AMSTERDAM--(BUSINESS WIRE)--Modra Pharmaceuticals today announced the initiation and the inclusion of the first patients in a Phase II study of its lead compound, ModraDoc006/r, in metastatic castration-resistant prostate cancer patients to investigate its safety, feasibility and pharmacokinetic profile. ModraDoc006/r is a proprietary oral formulation of docetaxel (ModraDoc006) co-administered with boosting-agent ritonavir (r) to enhance the chemotherapy’s bioavailability. Chemotherapy remains an integral part of current cancer treatment regimens and achieving its oral delivery while retaining both efficacy and safety could significantly improve the therapeutic landscape for treating many types of cancer.
“Modra Pharmaceuticals aims to apply its oral formulation technology in oncology, with an initial focus on taxane-based chemotherapy, to offer patients a better quality-of-life through a simpler and more effective route of administration. Our goal is to also provide clinicians with more options for prescribing combinatorial treatments in the rapidly developing landscape of cancer regimens,” said Eric van der Putten, CEO of Modra Pharmaceuticals. “With the promising results we have seen in our Phase I studies and given the nature of our approach, we are highly confident that we can advance this compound quickly with the aim to initiate a pivotal program by early 2018.”
The Phase II multi-center study will investigate safety and establish a feasible dosing regimen of ModraDoc006/r in chemotherapy naïve patients with metastatic castration-resistant prostate cancer for whom treatment with intravenous (IV) docetaxel is indicated. The study will enroll 20 patients and includes dose-escalation aiming to define the maximum tolerated dose that can be safely administered in a bi-daily weekly schedule without interruptions. Pharmacodynamics will be determined as secondary outcome measures. The first patients have already been treated as part of the trial.
Modra Pharmaceuticals’ technology has been developed to address an unmet need for improving patient convenience while maintaining chemotherapy’s effectiveness. As the lead program in the Company’s pipeline, ModraDoc006/r has successfully been tested in Phase I clinical trials in patients with solid tumors.
ModraDoc006 is a proprietary tablet formulation of the widely-used chemotherapy drug docetaxel, which contains no toxic excipients and has excellent water solubility. ModraDoc006 is given in combination with ritonavir, an inhibitor of the drug efflux transporter protein P-glycoprotein (P-gp) and the liver enzyme cytochrome P450 3A4 (CYP3A4). Ritonavir increases the systemic bioavailability of docetaxel through inhibiting its metabolism and helps to circumvent side effects associated with IV-delivered docetaxel.
About metastatic Castration-Resistant Prostate Cancer (mCRPC)
mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells. IV Docetaxel is currently the first-line treatment in this indication in chemotherapy naïve patients.
About Modra Pharmaceuticals
Modra Pharmaceuticals is contributing to modern cancer treatment options by improving the delivery and bioavailability of chemotherapy, the backbone of oncology regimens today. Through our oral formulation technology, we can bypass limitations of IV-delivered drugs, enabling a better product for patients. Our pipeline includes two of the most broadly used chemotherapies, docetaxel and paclitaxel, which we will advance rapidly through clinical evaluation. Our vision is to work together with cancer leaders and innovators to be an integral part of the rapidly evolving landscape of combination therapy and expedite the development of next-generation cancer regimens.