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Athersys治疗中风干细胞疗法折戟 公司前景命悬一线
# c# N+ P- b$ A4 t9 h9 b来源：生物谷 2015-04-19 14:279 c+ i5 ]2 c7 t r% l2 f1 q
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2015年4月19日讯 /生物谷BIOON/ --中风一直是困扰中老年人的一个重大疾病，众所周知，中风的发生会给中风患者的神经系统造成严重伤害，这也是许多患者在中风发生后都留下了重大的后遗症的原因之一。而干细胞由于具有强大的分化潜力，许多科学家认为在体内通过适当诱导就能使患者的神经系统损伤获得修复。$ |" a0 u* f: Q2 `: z# L9 x
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因此，随着干细胞疗法的兴起，研究人员们开始看到了让中风患者重新恢复正常生活的希望。不过，最近Athersys公司相关疗法MultiStem的临床二期实验则向众人证明，这条路仍然任重而道远。
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: C9 f( j V. t3 WAthersys公司最近艰难的宣布，公司开发的用于中风后恢复的干细胞疗法在临床二期中未能与安慰剂组表现出显着性差异而宣告失败。在这项研究中，Athersys公司招募了140名中风患者。整个实验采用全球中风恢复评估体系作为首要预期终点，即患者接受治疗90天后的恢复效果。此外，公司同时还宣布，这一研究同时也未能达到采用其他两种评价体系的次要预期终点。研究人员仅表示，现有数据仅表明尽早接受MultiStem治疗的患者恢复情况要好于接受治疗较晚的患者，但即使考虑到这个因素，实验也未能出现显著性差异结果。
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这一结果对Athersys可以说是毁灭性的。MultiStem是Athersys公司目前仅有的处于临床研究的疗法，此前公司开发的治疗肠炎药物于去年宣告失败。可以说MultiStem是公司证明自身价值的最后机会。然而，随着此次临床二期研究的失败，众多投资者对Athersys的信心大减，公司股价随之暴跌50%以上，价值所剩无几。
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而日本Chugai则成为此次失败的另外一个受损者。就在上个月，Chugai公司和Athersys公司达成协议，以1000万美元的预付款获得了MultiStem在日本的所有权，双方更约定了近2亿美元的相关里程碑奖金。现在看来，这些随着此次失败都成为了水中之月。（生物谷Bioon.com）) A* g$ N, v) I' e# i) ?
: S. Y, i% N0 w I详细英文报道：
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( z" o1 @4 |/ W, S0 z8 u' n: |Athersys' ($ATHX) in-development stem cell treatment failed to beat placebo in a Phase II trial on stroke patients, demolishing the company's value as management digs for a positive spin.4 ?4 t3 i. q' ?8 z! w& `* I: A; I
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The company's treatment, called MultiStem, is meant to reverse the neurological damage caused by strokes, and Athersys recruited 140 patients to test whether the injection could make a meaningful difference on the Global Stroke Recovery Assessment scale. Looking at 90-day interim results, things aren't working out: MultiStem failed to chart any significant difference compared to placebo on the primary endpoint, the company said, and it failed secondary goals of improvement on two other measures of stroke rehabilitation.
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3 j7 |. R; h. h4 h6 W. Q. X% x# cThe news sent Athersys' shares down by more than 50%, plunging the biotech into penny-stock territory as investors sprint from what looks like a valueless company. MultiStem is Athersys' only asset, and, after a major flop in inflammatory bowel disease last year, stroke was looking like its last chance to demonstrate efficacy.% N7 K# R; g* G/ n1 A
+ D! P6 p7 ~. q! ]- hBut management, as ever, sees a silver lining in the latest Phase II failure. Dicing up the data after the fact, Athersys notes that patients who got MultiStem earlier in the treatment window did better against the study's endpoints than those who got it later. That group consists of only 27 out of the 65 who got the stem cell treatment, however, and even those results failed to meet statistical significance. But it's enough of a signal to keep the project alive, CEO Gil Van Bokkelen said.0 I: N& j C8 p3 w" a
, f& n5 k k, q; O/ h& y% S3 o"While the trial did not achieve the primary or component secondary endpoints, we believe the evidence indicating that patients who received MultiStem treatment early appeared to exhibit meaningfully better recovery is very important and promising," Van Bokkelen said in a statement. "... We anticipate additional data and information from the study and will conduct further analyses to generate more insight about the potential for MultiStem treatment in this area."
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7 |( D' ]- l# p# e- iThe results also deal a minor blow to Japanese drugmaker Chugai, which stepped in last month to buy the rights to MultiStem in its home country. Under the agreement. Chugai handed Athersys a $10 million up-front payment and promised up to $195 million more tied to development and sales milestones. |
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发表于 2015-4-22 00:18
发表于 2015-4-22 08:50
