Dynavax Tech (DVAX) Said TOLAMBA Fails To Achieve Primary Endpoint, Discontinues Development

May 16, 2008 7:16 AM EDT

Dynavax Technologies Corporation (Nasdaq: DVAX) reported primary endpoint data from a chamber study of TOLAMBA that showed a measurable clinical benefit, reducing total nasal symptom score by 41% vs. placebo in 253 patients in the intent-to-treat population (p=0.09) and by 51% vs. placebo in 222 patients in the per-protocol population (p=0.053). Statistical significance on the primary efficacy endpoint (change in TNSS for the intent-to-treat population) for this Phase 2b environmental exposure chamber study was not achieved.

Martin Sanders, MD, Executive Vice President and Chief Development Officer, said, "Consistent with the results of earlier trials, TOLAMBA showed a trend toward a reduction of the symptoms of ragweed allergic individuals relative to placebo, although statistical significance was not achieved. The current trial displayed an unexpectedly high degree of variability in the data set possibly due to the subjective nature of symptom scoring used to assess efficacy. A similar effect was observed in previous TOLAMBA clinical trials. We have concluded that this problem may be difficult to overcome in future clinical studies. We have therefore decided to discontinue clinical development of TOLAMBA."

As a result of discontinuing the TOLAMBA program and other measures, the company is revising its financial outlook for 2008. The Company's consolidated cash, cash equivalents, marketable securities and investments held by SDI, or total cash, is projected to be greater than $50 million at the end of 2008, increased from the range of $40 to $44 million projected in February. Total pro forma revenues for 2008 are unchanged and continue to be expected to be in the range of $42 to $46 million. Total pro forma operating expenses for 2008 are projected to be in the range of $70 to $78 million, reduced from the range of $80 to $88 million projected in February.

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