Dynavax Initiates Large-Scale Phase III Trial of HEPLISAV™
News Feb 09, 2010
Dynavax Technologies Corporation announced initiation of a large-scale Phase III trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV™, the Company's investigational adult hepatitis B vaccine.
This study and the ongoing Phase III trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. HEPLISAV has been shown in two pivotal Phase III trials to enhance protection and with fewer doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll 2,000 patients in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B®, a currently licensed hepatitis B vaccine. The primary objectives are:
• Non-inferiority of the immune response to HEPLISAV vaccination as measured by the seroprotection rate at 8 weeks after the last active dose, compared to Engerix-B vaccination at 8 weeks after the last active dose; and
• Lot-to-lot consistency for immune response as measured by geometric mean concentration at 4 weeks after the last active dose among 3 consecutively manufactured lots of HEPLISAV.
The secondary objectives include the safety of HEPLISAV as compared to Engerix-B.
Data from this trial is expected in the first half of 2011. The hepatitis B surface antigen in the HEPLISAV lots being evaluated was produced in Dynavax's manufacturing facility in Duesseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.
Advanced Prostate Cancer: EMA Approves Abiraterone Combined With Hormone Therapy as First-line TreatmentNews
The prostate cancer drug abiraterone has been approved by the European Medicines Agency in combination with standard hormone therapy for use as a first-line treatment for advanced prostate cancer.READ MORE
Diabetes Drug Could Be Re-purposed to Help End Transplant RejectionNews
A diabetes drug currently undergoing development could be repurposed to help end transplant rejection, without the side-effects of current immunosuppressive drugs.READ MORE
Study Shows Cancer Patients Are Choosing Less Severe Side Effects Over Treatment EfficacyNews
When choosing their preferred treatment, people with chronic lymphocytic leukemia (CLL) place the highest value on medicines that deliver the longest progression-free survival, but are willing to swap some drug efficacy for a reduced risk of serious adverse events according to a new study.READ MORE