Replies to post #76734 on Biotech Values

[Preciouslife1]

Dynavax Presents Additional Phase 3 Data for HEPLISAV Hepatitis B Vaccine at EASL Medical Conference

http://finance.yahoo.com/news/Dynavax-Presents-Additional-bw-15037316.html?.v=1

On Monday April 27, 2009, 6:45 am EDT

BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX - News) today announced the oral presentation of additional Phase 3 clinical data for HEPLISAV™ hepatitis B vaccine in a session for late-breaking abstracts at the 44th Annual Meeting of the European Association for the Study of Liver Disease (EASL) in Copenhagen, Denmark. As previously reported, HEPLISAV met its primary endpoint in this Phase 3 trial and demonstrated the vaccine’s potential to provide more rapid and increased protection against hepatitis B viral infection and with fewer doses than the licensed vaccine.

This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults.
The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B® at 0, 1, and 6 months. At each time point, there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.

Treatment Group
Dosing Regimen
Seroprotection Rate (1) at Month

1 2 3 6 7
HEPLISAV 2 doses (0, 1 month) 24% 89% 95%(2) 98% 98%
Engerix-B 3 doses (0, 1, 6 months) 4% 26% 23% 32% 81%(2)


(1) Seroprotection rate – percentage of subjects with anti-HBsAg antibodies ≥ 10 mlU/mL

(2) Primary endpoint

As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener’s granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration. Dynavax is clarifying the remaining regulatory requirements for the potential development and licensure of HEPLISAV in the United States and Europe.

A copy of the presentation is available at http://investors.dynavax.com/events.cfm. Dynavax’s abstract #587659 was titled “A Phase 3 Safety and Efficacy Study Comparing Immunogenicity of Two Doses of Hepatitis B Surface Antigen Combined with Immunostimulatory Sequence with Three Doses of Licensed Hepatitis Vaccine.”

About HEPLISAV

HEPLISAV is a Phase 3 hepatitis B vaccine aimed at unmet medical needs in the vaccination of adults and end-stage renal disease patients by providing rapid and increased protection with fewer doses. HEPLISAV combines Dynavax’s proprietary immunostimulatory sequences (ISS), which target Toll-like Receptor 9, with hepatitis B surface antigen (HBsAg). HEPLISAV targets an estimated $500 million global market opportunity for adult hepatitis B vaccines.

About Hepatitis B

Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccines is critical to reducing the spread of the disease. Current hepatitis B vaccines for adults usually require 3 doses given over 6 months to provide seroprotection of approximately 30%, 75%, and 90% after the first, second, and third doses respectively. The effectiveness of current vaccines is further compromised because only 30% of people receive all 3 doses.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.

[mlkrborn]

Flue index by tickerspy up !!!
Swine Flu Index Jumps on Pandemic Fears

* the tickerspy.com Staff
* On Monday April 27, 2009, 1:12 pm EDT



* Alpha Pro Tech Ltd.
* , BioCryst Pharmaceuticals Inc.
* , Generex Biotechnology Corp.

Swine flu headlines sent vaccine producers and related stocks flying on Monday as investors bought up shares.
Related Quotes
Symbol Price Change
APT 1.80 +0.44
Chart for ALPHA PRO TECH
BCRX 3.87 +1.66
Chart for BioCryst Pharmaceuticals, Inc.
GNBT 0.4954 +0.1604
Chart for Generex Biotechnology Corporati
HEB 0.77 +0.19
Chart for HEMISPHERX BIOPHARMA
NVAX 2.97 +1.55
Chart for Novavax, Inc.
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The latest pandemic fear is driving multiple sectors of the market today. Some of the largest gains are in the biotech industry, which has some exposure to antiviral drug makers. If the disease spreads as rapidly as some fear it will, vaccine companies will rake in profits. Some of the day's best performances come from companies involved with avian and swine flu vaccine production.

As a whole the Swine Flu and Bird Flu Stocks Index is up by 20%. It is now beating the S&P 500 by 26% this month.

Leading the index higher today is Novavax (NASDAQ: NVAX - News), up by more than 110%. The company claims it can reduce its avian flu vaccine's production time by 50%, allowing for quicker response if swine flu spreads.

BioCryst Pharmaceuticals (NASDAQ: BCRX - News) is also shooting higher today on swine flu fears. The stock is up by more than 77%. Vical (NASDAQ: VICL - News) is also benefiting from potential vaccine demand, up by 14%.

Pure Bioscience (NASDAQ: PURE - News) and Generex Biotechnology (NASDAQ: GNBT - News) are both up by more than 48%.

On the AMEX several flu stocks are trading higher by more than 30%, including Alpha Pro Tech (AMEX: APT - News), Hemispherx Biopharma (AMEX: HEB - News), and Sinovac Biotech (AMEX: SVA - News).

Most of the stocks in the index are also experiencing a huge volume spike of more than 10 times the daily average.

As of this writing the Swine Flu and Bird Flu Stocks Index is one of the top-10 performing tickerspy Indexes this month, up by 34%.