A re-examination of data from phase III clinical trials for the new drug P1101 has revealed superior long-term effectiveness against the rare blood disease polycythemia vera (PV) that could also reduce chances of further complications, PharmaEssentia Corp (藥華醫藥) said yesterday.
Based on a recommendation from the US Food and Drug Administration (FDA), it hired a statistical consulting firm to determine whether P1101 or the interferon ropeginterferon-alfa-2b had achieved improvements in durable response rates among patients who had undergone 21 to 24 months of treatment, the company said.
It was also reanalyzing its clinical trial data as it prepares to file for market approval for P1101 in the US, it said.
The drug produced a 66.3 percent durable response rate, compared with 47.4 percent among patients in the control group treated with the chemotherapy drug hydroxyurea and other best available treatments, the company said, citing the consulting firm’s findings.
The durable response rate improved to 74.2 percent among patients who had prior treatment with hydroxyurea, compared with 32 percent of the control group, the company said.
Most notably, the re-examined data showed that patients’ durable response rate was diminished by prolonged use of hydroxyurea, leaving them at increased risk of contracting leukemia, it said.
The outcome also suggest that P1101 is a viable alternative as a first line treatment for PV patients who are on a regimen of hydroxyurea, it said.
The company is upbeat on P1101’s potential as a long-term treatment for PV, due to its ability in producing an improved 69.6 percent partial molecular response among patients who have undergone 24 months of treatment, compared with 28.6 percent among the control group.
Interferons such as P1101 could be the only therapeutic option that has potentially curative effects on PV, and patients treated with the drug have demonstrated its disease-modifying property, PharmaEssentia has previously said.
Patients had shown reduced allele burden from the JAK2 gene mutation, which has been found to be directly linked to PV, the company said.
While the severe side effects that come with other interferons have prevented patients from receiving the required dosage for effective treatment, P1101 has been proven to be more tolerable, the company said.
A fresh look
‧ The company is reanalyzing its clinical trial data on the interferon known as P1101 as it prepares to file for market approval in the US.
‧ The outcome suggests that P1101 is a viable alternative for PV patients on a regimen of hydroxyurea, the firm said.
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