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xenetic biosciences inc (XBIO) Snapshot

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01/3/14 - $15.00
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124.7M
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xenetic biosciences inc (XBIO) Details

Xenetic Biosciences, Inc., a clinical stage biopharmaceutical company, focuses on the discovery, development, and planned commercialization of human drug therapies for the treatment of various conditions. Its drug technology platforms include PolyXen for creating next generation biologic drugs; OncoHist for the development of novel oncology drugs focused on orphan indications; and ImuXen for the development of vaccines that can simultaneously deliver multiple active pharmaceutical ingredients. The company’s lead product candidates comprise ErepoXen, a polysialylated erythropoietin in Phase IIa clinical trials for the treatment of anemia in chronic kidney disease patients; and OncoHist, an orphan drug that is in pre-clinical stage of development for the treatment of refractory acute myeloid leukemia. It is also developing a pipeline of drug candidates for next generation biologics and novel oncology therapeutics in various orphan disease indications. The company has a research, development, and license agreement with Baxter Healthcare SA and Baxter Healthcare Corporation; a collaborative development agreement with SynBio LLC; a license agreement with Serum Institute of India Limited; and a collaborative research and development license agreement with OJSC Pharmsynthez for the development of various products. Xenetic Biosciences, Inc. is based in Lexington, Massachusetts.

xenetic biosciences inc (XBIO) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $877.0K
Secretary and Director
Total Annual Compensation: $247.8K
Chief Scientific Officer and Member of Scient...
Total Annual Compensation: $160.9K
Compensation as of Fiscal Year 2013.

xenetic biosciences inc (XBIO) Key Developments

Xenetic Biosciences, Inc. Announces Ongoing Safety Data from Phase 2 Trial of ErepoXen

Xenetic Biosciences, Inc. announced results from its ongoing data analysis of the first cohort of its Phase 2, sequential multiple dose study evaluating the safety and efficacy of ErepoXen, subcutaneously administered polysialylated erythropoietin (PSA-EPO), for the treatment of anemia in Chronic Kidney Disease (CKD) patients who are neither on dialysis nor receiving erythropoiesis stimulating agents. ErepoXen was found safe and well tolerated to date, with no serious adverse events. This is the first data on repeat dosing of PSA-EPO in human subjects demonstrating its tolerability and safety in Western clinical trials. On this basis, the Safety Review Committee authorized a dose increase for the second cohort of the study, which is currently underway and demonstrating early signs of clinical efficacy. The Safety Review Committee intends to meet again in August 2014, and the Company expects additional results to be available in the third quarter of 2014. ErepoXen is an improved, polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia. ErepoXen is designed to reduce the required frequency of dosage and side effects, and to be less immunogenic than existing treatments. This open-label, sequential multiple dose finding study is designed to determine the dose of ErepoXen that is safe and moves the patient's hemoglobin level into the 10-12 g/dL range. No serious adverse events were reported in the 15 patients evaluated. Gastrointestinal disorders and infections of mild to moderate intensity were reported by 13 patients. None of the events were assessed as being related to the study drug. In addition there is no indication of antibody formation against polysialic acid (PSA), EPO or PSA-EPO in any of the subjects tested to date.

Xenetic Biosciences Deleted From OTCBB

Xenetic Biosciences, Inc.’s common stock has been deleted from OTC Bulletin Board effective June 30, 2014 on account of its ineligibility for quotation on OTCBB due to quoting inactivity under SEC Rule 15c2-11.

Xenetic Biosciences, Inc. Announces Dosing of First Patient on Dialysis in Phase 2a Clinical Study of ErepoXen

Xenetic Biosciences, Inc. announced that its partner, the Serum Institute of India, has dosed the first patient in the second cohort of a Phase 2a clinical, sequential single dose study of intravenously (IV) administered ErepoXen(PSA EPO) for the treatment of anemia in Chronic Kidney Disease (CKD) patients on dialysis. ErepoXen is an improved, polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia. ErepoXen is designed to reduce the required frequency of dosage and side effects, and to be less immunogenic than existing treatments. In the second cohort of the Phase 2a trial, patients will start with a single ErepoXen dose of 1.5 mcg/kg body weight. The patient's pharmacodynamic, pharmacokinetic and immunogenic parameters are then followed for the next 28 days. Dose levels in escalating form will then be administered. Safety and experimental parameters will be examined at the end of each dosing cohort before moving onto the next level. The first cohort of patients at the lowest dose level has been finished. The total cost of this India-based trial is being borne by the Serum Institute. This open-label intravenous trial follows the successful completion of two subcutaneous ErepoXen clinical trials in India, and is designed to determine the maximum tolerated single dose of ErepoXen. The first was a Phase 1 single dose range finding study for subcutaneously administered PSA-EPO in healthy volunteers. The second was a Phase 2 single dose range finding study for subcutaneously administered PSA-EPO in CKD patients not on dialysis. There have been no serious adverse events attributable to PSA-EPO reported thus far in over 130 subjects dosed to date.

 

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