Pharma Pioneer

Plus Therapeutics Finishes Dosing in ReSPECT-LM Phase 1 Trial for Leptomeningeal Metastases

19 May 2024
2 min read

Plus Therapeutics, a clinical-stage pharmaceutical company, has made significant progress in its clinical trial for a novel radiotherapeutic treatment. The company has successfully dosed 18 patients in the ReSPECT-LM Phase 1 trial, which focuses on the treatment of leptomeningeal metastases (LM) from solid tumors using rhenium (186Re) obisbemeda. This treatment is designed to deliver targeted radiation directly to the tumor site, with the aim of preserving normal cell and tissue function while potentially eliminating cancer cells.
The recent completion of Cohort 5, which included three patients, marks a ten-fold increase in radiation dosage over the initial cohort without observing dose limiting toxicities. The company is now preparing to advance to Cohort 6 in the second quarter of 2024, subject to approval from the Data Safety Monitoring Board (DSMB). The expansion of clinical trial sites to seven is expected to facilitate maximum enrollment under the protocol.
Rhenium (186Re) obisbemeda has received Fast Track designation from the FDA for the treatment of LM and Orphan Drug Designation for breast cancer with LM. The ReSPECT-LM program is partially funded by a substantial grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Interested patients can find more information on the trial through ClinicalTrials.gov.
LM is a serious complication where cancer spreads to the cerebrospinal fluid and the tissues surrounding the brain and spinal cord. It is most commonly associated with breast cancer but can also occur with lung cancer, gastrointestinal cancers, and melanoma. The condition is usually terminal, with low survival rates at one and two years. There are currently no FDA-approved therapies specifically for LM, and standard chemotherapies often fail to reach effective concentrations in the spinal fluid.
Plus Therapeutics is developing targeted radiotherapeutics for central nervous system cancers, with a focus on enhancing patient outcomes. The company's lead programs address recurrent glioblastoma and LM, and it has established strategic partnerships to support product development, manufacturing, and potential commercialization. The company operates in key cancer clinical development hubs and is led by a team with extensive experience in the field.

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