Boehringer Ingelheim presents positive results from Phase I tumor study

In the study, which assessed the maximum tolerated dose, overall safety, pharmacokinetics and preliminary efficacy of BI 6727, a total of 50 patients were treated at doses of 12 to 450mg. Results were encouraging; 32% of patients had stable disease and two patients with advanced bladder and ovarian cancers showed confirmed responses, both of whom had previously failed other standard and experimental treatments, the company said.

According to the company, the clear antitumor activity demonstrated, not typically seen in a Phase I trial, illustrates the significance of these findings. Furthermore, BI 6727 was shown to be well-tolerated with no serious side effects detected.

Preclinical data also showed highly selective target inhibition, cellular activity at very low levels and long-lasting tumor exposure for BI 6727. This, combined with the Phase I data presented suggests a promising future for BI 6727, supporting Plk1 as a therapeutic target and warranting further investigation, said Boehringer Ingelheim.

Based on the encouraging results, BI 6727 will advance further in clinical development. The Phase II program will assess the efficacy and safety of BI 6727 in several tumor types.

Manfred Haehl, corporate senior vice president of medicine at Boehringer Ingelheim, said: “The latest data for our Plk1 inhibitor BI 6727, including initial safety and efficacy results, further reinforce our continued growth in oncology research and are evidence of our sustained leadership in Plk1 inhibition. As a company, we are really excited by the potential these impressive first results hold and look forward to ongoing growth within our oncology pipeline.”