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7 j( G4 p R8 z5 L0 X0 a似乎有忽悠之嫌，见下面的新闻。目前干细胞能进入临床试验都是重大新闻。要是考虑到其他生物医药产品和技术的临床试验成功率，未来干细胞临床试验中所需要挤的水分可能会是几何级的高。尤其是靠临床试验上市的公司，将来股市不会少浪费钱。重庆啤酒与三军医大的乙肝疫苗忽悠了十年了，多少股民钱打了水漂。当然，有些水分是无法避免的。不过，会有很多是人为的。这些可以避免的临床试验风险，不仅对投资和股市有损害，而且也会反过来打击干细胞产业的发展。, S0 r9 T% F' f% A
7 m9 u* v# |) Z6 z: F2 xOsiris stem cell treatment can't beat placebo in diabetes study3 u1 o8 S* _+ x
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January 3, 2012
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; _. t% X5 _" u9 }It takes a considerable level of patience, but if you dig deep into Osiris Therapeutics's latest update on its: Q6 `9 ~, o% R+ C: k$ @4 K7 |
mid-stage study of the adult stem cell therapy Prochymal for Type 1 diabetes, you'll find that after a year of
3 J" B/ J; e" ]8 a# F2 Otreatment patients taking the therapy aren't doing any better than the placebo arm when it comes to a; b m( m( f2 W5 L) U
key endpoint of the study.: e9 s1 i" l! B9 |
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The study still has a year left to run, and the biotech touted data on how well patients tolerated the
e8 g1 [% m; E" @6 _. @) _treatment and how it matches the placebo on adverse events. Then there's this note: "No significant' U' J% K6 N+ v" d; e* x+ g# l
differences in the rates of disease progression, as measured by stimulated C-peptide levels at the one year7 v9 w* P2 d( W" j- N( M# X
time point, have been observed. However there was a trend towards fewer hypoglycemic events for
+ ^8 ]# k; h! U6 }* l+ |patients treated with Prochymal as compared to controls."
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Osiris ($OSIR) has been harshly criticized in the past for spinning the news on Prochymal, which ran into
6 Q7 F* L0 U+ l" e0 f6 N( dsome severe trouble in the clinic when it was studied as a potential treatment for graft vs. host disease,
' u& `' m' |; U# o) \% {5 t% CCrohn's disease and more. TheStreet's Adam Feuerstein, in particular, has enjoyed heckling the company
3 b% x& s9 j2 p, N4 p, D. H* Zfor its sunny releases. And he wasn't missing a beat following today's announcement.! W/ A: I" z$ t) _: b4 V
9 F, Y) u* d' c' e( ?' [0 M8 ]Following a note on Osiris's regulatory troubles, Feuerstein notes: "Osiris finds it easier apparently to
( V1 }2 I& ]4 T6 \/ nbamboozle retail investors about failed stem-cell therapies than regulators." |
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发表于 2012-1-10 17:01
