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]).

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"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.

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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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

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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 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that it has enrolled the first patient into its FOCUS Study, a phase 2/3 clinical trial of CA4P for the treatment of patients with platinum-resistant ovarian cancer (Press release, Mateon Therapeutics, JUN 23, 2016, View Source [SID:1234513521]). The FOCUS Study is designed to demonstrate whether the addition of CA4P to bevacizumab and chemotherapy, the current standard of care for platinum-resistant ovarian cancer, improves treatment outcomes for these patients.

“The initiation of the FOCUS Study is an important achievement for the company,” stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. “Building upon the results of the GOG-0186I study recently published in the Journal of Clinical Oncology, we have designed this trial to be the one that we believe is most likely to lead to an FDA approval for CA4P in the shortest time possible. I look forward to providing updates as the trial progresses.”

The FOCUS Study has two stages. In the first stage the company plans to enroll up to 80 patients and conduct regular interim analyses to verify the safety and efficacy of the drug combination and to confirm powering assumptions for the second stage. In the second stage, which would support a New Drug Application (NDA) if positive, the company plans to enroll up to 356 patients without any planned interim analyses. The primary endpoint of the FOCUS Study is progression free survival (PFS). The company will also evaluate CA4P’s effect on objective response rate (ORR), overall survival (OS) and other parameters.

For further information about the clinical trial, please visit www.clinicaltrials.gov, Study NCT02641639.

Mateon reminds investors that it plans to hold an event to describe advances in ovarian cancer treatment, including updated data from the GOG-0186I Study in recurrent ovarian cancer, on Monday, June 27, 2016 at 12:00 pm at the Lotte New York Palace Hotel, with presentations expected to begin at approximately 12:15 pm eastern time. To listen to a webcast, please visit the company’s website, www.mateon.com – under the “Investors & News” tab, select the link to “Events & Presentations.” A replay of the webcast will be available after the conclusion of the live event.

On June 23, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that it has enrolled the first patient into its FOCUS Study, a phase 2/3 clinical trial of CA4P for the treatment of patients with platinum-resistant ovarian cancer (Press release, Mateon Therapeutics, JUN 23, 2016, View Source [SID:1234513521]). The FOCUS Study is designed to demonstrate whether the addition of CA4P to bevacizumab and chemotherapy, the current standard of care for platinum-resistant ovarian cancer, improves treatment outcomes for these patients.

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

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"The initiation of the FOCUS Study is an important achievement for the company," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "Building upon the results of the GOG-0186I study recently published in the Journal of Clinical Oncology, we have designed this trial to be the one that we believe is most likely to lead to an FDA approval for CA4P in the shortest time possible. I look forward to providing updates as the trial progresses."

The FOCUS Study has two stages. In the first stage the company plans to enroll up to 80 patients and conduct regular interim analyses to verify the safety and efficacy of the drug combination and to confirm powering assumptions for the second stage. In the second stage, which would support a New Drug Application (NDA) if positive, the company plans to enroll up to 356 patients without any planned interim analyses. The primary endpoint of the FOCUS Study is progression free survival (PFS). The company will also evaluate CA4P’s effect on objective response rate (ORR), overall survival (OS) and other parameters.

For further information about the clinical trial, please visit www.clinicaltrials.gov, Study NCT02641639.

Mateon reminds investors that it plans to hold an event to describe advances in ovarian cancer treatment, including updated data from the GOG-0186I Study in recurrent ovarian cancer, on Monday, June 27, 2016 at 12:00 pm at the Lotte New York Palace Hotel, with presentations expected to begin at approximately 12:15 pm eastern time. To listen to a webcast, please visit the company’s website, www.mateon.com – under the "Investors & News" tab, select the link to "Events & Presentations." A replay of the webcast will be available after the conclusion of the live event.