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Celsion 肝癌新药ThermoDox研究宣告失败

来源:生物谷 2013-02-02 10:48

2013年2月2日讯 /生物谷BIOON/ --Celsion公司曾被认为是有希望成功研制出癌症药物的小型公司之一,但是在1月31日,公司宣布公司研发的用于治疗肝癌的药物ThermoDox未能达到预期疗效而宣告失败。公司CEO Michael H. Tardugno称,很遗憾该研究未能成功,公司下一步将再次分析所有的研究数据以便对ThermoDox的价值进行重新评估。

此前,Celsion公司曾被外界认为有希望打破所谓的Feuerstein-Ratain 定律。Feuerstein-Ratain 定律是由Feuerstein提出的,Feuerstein认为公司市值在3亿美元以下的生物技术公司不可能研制成功抗癌药物。而今,Celsion公司的失败似乎再次验证了该定律。然而,就在该消息公布的几天前,中国浙江的海正药业与Celsion公司签订了价值500万美元的关于ThermoDox在亚洲推广的协议。(生物谷Bioon.com)

详细英文报道:

Celsion was the center of a considerable amount of market buzz over the last year as the small biotech pushed a late-stage cancer drug through a Phase III liver cancer study. Its stock price tripled as investors rode a swell of enthusiasm that Celsion ($CLSN) could beat the tough odds that face any small-cap company trying to make it all the way through an oncology program.

Until this morning. Celsion announced that its late-stage drug ThermoDox failed the study, unable to demonstrate a significant improvement in progression-free survival. And its stock price instantly popped on the news, dropping 83% in minutes.

"We are disappointed that the HEAT Study did not provide sufficient evidence of clinical effectiveness of ThermoDox as measured by the trial's primary endpoint," said Celsion CEO Michael H. Tardugno. "We will consider following the patients currently enrolled in the HEAT Study to the secondary endpoint, overall survival, and are conducting additional analyses of the data from the trial in order to assess the future strategic value of ThermoDox."

Some traders had been betting that Celsion could beat the Feuerstein-Ratain rule, named in part after TheStreet's Adam Feuerstein, which concludes that biotechs with a market cap under $300 million have had a 100% failure rate with Phase III cancer studies. Just days ago China's Zhejiang Hisun Pharmaceutical provided a $5 million upfront to grab an Asian development deal for ThermoDox.

The traders and Hisun, though, bet wrong and the Feuerstein-Ratain rule remains unbroken. Celsion will release data at an upcoming scientific conference, but company officials said the PFS data wouldn't support a filing in any of the world's biggest markets. Company officials said this morning that they will be in touch with Hisun later today. There's enough cash on hand to get "well into 2014," but a strategic review of its spending plans will be launched.

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