[Asia Economy Reporter Hyunseok Yoo] The Phase 3 clinical trial of Allison Pharmaceuticals' (hereafter Allison) new pancreatic cancer drug, 'Glufosfamide,' which was delayed due to COVID-19, is expected to resume soon.
VIDI announced on the 10th that through a regular report from its subsidiary Allison, the clinical trial of 'Glufosfamide' has been normalized, and additionally confirmed details of the Phase 2 and Phase 3 clinical trials of the inhalable lung cancer treatment 'ILC.'
With this normalization, Allison expects to complete the clinical trial of Glufosfamide promptly, finish FDA new drug registration, and be able to sell the new drug by 2023 at the latest.
Allison has been conducting the Phase 3 clinical trial of Glufosfamide on 480 patients across 22 clinical trial institutions in 16 regions within the United States. Recently, the clinical trial was delayed due to the suspension of human interactions caused by COVID-19.
A VIDI official stated, “Specific clinical efficacy data of the ongoing Glufosfamide trial cannot be accessed until the clinical trial is completed in accordance with standard regulatory requirements, but safety data is regularly reported by Allison,” adding, “So far, no new safety issues have been found, and we have been informed that the trial is progressing smoothly.” He further added, “Following the United States, new registrations are expected in Asia and Europe in the second half of next year, which is anticipated to accelerate the clinical trial of Glufosfamide.”
Allison also reported through the regular report that ILC has been progressing smoothly since the Phase 2 clinical trial began in China in February last year. Allison submitted the Phase 2/3 clinical trial protocol for ILC last month and is awaiting final approval from the FDA. If approval is completed in the second half of this year, clinical trials will be conducted on 240 patients.
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