A pharmaceutical company has produced positive phase 2 results for its drug to treat advanced breast cancer with an oral version of a chemotherapy treatment. The findings come at a critical time for the drugmaker and could lead to additional investment as it seeks to advance the drug’s development.
The clinical trial is led by Memorial Sloan-Kettering Cancer Center in New York City in collaboration with three other U.S. centers, according to a company statement.
Major objective responses were observed in 20 of 44 patients, including one complete response and 19 partial responses, according to the statement. Seven of the major responders cleared more than 75 percent of their measurable disease. The disease-control/clinical-benefit rate, which includes major responders and patients with stable disease, was 82 percent.
Dr. Loretta M. Itri, Genta’s chief medical officer, said the data confirm results from another study, which both showed substantial activity for tesetaxel in patients with advanced, HER2-negative breast cancer.
“Based on this favorable experience, and after conferring with regulatory authorities in the U.S. and EU, Genta plans to proceed with a new randomized trial of tesetaxel as initial, single-agent chemotherapy for patients with recurrent breast cancer,” Itri said.
Looking at the trial findings, tesetaxel appears to be associated with a substantially lower incidence of side effects, such as peripheral nerve damage, a common side effect of taxanes.
The findings come at a critical time for the Berkeley Heights, New Jersey-based drugmaker. In a document filed with the Securities and Exchange Commission earlier this month, it said: “Presently, with no further financing, the company projects that it will run out of funds during June 2012.”
Earlier this year, the company was granted fast track approval for tesetaxel’s application for gastric cancers, which also received orphan drug status for the application.
Fast Track designation streamlines the development and hastens the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The company can submit a new drug application on a rolling basis with ongoing FDA review during the submission process.