Simcere Pharmaceutical Group
Simcere Shows Positive Data from Cancer Drug Trial
Simcere Pharma (SCR) reported that interim results from a Phase IV trial of its patented anti-cancer drug Endu showed the drug displayed both safety and efficacy. The data were in line with Enduâ€™s Phase III trial. An anti-angiogenesis drug, Endu is a modified version of recombinant human endostatin. It is approved for use in China against non-small cell lung cancer, administered as an adjunct to platinum-class chemotherapy. Simcere said the results showed that Endu has a synergistic effect in this patient population, though the trial did not include patients who received platinum-class chemotherapy by itself.
After 648 patients, Endu produced overall response rates of 24% and therapeutic activity in 81% of patients. In newly-treated patients, the response rate was 31%, a level that dropped to 17% in previously treated patients. Similar to the response rate, the drug was tolerated by patients at about the same levels as was evident in the Phase III trial. The trial has a single arm, open label design.
In the trial, Endu has been administered to more than 2000 patients with advanced-stage NSCLC. Full results from the Phase IV test are expected in 2010.
When the company announced its Q2 results, Simcere said the fall-off in Endu revenue during the period was due to the Phase IV trial. Patients meeting the trialâ€™s criteria receive the drug for free.
Endu is approved as a first-line treatment for NSCLC in China.