Wed, Jan 24, 2018 - Page 12 News List

Novel oncology treatment Oraxol reaches milestones

By Ted Chen  /  Staff reporter

PharmaEssentia Corp (藥華醫藥) yesterday announced new milestones in the development of Oraxol, its new oncology treatment for gastric and breast cancer.

The company announced encouraging preliminary efficacy and safety data for Oraxol in the treatment of breast cancer in a pharmacokinetics and phase I/II clinical trial of 24 patients in Taiwan.

The Ministry of Health and Welfare’s Center for Drug Evaluation is to allow a new drug application with the Food and Drug Administration for Oraxol along with the findings of a phase III interim analysis that was conducted in the US by Buffalo, New York-headquartered Athenex Inc, PharmaEssentia said.

In the study, Oraxol demonstrated results similar to those of the US-based phase III study conducted in October last year, with more than half of the patients seeing a tumor size reduction of more than 30 percent, which is encouraging given the small number of patients who participated in the 1.8-month study.

Participants in the study for Oraxol, which is administered orally, exhibited milder side effects compared with the intravenous formulation of the drug, the firm said.

Oraxol is a novel oral formulation of paclitaxel that is being studied as a breast cancer treatment in combination with HM30181A, an inhibitor that could potentially allow for an improved safety and efficacy profile relative to intravenous paclitaxel.

In 2013, PharmaEssentia secured exclusive rights from Athenex to commercialize the combination of Oraxol and HM30181A in Taiwan, Singapore and Vietnam, it said, adding that it plans to expand its reach to include China and Southeast Asian countries targeted by the government’s New Southbound Policy.

The company also announced encouraging phase IV clinical trial results for a combination treatment of Oraxol and the antibody ramucirumab for late-stage gastric cancer that was conducted with six patients in Taiwan.

Of the group, one had a 42 percent reduction in tumor size, while four saw a tumor size reduction of between 26 percent and 27 percent, PharmaEssentia said.

The combination could become an option for gastric cancer patients who do not respond to chemotherapy, the company said.

A follow-up study with a higher dosage has been initiated to find the optimal dosage for gastric cancer patients, it added.

Earlier clinical studies had found that Oraxol extends the progression-free survival of gastric cancer patients to 10.7 months, compared with four months for patients who did not receive second-line treatment after chemotherapy, PharmaEssentia said.

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