XS005 / Xellsmart Biomedical - LARVOL DELTA

XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM) (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: Dushu Lake Hospital Affiliated to Soochow University | Suspended ➔ Active, not recruiting | N=30 ➔ 13 | Trial completion date: Dec 2025 ➔ Aug 2026 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM) (clinicaltrials.gov) - P1/2 | N=30 | Suspended | Sponsor: Dushu Lake Hospital Affiliated to Soochow University | Recruiting ➔ Suspended

Trial suspension • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Scientific Article in Leading Journal Endorses Xspray Pharma’s HyNap Technology (Businesswire) - "A new scientific article, published in the US journal Clinical Pharmacology in Drug Development, shows how Xspray Pharma's HyNap technology improves the bioavailability and reduces variability of two important tyrosine kinase inhibitors (TKIs), Dasynoc (XS004, dasatinib) and XS005 (sorafenib)....Dasynoc (XS004, dasatinib): Bioequivalence at 30% lower dose, with up to 4.8 times less variation in plasma exposure compared to the reference product. XS005 (sorafenib): 45% increase in absorption and up to 2.8 times less variability in plasma exposure compared to the reference product."

Clinical • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Oncology

Enhanced Bioavailability and Reduced Variability of Dasatinib and Sorafenib with a Novel Amorphous Solid Dispersion Technology Platform. (PubMed, Clin Pharmacol Drug Dev) - "The PKs of XS004 (dasatinib-ASD, 100 mg tablet) and XS005 (sorafenib-ASD, 2 × 50 mg capsules) were compared with their crystalline formulated reference drugs (140 mg of dasatinib-reference and 200 mg of sorafenib-reference). XS005 had an increased absorption and bioavailability of 45% and 2.2-2.8 times lower variability, respectively, but it was not bioequivalent at the investigated dose level. Taken together, the formulation platform is suited to generate improved PKI formulations with consistent bioavailability and a reduced pH-dependent absorption process."

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