The first patients were dosed in a phase 2 trial for a topical gel to treat lesions in patients with colorectal cancer receiving EGFR inhibitor therapy.
In early August, Lutris Pharma announced that it has officially kicked off a phase 2 trial to reduce dose-limiting acneiform lesions experienced by patients with metastatic colorectal cancer who have been treated with EGFR inhibitor therapy.
The biopharmaceutical company treated its first U.S. patients in the trial, which will enroll a total of 117 patients at 20 different sites – 15 in the U.S. and five in Israel.
"Development of the acneiform rash caused by EGFR inhibitors including cetuximab, panitumumab and others, may affect quality of life and consistent dosing, and in the absence of any approved treatments, there is an unmet need for approved topical therapies,” said Dr. Mario E. Lacouture, director of the Oncodermatology Program at Memorial Sloan Kettering Cancer Center, in a release. “Lutris' phase 1 results in patients with mCRC were promising, with no dose limiting toxicities and a therapeutic benefit in all patients. As a result, we look forward to participating in the phase 2 trial and to the interim results later this year."
The researchers will use the trial to determine the efficacy and safety of two different strengths of LUT014 Gel – 0.03% and 0.10%, applied once per day for four weeks. They will compare the gel with a placebo treatment for patients. All patients in the trial will have developed grade 2 EGFR-inhibitor-induced acneiform lesions. The results will be examined in a four-week follow up period, in which researchers will consider it successful if there is a decrease by at least one grade in the severity of the lesions.
"While EGFR inhibitors are critical treatment options, over 80% of mCRC patients experience adverse dermatological side effects, including papulopustular skin rash – also known as acneiform lesions – which reduces their quality of life, and more importantly, may lead to a reduction or discontinuation of treatment,” said Noa Shelach, Lutris Pharma CEO. “By reversing the inhibitory effect of EGFR inhibitors on downstream proteins in the skin cells, we believe that LUT014 has the potential to become an important addition to therapeutic regimens and can have a tremendous impact for patients who currently have no other treatment options."
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