Dynavax says Tolamba trial shows allergy treatment safe, effective

By E. Janene Geiss

Philadelphia, March 6 - Dynavax Technologies Corp. said Monday that results from a two-year, multi-center phase 2/3 clinical trial showed that Tolamba, a ragweed allergy immunotherapeutic, was safe and met its primary endpoints.

"The results of the Tolamba phase 2/3 clinical trial are encouraging and suggest that Tolamba has potential as a disease modifying agent that can reprogram the immune system and reduce the allergic response," said William W. Busse, professor of medicine, University of Wisconsin-Madison, Clinical Science Center and a past president of American Academy of Allergy, Asthma & Immunology, in a company news release.

"The data suggest that Tolamba can produce a meaningful treatment effect above that which can be achieved with conventional allergy medications, that it is safe and provides a long duration of effect after only a single short course of therapy. Tolamba warrants continued development and has the potential to represent a new standard of care for ragweed allergics who today remain underserved by treatments that provide only temporary symptomatic relief," Busse added in the release.

The phase 2/3 trial achieved its efficacy endpoint, which was the change from baseline in total nasal symptom scores during the peak period of the 2005 ragweed season for the Tolamba-treated group compared to the placebo group.

Secondary endpoints included: Nasal system discharge change from baseline in the first season; ocular symptoms scores; nasal/ocular symptom scores; combined hayfever symptom scores; medication use (fexofenadine and pseudoephedrine) and safety, officials said.

The Tolamba-treated group received a single short, six-injection/six-week course of therapy prior to the 2004 ragweed season. Prior to the 2005 season, one half of these subjects received a two injection/two week booster. Total nasal system discharge is measured using four parameters (congestion, sneezing, itching and runny nose) each rated on a four-point scale.

Key results from the study include:

• Patients treated with a single six-week course of Tolamba prior to the 2004 season experienced a statistically significant reduction in total nasal symptom scores change from baseline during the two-week peak season compared to placebo-treated patients in the first year of the trial and in the second year of the trial. The treatment effect was achieved on top of a background of antihistamine and decongestant use.

• The group receiving a single course of Tolamba achieved a statistically significant reduction in actual nasal discharge compared to a placebo in both the 2004 and 2005 seasons.

• The group receiving a single course of Tolamba achieved a statistically significant reduction in major secondary endpoints such as hayfever composite score.

• The group receiving a single course of Tolamba achieved a statistically significant reduction in antihistamine use and in decongestant use.

• The safety profile of Tolamba was favorable. Systemic side effects were indistinguishable from a placebo; there were no incidents of anaphylaxis. Local injection site tenderness was minor and transient.

The trial, which began in early 2004, was a two-year, randomized, double-blind, placebo-controlled study conducted at 29 sites in the midwestern, southwestern and eastern United States.

The trial involved 462 subjects, aged 18 to 55 years, with moderate to severe ragweed allergy. Prior to the 2004 ragweed season, which generally lasts from August through October, subjects received six weekly doses of either a placebo or escalating doses of up to 30 micrograms of Tolamba in a two-to-one randomization of Tolamba to a placebo group.

The primary objective of the trial was to assess the treatment difference in a subject-rated 24-hour total nasal symptom score. Efficacy is measured as the change from baseline in nasal system discharge during the peak period of the 2005 ragweed season of the Tolamba-treated groups compared to the placebo group.

Results from the trial were presented at the 2006 annual meeting of the American Academy of Allergy, Asthma & Immunology in Miami.

Dynavax is a Berkeley, Calif., pharmaceutical company that develops and commercializes 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.

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