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Xenetic Biosciences, Inc. Announces Positive Data from Partner’s Pivotal Phase 3 Clinical Trial Utilizing PolyXen(R) Platform Technology
Xenetic leverages its proprietary drug delivery platform, PolyXen, through partnerships with biotechnology and pharmaceutical companies to improve the
About this update from Xenetic Biosciences, Inc.
[{"type":"text","content":"Xenetic leverages its proprietary drug delivery platform, PolyXen, through partnerships with biotechnology and pharmaceutical companies to improve the half-life and other pharmacological properties of next-generation biologic drugsEpolong, a polysialylated form of recombinant human erythropoietin that leverages PolyXen, has been shown to be effective and generally well tolerated in Pharmsynthez-conducted trial as a treatment for anemia in patients with chronic kidney diseaseFRAMINGHAM, MA / ACCESSWIRE / December 9, 2020 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) (\"Xenetic\" or the \"Company\"), a biopharmaceutical company focused on advancing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today announced its partner, PJSC Pharmsynthez, has reported in a press release positive data from its pivotal Phase 3 clinical study leveraging PolyXen® to develop a treatment for anemia in patients with chronic kidney disease (CKD).PolyXen is Xenetic's patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug's circulating half-life and potentially improving other pharmacological properties. The PolyXen technology platform was used by Pharmsynthez to develop Epolong (also known as ErepoXen™ or PSA-EPO), a polysialylated form of recombinant human erythropoietin, a hormone produced by the kidneys to promote blood cell production. Pharmsynthez reported in its press release that Epolong is under investigation with the goal of reducing the required dosing frequency and reducing potential side effects, as compared to existing EPO products.As reported in the press release issued by Pharmsynthez, the pivotal Phase 3 multi-center randomized study was conducted in Russia by Pharmsynthez and was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp® (darbepoetin alfa), the current leader in the long-acting erythropoietin segment. The study enrolled approximately 150 patients with CKD across 36 medical institutions. The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints. Furthermore, the proportion of patients who achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) during the evaluation...