Stressgen to develop reformulated version of HspE7 human papillomavirus vaccine

By Angela McDaniels

Seattle, April 19 - Stressgen Biotechnologies Corp. said it will not begin a phase 3 study of its HspE7 vaccine as planned but will instead focus on the development of a more potent, reformulated version of the vaccine.

The decision follows a company evaluation of HspE7, an investigational therapeutic vaccine for the treatment of human papillomavirus-related diseases.

"Impressive preclinical data have been generated around several reformulated versions of HspE7 combined with low concentrations of an adjuvant," president and chief executive officer Gregory M. McKee said in a company news release.

"These data indicate dramatically increased potency, which we believe provides us with both a clearer and lower-risk commercialization pathway and may provide expanded marketing opportunities for the compound, factors that we believe outweigh any delay in the clinical development pathway of HspE7."

Over the next year, the company plans to focus on:

• Completion of acute safety, toxicology and pharmacodynamic studies of the reformulated drug candidate;

• Completion of preclinical and clinical regulatory packages and submission to the Food and Drug Administration;

• Initiation of a 400-patient, placebo-controlled, three-arm, phase 1/2 study in patients with genital warts or high-grade cervical dysplasia; and

• Evaluation and design of a phase 2/3 study in patients with recurrent respiratory papillomatosis, a trial that the company said could potentially be used as a single registration trial, given the orphan indication and high unmet medical need.

Stressgen estimated that the two clinical trials described above will each cost about $5 million. The company noted, however, that is has decreased its core burn rate to about C$650,000 per month and expects this base spending rate to continue.

The company will hold a conference call at 10 a.m. ET on April 20 to discuss the changes. To participate, call 800 274-4979 and enter conference code 8095549 or register at http://audioeventmshow.com/296461 and then go to mms://winaudio.mshow.com/296461.asf to view the conference.

Stressgen is a biopharmaceutical company based in Victoria, B.C., that develops stress protein-based immunotherapeutics.

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