SOUTH SAN FRANCISCO, Calif., June 23, 2016 (GLOBE NEWSWIRE) — Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced 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. 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.
Mateon Therapeutics, Inc. is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy (VTT) in oncology. VTT includes vascular disrupting agents (VDAs) such as the investigational drugs that Mateon is developing, and anti-angiogenic agents (AAs), a number of which are FDA-approved and widely used in cancer treatment. These two approaches have distinct yet complementary mechanisms of action.
At Mateon, we believe that we can significantly improve cancer therapy by employing these two complementary approaches simultaneously. When utilized this way, VDAs obstruct existing blood vessels in the tumor leading to significant central tumor cell death while AAs prevent the formation of new tumor blood vessels.
Mateon is committed to leveraging our intellectual property and the product development expertise of our highly skilled management team to enable VTT to realize its true potential and to bring much-needed new therapies to cancer patients worldwide.
Safe Harbor Statement
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions Mateon might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Mateon’s reports to the Securities and Exchange Commission, including Mateon’s reports on Form 10-K, 10-Q and 8-K. However, Mateon undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015.
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