PharmaEssentia Corp (藥華醫藥) yesterday announced that it is backing a physician-led clinical study in Europe testing its drug to treat polycythemia vera (PV) as a preventative measure for a wider age range of patients.
An investigator-initiated trial application has been submitted to the European Medicines Agency to test ropeginterferon alfa-2b (P1101) on PV patients aged 18 to 60, the company said.
P1101 testing had previously been conducted on patients older than 60.
Findings from the new trials could help expand the potential market for the drug, the company said.
While an investigator-initiated trial is not required for market approval, the findings from such a trial would contribute to further studies, and physician-led studies can help doctors decide which drugs to prescribe, it added.
The study is to be led by Tiziano Barbui, professor of hematology and scientific director at the Research Foundation at Ospedali Riuniti di Bergamo, Italy, PharmaEssentia said.
The cohort is expected to be 150 people aged 18 to 60, with a control group administered a low dosage of aspirin. The trial is expected to take three years.
Many researchers have expressed an interest in exploring P1101’s potential as an alternative interferon that can cause less severe side effects compared with other medications, such as Roche Holding AG’s peginterferon alfa-2a (Pegasys), the company said.
Although no comparative studies have been conducted between P1101 and Pegasys, separate clinical trials of the two drugs against the sickle-cell disease medication hydroxyurea shows that P1101 might have fewer side effects such as anemia, reduction in white blood cell count, depression, dizziness, fatigue, nausea and vomiting, the company added.
The company is planning another clinical study before the end of this year to compare Pegasys with P1101, as well as to continue testing P1101 as a hepatitis treatment.
PharmaEssentia shares yesterday gained 1.66 percent to NT$153.5 in Taipei trading, outperforming the TAIEX, which gained 0.46 percent.
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