Modra Pharmaceuticals Announces First Patients Treated in Phase IIa Metastatic Breast Cancer Trial

March 21, 2019 Off By BusinessWire

–Study will test efficacy and safety of novel docetaxel-based oral
therapeutic–

AMSTERDAM–(BUSINESS WIRE)–Modra Pharmaceuticals B.V. (“Modra”) today 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.

About Metastatic Breast Cancer

Breast cancer is the most common type of cancer in women. Once breast
cancer becomes metastatic it is rarely curable, and it is widely
accepted that women with metastatic disease should receive a form of
systemic chemotherapy at some time during the course of their disease.
Docetaxel has proven to be clinically effective in multiple tumor types
including breast cancer.

About ModraDoc006/r

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.

About Modra Pharmaceuticals

Modra Pharmaceuticals aims to re-define chemotherapy by developing
better taxanes that are less toxic, more effective and can be taken at
home in tablet form. The Company’s goal is to radically improve the
therapeutic outcomes and everyday lives of the hundreds of thousands of
cancer patients undergoing taxane chemotherapy worldwide. Modra’s lead
program is advancing into Phase 2 clinical studies in prostate and
breast cancer to further demonstrate the value of the approach.