BERKELEY, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation announced presentation of data from a Phase 1 trial of its ragweed allergy immunotherapy, TOLAMBA, demonstrating that it was safe to test further in ragweed allergic children at a dose level equivalent to the regimen used in adults. TOLAMBA is currently being evaluated in two large- scale clinical trials. A two-year Phase 2/3 trial in adults is anticipated to yield data in the first quarter of 2006. A trial in 313 ragweed allergic children, designed to be supportive of the company’s planned pivotal Phase 3 clinical program, and using the dosing regimen equivalent to the adult regimen, is anticipated to yield primary endpoint data early in 2007. A pivotal Phase 3 trial could begin in the first half of 2006, pending results of the Phase 2/3 trial. Combined results from these trials, if positive, could form the basis of a regulatory filing for TOLAMBA, pending discussions with the FDA.
“TOLAMBA has potential as an important, new approach for treating allergic rhinitis in children as well as adults, and in preventing the development of allergic asthma in children,” said Anjuli S. Nayak, MD, principal investigator on the trial. “People who suffer from allergies suffer an impaired quality of life and long-term dependence on medications that have negative side effects and only temporarily relieve symptoms. An innovative treatment such as TOLAMBA, which has shown safety and ease of administration across multiple age groups, has the potential to change the course of their disease and provide long-term benefit. As such, TOLAMBA could represent a major therapeutic advance for allergy patients and the allergists who treat them, and warrants further study in large-scale clinical trials.”
Medical management of seasonal allergic rhinitis is a multibillion-dollar global market. In the US 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. It is estimated that approximately 25% of those who suffer from allergic rhinitis progress to asthma, leading to increased morbidity and disease management costs. Approximately 20 million Americans suffer from asthma and approximately nine million of those sufferers are children.
The Phase 1 data were presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting, in a presentation entitled, “Phase 1 Study of Amb a 1 Oligodeoxyribonucleotide Conjugate (AIC) in Ragweed-Allergic Children.” The presentation was made by Anjuli S. Nayak, MD., Peoria School of Medicine, University of Illinois, and of Sneeze, Wheeze & Itch Associates, Normal, IL.
Phase 1 Trial Design
TOLAMBA consists of Dynavax’s proprietary immunostimulatory sequence (ISS) molecule linked to the purified major allergen of ragweed, called Amb a 1. TOLAMBA is designed to target the underlying cause of seasonal allergic rhinitis caused by ragweed. 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.
The double-blind, placebo-controlled Phase 1 trial of TOLAMBA enrolled 24 children aged 6-17 years with mild to moderate ragweed allergy. The subjects were randomized into four treatment arms. One group received six injections of placebo (saline) over six weeks. Patients in the three groups treated with TOLAMBA on a dose-escalating basis received six weekly injections starting at 0.6 micrograms, 0.3 micrograms or 1.2 micrograms, and finishing at 12 micrograms, 21 micrograms or 30 micrograms, respectively. The dosing regimen of 1.2 to 30 micrograms is currently being used in the Phase 2/3 clinical trial in adults.
Patients were evaluated for adverse events, local injection reactions, induction of antibodies to Amb a 1/ragweed and skin test reactions to ragweed extract. Allergy symptoms and use of relief antihistamines/decongestants were assessed using electronic diaries before and during the 2004 ragweed season. Most subjects in both groups had allergies to other seasonal and perennial allergens. All patients in each cohort were compliant and received all of their injections. Two-thirds of the patients in each group had no treatment- related adverse events and there were no serious adverse events. TOLAMBA- treated patients had greater increases in IgG antibodies to Amb a 1 and ragweed, and placebo-treated patients had greater increases in IgE antibodies to Amb a 1 and ragweed. These data are consistent with the mechanism of action of TOLAMBA in stimulating a protective Th1 response and suppressing an inflammatory Th2 response.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, 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(TM), a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial, and in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the therapeutic potential and development and regulatory timelines for TOLAMBA; statements concerning the company’s other clinical programs and its ability to demonstrate the potential of its ISS technology. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “slated,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax’s business including, without limitation, risks relating to: plans and timing for completing the ongoing Phase 2/3 clinical trial of TOLAMBA, for completing the ongoing clinical trial in ragweed allergic children, and for initiating a pivotal Phase 3 clinical trial for TOLAMBA; plans to submit a regulatory filing for TOLAMBA based on data from ongoing and planned clinical trials; the potential for TOLAMBA to demonstrate a therapeutic benefit lasting into a second season; the progress and timing of clinical trials for the company’s other products in development; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the “Risk Factors” sections of Dynavax’s Annual Report on Form 10-K filed on March 18, 2005, Dynavax’s quarterly report on Form 10-Q filed on August 9, 2005 and Dynavax’s Prospectus Supplement filed on October 11, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Dynavax Technologies Corporation
CONTACT: Jane M. Green, PhD, Vice President, Corporate Communications ofDynavax Technologies Corporation, +1-510-665-4630, or jgreen@dvax.com
Web site: http://www.dynavax.com/
