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回复 botizhou 的帖子3 {. Q+ m' v8 a% C/ Q: Q
# o* E4 V. S+ P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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% }& K) f6 v M! k" k$ f; QOsiris stem cell treatment can't beat placebo in diabetes study
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January 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
2 z7 e) P" G. d& D8 Vmid-stage study of the adult stem cell therapy Prochymal for Type 1 diabetes, you'll find that after a year of
6 l2 H: e9 p ]% o+ s3 J9 J$ ytreatment patients taking the therapy aren't doing any better than the placebo arm when it comes to a# V; w# s. _3 }2 u- c* x' a) X
key endpoint of the study.
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/ O! k! v* ]" {+ I4 \' V% ]The study still has a year left to run, and the biotech touted data on how well patients tolerated the- S! K' y& A+ o" h# u2 N
treatment and how it matches the placebo on adverse events. Then there's this note: "No significant
* d: B8 u/ L6 d& pdifferences in the rates of disease progression, as measured by stimulated C-peptide levels at the one year
% f+ a7 j$ p3 g/ m$ e3 T6 Vtime point, have been observed. However there was a trend towards fewer hypoglycemic events for5 a" l' I$ E4 N
patients treated with Prochymal as compared to controls."7 y4 E$ O- G) C
2 L% T3 q) k) r7 t/ a7 |Osiris ($OSIR) has been harshly criticized in the past for spinning the news on Prochymal, which ran into
6 D, j/ Z3 r+ j1 y% o$ v" ]0 \some severe trouble in the clinic when it was studied as a potential treatment for graft vs. host disease,0 v. ^8 y# c. U# q- ]. R
Crohn's disease and more. TheStreet's Adam Feuerstein, in particular, has enjoyed heckling the company
6 |. L; n6 L8 D' B) i6 Zfor its sunny releases. And he wasn't missing a beat following today's announcement.( D1 ?5 C; d6 q0 ?& \6 J
4 a# v8 W" a0 i, M* f9 I" QFollowing a note on Osiris's regulatory troubles, Feuerstein notes: "Osiris finds it easier apparently to: U" Y- \( z, n& r
bamboozle retail investors about failed stem-cell therapies than regulators." |
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发表于 2012-1-10 17:01
