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news.Lipoxen, a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, has reported that its partner, the Serum Institute of India (Serum Institute), has now commenced first dosing of patients for Lipoxen's expanded Phase II trial of ErepoXen in India.
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Lipoxen’s ErepoXen product candidate is an enhanced polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anaemia caused by chronic renal (kidney) failure or chemotherapy.
ErepoXen uses Lipoxen’s PolyXen platform technology to attach polysialic acid (PSA), a polymer of sialic acid (a biodegradable sugar that is found naturally in the human body) to protein drugs.
Lipoxen said that the trial is an open label Phase II ICH-GCP compliant trial involving 30 patients with anaemia, across 6 trial centres in India. The primary endpoints of the trial are improved red blood cell count, reticulocytes, hemoglobin and hematocrit.
Wherein, the secondary endpoints is expected to measure safety, a reduction in the frequency of injections versus current EPOs, and immunogenicity. Clinigene International, a Biocon group company based in Bangalore is the contract research organisation running the trial. Results on this trial are scheduled to be reported early Q3 this year.
As reported in early February, the Serum Institute has agreed to accelerate the product candidate towards marketability by expanding the planned trial into a fully integrated Phase II FDA compliant trial and to meet the additional costs associated.
Scott Maguire, CEO of Lipoxen, said: “The commencement of our Phase II ErepoXen trial with the Serum Institute under European regulations in India is a very exciting step forward. EPO is a currently $9B drug and is injected 1-3 times per week. Our EPO is designed to last for one month so we are very excited about moving this potential blockbuster candidate into patient trials having had a successful Phase I trial.
“Not only will the trial measure the potential benefits of our enhanced EPO product candidate, but positive results will assist Lipoxen to execute further licensing deals that combine our versatile PolyXen platform technology with existing protein drugs.”