Dynavax Initiates Phase I Trial of Hepatitis B Therapy
- Category: Vaccines
- Published on Friday, 02 March 2007 02:00
- Hits: 2615
BERKELEY, CA, USA | Mar 01, 2007 | Dynavax Technologies Corporation (Nasdaq: DVAX) today announced that it had initiated a Phase 1 trial of its novel therapy for chronic hepatitis B virus (HBV) infection. The trial is being conducted in Hamburg, Germany and will enroll 20 healthy subjects to evaluate the safety of the therapy at two dosing schedules. The novel HBV therapy combines, for the first time, the surface and core antigen of HBV, manufactured at Dynavax Europe. Results are expected in the second half of 2007.
According to Dr. Eduardo Martins, VP, Clinical Development, "The trial represents the first evaluation of this therapeutic approach in humans. In addition to verifying safety, we will measure subjects' T-Cell responses to evaluate whether the vaccine demonstrates the same pharmacologic effects as those seen in animal models, namely the induction of virus-specific cellular immune responses."
Dynavax indicated that the hepatitis B therapy trial is the second of several trials slated to enter the clinic with funding from Symphony Dynamo, Inc. (SDI). In April, 2006, SDI committed $50 million to Dynavax to advance its cancer program and both its therapies for chronic hepatitis B and chronic hepatitis C into human clinical trials. Dynavax announced the initiation of its SDI-funded Phase I cancer program in metastatic colorectal cancer in late 2006.
More than 350 million people worldwide are chronically infected with hepatitis B. Approximately 25% of individuals with chronic hepatitis B infections die prematurely from cirrhosis or liver cancer. Current treatment for hepatitis B involves lengthy cycles of antiviral medication or injected interferon-alpha and rarely results in resolution of the infection.
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our pipeline includes: HEPLISAV(TM), a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapeutic; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. NIH partially funds our preclinical work on a vaccine for influenza; Symphony Dynamo, Inc., funds our colorectal cancer and hepatitis B therapy trials and our preclinical hepatitis C therapeutic program. While the NIH and Symphony provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our hepatitis B therapy product candidate, clinical development plans and timelines and business plans. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
SOURCE Dynavax Technologies Corporation