weeks after the last active dose.
Dynavax is evaluating Heplisav in patients with chronic kidney disease in the other late-stage trial. These two studies are aimed at fulfilling licensing requirements in the U.S., Canada and Europe. Heplisav aims to provide increased and rapid protection, utilizing fewer doses than currently available vaccines.
A lower vaccine regimen could help Dynavax’s vaccine gain share from currently available hepatitis B vaccines which need to be administered in three doses over a period of six months in healthy patient populations. A lower vaccine regimen would lead to increased patient compliance.
Dynavax expects to report data from the phase III studies in mid-2011. Positive results should allow Dynavax to file for approval in the third quarter of 2011, six months ahead of earlier expectations.
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