September 27, 2017
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO, Calif. – Following a failure to determine clear efficacy in its experimental combination ovarian cancer drug, Mateon Therapeutics said it will scrap the drug program along with 60 percent of its employees.
Mateon’s FOCUS study was evaluating its lead tubulin-binding vascular disrupting agent CA4P in combination with the Blood vessel growth inhibitor bevacizumab (Genentech ’s Avastin) and physician’s choice chemotherapy in patients with platinum-resistant ovarian cancer. In the Phase II/III FOCUS study the company was studying if the addition of CA4P to the treatment regimen of ovarian cancer patients would improve progression-free survival (PFS) as well as objective response rates. An interim analysis of 70 patients in the study shows little difference between control and placebo. Company data shows slight 32 day improvement (202 days versus 170 days) in progression free survival for patients in the CA4P group. Mateon said that one month difference was not clinically meaningful. Additionally, the company said that 12 patients in the CA4P group and 12 in the placebo group died or had their disease worsen over the course of the study.
Mateon said that due to the lack of a meaningful improvement in PFS, combined with the unfavorable partial response data, the company does not believe that continuation of the FOCUS study is appropriate. Mateon said it is terminating the FOCUS study as well as further development of CA4P. Mateon will continue to support investigator-sponsored studies and preclinical studies in combination with immuno-oncology agents. A total of 91 patients had been enrolled in the FOCUS study.
“We are clearly disappointed that CA4P did not show a clinically meaningful benefit when it was added to the current standard of care in platinum-resistant ovarian cancer,” William D. Schwieterman, president and chief executive officer of Mateon, said in a statement. “I want to thank our investigators and advisors, as well as the patients that we treated, for their efforts to advance future cancer care. These external participants, along with our internal team, did a great job planning and executing the study, but the outcome is clear, and unfortunately negative.”
Along with terminating the study and CA4P program, Mateon said it has been forced to terminate 60 percent of its employees in order to reduce expenses. Not only will the company terminate a large portion of employees, Mateon said the remaining members of the senior management team will take 50 percent salary reductions, effective immediately.
Schwieterman touted the employees who had been working on the development of CA4P. Not only had the team been working on ovarian cancer, Schwieterman said the employees completed five cohorts of an on-going OXi4503 study for relapsed/refractory Acute Myeloid Leukemia.
OXi4503 is a VDA that disrupts tumor vasculature residing within bone marrow while simultaneously targeting malignant myeloid cells.
“With the company’s needs now very different, it is disheartening to terminate most of these employees following their solid work performances. Going forward, our immediate focus is to obtain value from our OXi4503 program in AML, which, within the last two months, has shown clear positive clinical outcomes in relapsed/refractory patients. As always, we are exploring all options for additional fundraising and adding value for our stockholders, which includes continuing to look for buyers for any or all of our assets,” Schwieterman said.
