Early-Stage Clinical Trial Treats First Patient With Life-Threatening Cancer Metastases With Investigational Drug

It is expected that up to 18 patients with leptomeningeal metastases — a serious form of cancer that has spread from its original location to an area surrounding the brain and spinal cord — will receive treatment with the investigational drug.

A patient with leptomeningeal metastases, a form of cancer that has spread from its original location to an area surrounding the brain and spinal cord, has received treatment with an investigational drug in an early-phase clinical trial, according to the drug’s manufacturer, Plus Therapeutics.

Solid-tumor leptomeningeal metastases, according to the press release, are diagnosed in approximately 110,000 patients with cancer in the United States each year. The complication — which has one-year and two-year survival rates are 7% and 3%, respectively — most commonly occurs in patients with breast cancer, lung cancer, gastrointestinal cancer and melanoma.

Currently, according to the releaser, no “meaningfully effective” Food and Drug Administration-approved treatments are available for this patient population.

The multicenter phase 1/2a trial, known as ReSPECT-LM, will assess the maximum tolerated dose as well as safety and efficacy of a single administration of Rhenium-186 NanoLiposome (186RNL) in approximately 18 patients.

The investigational drug, according to Plus Therapeutics, delivers radiation to the area that is safe for normal tissues, but effective enough to target DNA repair mechanisms of the cancer cells.

“The rationale for use of 186RNL in (leptomeningeal metastases) patients is scientifically quite attractive, and in clinical practice was very straightforward to administer to our first patient,” Dr. Michael Youssef, an assistant professor of Neuro-Oncology at University of Texas Southwestern in Dallas, said in the release. “Quality of life and survival rates are poor among patients diagnosed with (leptomeningeal metastases) from solid tumors. With no standard of care, this represents a true unmet medical need in neuro-oncology.”

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