Modra Pharmaceuticals announces first patients treated in phase IIa metastatic breast cancer trial
March 21, 2019
Thursday, March 21, 2019. Modra Pharmaceuticals B.V., announced that the first patients have been treated in its Phase IIa study in patients with recurrent or metastatic HER-2 negative breast cancer. The trial will evaluate the efficacy and safety of Modra’s lead product, ModraDoc006/r, a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In addition to enabling patients to take their chemotherapy at home, the novel approach has, in prior pre-clinical and clinical testing, demonstrated the potential to reduce toxicity and increase the efficacy of the treatment. As the lead program in the Company’s pipeline, ModraDoc006/r has successfully completed Phase I clinical trials in patients with solid tumors and specifically in patients with prostate cancer.
“Chemotherapy remains a fundamental component of many modern cancer treatment regimens, including for patients with breast or prostate cancer, and ModraDoc006/r has been designed to improve the therapeutic outcomes and quality-of-life of patients as it offers a potentially safer and more efficacious solution that can be taken at home,” commented Colin Freund, CEO of Modra Pharmaceuticals. “The swift start of this trial represents an important development milestone for Modra, and, together with our planned Phase IIb clinical trial in metastatic castration resistant prostate cancer, which recently received IND approval from the FDA, builds momentum for our global clinical development strategy.”
The Phase IIa international multi-center study will determine the efficacy and tolerability of ModraDoc006/r in patients with recurrent or metastatic HER-2 negative breast cancer. For this trial, up to 24 evaluable patients will be treated. All patients will be given tablets of ModraDoc006/r twice daily, one day per week. The primary endpoint is objective response rate according to response evaluation criteria in solid tumors (RECIST). The secondary endpoints include progression-free survival and safety assessments. An additional exploratory objective is to determine whether ModraDoc006/r can be utilized safely in frail patients.
ModraDoc006 is a proprietary tablet form of the taxane chemotherapy drug, docetaxel. ModraDoc006 is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard intravenously-administered docetaxel.