--赛诺菲（Sanofi）疫苗事业部——赛诺菲-巴斯德（Sanofi Pasteur）和KaloBios制药今天宣布，FDA已授予KB001A快车道地位（Fast Track designation），这是一种抗体片段，旨在开发用于机械通气（mechanically-ventilated）患者，保护患者免受铜绿假单胞菌（PA）引发的细菌性肺炎。
机械通气是临床上利用机械辅助通气的方式，达到维持、改善和纠正患者因诸多原因所致的急、慢性重症呼吸衰竭的一种治疗措施。
英文原文：Sanofi, KaloBios Get Fast-Track Designation For KB001A to Treat Bacterial Pneumonia
Sanofi ( SNY ) and its partner KaloBios Pharmaceuticals ( KBIO ) said the U.S. Food and Drug Administration has granted fast-track designation for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa in mechanically-ventilated patients.
KaloBios's shares jumped 13% to $6.99, while Sanofi's shares rose 2.3% to $53.98 in recent light premarket trading.
The FDA's fast-track program is designed to facilitate the clinical development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Sanofi Pasteur, the vaccines division of Sanofi, is responsible for clinical development under the terms of the agreement with KaloBios. The division is currently conducting a Phase I trial of the monoclonal antibody in the U.S. and has started the planning of a Phase IIb study.
"Sanofi Pasteur is currently targeting the antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospitals and we are also interested in providing prevention of relapses and improvement of treatment outcomes in patients with an ongoing Pa infection," said Michel DeWilde, senior vice president of research and development. "Additional indications may be considered later in the life cycle of the product."
Under the terms of the current agreement, Sanofi Pasteur has worldwide rights to KaloBios' KB001A technology for all disease indications related to Pseudomonas aeruginosa infections, except cystic fibrosis and bronchiectasis, the rights in which were retained by KaloBios, and Sanofi Pasteur has the option to obtain at a later date.
Most serious Pseudomonas aeruginosa infections occur in hospitalized and critically or chronically ill patients-- primarily affecting the respiratory system in susceptible individuals--and are a serious clinical problem due to the bacteria's resistance to antibiotics.