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Clinical Trial Update（July 11, 2006）
最近2週間で、2社が膵癌治療のための第Ⅲ相試験でよい結果を出せなかったと報告した。 ジェネンテックのAvastinは、珍しく失敗し、患者に対する延命効果を示すことができなかったとして治験を中止した。 また、その発表の一日後に、別の膵癌薬(Therion BiologicsのPanvac-VF)もプライマリー・エンドポイントを得ることに失敗した。（FierceBiotech、2006年7月11日）
DRUG / COMPANY | INDICATION | RESULTS | SCOOP |
PHASE I | |||
Cytokinetics | Chronic heart failure | CK-1827452 produced a statistically significant and clinically relevant increase in ejection fraction and fractional shortening. | CK-1827452 is being developed as a potentially improved form of inotropic therapy more information |
PHASE II | |||
Vectura Group and Sosei | Chronic obstructive pulmonary disease (COPD) | NVA237 has successfully completed a Phase IIb multiple dose-ranging clinical trial. | The outcome of the study supports the progression of NVA237 and Novartis are proceeding as planned with the development program. more information |
Shionogi | Obesity | The company announced positive top-line efficacy results from a Phase IIa proof-of-concept trial with S-2367, a drug candidate for obesity and related conditions. | A full analysis of the current study data, including secondary efficacy and metabolic parameters is underway. more information |
Avera | Adjunct to general anesthesia | Gantacurium chloride as an adjunct to general anesthesia enabled rapid intubation of patients undergoing surgery. | Gantacurium chloride is a non-depolarizing ultra-short acting neuromuscular blocker. more information |
PHASE III | |||
Genentech | Pancreatic cancer | Avastin in combination with gemcitabine chemotherapy did not meet its primary endpoint of overall survival. | The trial was stopped at the recommendation of an IDMB based on an interim analysis indicating that it is unlikely that differences in overall survival will be shown between treatment arms as the data mature. more information |
Cephalon | Generalized anxiety disorder | Gabitril did not reach statistical significance on the primary study endpoints. | Cephalon will conduct a complete analysis of the data to assist in its evaluation of future clinical development plans for Gabitril in other therapeutic areas. more information |
Therion | Advanced pancreatic cancer | The trial did not meet its primary efficacy endpoint of improving overall survival compared with palliative chemotherapy or best supportive care. | The company no longer plans to file a BLA with the FDA. more information |
