U.S. authorities have recently permitted Dynavax Technologies Corp to resume trials of
Hepatitis B vaccine. As a result, 73% of the Company's shares went up in the pre-market trading.
Last November the company's shares dropped to 15 cent each that equal to more than $10.00 per a share at the end of 2006. In the pre-marketing trading the company received $3.03 up in Wednesday close deal of $1.75. The investors in Heplisav vaccine shall be pleasantly surprised with the news that after 18 months on clinical hold the product for safety by the USA Food and Drug Administration there has been given the permit for Dynavax to start immunization of the patients suffering from chronic kidney illness and obtaining negative results of treatment from the current medicine.
Actually there is no cure for liver cirrhosis led with hepatitis B. Nowadays there is Engerix-B vaccine produced by GlaxoSmithKline Plc and available at the market. But Heplisav could be more effective with fewer dosage and administration that Engerix-B as Dynavax specialists considered.
Last march it happened that Heplisav was frozen by the FDA. The reason was the case of Wegener's granulomatosis that was developed in a patient that affected blood vessels and caused extensive tissue damage. The genetically engineered viral antigen with adjuvant is in content of Heplisav for the vaccine creation. Adjuvant designed to improve the efficiency of antigen targets Toll-like receptor 9, a protein that instructs the immune system for self-activation.
The final phase of the vaccine study has been done by Dynavax established in Berkeley, California with announcement to enroll patients in the testing for comparison the vaccine produced for commercial purposes with the vaccine produced for clinic trials. The subject for this study is to ensure the both vaccines are similarly effective.
For development of unique influenza vaccine used against seasonal and pandemic flu different forms of its adjuvant is used by Dynavax in the pre-clinical development these days.