Phase III Products
We completed enrollment and the original protocol for the Phase III trial for high-dosage (36,000 IU) EPIAO with positive results. However, to ensure the safety of the product, the clinical centers have extended the post- treatment observation period due to concerns with higher hemoglobin levels caused by ESAs (Erythropoiesis-Stimulating Agents) in the United States. We fully support the additional observation period and remain confident in the overall safety and efficacy of the product and expect filing with SFDA in Q3 of 2008.
The initial results of the Phase III trial for TPIAO for the treatment of idiopathic thrombocytopenic purpura (ITP) demonstrated excellent efficacy and a high safety profile based on our data to date. Enrollment has been completed, but we experienced a higher than expected drop-off rate (patients left the hospital before the required observation time) due to the protocol setting employed by the clinical centers. As a result, more cases are required. We expect completion of replenished cases in Q3 of 2008 and filing with SFDA in Q4 of 2008.
We completed enrollment for the Phase III trial for NuLeusin, our second generation IL-2, with positive results based on our data to date. During the trial, the number of cases enrolled increased from our original plan and as a result, these additional cases are still in the observation period, which we expect will conclude in the second quarter 2008.
Early Stage Products
We completed efficacy and pharmacokinetics studies for NuPIAO, our second- generation EPO product, with the toxicology study currently underway. We expect to submit the application for clinical trial in the second half of 2008.
Our first humanized monoclonal antibody (mAb) in development, anti-TNF
mAb (SSS07), completed characterizatio
|SOURCE 3SBio Inc.|
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