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August 12, 2014
16:17 EDTCERUCerulean reports Q2 EPS (44c), consensus (36c)
Reports Q2 revenue $33K. As of June 30, Cerulean had cash and cash equivalents of $64.3M. Cerulean estimates that its current cash and cash equivalents will allow it to fund several ongoing single-arm clinical trials of CRLX101, an ongoing randomized Phase 2 clinical trial of CRLX101, and a planned Phase 1 trial of CRLX301. CEO Oliver Fetzer said, "We anticipate announcing data from two ongoing single-arm CRLX101 trials in the first quarter of 2015, data from an ongoing randomized CRLX101 trial by the end of 2015, and data from a planned Phase 1 CRLX301 trial by the end of 2015."
News For CERU From The Last 14 Days
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December 17, 2014
08:30 EDTCERUCerulean announces first patient dosed with CRLX301 in Phase 1/2a trial
Cerulean Pharma announced that the first patient has been dosed with CRLX301 in Cerulean’s Phase 1/2a trial in patients with advanced solid tumor malignancies. CRLX301 is a nanoparticle-drug conjugate, or NDC, with a docetaxel payload, and it is the second clinical candidate from Cerulean’s Dynamic Tumor Targeting Platform.“CRLX301 was superior to docetaxel in seven of seven animal models, with a statistically significant survival benefit in five of those preclinical models,” said Paul Friedman, M.D., Executive Chairman of Cerulean. “We also saw preclinical tolerability that is consistent with our expectations of the platform -- specifically, improved tolerability relative to published data with docetaxel. We look forward to learning if these preclinical results will translate in the clinic.” This is the first clinical trial of CRLX301. The Phase 1/2a trial is commencing in Australia and is expected to expand to the U.S. The Phase 1 portion is a single-arm, open-label, dose-escalation study of CRLX301 in up to 36 patients with advanced solid tumor malignancies that is designed to identify the maximum tolerated dose and establish the recommended Phase 2 dose of CRLX301 when administered by intravenous infusion once every three weeks. The Phase 2a portion will be an expansion cohort that will enroll an additional 24 patients. The primary endpoints are pharmacokinetics, safety and tolerability of CRLX301. Preliminary evidence of efficacy also will be evaluated.
December 15, 2014
09:04 EDTCERUCerulean completes enrollment in Phase 1b/2 study of CRLX101, Avastin
Cerulean Pharma announced completion of enrollment of 22 patients in a Phase 1b/2 clinical proof of principle trial of its lead nanoparticle-drug conjugate, CRLX101, in combination with Avastin in relapsed renal cell carcinoma. This study is an investigator-sponsored trial being conducted by the University of Pennsylvania and Thomas Jefferson University Hospital with support from Cerulean. The Principal Investigator is Dr. Stephen Keefe of the University of Pennsylvania Abramson Cancer Center. Data previously presented from the first 11 patients from this study showed a 27% response rate in a setting where standard of care historically provides only a 2-4% response rate. A 7.6 months median progression-free survival was observed, which is double the roughly 3.5 months PFS achieved by standard-of-care in this setting. Based on these data, Cerulean launched a company-sponsored randomized Phase 2 trial of CRLX101 in combination with Avastin in 3rd and 4th line RCC in August 2014, which is currently ongoing.

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