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Stressgen Highlights

Stressgen Highlights. Late-stage lead product candidate, HspE7, addressing large, unmet clinical need of HPV-related diseases including: Recurrent Respiratory Papillomatosis (RRP) High-grade cervical dysplasia and LEEP Failures, Patients co-infected with HIV and HPV Genital Warts

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Stressgen Highlights

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  1. Stressgen Highlights • Late-stage lead product candidate, HspE7, addressing large, unmet clinical need of HPV-related diseases including: • Recurrent Respiratory Papillomatosis (RRP) • High-grade cervical dysplasia and LEEP Failures, • Patients co-infected with HIV and HPV • Genital Warts • Near-term product launch opportunity with 1st generation HspE7 in initial indication, RRP (orphan/fast track) • Q1:06 - Initiate primary RRP registration trial • Clinical proof-of-concept in multiple phase II studies, including studies in patients with RRP, high-grade dysplasias, and GW

  2. Stressgen Highlights • Reproducible, large scale cGMP manufacturing process in hand • Parallel 2nd generation HspE7 development pathway with drug that may provide greater efficacy in difficult-to-treat HPV patients • Platform technology with capacity to generate additional product candidates targeting Hepatitis B, HSV, and Influenza

  3. Management Team

  4. Recent and Anticipated Milestones • Q2:05 - Announced new President and Chief Executive Officer • Q2:05 - Announced and closed sale of bioreagent business to Ampersand Ventures for C$8.0 • Q2:05 - Announced corporate restructuring with 50% staff reduction, planned closure of Collegeville, PA office and annual saving of approximately C$5.0M/year • Q2:05 - Announced successful completion of process development and cGMP production of HspE7 bulk drug • Q3:05 - Complete fill/finish of cGMP bulk HspE7 • Q4:05 Announce outcome from European Patent Office on IP challenge • Q1:06 – Initiate RRP primary registration trial • 1H:06 - Initiate Phase I/II proof-of concept trial GW or LEEP failures • Begin additional NCI studies

  5. The Immune System Immune System Cellular Immunity Humoral Immunity • Killer T cells • Destroy cells already infected or diseased • Therapeutic vaccines • In development e.g. cancer, chronic viral infections • Antibodies • Destroy viruses outside of cells • Preventive vaccines • Marketed e.g. polio, influenza, HBV

  6. CoValTM Fusion ProductsThe Stressgen Solution

  7. HspE7 Development Pathways HspE7 1st Generation HspE7 2nd Generation HspE7 (reformulated with adjuvant) Use in RRP primary registration trial Use in phase I/II proof-of concept study in GW or LEEP Failures

  8. 100 3ug adjuvant 10ug adjuvant 90 30ug adjuvant cGMP 80 70 60 Percent Tumor Incidence 50 40 30 20 10 0 0 100 200 300 400 500 600 700 800 HspE7 Dose Interim day 28 TC-1 Tumor Regression Data for Dose Response Studies Utilizing an Admix of HspE7 and Adjuvant DNA Even at the lowest doses of HspE7 and adjuvant tried (25ug HspE7 and 3ug adjuvant) tumor incidence was only 10%. This is better than an 800ug dose of cGMP Process B material. Average cGMP (historical)

  9. Mean of First Post-treatment Interval Between Surgeries Increased Significantly 120 106 (p<0.02) 100 80 55 Days 60 40 20 0 Baseline Post-treatment RRP Phase II Clinical Trial Results • In overall population, first post-treatment interval increased 95% (p<0.02) • Median of all surgeries reported following treatment suggests 87 fewer surgeries • Statistically significant decrease in Adjusted Derkay-Coltera Score at end of study (p<0.04)

  10. RRP Phase II Study Data vs.National Registry No. surgeries/year National Registry Data Age (years) Redrawn from Fig. 3 in Reeves, W.C., et al, Arch Otolaryngology Head Neck/Vol 129, Sep. 2003

  11. Next Steps for RRP • Manufacture commercial grade API (active pharmaceutical ingredient) material (Avecia, Ltd.) • Complete fill-finish of final drug product • Initiate primary registration trial • Expected design • Placebo controlled, double - blinded • 160 Patients, 55 sites in US/Canada • Similar endpoint as Phase II study (post-treatment surgical interval) • Start Date: Q1:06 • Anticipated trial timelines: • Patient recruitment: six months • Patient follow-up: 1 year • File BLA: six months • Launch HspE7 for RRP six months after filing BLA • Total timeframe: 2 ½ years from start of phase III

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