Acute Myeloid Leukemia Treatment Drug Phase 1a/b Clinical Trial Results to Be Announced
Pharos iBio is showing strong performance. The news that the company will present the Phase 1 clinical trial results of the acute myeloid leukemia (AML) treatment ‘PHI-101’ at the American Society of Hematology (ASH) appears to be influencing its stock price.
As of 1:40 PM on the 6th, Pharos iBio is trading at 12,750 KRW, up 7.59% from the previous trading day.
The American Society of Hematology is the world's largest academic event in the field of hematologic cancers. It will be held in San Diego, USA, from the 9th to the 12th of next month (local time). Pharos iBio will present the Phase 1a/b clinical trial results of the AML treatment PHI-101 at the conference.
The Phase 1b trial of PHI-101 is being conducted at a 160 mg dose. The Phase 1 results showed excellent tolerability at all doses, with no dose-limiting toxicities (DLT) observed. Additionally, clinical benefit was confirmed in 9 out of 14 AML patients who had relapsed or were refractory despite prior treatment with approved drugs.
Four patients achieved complete remission (CRc). CRc includes complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
PHI-101 is an anticancer drug targeting the FLT3 gene mutation found in approximately 30-35% of AML patients. The Phase 1 trial also included patients who relapsed or were refractory after treatment with Xospata (active ingredient gilteritinib) from Astellas Pharma, Japan, which dominates the FLT3 inhibitor market. Detailed results, including that all patients evaluated for efficacy in the Phase 1b trial showed an objective response rate after PHI-101 administration, will be disclosed at this conference.
Pharos iBio focuses on research for rare and intractable diseases where urgent new drug development is critical. PHI-101 received two approvals for compassionate use in AML patients in August this year alone. Compassionate use approval is a system where the Ministry of Food and Drug Safety permits the use of drugs for patients in life-threatening or serious conditions who have no adequate treatment options. In 2019, PHI-101 was designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA). After completing Phase 2 clinical trials, the company plans to apply for conditional marketing authorization using the ‘development-stage orphan drug system.’ Clinical trials are ongoing with the goal of early commercialization of PHI-101.
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