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news.US-based biopharmaceutical firm Xenetic Biosciences has announced that its partner, the Serum Institute of India, has started dosing patients in the second group of a Phase IIa clinical, sequential single dose trial of intravenously (IV) administered ErepoXen (PSA EPO) to treat anemia in Chronic Kidney Disease (CKD) patients on dialysis.
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ErepoXen is an improved, polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys for maintaining the production of red blood cells and prevent anemia.
The drug is designed to reduce the required frequency of dosage and side effects, and to be less immunogenic than existing treatments.
Xenetic chief executive officer Scott Maguire said the Serum Institute-run trial represents the company’s third study of the compound, and joins other trials currently underway in Australia, New Zealand and Russia, where it is holding ICH Compliant and Russian studies of the compound, respectively.
"We are pleased with the success of our earlier Phase 2 subcutaneous PSA-EPO trials in India, and look forward to working with our international partners to continue developing ErepoXen as a potential treatment option for anemic patients in need of more effective therapies," Maguire said.
"With this IV trial, we now cover the two forms of administration for EPO in renal compromised patients, a global market worth over $7 billion."
In the second group of the trial, patients will start with a single ErepoXen dose of 1.5 mcg/kg body weight.
The company said that patient’s pharmacodynamic, pharmacokinetic and immunogenic parameters are then followed for the next 28 days.
The company will evaluate safety and experimental parameters at the end of each dosing group before moving onto the next level.
The first group of patients at the lowest dose level has been finished and the total cost of this India-based trial is being borne by the Serum Institute.