The recent asthma results landed with a thud, what with no significant clinical benefit seen; but enough surrogate markers wobbled in order to advance it at least in management's eyes. Asthma is a long-shot program, and not worth much at the moment to outside investors. I have to admit I did not like the way the PR was written, well-spun and happy-faced.
But Hep-B and ragweed are the promising programs anyway. Heb-B/iss is potentially therapeutic also. (I believe the PR should say "compares" not "compared", first line, second para.)
Dynavax Announces Completion of Enrollment of Phase II/III Hepatitis B Prophylactic Vaccine Trial
Thursday September 2, 7:01 am ET
BERKELEY, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX - News), today announced that it has completed enrollment and administered the first round of immunizations in a Phase II/III clinical trial of its hepatitis B (HBV) prophylactic vaccine candidate containing Dynavax's Immunostimulatory Sequence (ISS). The study conducted at two study centers in Singapore began enrollment in June.
The double-blind study compared Dynavax's HBV vaccine candidate with GlaxoSmithKline's marketed HBV vaccine, Engerix-B® in 94 subjects. The subjects ranging between 40 and 70 years of age had not previously been immunized against HBV. The full immunization schedule will consist of three injections over six months, with antibody levels measured one month after each injection. The third injection is scheduled to be administered in early 2005.
The primary endpoint of the study will be comparative protective antibody levels measured after the third injection. Comparative protective antibody levels measured after the first injection are a secondary endpoint. The study is being conducted by Dr. Lim Seng Gee at the National University Hospital, and Dr. Chow Wan Cheng, at the Singapore General Hospital.
"We are pleased with the rapid enrollment of this study and are on track to receive interim results from this trial early next year," said Dr. Dino Dina, President and CEO of Dynavax. "If these data show that our HBV vaccine can provide superior protection against HBV infection for this sizeable segment of the population that historically respond poorly to currently marketed vaccines, we will initiate in the first half of 2005 phase III studies that would confirm this efficacy on a larger scale. In parallel, we will test this vaccine more broadly in young adults and adolescents." |
