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Cerulean (CERU) Kidney Cancer Drug Disappoints in Phase II
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Cerulean Pharma Inc. announced disappointing top-line results from a phase II study on its lead candidate, CRLX101, for the treatment of patients with advanced renal cell carcinoma (RCC). Investors are expected to react negatively to the news. Shares were down during pre-market trading session.
The randomized study evaluated CRLX101, in combination with Roche Holding AG’s (RHHBY - Free Report) Avastin, in comparison to investigator's choice of standard of care (SOC) therapy in patients (n=115) with RCC who progressed through two or three prior lines of therapy.
Data from the study demonstrated no statistical significant difference in median progression-free survival (PFS) and objective response rate for the CRLX101/Avastin combination compared to SOC. However, the combination was found to be safe and generally well tolerated. Moreover, its safety and tolerability profile was consistent with that observed in the previous studies.
The company expects to submit full data from the study for presentation at an upcoming medical conference.
Meanwhile, Cerulean is also evaluating CRLX101 in a phase Ib/II study, in combination with weekly paclitaxel, for the treatment of platinum-resistant ovarian cancer.
In the U.S., CRLX101 enjoys Orphan Drug designation for the treatment of ovarian cancer. Moreover, the candidate received Fast Track designation, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and in combination with Avastin for the treatment of metastatic RCC.
We note that the RCC market is already crowded with drugs like – Cabometyx, Sutent, Opdivo and Avastin among others.
Cerulean currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).
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Cerulean (CERU) Kidney Cancer Drug Disappoints in Phase II
Cerulean Pharma Inc. announced disappointing top-line results from a phase II study on its lead candidate, CRLX101, for the treatment of patients with advanced renal cell carcinoma (RCC). Investors are expected to react negatively to the news. Shares were down during pre-market trading session.
The randomized study evaluated CRLX101, in combination with Roche Holding AG’s (RHHBY - Free Report) Avastin, in comparison to investigator's choice of standard of care (SOC) therapy in patients (n=115) with RCC who progressed through two or three prior lines of therapy.
Data from the study demonstrated no statistical significant difference in median progression-free survival (PFS) and objective response rate for the CRLX101/Avastin combination compared to SOC. However, the combination was found to be safe and generally well tolerated. Moreover, its safety and tolerability profile was consistent with that observed in the previous studies.
The company expects to submit full data from the study for presentation at an upcoming medical conference.
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Meanwhile, Cerulean is also evaluating CRLX101 in a phase Ib/II study, in combination with weekly paclitaxel, for the treatment of platinum-resistant ovarian cancer.
In the U.S., CRLX101 enjoys Orphan Drug designation for the treatment of ovarian cancer. Moreover, the candidate received Fast Track designation, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and in combination with Avastin for the treatment of metastatic RCC.
We note that the RCC market is already crowded with drugs like – Cabometyx, Sutent, Opdivo and Avastin among others.
Cerulean currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>