Cellectar reporting favorable results from clinical trial

Cellectar Biosciences is reporting patients in a recent clinical trial of its cancer therapy medication are surviving longer.

The first four study groups of the Madison company’s ongoing Phase 1 clinical trial included 15 patients who had been previously treated with five lines of therapy on average. Each patient in those four study groups received a single 30-minute infusion of CLR 131, Cellectar’s cancer treatment drug.

Results from that research show those patients had a median overall survival rate of 22 months, which CEO and President James Caruso says is “very encouraging.”

“We believe extending [survival] with a more patient-friendly dosing regimen provides both a distinctive product profile and the potential to provide beneficial patient outcomes even in later lines of therapy,” Caruso said.

It’s noted in the release that CLR 131 hasn’t been directly compared against other therapies. But other similar studies have previously achieved median overall survival rates of up to 12 months for patients in the “heavily pretreated” population.

“These are patients with limited therapeutic options and, unfortunately, face poor prognoses,” Caruso said.

He says the treatment, which can be delivered in one or two doses, is less intrusive than treatments that must be administered overtime at regular intervals.

Cellectar’s Phase 1 trial focuses on multiple myeloma, a cancer of the body’s plasma cells. The goal is to better understand tolerability of CLR 131 at various dose sizes for patients with this disease.

In the first four cohorts, patients received a range of doses. It’s noted in a release that most patients had advanced forms of the disease, and about two-thirds had previously received at least one stem cell transplant.

In the fifth study group, patients received a split dose of CLR 131, which meant higher average drug exposure but lower peak levels of exposure. According to a release, that strategy could reduce “adverse events” related to cancer treatment and improve efficacy. The Data Monitoring Committee approved the split dose strategy for safety and recommended moving forward with a higher dose in the next cohort.

That led to a sixth cohort that was started in December 2018. This study group will include up to four patients, with each receiving slightly elevated doses of CLR 131 given one week apart. The split regimen will allow for 15 percent greater average total exposure over the fifth cohort, according to the release.

Aside from the Phase 1 clinical study of patients with multiple myeloma, CLR 131 is being examined in a Phase 2 clinical study of the same disease as well as other malignancies.

Cellectar also plans to start a second Phase 1 study, applying the same therapeutic molecule to pediatric solid tumors and lymphoma, as well as a third Phase 1 study focusing on external radiation for cancers of the head and neck.

–By Alex Moe