ActoGenix Raises 11.5 Million Euro's In Series A Stock Financing

ActoGeniX NV, a recently founded biopharmaceutical company, announced the successful closing of its Series A financing round, raising €11.5 million (US$15 million) from a syndicate of leading life sciences investors. The transaction was co-led by GIMV (Antwerp, Belgium) and Life Sciences Partners (LSP, Amsterdam, The Netherlands), with Biotech Fund Flanders also participating. ActoGeniX is a spin-off from the Flanders Interuniversity Institute of Biotechnology (VIB) and Ghent University and was founded last June with seed capital from GIMV, VIB and individuals of the management team.

This financing will allow ActoGeniX to initiate development of a pipeline of therapeutic products based on its TopActTM technology platform. TopActTM is a proprietary delivery system comprising living non-pathogenic micro-organisms for the oral administration of biopharmaceuticals. VIB and Ghent University, the original inventors of this technology, transferred to ActoGeniX the TopActTM patent portfolio. ActoGeniX' products will address a broad range of diseases, including gastrointestinal diseases, auto-immunity, allergy and metabolic diseases. The Company's lead product for the treatment of Crohn's disease has already been successfully tested in patients.

Dr. Mark Vaeck, who joined the company as CEO, brings considerable experience in the start-up and growth of biotech businesses in Europe and the USA. In his former position, as the co-founder and CEO of Ablynx NV (Ghent, Belgium) he raised €30 million in equity financing and concluded several corporate deals with major pharmaceutical companies. Dr. Bernard Coulie joins ActoGeniX as Vice President Research & Development coming from Johnson & Johnson Europe where he held the position of Therapeutic Area Leader Internal Medicine. Dr. Lothar Steidler, the principal inventor of the TopAct technology, will become Director Technology Development at ActoGeniX.

Commenting on the financing, Mark Vaeck said: 'I am delighted with the completion of this successful financing round, which provides ActoGeniX from the start with a substantial amount of money from high-quality and knowledgeable biotech investors, which is a clear endorsement of the future potential of this company. ActoGeniX is now well-positioned to execute its ambitious business plan and quickly build a valuable portfolio of preclinical and clinical-stage products based on its proprietary TopActTM platform.'

'We have built a proprietary position around the TopAct technology and products and we are glad to be able to transfer this platform into the hands of an experienced management team, supported by highly reputed international venture capital funds' said Rudy Dekeyser, vice-general director of VIB. 'We strongly believe that Actogenix will successfully apply this platform to develop innovative therapeutics for the benefit of its shareholders and the benefit of patients worldwide.'

Patrick Van Beneden, Director Life Sciences of GIMV added: 'We see Actogenix as one of the more promising companies that recently have been started here in Flanders. The combination of world class science, experienced management and strong financial backing should be the ingredients for a life sciences company that will develop new medical treatments for large unmet medical needs like Crohn's disease and other gastrointestinal disorders.'

'We see ActoGeniX as an interesting investment opportunity in our home market based on excellent science and with broad applicability of the technology platform,' said Martijn Kleijwegt, Managing Partner of Life Sciences Partners. 'The availability of clinical data, as is the case for ActoGeniX' lead program, is something that is rarely seen in such start-up initiatives. We are excited to be part of this venture and look forward to working with the management team to make this a success.'

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Contact: Sooike Stoops
VIB, Flanders Interuniversity Institute of Biotechnology

Food Allergies An American Obsession?

Food allergies are increasingly top-of-mind for many Americans. In fact, one out of every three people in this country claim to have a food allergy of one kind or another.* But the science doesn't support these fears. Government and medical association estimates put the actual incident rate at only between one in 25 and one in 70.

Parents are one of the groups most concerned about food allergies, especially as kids go back to school and eat more meals away from home. In many cases, they're also ill-informed about the differences between allergies and intolerances, and the proper course of treatment for each. A new survey conducted among California parents last month reveals that many are self-diagnosing food allergies and eliminating nutrient-rich foods from their child's diet without seeing a doctor first.

"Medical self-diagnosis is risky business," says Dr. Stuart Epstein, Beverly Hills Allergist, Associate Clinical Professor David Geffen UCLA School of Medicine and Cedars-Sinai Medical Center Attending Allergist. "Without professional advice, suffering is almost always extended and important foods eliminated unnecessarily."

And milk is often the "fall guy." In fact, nearly two-thirds (63%) of parents surveyed in this recent Omnibus Poll admitted to eliminating -- or limiting their children's intake -- of milk at the first sign of problems, believing dairy products to be at least partially responsible for their symptoms.

"Parents are sometimes quick to point the finger at cow's milk when their child comes down with unexplained symptoms like intestinal problems or allergic reactions," stresses Dr. Epstein. "Eliminating milk from your diet, especially a child's diet, without talking to your doctor first, is not a smart idea."

In fact, the American Academy of Pediatrics issued a statement last week urging parents not to eliminate dairy foods from their children's diet for lactose intolerance reasons. Dairy foods like milk are an important source of calcium and other nutrients that facilitate growth during a critical bone building time.

Americans often confuse food allergies with food sensitivities or intolerances. An allergy is a specific condition that involves immune response, where as an intolerance -- like lactose intolerance -- is very rare among young people. Medical experts like Dr. Epstein recommend seeking medical attention at the first sign of a problem.

From August 14th to 22nd Market Tools surveyed 551 California parents online to gauge food allergy and lactose intolerance awareness and milk allergies as a health concern for their children.

Key Findings:

- Sixty-three percent (63%) of California parents eliminate milk from their child's diet at the first sign of a food-related health issue.

- Forty percent (40%) of parents do not consult a doctor before eliminating foods from their child's diet.

About the CMPB

The California Milk Processor Board was established in 1993 to make milk more competitive and increase milk consumption in California. Awareness of GOT MILK? is over 90% nationally and it is considered one of the most important and successful campaigns in history. GOT MILK? is a federally registered trademark that has been licensed by the national dairy boards since 1995. GOT MILK? gifts and recipes can be viewed at http://www.gotmilk.com. The CMPB is funded by all California milk processors and administered by the California Department of Food and Agriculture.

-- National Institute of Health, Food Allergy Citation & Incidence Rates, pp 1-2, http://www.nih.org.

-- Paajanen L et al. Cow milk not responsible for most gastrointestinal immune-like syndromes -- evidence from a population-based study. American Journal of Clinical Nutrition. 2005; 82:1327-1235.

-- Heyman, Melvin B., M.D., M.P.H., FAAP, Lactose Intolerance in Infants, Children and Adolescents (Pediatrics, 2006;118:1279-1286).

The California Milk Processor Board
http://www.gotmilk.com

Allergy-free Cats For Sale At $3,950 Each

If you are allergic to cats, would like to have one and have $3,950 spare, this may be your lucky day. Allerca Inc., California, USA, says it has managed to breed the world's first hypoallergenic cats. People who are allergic to cats and buy one of these will not experience sneezing, red and itchy eyes or asthma - except in very acute cases.

The company says that as soon as the news got out people rushed to place orders and now there is a waiting list.

The company tested thousands of cats, looking for those tiny few that do not have glycoprotein Fel d1. Glycoprotein Fel d1 is what triggers allergic reactions in humans - it can be found in the fur, pelt, saliva, serum, urine, mucous, salivary glands, and hair roots of the cat. On finding a decent number of cats that did not carry glycoprotein Fel d1, the scientists selectively bred them.

The kittens of these selectively chosen cats do not produce human allergic reactions - they are hypoallergenic cats.

The company stressed that their cats are not the result of genetic engineering. About one in 50,000 cats do not carry Glycoprotein Fel d1 - it was a question of finding them and breeding them, there was no genetic modification.

It is estimated that about one third of all humans are allergic to cats. The market for hypoallergenic pets could be huge.

The company says its cats are friendly, playful and affectionate. They have cats in several coat colours and patterns. The coat is "medium-long, with low maintenance and minimal shedding."

Symptoms of Cat Allergy

Eyes
-- eyes become red, itchy and watery, and/or swollen

Nose
-- nose may be itchy, runny and congested, the patient may sneeze a lot

Ears
-- ears can become itchy and/or plugged (blocked)

Throat
-- nasal drip may make its way down to the throat. The throat can feel sore. The patient may often clear his/her throat. He/she may also experience hoarseness.

Skin
-- skin can be itchy, with rashes or hives

Lungs
-- patient may cough frequently, wheeze, experience tightness in the chest, shortness of breath, and often suffer from bronchitis

http://www.allerca.com

Written by: Christian Nordqvist
Editor: Medical News Today

Allergic Rhinitis Associated With Decline In Work And School Performance

Allergic rhinitis (AR), more commonly known as "hay fever" can have a profound impact on the daily lives of sufferers beyond its physical effect -- including psychological well-being, sleep quality, and ability to learn and process cognitive input, according to a new article scheduled to appear in the on-line issue of Allergy and Asthma Proceedings.

"The Burden of Allergic Rhinitis," authored by Robert A. Nathan, M.D., Clinical Professor of Medicine, Department of Internal Medicine, Division of Allergy and Immunology, University of Colorado Health Sciences Center, provides an overview of the impact of AR in our society based on findings in the landmark 2006 Allergies in America Survey (AIA) and other noteworthy surveys and studies conducted in the US and Europe. In his article, Dr. Nathan describes the negative cascade of events that adults and children can experience as a result of this condition.

"Nasal congestion profoundly affects quality of life, largely by undermining the restorative power of sleep. Poor-quality sleep leads to daytime drowsiness, fatigue, indecision and significant impairment in learning and cognition," he writes. "As a result, adults become moody, less efficient, and more likely to experience work-related injury; children are prone to be shy and may also become depressed, anxious or fearful."

Consequently, presenteeism (decreased productivity at work due to illness) and school absenteeism (habitual absence) escalate.

Lack of Effectiveness of Currently Available Intranasal Sprays

While intranasal corticosteroids are the gold standard for symptom control, patients report problems with effectiveness of currently available options. Only 16 percent of respondents in the AIA survey indicated that intranasal corticosteroids provide relief for all their symptoms, and almost half (48 percent) said they fail to provide 24-hour symptom relief.

"Patients self-adjust their use of over-the-counter and prescription products, but find that currently available options do not always provide the 24-hour relief, and if they do, there are bothersome side effects," explains Dr. Nathan. Consequently, the author concludes that there is a need for new nasal allergy medications that provide complete 24-hour symptom relief that is sustained over time.

About Allergies in America Survey

The Allergies in America survey is a landmark survey sponsored by ALTANA Pharma US, Inc. and is the largest survey ever conducted in a population of allergic rhinitis sufferers and healthcare practitioners. Analysis of the data from the 2,500 allergy sufferers and 400 physicians, nurse practitioners and physician assistants provides a window into to the behavioral and psychosocial effects of AR.

Asthma & Allergy Associates
http://www.texallergy.com/locations.htm

Model Homes Offer National IAQ Impact Results

Airborne contaminants in homes can range from allergic agents such as mold to potentially lethal threats such as carbon monoxide. Engineers at the National Institute of Standards and Technology (NIST) have developed a database of U.S. residential housing* to help conduct nationwide analyses of ventilation, air cleaning or moisture control strategies to reduce indoor air pollution.

Most people presume that the indoor air quality (IAQ) measures that rid one house of airborne contaminants should work in a similar house, but when it comes to ranking, on a regional or national scale, potentially expensive residential code or construction changes, housing and health authorities as well as homebuilders want more than conventional wisdom and supposition. They want data, and a lot of it. The new NIST set of more than 200 residential dwellings, representing 80 percent of the United States housing stock, can be combined with a computer simulation technique to determine the impacts of IAQ interventions.

NIST developed its database of model homes from the U.S. Census Bureau's American Housing Survey (AHS) and the U.S. Department of Energy's (DOE) Residential Energy Consumption Survey (RSECS). They then selected 209 dwellings as representative of 80 percent of U.S. housing stock. The homes, grouped into four categories--detached, attached, manufactured homes and apartments, were defined by their age, floor area, number of floors, foundation type and existence of a garage.

The engineers then developed floor plans for each house and created a model of each in NIST's multizone indoor air quality and ventilation assessment computer program, CONTAM. Analysts can use the models to simulate and examine energy, IAQ and human exposure issues in a particular type of dwelling or all the dwellings as a group. Conclusions drawn from simulations with a particular house type should be valid for similar houses on a nationwide or regional level. The current multizone representations of the 209 dwellings created with CONTAM are available at http://www.bfrl.nist.gov/IAQanalysis along with floorplans of the buildings. The U.S. Department of Housing and Urban Development sponsored this work.

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*A. Persily, A. Musser and D. Leber. A collection of homes to represent the U.S. housing stock. NISTIR 7330, August 2006.

Contact: John Blair
National Institute of Standards and Technology (NIST)

GMOs And Allergies: Tests May Help Answer Questions

The potential of genetically engineered foods to cause allergic reactions in humans is a big reason for opposition to such crops. Although protocols are in place to ask questions about the allergy-causing possibilities, there has been no test that offers definitive answers.

But all of that could change as a Michigan State University researcher has developed the first animal model to test whether genetically engineered foods could cause human allergic reactions. Venu Gangur, MSU assistant professor of food science and human nutrition, has received a $447,000 grant from the Environmental Protection Agency to validate the test.

Genetically engineered crops are created by inserting a protein from a different organism into the original crop's genome. This is usually done to create a plant that is more resistant to insects or diseases.

The Food and Agriculture Organization within the World Health Organization has a structured approach to determining whether genetically engineered foods cause allergies, according to Gangur, who also is a faculty member in the National Food Safety and Toxicology Center. "But it has a major flaw. A critical question in that process asks, 'Does the protein cause an allergic reaction in animals?' The problem is that there has been no good animal model available to test this."

Gangur and students in his lab have developed a mouse model - the first of its kind - to test the allergy-causing potential of genetically engineered foods. He'll use the EPA grant to examine whether the model works on a variety of proteins. If successfully validated, the testing could be available commercially in about five years.

Perhaps the best known case of a genetically engineered crop potentially causing allergies was StarLink corn. Created by Aventis in 1996, StarLink contained the cry9C protein from a common soil bacterium, a strain of Bacillus thuringiensis. The cry9C protein protected the corn from several types of corn borers and black cutworms. StarLink was approved by the EPA for use in animal feed and nonfood products in 1998. But in 2000, fragments of cry9C DNA were detected in taco shells and other food products.

"Many people believed that StarLink was responsible for their asthma attacks and other allergic reactions," Gangur said. "The Centers for Disease Control took samples and tried to figure out if StarLink was the cause, but the data were inconclusive. There was really no good method to determine if StarLink caused allergic reactions. This is why our model will be such a valuable tool. We'll be able to determine the allergenic potential of genetically engineered crops before they're released into the human or animal food chain."

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Robert Tempelman, MSU professor of animal science and statistics and probability, is the project's co-investigator.

Gale Strasburg, chairperson of the MSU Department of Food Science and Human Nutrition; and Jim Pestka and Maurice Bennink, MSU professors of food science and human nutrition, also are participating in the project.

The research of Gangur, Tempelman, Pestka and Bennink is supported by the Michigan Agricultural Experiment Station.

url: http://newsroom.msu.edu/site/indexer/2864/content.htm

Contact: Sue Nichols
American Society for Biochemistry and Molecular Biology

Flu Vaccine Recommended For People With Asthma

With flu season just around the corner, the American Academy of Allergy, Asthma & Immunology (AAAAI) is recommending that people with asthma and other chronic health conditions receive a flu vaccination as soon as possible.

Each year, millions of people in the United States get influenza. According to the Centers for Disease Control and Prevention (CDC), approximately 36,000 people per year in the United States die from influenza, and over 200,000 people have to be admitted to the hospital as a result of the flu.

Influenza is typically spread from person to person through coughing and sneezing via respiratory droplets. If someone with the flu coughs on you, there is a high chance you will develop flu symptoms within four days after the initial exposure to that person. Common flu symptoms include:

-- Fever
-- Muscle aches and tenderness
-- Headache
-- Fatigue
-- Dry cough
-- Sore throat
-- Runny nose

"Symptoms of influenza can be especially severe for patients with respiratory diseases, such as asthma," said Richard A. Nicklas, MD, FAAAAI, Chair of the AAAAI's Asthma Diagnosis and Treatment Interest Section. "In severe cases, influenza can cause pneumonia, may require hospitalization and sometimes can be fatal.

" Research has found that the flu vaccine decreases the risk of asthma exacerbations in patients by as much as 22% to 41%. In addition, it can also protect against acute asthma exacerbations in children. Vaccinating all children with asthma could prevent up to 78% of asthma hospitalizations and emergency room visits during influenza seasons.

The flu season usually ranges from November through March, and peaks in December, January and February. It takes approximately two weeks to develop immunity from the vaccine so it is important to get vaccinated each fall in October or November, before the flu season begins.

Contrary to popular belief, you cannot get the flu from the flu vaccine. If you feel sick with flu-like symptoms after being vaccinated, you may have caught another respiratory virus or already had the flu virus in your system when you received the vaccine.

Discuss any questions that you may have regarding influenza or the flu vaccine with your physician. For more information, visit the AAAAI Web site, http://www.aaaai.org, the Centers for Disease Control and Prevention (CDC) Web site, http://www.cdc.gov/nip/flu, or call the CDC Immunization Hot Line at (800) 232-2522.

The AAAAI's How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:

-- Need to confirm the diagnosis of asthma
-- Need education on asthma and guidance in techniques for self-management.
-- Need for daily asthma reliever medications
-- Are not using medications as prescribed, and this is limiting their ability to control their asthma
-- Have potentially fatal asthma, meaning a prior severe, life threatening episode that included intubation

To find an allergist/immunologist in your area, call the AAAAI Physician Referral and Information Line at (800) 822-2762 or visit the AAAAI Web site at http://www.aaaai.org/physref/.

The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,000 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at http://www.aaaai.org.

American Academy of Allergy, Asthma & Immunology (AAAAI)
http://www.aaaai.org

New England Journal OF MEDICINE Reports Positive Results From Dynavax' Ragweed Allergy Therapy Trial

The NEW ENGLAND JOURNAL OF MEDICINE (Vol. 355, October 5, 2006, No.14), today reported that a new approach to allergy therapy not only reduced the acute allergic responses of individuals with ragweed allergies but also sustained that effect for over 12 months. The novel treatment, called "AIC" in the paper, is a TLR9 agonist linked to ragweed allergen, developed by Dynavax Technologies Corporation (Nasdaq: DVAX).

Dr. Peter Creticos, principal investigator and lead author of the paper, entitled, "Immunotherapy with a Ragweed-Toll-like Receptor 9 Agonist Vaccine for Allergic Rhinitis," said that the pilot study "appears to offer a means of achieving long-term clinical efficacy in ragweed allergic rhinitis as the clinical effects suggest the induction of long-lasting disease modification. Furthermore, the demonstrated therapeutic properties and safety pave the way for a therapeutic intervention that is qualitatively superior to standard immunotherapy." Dr. Creticos is Associate Professor of Medicine and Clinical Director of the Division of Clinical Immunology of The Johns Hopkins University School of Medicine. He serves as Medical Director of the Johns Hopkins Asthma and Allergy Center in Baltimore, Maryland.

In the paper, Dr. Creticos pointed to statistically significant efficacy results including peak Nasal Symptom Complex Score (NSCS) reductions in AIC-treated patients of 55% (p=0.03) in 2001 which persisted through the 2002 ragweed season (53% reduction in NSCS, p=0.02) with no additional therapy. Additionally, the AIC-treated group used no relief medication at all during the second season, while placebo patients used antihistamines for 8 days (average) and decongestants for 4 days (average) of the two-week peak season. The intervention also generated clinically significant quality of life improvements for patients. Dr. Creticos added that the intervention was safely tolerated as no treatment-associated serious adverse reactions were reported, nor did any lab tests show abnormalities in the patients tested.

With funding from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network, and the study drug provided by Dynavax, Dr. Creticos conducted a blinded, randomized, placebo-controlled, clinical trial in 25 ragweed allergic patients beginning in May 2001 and concluding in October, 2002. Patients were treated with either the drug or placebo, using a 6-injection regimen, prior to the first ragweed season, and were followed for two years. Dynavax supplied the study drug, now known as TOLAMBA(TM), and contributed to trial design, but did not participate in data accrual, analysis, or funding of the trial. TOLAMBA, consisting of a TLR9 agonist linked to a specific ragweed allergen, is currently being evaluated in late-stage clinical trials for the treatment of allergic rhinitis.

DYNAVAX Clinical Trials Update

In the paper, Dr. Creticos recommends additional large-scale studies, which are now underway at Dynavax. Since the reported study's initiation in 2001, Dynavax has generated a substantial amount of data in 14 clinical trials in the U.S., France, and Canada. More than 7,000 TOLAMBA injections have been administered to over 1,100 patients. In these trials, TOLAMBA was shown to be safe and well tolerated, to provide measurable improvements in allergy symptoms, and to reduce medication use.

TOLAMBA consists of 1018 ISS, a TLR9 agonist, linked to the purified major allergen of ragweed, called Amb a 1. 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 effect suppressing the Th2 cells responsible for inflammation associated with ragweed allergy. Moreover, this treatment reprograms the immune response away from the Th2 response and toward a Th1 memory response so that, upon subsequent natural exposure to the ragweed allergen, long-term protection is achieved.

Other Clinical Results; Trial Background

A Dynavax-funded, 30-center, placebo-controlled study in 738 ragweed allergic subjects, aged 18 to 55 years, is expected to produce interim data at one-year in the first quarter of 2007. The study known as "DARTT" (Dynavax Allergic Rhinitis TOLAMBA Trial) randomized subjects into three arms: the same dosing regimen that was used in the completed Phase 2/3 trial; a higher total dose regimen; and placebo. Subjects received six doses over six weeks prior to the start of the 2006 ragweed season. Ragweed symptoms were followed over the 2006 ragweed season and will also be followed through the 2007 season. The primary endpoint is reduction in total nasal symptom scores (TNSS) during the second (2007) peak ragweed season. Dynavax anticipates that data from the DARTT interim analysis, if positive, combined with the safety and efficacy data from the recently completed two-year Phase 2/3 trial, and from an ongoing trial in ragweed allergic children, could provide sufficient patient data for determining the potential timeline to registration for the intervention.

Additionally, Dynavax is evaluating TOLAMBA in a three-year, 19-center, pediatric trial with over 300 patients, ages six to 15 years. The primary endpoint of the study is reduction in TNSS during the 2006 peak ragweed season; a key secondary endpoint is the prevention of progression to asthma. The study was initiated in early 2005. Primary endpoint data for the study is expected in early 2007.

In January 2006, Dynavax announced that results from a two-year Phase 2/3 clinical trial of TOLAMBA showed that patients treated with TOLAMBA experienced a statistically significant 28.5% reduction in total nasal symptom scores (TNSS) compared to placebo-treated patients in the second year of the trial (p=0.024). Results also showed significant clinical benefit relative to secondary endpoints, including composite hay fever symptoms and ocular effects, and a significant reduction in antihistamine use (p=0.01). These results were achieved after a single short course of therapy prior to the first ragweed season (2004), and demonstrated that a booster dose prior to the second season (2005) was not required to achieve clinical benefit. The safety profile of TOLAMBA was favorable; systemic side effects were indistinguishable from placebo and local injection site tenderness was minor and transient.

TOLAMBA represents the foundation of a comprehensive allergy franchise for Dynavax, and has the potential to be a novel entrant in the multibillion- dollar global allergy market. In the U.S. alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis, or 30 million Americans. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy, which generally requires 60-90 shots over three to five years and represents a significant treatment burden for allergy sufferers. Dynavax believes that TOLAMBA has the potential to become the first of several new and important disease-modifying therapeutic options for patients and physicians.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent allergies, infectious diseases, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs 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. Dynavax's pipeline includes: TOLAMBA, a ragweed allergy therapeutic, for which a major safety and efficacy trial (DARTT) is currently underway, and that is in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine in Phase 3; and a therapy for non-Hodgkin's lymphoma in Phase 2. Its preclinical asthma and COPD programs are partnered with AstraZeneca. Funding for the company's other preclinical programs in cancer, hepatitis B and hepatitis C therapies, and for an influenza vaccine have been provided by Symphony Dynamo and NIH, and represent future partnering opportunities. Preliminary data from the study published today in the NEJM were previously reported at the AAAAI 2003 annual meeting. 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 clinical development plans and timelines, business plans, future operating results, intellectual property position and potential sources of funds. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in our business, including difficulties or delays in development, achieving the objectives of our collaborative and licensing agreements and obtaining regulatory approval for our products; the scope and validity of patent protection for our products; competition from other companies; our ability to obtain additional financing to support our operations; and other 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.

Dynavax Technologies Corporation
http://www.dynavax.com

Ragweed Allergy Vaccine Effective For At Least One Year

A new vaccine trial has been shown to protect people from ragweed pollen allergy for at least one year, according to an article in the New England Journal of Medicine. This experimental treatment requires just six injections, once a week. Current treatments require taking several medications each day throughout the ragweed season.
Allergic reactions to plant pollens are commonly known as Hay Fever

Trial researchers said further studies have to be carried out on a larger group of volunteers.

Study author, Dr. Peter Socrates Creticos, Johns Hopkins Asthma and Allergy Center, Baltimore, USA, and team, expanded on studies that had been carried out at the University of California, San Diego, which discovered that a bacterium DNA sequence shuts down Th2 (T-helper) cell activity - an inflammatory immune system response. Th2 is commonly found to be a major factor in human allergic responses.

To create a new vaccine the team attached the DNA sequence that halts Th2 response to a portion of the ragweed pollen. Th2 cells often overreact to ragweed pollen - the new vaccine stops the Th2 from overreacting.

The Th2 cells of people who are allergic to ragweed make the body produce igE, which causes the watery eyes and sneezing. The vaccine stops the Th2 cells from sending signals which make the body produce IgE when exposed to ragweed.

The problem with current allergy medications is that they are not well targeted. Current medications have side effects because they undermine the body's immune system. This new vaccine is finely targeted - there are fewer side effects, say the researchers.

Twenty-five volunteers, aged 23-60, took part in this pilot trial,. All of them suffered from ragweed allergy. 14 were given six injections with the new vaccine, one each week consecutively. The other 11 were given a placebo injection, once a week for six weeks. Both groups started treatment before the ragweed season began.

Allergy symptoms during the ragweed season were 60% lower for the 14 who received the new vaccine, compared to the placebo group. Allergy relief continued during the next season, a year later (no additional treatment had been given).

Ragweed Allergy - Some Facts

The ragweed pollen season runs from August to November. Most areas in the USA see a peak in ragweed pollen levels in mid-September. Pollen counts tend to peak between 5am to 10am.

If you suffer from ragweed pollen allergy

-- Try to stay indoors between 5am to 10am - unless there has been some heavy rain
-- Try to keep the windows of your home and car closed
-- Avoid using fans
-- If your allergy is severe, remember that people can bring the pollen into the home on their clothing
-- Pets can bring the pollen in
-- Avoid drying your clothes by hanging them outside

Symptoms

-- eye irritation
-- inflamed, itchy nose and throat
-- puffy eyes
-- runny nose
-- sneezing
-- stuffy nose
If your allergy is more severe, symptoms may also include the following:
-- asthma attacks
-- chronic sinusitis
-- headaches
-- impaired sleep

Immunotherapy with a Ragweed-Toll-Like Receptor 9 Agonist Vaccine for Allergic Rhinitis
Peter S. Creticos, M.D., John T. Schroeder, Ph.D., Robert G. Hamilton, Ph.D., Susan L. Balcer-Whaley, M.P.H., Arouna P. Khattignavong, M.D., Robert Lindblad, M.D., Henry Li, M.D., Ph.D., Robert Coffman, Ph.D., Vicki Seyfert, Ph.D., Joseph J. Eiden, M.D., Ph.D., David Broide, M.B., Ch.B., and the Immune Tolerance Network Group
NEJM Volume 355:1445-1455 - October 5, 2006 - Number 14
Click here to see abstract online

Written by: Christian Nordqvist
Editor: Medical News Today

Allergy Sufferers Offered Longer Relief With Fewer Shots Using Experimental Ragweed Therapy

Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of i The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.

"As many as 40 million Americans suffer from seasonal allergies caused by airborne pollens produced by grasses, trees and weeds," says NIH Director Elias A. Zerhouni, M.D. "Finding new therapies for allergy sufferers is certainly an important research goal."

"This innovative research holds great promise for helping people with allergies," says NIAID Director Anthony S. Fauci, M.D. "A short course of immunotherapy that reduces allergic symptoms over an extended period of time will significantly improve the quality of life for many people."

Ragweed is one of the most common pollens in the United States and is prevalent in the Northeast, Midwest and the South. In Baltimore, where the NEJM study was conducted, the ragweed pollen season lasts from mid-August to October.

Physicians treat people suffering from mild and moderate ragweed allergies with antihistamines or nasal corticosteroids. However, when people with allergies do not respond to these treatments or experience severe symptoms, the next therapeutic option is a course of subcutaneous injections of the allergen, which is called allergen immunotherapy. Although this standard immunotherapy is often effective, it has two major drawbacks. First, it can cause systemic allergic reactions, such as anaphylaxis, a hypersensitivity reaction that can lead to severe and sometimes life-threatening physical symptoms. Second, to provide long-lasting relief, standard immunotherapy may require frequent injections over a 3- to 5-year period. The large number of injections over such an extended period of time often results in many people not completing the treatment.

In the study detailed in NEJM, lead investigator Peter Creticos, M.D., medical director of the Johns Hopkins Asthma and Allergy Center in Baltimore, and his research team found that an investigational therapy based on the major ragweed allergen, Amb a 1, coupled to a unique short, synthetic sequence of DNA that stimulates the immune system, reduced allergy symptoms in adults for at least one year when given just once a week over a 6-week period. The therapeutic agent was provided by Dynavax Technologies Corp., based in Berkeley, CA.

"For almost 100 years, we've been using the tedious process of giving allergy sufferers one to two shots a week for up to 4 to 5 years to ensure its success," Dr. Creticos says. "This study is an important immunotherapy advance in that we've shown you can induce long-lasting relief from allergic rhinitis with just a few weeks of injections."

The study initially involved 25 adult volunteers, ages 23 to 60, with a history of seasonal allergic rhinitis, positive skin test reactions to ragweed pollen, and an immediate reaction when nasally challenged with ragweed. Prior to the start of the 2001 fall ragweed season, the study participants received six injections, each a week apart, of either the investigational therapy in increasingly higher doses or a placebo. They received no other injections throughout the course of the study. Fourteen volunteers received the study drug; 11 were given the placebo. The therapy was well-tolerated and caused only limited local reactions, which required neither medication nor change in treatment dose. No clinically significant, therapy-related adverse events occurred.

Throughout the 2001 and 2002 ragweed seasons, the volunteers were monitored for allergy-related symptoms, including the number of sneezes and the degree of post-nasal drip, allergy medication use and quality-of-life scores. Compared with the placebo recipients, the group that received the therapy experienced dramatically better outcomes that continued throughout the 2002 ragweed season even though therapy ended one year earlier.

Clearly, the regimen of only six injections showed therapeutic promise when compared with the current therapy, the study authors note. However, because the results are based on a small number of volunteers and the long-term safety of the therapy is unknown, they say additional clinical trials with longer-term follow-up to adequately assess the therapy's safety and effectiveness are necessary.

How the experimental therapy relieves ragweed allergy symptoms is not fully understood at this time. When exposed to ragweed pollen, people who are allergic to ragweed experience an increase in IgE (immunoglobulin) antibodies; immunotherapy blocks this increase in IgE. Researchers believe the experimental therapy tempers the release of immune regulatory proteins called cytokines, which blocks increases in the level of IgE antibodies.

"Using ragweed as a model allergen system with a predictable seasonal pattern of symptoms and pollen counts, it is possible to correlate pollen levels with symptoms and measure treatment effects on symptoms. This enables us to better understand immune response to allergens and serves as an approach to similar therapies to manage other allergic reactions for which there are currently no treatments, such as food allergies," says Marshall Plaut, M.D., chief of the Allergic Mechanisms Section of NIAID's Division of Allergy, Immunology and Transplantation.

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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: PS Creticos et al. Immunotherapy with a ragweed-TLR9 agonist vaccine for allergic rhinitis. The New England Journal of Medicine DOI: 10.1056/NEJMoa052196 (2006).

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases