This Company Is Making Progress In Its Fight Against Rare, Terminal Cancers

Photo by National Cancer Institute on Unsplash

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Pharmaceutical companies around the world have taken innovative and diverse approaches over the past few years as they increase research and the number of clinical trials specifically targeting cancer.  

One of the latest is the development of a new class of drugs utilizing radiopharmaceuticals. The drugs’ unique ability to deliver targeted radiation therapy has resulted in an explosion of new research. 

Radiopharmaceutical therapy has the potential to reduce the risk of both short- and long-term side effects of cancer treatment and concurrently enable even tiny deposits of cancer cells to be killed throughout the body. Several companies have already developed successful radiopharmaceuticals including Bayer’s XOFIGO for prostate cancer, Novartis’ NVS LUTATHERA for gastroenteropancreatic neuroendocrine tumors, and Lantheus’ LNTH AZEDRA for pheochromocytoma and paraganglioma. Pharma companies including Y-mabs Therapeutics YMAB, Point Biopharma PNT, and Fusion Pharma FUSN have all invested heavily in the promise of radiopharmaceuticals. 

Additionally, Austin, Texas-based Plus Therapeutics Inc. PSTV, a clinical-stage pharmaceutical company developing new and targeted radiotherapeutics for rare and difficult-to-treat cancers, has also reported advancement in this space. The company recently announced that the first patient was dosed with Rhenium-186 NanoLiposome (186RNL), its lead product candidate, in the ReSPECT-LM Phase 1 clinical trial examining the drug’s use for the treatment of leptomeningeal metastases (LM). 

LM is a rare cancer complication in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. It occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately four to six months following treatment. The most common cancers to include the leptomeninges are breast, lung, and melanomas.

Plus Therapeutics has also announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 186RNL for the treatment of LM, signaling the critical need to advance novel treatment options for these patients.

“Dosing the first LM patient with 186RNL marks an exciting milestone for us as we take the next step to expand the potential versatility application of our radiotherapeutic candidate across disease states to additional rare cancers,” Plus Therapeutics President and CEO Dr. Marc H. Hedrick said. “As we progress through the ReSPECT-LM trial, we will look to leverage our experience and results in glioblastoma and translate them into the ReSPECT-LM trial to further advance and refine the potential of radiotherapeutics in cancer treatment.”

Plus Therapeutics’ ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single-dose escalation study. In Phase 1, the company will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment.

The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events, and dose-limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression-free survival, and overall survival.

Additionally, Plus Therapeutics recently entered a master services agreement with IsoTherapeutics Group LLC, a radiopharmaceutical company that offers technologies for developing novel diagnostic and therapeutic agents for severe diseases, to develop, manufacture and supply Rhenium-186 isotope for its 186RNL investigational radiotherapeutic. The agreement helps ensure Rhenium-186 meets FDA requirements for use in late-stage clinical trials and is an important step towards Plus Therapeutics' goal to confirm fully compliant 186RNL is available by mid-2022

For more information on Plus Therapeutics, visit

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