Transcript No Slide Title - Recurrent Respiratory Papillomatosis Foundation

Stressgen Highlights
• Late-stage lead product candidate, HspE7, addressing large,
unmet clinical need of HPV-related diseases including:
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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
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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
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Management Team
Gregory M. McKee, President, Chief
Executive Officer
Genzyme, Valentis, GeneSoft
Marvin I. Siegel, Ph.D., EVP, Research
& Development
Telik, Schering-Plough, Burroughs
Wellcome
John Neefe, M.D., SVP, Clinical
Development
Sanofi, Sterling-Winthrop, Centocor
Howard T. Holden, Ph.D., VP,
Regulatory Affairs and Compliance
Ligand, Parke-Davis, Centocor
Kendra Berger, Executive Director
Finance & Controller
Discovery Partners Int’l., FPA Medical
Management, Price Waterhouse
Michael Brown
Acting General Counsel
Paramount Law, DLP (Formerly Gray
Cary)
Derek Kelaita, Director – Business
Development
Corvas, Dendreon
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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
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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
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CoValTM Fusion Products
The Stressgen Solution
HspE7 Development Pathways
HspE7
1st
2nd Generation HspE7
(reformulated with adjuvant)
Generation HspE7
Use in RRP primary
registration trial
Use in phase I/II proof-of
concept study in GW or LEEP
Failures
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Interim day 28 TC-1 Tumor Regression Data for
Dose Response Studies Utilizing an Admix of HspE7
and Adjuvant DNA
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3ug adjuvant
10ug adjuvant
30ug adjuvant
cGMP
Average cGMP (historical)
90
Percent Tumor Incidence
80
70
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20
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HspE7 Dose
600
700
800
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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.
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)
Mean of First Post-treatment Interval Between
Surgeries Increased Significantly
120
106
(p<0.02)
100
Days
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60
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20
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Baseline
Post-treatment
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RRP Phase II Study Data vs.
National Registry
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National Registry Data
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Age (years)
Redrawn from Fig. 3 in Reeves, W.C., et al, Arch Otolaryngology Head
Neck/Vol 129, Sep. 2003
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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:
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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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Randomized
Debulking surgery
HspE7 injection
Placebo injection
Intersurgical interval
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