Cerulean Receives FDA Fast Track Designation for CRLX101 for the Treatment of Platinum-Resistant Ovarian Cancer Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Wednesday, July 20, 2016

Cerulean Receives FDA Fast Track Designation for CRLX101 for the Treatment of Platinum-Resistant Ovarian Cancer



Business Wire


CRLX101 is being evaluated in combination with weekly paclitaxel for the treatment of recurrent platinum-resistant ovarian carcinoma in a Phase 1b/2 clinical trial. Data from the Phase 1b portion of the trial were the subject of an oral presentation at the Gynecologic Oncology 2016 Conference in May. These data showed that five of the first nine patients (56%) enrolled in the trial achieved partial responses. Of note, five of the nine patients enrolled in the Phase 1b trial previously failed Avastin® (bevacizumab) and three of these five patients achieved partial responses. Cerulean is conducting this trial in collaboration with the GOG and expects to provide an update at the European Society for Medical Oncology 2016 Congress.

In 2015, CRLX101 was granted Orphan Drug designation for the treatment of ovarian cancer.

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