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Biotech / Medical : Stressgen (VSE: SSB)
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To: Heat Shock who wrote (228)5/7/2004 7:07:59 PM
From: Heat Shock  Read Replies (1) of 236
 
Re the recent conference call- here is post 7856537 by grisled on stockhouse.ca-

There was a very thorough presentation followed by a busy Q&A session.
Company is meeting with the FDA on June 30th regarding FDA's design requirements for the pivotal (final)RRP trial.
In other words, how large a trial of what design if successful will the FDA require in order to approve the drug.

Next Steps for HspE7
RRP (orphan drug and fast track)
End Of-PII meeting with FDA on June 30 2004
Clinical supplies available 1Q05
Dysplasia
Completing HIV+ HPV trial
[Palefsky]; potential new label approval in 2009
Completing cervical dysplasia/LEEP trial
[Weber]; potential new label approval in 2010
Cancer (viral-related)
Head/neck (1/3) caused by HPV – TBD by SSB/partner
Cervical cancer – TBD by SSB/partner
Anal cancer – TBD by SSB/partner

There was also disclosure of on-going negotiations with unknown parties about new partnership(s)as a means of moving forward the cancer research & development.

There are currently 4 trials on-going under the auspices of the NCI (National Cancer Institute)studying anal and cervical dysplasia in both HIV positive and negative patients. Management stated during questioning that the DR Palefsky High grade anal dysplasia
trial with 15 HIV+ patients at University of California San Francisco has seen some remarkable response(s) (from high-grade to no-grade) so far. This trial and one other concludes in the 4th qtr this year. A followup trial to build on the results of the Palefsky study is already planned. Two other NIC cervical dysplasia Phase 11 trials are ready to begin as soon as the new commercial HspE7 is avaialable in 1st qtr 2005

Total Potential U.S. Revenues for Top Three Indications Based on $15,000 [3 x 500 mcg] Pricing Scenario in US Million Dollars


                   2008 2009  2010  2011 
RRP                  96  141   170   161 
HIV+ HPV                 509   834 1,174 
CIN/LEEP failures              111   178 
Total                96  650 1,115 1,513 

Penetration         25%  40%   55%   62%



Also Bioreagent sales rebounded srongly from recent weakness, some discussion of monetizing this asset.
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