Navigation Links
Dynavax Begins TOLAMBA(TM) Environmental Exposure Chamber Study
Date:10/22/2007

BERKELEY, Calif., Oct. 22 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today reported that it had begun dosing of TOLAMBA(TM), its novel ragweed allergy therapy, to subjects as part of an environmental exposure chamber study that is expected to enroll a total of 300 subjects. Subjects are being screened based on a history of ragweed allergy and a positive skin test. Exposure to ragweed allergen in the chamber is being used to select those individuals with confirmed ragweed allergic disease and establish their baseline level of symptoms. Subjects are being treated and will be re-exposed in the chamber to determine the effect of the six-week, six-injection TOLAMBA regimen as compared to placebo. Data from this study are expected in the first half of 2008 and, if positive, will be followed by a pivotal field study in the 2009 ragweed season, with a potential BLA submission planned for 2010.

FINANCING SUMMARY

On July 18, 2007, Dynavax announced that Deerfield Management, a healthcare investment fund, had committed up to $30 million in loan-based project financing to accelerate the development of Dynavax's allergy franchise, including TOLAMBA and the preclinical peanut and cat allergy programs. Repayment of a portion of the loans for TOLAMBA is contingent upon the positive outcome of the chamber study. If the TOLAMBA program is discontinued, Dynavax has no obligation to repay Deerfield up to $9 million of the funds earmarked for that program; any other remaining outstanding principal will be due in July 2010.

The initiation of dosing in the TOLAMBA chamber study triggered the release of additional funding to Dynavax pursuant to the loan agreement, as well as the issuance of warrants to Deerfield and its affiliates to purchase an aggregate of 1.3 million shares of Dynavax common stock at an exercise price of $5.75 per share.

ABOUT TOLAMBA

TOLAMBA consists of Dynavax's proprietary immunostimulatory sequences (ISS) linked to the purified major allergen of ragweed, Amb a 1. TOLAMBA is designed to target the underlying cause of ragweed allergic rhinitis. The linking of ISS to Amb a 1 ensures that both ISS and ragweed allergen are presented simultaneously to the same immune cells, producing a highly specific and potent inhibitory effect and suppressing the Th2 cells responsible for inflammation associated with ragweed allergy. Since ragweed is the most common cause of seasonal allergies, commercialization of a disease-modifying therapy versus drugs that only offer short-term symptomatic relief could dramatically impact the quality of life for the approximately 40 million ragweed allergy patients in the US.

ABOUT DYNAVAX

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 product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapy in Phase 2; a therapy metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program and Deerfield has committed funding for our allergy programs. While Deerfield, NIH and SDI 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 the initiation and timing of clinical trials and potential pivotal studies and BLA submission for TOLAMBA. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in research and development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; achieving our collaborative and licensing agreement objectives and obtaining regulatory approval; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our 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
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
8. Protox Announces Positive Clinical Data from Prostate Cancer Study
9. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
10. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
11. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
Breaking Medicine News(10 mins):