Mateon Announces Initiation of FOCUS Study in Platinum-Resistant Ovarian Cancer

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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"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.

Mateon Announces Initiation of FOCUS Study in Platinum-Resistant Ovarian Cancer

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.