Dynavax Reports Interim Analysis of Ongoing Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis
- Demonstrated seroprotection rate of 86.4% at week 20 after 4 standard doses of HEPLISAV-B
- Safety data showed HEPLISAV-B was well tolerated
- Company to host webinar review of data
Thursday, April 30, 2020at 1:00 p.m. ET/10:00 a.m. PT
Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis, showed HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients. Full study data are anticipated in the second half of 2020.
“We are pleased with these interim results from the hemodialysis trial which reinforce the existing clinical data set regarding the safety and rates of protection provided by HEPLISAV-B,” commented
The study, HBV-24, is an ongoing, open-label, single-arm trial being conducted in
As a result of the cancellation of the NFID ACVR,
To view this poster and the additional
Please see Important Safety Information below.
For more information about HEPLISAV-B, visit http://heplisavb.com
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here
This press release contains forward-looking statements, including statements regarding use of HEPLISAV-B in adults undergoing hemodialysis. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether and when the clinical study will be completed and what the final results will reflect. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Dynavax in general, see risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
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Source: Dynavax Technologies Corporation