SuperGen reports positive data from Phase Ib lung cancer study

SuperGen, a US-based pharmaceutical company, has reported that Phase Ib data for MP-470, its multi-targeted, tyrosine kinase inhibitor and RAD51 suppressor, demonstrated an overall clinical benefit rate of 54% when the drug is given in combination with standard of care anti-cancer therapies in patients with non-small cell lung cancer and small-cell lung cancer.

The Phase Ib dose escalation study enrolled 13 poor prognosis patients: nine with non-small cell lung cancer (NSCLC) and four with SCLC as of August 31, 2008. Of 11 evaluable patients, only one showed progressive disease, five showed stable disease, and five showed partial response. MP-470 did not alter the pharmacokinetics of standard of care (SOC) agents, said SuperGen.

The primary objectives of the Phase Ib study were to estimate the maximum tolerated dose (MTD) in combination with SOC regimens, as well as define safety profiles of specific MP-470 combinations.

Secondary objectives included estimating the therapeutic response rate (RECIST), and defining the effect of MP-470 on the PK profile of SOC. MP-470 doses were started at 100mg orally once per day, increasing to twice daily dosing based on the modified Fibonacci sequence. The MTDs have not been reached and no dose limiting toxicities have been identified.

Gavin Choy, vice president of clinical operations at SuperGen, said: We continue to be very encouraged by the clinical data resulting from our MP-470 trials. A 54% overall clinical benefit rate is a positive step forward for these poor prognosis patients for whom current therapies have limited effectiveness. These results support the pursuit of Phase II clinical trials in lung cancer once we have determined the optimal dose.