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Dynavax Announces Completion of Enrollment in TOLAMBA(TM) Ragweed Allergy Trial

07 Jun 2006

Physician and Patient Demand Led to Accelerated Recruitment of More Than 700 Subjects

BERKELEY, CA, USA | Jun 07, 2006 | Dynavax Technologies Corporation (Nasdaq: DVAX) announced that enrollment in the

Dynavax Allergic Rhinitis TOLAMBA Trial (DARTT) has exceeded expectations relative to the speed and number of study subjects. More than 700 subjects were enrolled in the study in less than eight weeks, prompting Dynavax to close enrollment early. Enrollment in the DARTT study has been completed and all subjects have been randomized. The company believes that strong investigator and patient interest in TOLAMBA as a potentially disease-modifying allergy intervention, as well as TOLAMBA's safety profile, were important factors in accelerating enrollment in the trial.

"We believe that the upsurge in interest in the TOLAMBA trial among allergists and allergy patients is reflective of the strong market demand for potentially safer and more effective allergy treatments that provide more than just temporary, symptomatic relief," said Dino Dina, MD, president and chief executive officer. "We share our investigators' enthusiasm to fully explore the strength and durability of TOLAMBA's treatment effect and their optimism that TOLAMBA could provide long-term benefit and represent a new therapy for the tens of millions of people who suffer from ragweed allergy every year."

DARTT is a 30-center, placebo-controlled study in 738 ragweed allergic subjects, aged 18 to 55 years, in which subjects are randomized into three arms: a lower total dosing regimen consistent with the recently completed Phase 2/3 trial; a higher total dose regimen; and placebo. Subjects receive six injections over six weeks prior to the start of the 2006 ragweed season. Ragweed symptoms will be followed over the 2006 and 2007 ragweed seasons. The primary endpoint is reduction in total nasal symptom scores (TNSS) in the higher total dose arm compared to placebo during the second (2007) ragweed season. The trial design includes an interim analysis to be conducted in early 2007 following completion of the 2006 ragweed season. The company 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.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR-9 agonist-based 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, a ragweed allergy immunotherapeutic, 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, a hepatitis B vaccine that is currently in a Phase 3 clinical trial; SUPERVAX, a hepatitis B vaccine; a cancer therapy currently in a Phase 2 clinical trial in non-Hodgkins lymphoma; an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial; and preclinical programs in hepatitis B and hepatitis C therapy.

Dynavax cautions you that this press release contains forward-looking statements, including without limitation: statements regarding the potential safety and efficacy of TOLAMBA; expectations concerning the disease-modifying properties and strength and durability of TOLAMBA's treatment effect; TOLAMBA's potential to represent a new therapy to treat ragweed allergy; the potential for use of interim data as well as prior and ongoing studies to identify a timeline to registration; and the potential attractiveness of TOLAMBA to physicians and patients; in addition to statements related to plans to advance clinical programs in ragweed allergy, hepatitis B, cancer, hepatitis B and hepatitis C therapy and the commercial opportunities for those programs. 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 related to Dynavax's business. These and other risks related to our industry are detailed in the "Risk Factors" section of Dynavax's Annual Report on Form 10-K filed on March 16, 2006 and Dynavax's Quarterly Report on Form 10Q filed on May 5, 2006. You are cautioned not to place undue reliance on these forward- looking statements, which speak only as of the date hereof, and Dynavax disclaims any obligation to revise or update information provided in this release.

SOURCE Dynavax Technologies Corporation

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