Mateon shuts down lead trial due to bad data
- Penny-stock Mateon Therapeutics announced Wednesday morning that it has halted its lead clinical trial due to lack of efficacy.
- The South San Francisco-based biotech, which focuses on the development of orphan oncology indications, shut down the trial after reviewing results from a third scheduled interim analysis of the Phase 2/3 study, dubbed FOCUS.
- FOCUS had been testing Mateon’s lead drug candidate CA4P in combination with Avastin and chemotherapy in patients with platinum-resistant ovarian cancer. The decision to shutter the study will also lead to layoffs for 60% of the small company's staff.
The FOCUS study was designed to compare progression-free survival and objective response rates between CA4P and placebo when either were added to Avastin (bevacizumab) and chemo. Data reviewed by Mateon was based on initial results from 70 patients who had been on study for two months.
Patients treated with CA4P experienced a median progression-free survival of about 6.7 months compared to 5.7 months for those patients who received placebo. Despite the numerical increase, the difference was not statistically significant.
"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 study is appropriate," the company said in a statement. "Therefore, Mateon is immediately terminating the FOCUS Study and further development of CA4P."
CA4P was Mateon's most advanced program, and was also being tested in a Phase 1b/2 study in ovarian cancer patients and a Phase 1 study focusing on neuroendocrine tumors.
Aside from CA4P, Mateon has one other drug in its pipeline — currently in a mid-stage trial for acute myeloid leukemia and myelodysplastic syndrome.
As a result of the setback, the company said it would cut its workforce by 60%, which would bring the company's headcount into the single digits. Sixteen employees were employed full time as of March 30, according to a filing with the Securities and Exchange Commission.
Senior management will also take a 50% reduction in salary, effective immediately.
"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," said company CEO William Schwieterman.
- Mateon Therapeutics Press release
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