On June 23, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (“the company”), an oncology-focused biotechnology company, reported the results of the first phase of a National Cancer Institute (NCI)-funded Small Business Innovation Research (SBIR) Phase 1 contract for a study of CLR 125, a radiotherapeutic isotope, which may be uniquely suited to treat micro-metastatic disease, conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform (Filing, 8-K, Cellectar Biosciences, JUN 23, 2016, View Source [SID:1234513530]).

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The study demonstrated that a single dose of CLR 125 reduced the volume of human-derived primary triple negative breast cancer xenografts (tumor models) by approximately 60 percent, compared to a control vehicle (p<0.001), as well as significantly extending survival. CLR 125 also significantly weakened the progression of micrometastases (p< 0.01) and reduced established metastases (p< 0.01) compared to the control vehicle. Importantly, within 96 hours of dosing, investigators observed that radioactivity cleared from subjects’ blood and organs and accumulated primarily in the tumor cells where it was retained past 144 hours. "These study results provide further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, whether in cytotoxics, as in our previously announced paclitaxel program or radiotherapeutics, as this study demonstrated," said Jim Caruso, president and CEO of Cellectar Biosciences. "Further, these data clearly show that our PDC delivery platform may possess clinical utility in a broad range of cancer types with a wide variety of cytotoxic compounds." This trial represents the first phase of the SBIR contract for a Phase 1 study sponsored by NCI. Following a complete review of the data, an assessment of potential clinical applications, and differentiated product benefits, both NCI and the company will determine whether to advance CLR 125 into phase 2 of the contract.

On June 23, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (“the company”), an oncology-focused biotechnology company, reported the results of the first phase of a National Cancer Institute (NCI)-funded Small Business Innovation Research (SBIR) Phase 1 contract for a study of CLR 125, a radiotherapeutic isotope, which may be uniquely suited to treat micro-metastatic disease, conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform (Filing, 8-K, Cellectar Biosciences, JUN 23, 2016, View Source [SID:1234513530]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study demonstrated that a single dose of CLR 125 reduced the volume of human-derived primary triple negative breast cancer xenografts (tumor models) by approximately 60 percent, compared to a control vehicle (p<0.001), as well as significantly extending survival. CLR 125 also significantly weakened the progression of micrometastases (p< 0.01) and reduced established metastases (p< 0.01) compared to the control vehicle. Importantly, within 96 hours of dosing, investigators observed that radioactivity cleared from subjects’ blood and organs and accumulated primarily in the tumor cells where it was retained past 144 hours. "These study results provide further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, whether in cytotoxics, as in our previously announced paclitaxel program or radiotherapeutics, as this study demonstrated," said Jim Caruso, president and CEO of Cellectar Biosciences. "Further, these data clearly show that our PDC delivery platform may possess clinical utility in a broad range of cancer types with a wide variety of cytotoxic compounds." This trial represents the first phase of the SBIR contract for a Phase 1 study sponsored by NCI. Following a complete review of the data, an assessment of potential clinical applications, and differentiated product benefits, both NCI and the company will determine whether to advance CLR 125 into phase 2 of the contract.

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.

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!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free 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."

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.

On June 23, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (“the company”), an oncology-focused biotechnology company, reported the results of the first phase of a National Cancer Institute (NCI)-funded Small Business Innovation Research (SBIR) Phase 1 contract for a study of CLR 125, a radiotherapeutic isotope, which may be uniquely suited to treat micro-metastatic disease, conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform (Filing, 8-K, Cellectar Biosciences, JUN 23, 2016, View Source [SID:1234513530]).

The study demonstrated that a single dose of CLR 125 reduced the volume of human-derived primary triple negative breast cancer xenografts (tumor models) by approximately 60 percent, compared to a control vehicle (p<0.001), as well as significantly extending survival. CLR 125 also significantly weakened the progression of micrometastases (p< 0.01) and reduced established metastases (p< 0.01) compared to the control vehicle. Importantly, within 96 hours of dosing, investigators observed that radioactivity cleared from subjects’ blood and organs and accumulated primarily in the tumor cells where it was retained past 144 hours. "These study results provide further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, whether in cytotoxics, as in our previously announced paclitaxel program or radiotherapeutics, as this study demonstrated," said Jim Caruso, president and CEO of Cellectar Biosciences. "Further, these data clearly show that our PDC delivery platform may possess clinical utility in a broad range of cancer types with a wide variety of cytotoxic compounds." This trial represents the first phase of the SBIR contract for a Phase 1 study sponsored by NCI. Following a complete review of the data, an assessment of potential clinical applications, and differentiated product benefits, both NCI and the company will determine whether to advance CLR 125 into phase 2 of the contract.