關鍵詞： Celsion ThermoDox
2013年2月2日訊 /生物谷BIOON/ --Celsion公司曾被認為是有希望成功研制出癌癥藥物的小型公司之一,，但是在1月31日,，公司宣布公司研發(fā)的用于治療肝癌的藥物ThermoDox未能達到預期療效而宣告失敗,。公司CEO Michael H. Tardugno稱，很遺憾該研究未能成功,，公司下一步將再次分析所有的研究數(shù)據(jù)以便對ThermoDox的價值進行重新評估,。
此前，Celsion公司曾被外界認為有希望打破所謂的Feuerstein-Ratain 定律,。Feuerstein-Ratain 定律是由Feuerstein提出的,，F(xiàn)euerstein認為公司市值在3億美元以下的生物技術公司不可能研制成功抗癌藥物。而今,，Celsion公司的失敗似乎再次驗證了該定律,。然而，就在該消息公布的幾天前,，中國浙江的海正藥業(yè)與Celsion公司簽訂了價值500萬美元的關于ThermoDox在亞洲推廣的協(xié)議,。（生物谷Bioon.com）
詳細英文報道：
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.
