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news.3SBio, a fully integrated biotechnology company, has filed with the Chinese State Food and Drug Administration for approval of a 36,000 IU dosage formulation of EPIAO for the treatment of anemia associated with chemotherapy in cancer patients. If approved, high-dose EPIAO would be the only dosage form of this kind available in China, the company said.
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High-dose EPIAO is designed for the rapid restoration of hemoglobin to normal levels among cancer patients. According to the company, the 36,000 IU dosage is comparable to the standardized dose used globally for the chemotherapy-induced anemia, allowing for less frequent administration than lower dosage forms, which in turn is expected to provide greater convenience for both patients and caregivers.
The clinical trial examined the safety and efficacy of a weekly subcutaneous injection of 36,000 IU EPIAO in oncology patients compared with a regimen of three times per week administration of 10,000 IU EPIAO.
The results showed that 70% of the patients receiving high-dose EPIAO injections had hemoglobin improvement of 1-2g/dL from baseline, similar to those receiving three times per week dosing of 10,000 IU EPIAO. More importantly, the weekly administration of 36,000 IU EPIAO demonstrated equivalent safety and tolerability profiles as the three times per week 10,000 IU EPIAO, the company said.
Jing Lou, CEO of 3SBio, said: “If approved, high-dose EPIAO will provide patients and physicians in China with a new, safe and more convenient treatment of anemia resulting from chemotherapy.”