Modra Pharmaceuticals has enrolled its first patient in a Phase 2 clinical trial (NCT03136640) of ModraDoc006/r as a treatment for metastatic castration-resistant prostate cancer — an advanced and often fatal form of the disease
ModraDoc006/r is a tablet formulation of docetaxel. Doctors administer it with the chemotherapy ritonavir to boost ritonavir’s bioavailablity, or amount that the body can absorb.
“Modra Pharmaceuticals aims to apply its oral formulation technology in oncology [cancer treatment], 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,” Eric van der Putten, Modra’s CEO, said in a press release.
The company has been working to develop more convenient, yet equally efficient, ways to administer chemotherapy. ModraDoc006/r is its lead candidate. It performed well in Phase 1 clinical trials of patients with solid tumors.
The Phase 2 trial aims to recruit 20 patients who have yet to be treated with chemotherapy. To be eligible, men should have metastatic castration-resistant prostate cancer, a condition that is usually treated with intravenous docetaxel.
To establish the maximum tolerated dose of the treatment — the main goal of the trial — participants will receive increasing doses of ModraDoc006/r. Six patients will be treated and evaluated for toxic effects before the next group receives dosing.
Researchers will also analyze ModraDoc006/r’s pharmacokinetics, or the way the body affects the therapy. One measure will be the blood concentration of the drug.
The therapy’s anticancer effects will be analyzed with levels of prostate-specific antigen, or PSA — a protein that is a biomarker of the disease — and by imaging of the prostate and metastatic tumors.
Ritonavir, sold under the brand name Norvir, is used to treat HIV. But it also has properties that make it suitable for combining with an oral chemotherapy such as docetaxel. It blocks a protein that expels drugs from the inside of cells, slowing the body’s metabolism of docetaxel.
“Our goal is to also provide clinicians with more options for prescribing combinatorial treatments in the rapidly developing landscape of cancer regimens,” Van der Putten said. “With the promising results we have seen in our Phase 1 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.”