This large Phase I trial was a randomized, double-blind, placebo-controlled single dose study and comprised 64 healthy adult males, 48 of whom received ErepoXen while 16 received a placebo, said Lipoxen.
The subjects who received ErepoXen were assigned to four dose cohorts: 0.5, 1.5, three and 4.5 micrograms/kg respectively. The trial was designed to assess the safety, pharmacokinetics and pharmacodynamics of ErepoXen, the polysialylated erythropoietin (EPO), formulated using Lipoxen’s proprietary PolyXen technology.
According to Lipoxen, the pharmacodynamic data showed that ErepoXen exerts a dose-dependent increase in reticulocyte (immature red blood cell) count. This increase was particularly prominent in the subjects receiving the two higher doses of ErepoXen, with maximum reticulocyte count reached seven days after dosing. These subjects’ reticulocyte counts then took between 14 and 20 days to return to baseline values, suggesting that ErepoXen could exert a long-acting effect on erythropoiesis (red blood cell production).
This effect is comparable to that observed with CERA (continuous erythropoietin receptor activator), a Roche product, and is significantly longer than that observed with other shorter acting currently marketed EPOs, said Lipoxen. Subjects receiving ErepoXen also saw an increase in hemoglobin levels when compared to baseline and these effects lasted up to 28 days after dosing, the company added.
ErepoXen is being developed as a long-acting form of EPO for the treatment of anemia in cancer and renal disease patients. The study was conducted and funded by Lipoxen’s partner and major shareholder, Serum Institute of India Limited (SIIL).
Phase II studies with ErepoXen are planned to commence in India this quarter and market launch is expected in Russia in 2011. A Phase I/II study in Canada will be conducted according to FDA guidelines and will also commence in the second half of 2009. These clinical studies will be funded by SIIL.
Scott Maguire, CEO of Lipoxen, said: “We are very excited about this new clinical data which indicates that Lipoxen’s ErepoXen candidate has the potential to provide an improved and more convenient dosing regime for patients plus significant economic benefits for healthcare providers compared to current EPO products.
“The revenues for current EPOs (injected once to three times per week) totaled $9 billion in 2007 and thus we look forward to moving this product, which is funded by our partner, SIIL, forward and into Phase II clinical trials next month. We have already begun discussions with potential commercial partners around this candidate and expect to sign a significant licensing deal in due course.”