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 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.

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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 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 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, JUN 23, 2016, View Source [SID:1234513520]). The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

“We are disappointed that we did not receive a positive recommendation for Arzerra in the maintenance CLL setting in Europe. We will continue to work with Novartis to define the best path forward for Arzerra,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The MAA was based on positive data from an interim analysis from the Phase III PROLONG study (OMB112517), which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL.

Safety and Efficacy Data from the Phase III PROLONG study
A total of 474 patients were included in the analysis. Patients who received ofatumumab maintenance treatment lived 14.2 months longer without their disease worsening than patients who received no further treatment. Median progression free survival (PFS) as assessed by the investigators was 29.4 months for the ofatumumab treatment arm, and 15.2 months for the observation arm (Hazard Ratio 0.50; p<0.0001). There were no unexpected safety findings. The most common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection. The two most common grade 3-4 adverse events were neutropenia (22% in ofatumumab arm vs 8% in observation arm), and pneumonia (5% in ofatumumab arm vs 3% in observation arm). During the period between the first dose and 60 days after the last dose there were two patients (1%) in the ofatumumab group and five patients (2%) in the observation group who died due to adverse events. About the Phase III PROLONG study This Phase III study was designed to randomize up to 532 patients with relapsed CLL who have responded to treatment at relapse, to either ofatumumab maintenance treatment or no further treatment (observation). Patients in the ofatumumab arm received an initial dose of 300 mg of ofatumumab, followed one week later by a second dose of 1,000 mg, then doses of 1,000 mg every 8 weeks for up to two years, while patients in the observation treatment arm received no further treatment. The primary endpoint of the study was PFS. Secondary objectives were evaluation of clinical benefit, overall survival, safety, tolerability, the health-related quality of life of subjects treated with ofatumumab versus no further treatment, and pharmacokinetics among relapsed CLL patients receiving maintenance therapy with ofatumumab. About CLL CLL is the most commonly diagnosed adult leukemia in Western countries, and accounts for approximately 1 in 4 cases of leukemia.1 Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.2 About Ofatumumab (Arzerra) Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes. In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab). Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

On June 23, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, JUN 23, 2016, View Source [SID:1234513520]).

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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 Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

"We are disappointed that we did not receive a positive recommendation for Arzerra in the maintenance CLL setting in Europe. We will continue to work with Novartis to define the best path forward for Arzerra," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The MAA was based on positive data from an interim analysis from the Phase III PROLONG study (OMB112517), which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL.

Safety and Efficacy Data from the Phase III PROLONG study
A total of 474 patients were included in the analysis. Patients who received ofatumumab maintenance treatment lived 14.2 months longer without their disease worsening than patients who received no further treatment. Median progression free survival (PFS) as assessed by the investigators was 29.4 months for the ofatumumab treatment arm, and 15.2 months for the observation arm (Hazard Ratio 0.50; p<0.0001).

There were no unexpected safety findings. The most common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection. The two most common grade 3-4 adverse events were neutropenia (22% in ofatumumab arm vs 8% in observation arm), and pneumonia (5% in ofatumumab arm vs 3% in observation arm). During the period between the first dose and 60 days after the last dose there were two patients (1%) in the ofatumumab group and five patients (2%) in the observation group who died due to adverse events.

About the Phase III PROLONG study
This Phase III study was designed to randomize up to 532 patients with relapsed CLL who have responded to treatment at relapse, to either ofatumumab maintenance treatment or no further treatment (observation). Patients in the ofatumumab arm received an initial dose of 300 mg of ofatumumab, followed one week later by a second dose of 1,000 mg, then doses of 1,000 mg every 8 weeks for up to two years, while patients in the observation treatment arm received no further treatment.

The primary endpoint of the study was PFS. Secondary objectives were evaluation of clinical benefit, overall survival, safety, tolerability, the health-related quality of life of subjects treated with ofatumumab versus no further treatment, and pharmacokinetics among relapsed CLL patients receiving maintenance therapy with ofatumumab.
About CLL

CLL is the most commonly diagnosed adult leukemia in Western countries, and accounts for approximately 1 in 4 cases of leukemia.1 Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.2

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.