- The shares of Plus Therapeutics, Inc. (Nasdaq: PSTV) increased by over 20% pre-market. This is why it happened.
The shares of Plus Therapeutics, Inc. (Nasdaq: PSTV) – a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers – increased by over 20% pre-market. Investors are responding positively to the company presenting data from the NIH-supported ReSPECT Phase 1 clinical trial evaluating its lead investigational drug Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM).
The data from the trial shows that the administration of 186RNL, which is designed to allow for targeted beta radiation to the tumor via convection-enhanced delivery (CED) with limited exposure to surrounding tissues, was well tolerated in adult patients with recurrent GBM at significantly higher doses than with standard treatment modalities such as external beam radiation therapy (EBRT).
Plus this data is being presented as an e-Poster video entitled “A two-part, Phase 1 study of Rhenium-186 NanoLiposome (186RNL) delivered by convection-enhanced delivery for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG) and newly diagnosed diffuse intrinsic pontine glioma (DIPG)” at the 2021 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, which is being held virtually August 21-25, 2021.
These are the additional key findings from ReSPECT clinical trial for adult recurrent GBM:
— The mean dose of 186RNL when coverage was 75% or greater (n=10) was 392 Gy (CI 306 – 478).
— The treatment has been well-tolerated, with no dose-limiting toxicity or serious adverse events observed (n=18).
Plus Therapeutics had presented plans for a proposed two-part, Phase 1 dose-finding study to be followed by an expansion cohort to explore the efficacy of 186RNL in pediatric patients with brain tumors. And part one of the trial will enroll up to 18 subjects to determine the maximum feasible dose of 186RNL administered by CED with the tumor diameter limited to 4 centimeters and a volume of 34 milliliters.
While Part two of the study will independently evaluate 186RNL in up to 39 patients across 3 different cohorts based on their specific disease diagnosis. And the primary endpoint of the study will be the overall response rate, and the secondary endpoints will include progression-free survival-24 and overall survival-24 or progression-free survival-12 and overall survival-12 in cohort A and cohorts B and C, respectively. The patient enrollment for this study is expected to begin by mid-2022.
“The ReSPECT trial demonstrates how 186RNL can deliver a very high dose of radiation directly to adult brain tumors safely, effectively and conveniently. Children with brain tumors have limited options and 186RNL delivered with a minimally invasive procedure could be an important new potential option for these patients.”
— Michael G. DeCuypere, MD, PhD, FAANS, Northwestern University Feinberg School of Medicine, and presenter of the E-Poster
“We are eager to explore the use of 186RNL in children with pediatric brain tumors of various types. Dr. DeCuypere and the team at Lurie Children’s Hospital in Chicago have been great academic partners and are uniquely positioned to bring RNL forward rapidly to treat these tough problems in children.”
— Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics
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