Positive Hepatitis B Prophylaxis Data

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Dynavax and Triangle Announce Positive Hepatitis B Prophylaxis Data   



20 Dec 2001



Dynavax Technologies and its partner, Triangle Pharmaceuticals have announced positive results for a Phase I/II trial for hepatitis B prophylaxis.



The double blind study compared hepatitis B surface antigen (HBsAg) alone and coadministered with Dynavax' proprietary immunostimulatory DNA sequences (ISS). At the highest dose tested, the coadministered vaccine produced protective antibody titers in 88% of subjects after a single immunization. Over all dose levels, 31 of 32 subjects had protective antibody levels after two doses delivered in a two-month regimen. The vaccine was generally well tolerated with the exception of mild injection site pain.



The principal investigator for the trial is Dr. Scott Halperin, M.D. of Dalhousie University and the IWK Health Centre in Halifax, Nova Scotia, Canada.



Dr. Halperin said, "This result is remarkable when you consider that commercially available vaccines require up to three immunizations over a period of six months before achieving this level of seroprotection. This new vaccine candidate has the potential to improve on the major problems with the current vaccines -- the number of immunizations, poor compliance in completing the regimen, time to seroprotection and percentage of non-responders."



In the study, 48 subjects received two immunizations over a two-month period. The active arm consisted of four groups of eight subjects each receiving two immunizations of HBsAg and ISS. The ISS dosage in these groups was 300, 650, 1,000 and 3,000 micrograms. After a single immunization at the 3,000 microgram dose level, seven of eight subjects achieved antibody titers that are considered protective, with a geometric mean titer (GMT) over 200 mIU/ml. The 3,000 microgram group had a GMT of over 3,000 mIU/ml after the second immunization. Only one subject from the lowest dose group failed to achieve a protective titer after the second immunization. 31 of 32 subjects reached protective titers, representing 100% protection of the subjects from the 650, 1,000, and 3,000 dose levels.



Dino Dina, M.D., chief executive officer of Dynavax Technologies said, "Our ISS vaccine candidate has the potential to be a single injection product which provides protection shortly after immunization. We believe this to be the only HBV vaccine under development that can produce significant levels of immunity with a single injection. The high response rates coupled with the excellent tolerability profile indicate that our ISS oligonucleotide technology may be superior to that used in other hepatitis B candidate vaccines. We expect to move directly to pivotal trials beginning in 2002."



David W. Barry, M.D., chief executive officer of Triangle Pharmaceuticals said, "Triangle is committed to developing therapies for hepatitis B. This result highlights the potential of our collaboration with Dynavax toward a commercialized product. This also represents a first step toward developing a therapeutic vaccine for use in combination with Triangle's antiviral drug candidates."



Dynavax Technologies is a privately held biopharmaceutical company developing innovative products to treat allergy, inflammation-mediated diseases, infectious diseases and cancer.



Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the development of new antiviral drug candidates, with a particular focus on therapies for the human immunodeficiency virus (HIV) and hepatitis.

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