On June 23, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported that the first patient has been dosed in the Phase 2a stage of an ongoing Phase 1/2a clinical trial of CRLX301 in patients with advanced solid tumors (Press release, Cerulean Pharma, JUN 23, 2016, View Source [SID:1234513533]). Schedule your 30 min Free 1stOncology Demo! "Advancing CRLX301 into Phase 2a is a significant milestone for our second platform-generated NDC," stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. "We will further explore the once every-three-weeks dosing schedule at the Phase 1 established maximum tolerated dose in the Phase 2a expansion, while we continue the escalation study of weekly dosing in the ongoing Phase 1 stage. Our goal is to move into a pivotal study once the preferred dosing regimen and indication have been determined."
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This Phase 2a expansion includes two stages. Stage 1 will enroll up to 8 patients in each dosing schedule. This stage of the study is designed to further establish the safety and tolerability of each dosing schedule and to provide additional data on pharmacokinetics, pharmacodynamics and antitumor activity. Stage 2 will enroll up to 36 additional patients with specific tumor types using the optimal dosing schedule.
About CRLX301
CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in Phase 2a clinical development.
Cerulean Announces First Patient Dosed in Phase 2a Expansion Stage Evaluating CRLX301 in Patients with Advanced Solid Tumors
On 23, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported that the first patient has been dosed in the Phase 2a stage of an ongoing Phase 1/2a clinical trial of CRLX301 in patients with advanced solid tumors (Press release, Cerulean Pharma, JUN 23, 2016, View Source [SID:1234513533]).
“Advancing CRLX301 into Phase 2a is a significant milestone for our second platform-generated NDC,” stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. “We will further explore the once every-three-weeks dosing schedule at the Phase 1 established maximum tolerated dose in the Phase 2a expansion, while we continue the escalation study of weekly dosing in the ongoing Phase 1 stage. Our goal is to move into a pivotal study once the preferred dosing regimen and indication have been determined.”
This Phase 2a expansion includes two stages. Stage 1 will enroll up to 8 patients in each dosing schedule. This stage of the study is designed to further establish the safety and tolerability of each dosing schedule and to provide additional data on pharmacokinetics, pharmacodynamics and antitumor activity. Stage 2 will enroll up to 36 additional patients with specific tumor types using the optimal dosing schedule.
About CRLX301
CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in Phase 2a clinical development.