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Carbylan Therapeutics Offers Update to Timeline for Phase 3 Program: COR1.1 On Track for Q1 Data Availability, Second Phase 3 Trial COR1.2 Will Enroll Early '16, NDA Submission Expected Mid-'17

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Carbylan Therapeutics (NASDAQ: CBYL), a specialty pharmaceutical company focused on the development of novel and proprietary combination therapies, today provided an update regarding its Phase 3 clinical program.

As was recently announced, Carbylan has completed enrollment of its first pivotal phase 3 trial, COR1.1, which enrolled over 500 patients.

As the Company moves forward with clinical development in anticipation of its second Phase 3 trial, COR1.2, Carbylan has been transferring its drug manufacturing processes to two contract manufacturers (CMOs) to replace in-house manufacturing and provide for commercial-scale capabilities. In this transfer process, unforeseen delays were recently encountered, which have required a revision to the production timeline. Carbylan has been working closely with its CMOs on a revised timeline, and now anticipates enrolling the first patients in its COR1.2 trial in early 2016. In addition, the Company plans to open an Investigational New Drug Application (IND) and begin enrolling U.S. patients in the first half of 2016. Carbylan expects data availability from COR1.2 and the submission of its New Drug Application (NDA) for Hydros-TA by mid-2017. The Company had previously anticipated an NDA submission in early 2017.

The revised Phase 3 timeline does not alter anticipated availability of data from the Company's COR1.1 trial during the first quarter of 2016.

Posted-In: News Press Releases

 

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