Monday, March 23, 1998
Disappointing Phase III clinical trial announcements last week provide yet another reminder if one is needed - and it appears to be - of three facts of life: Data rule, it's the Phase II trial that counts, and multifactorial diseases are hell on companies.
Having just finished arguing the case for science-based regulation (see BioCentury, March 16), it seems only fair to take the position that companies should pursue science-based business development. By that we mean that companies need to respect the scientific process: properly designing trials, repeating experiments to confirm their validity and moving on to the next step only after a proper foundation has been laid in prior work.
As noted by Kirk Raab, erstwhile chief executive of Genentech Inc. and now chairman of a multinational portfolio of biotech companies, "There is a cultural thing that we characters who are in the high-risk biotech business are risk-takers. But there's a difference between taking risks by going into a small company and running clinical trials."
The first piece of bad news came from Alteon Inc., which announced on Wednesday that its External Safety Monitoring Committee recommended suspension of its ACTION II Phase III trial of pimagedine in Type II diabetics with overt nephropathy (see A4, and BioCentury Extra, March 19).
Next came Transcend Therapeutics Inc., which on Friday suspended its Phase III trial of intravenous Procysteine for acute respiratory distress syndrome (ARDS) after its Independent Safety Monitoring Board said that all-cause mortality in treated patients was higher than in the placebo group (see A3).
Phase III or not Phase III
One of the raps