Trial of Direct-to-Tumor Skin Cancer Drug Doses First Patient

A phase 2 trial will investigate LTX-315 in patients with basal cell carcinoma, the most common form of skin cancer.

The first patient has been dosed in a phase 2 trial investigating the novel drug LTX-315 in patients with basal cell carcinoma, the most common form of skin cancer, according to the drug’s developer, Verrica Pharmaceuticals.

Currently, many patients with basal cell carcinoma are treated with surgery, though that can lead to scarring and other complications. Researchers developing LTX-315 are hoping that it may offer a non-surgical option for this patient population.

“Current invasive treatments for basal cell carcinoma can cause bleeding, pain, infection and scarring,” said Dr. Neal Bhatia, director of Clinical Dermatology at Therapeutics Clinical Research in San Diego and lead primary investigator in the trial, in a press release. “LTX-315 has the potential to bring patients a much-needed non-surgical treatment option. I am thrilled to lead the investigation of LTX-315 in this phase 2 trial.”

LTX-315 is a chemotherapeutic oncolytic peptide, meaning that it targets cancer cells based on certain properties that they exhibit, that is delivered directly to the tumor and activates T-cell responses to kill the cancer cells.

The goals of the phase 2 trial are to determine if the drug is efficacious in treating basal cell carcinoma; determine the right dosage of the drug; analyze how the drug moves throughout the body (pharmacokinetics); and how well it works in patients with biopsy-proven basal cell carcinoma. Researchers expect to enroll approximately 66 adults across multiple cancer centers in the United States.

Verrica’s Chief Medical Officer Dr. Gary Goldenberg mentioned that the study of LTX-315 may go beyond the skin cancer space, too.

“Non-melanoma skin cancers, including basal cell and squamous cell carcinomas, are the most common form of cancer in the U.S., with over five million diagnoses each year, and there is a high unmet need for new treatments. While basal cell carcinoma is our lead indication for LTX-315, we also look forward to potentially expanding the program into squamous cell carcinoma in the future,” Goldenberg said.

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