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回复 botizhou 的帖子% h N$ l* e9 G6 M2 n
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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。
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3 p% v/ g" c% h% t# T8 N0 ^Osiris stem cell treatment can't beat placebo in diabetes study& D( ^( H1 e; b4 u1 u, j+ B5 t0 V4 g; [
1 m' P& Q6 a3 vJanuary 3, 2012
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It takes a considerable level of patience, but if you dig deep into Osiris Therapeutics's latest update on its
& }6 d2 P5 [( |3 {6 n" j+ Y, Imid-stage study of the adult stem cell therapy Prochymal for Type 1 diabetes, you'll find that after a year of* F8 K8 v" r& W% \
treatment patients taking the therapy aren't doing any better than the placebo arm when it comes to a
/ }; ?+ g: E$ G: H- vkey endpoint of the study.% s1 m. S9 E: o0 `8 K
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The study still has a year left to run, and the biotech touted data on how well patients tolerated the
0 |9 ^& {# P: w! P" |) ~/ W' Gtreatment and how it matches the placebo on adverse events. Then there's this note: "No significant0 g& d' q0 d+ V4 w/ F0 _) V
differences in the rates of disease progression, as measured by stimulated C-peptide levels at the one year: \2 ?+ n+ G: {
time point, have been observed. However there was a trend towards fewer hypoglycemic events for
3 ^3 V+ ?! D# s( y$ u9 xpatients treated with Prochymal as compared to controls."
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3 G9 Z' f& I! l% I5 H0 ]" v0 ?Osiris ($OSIR) has been harshly criticized in the past for spinning the news on Prochymal, which ran into- A/ K) t0 ^9 I" _5 h$ X& v s0 {, j h
some severe trouble in the clinic when it was studied as a potential treatment for graft vs. host disease, f7 l' y, Q9 }6 ^8 o
Crohn's disease and more. TheStreet's Adam Feuerstein, in particular, has enjoyed heckling the company2 L5 g* _3 I L. \
for its sunny releases. And he wasn't missing a beat following today's announcement.
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2 C$ U- J; B+ \; B' t3 M1 QFollowing a note on Osiris's regulatory troubles, Feuerstein notes: "Osiris finds it easier apparently to
& k; q, o! [) ]# |: Z& D8 zbamboozle retail investors about failed stem-cell therapies than regulators." |
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发表于 2012-1-10 17:01
