FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer
Excerpt from the Press Release:
FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, Inc., a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022.
The application, designated IND 161602, was approved on December 30, 2022. It contained the clinical protocol for ABV-1519 and was entitled “A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Patients.” BLEX 404, the primary active ingredient, is extracted from the Maitake mushroom (Grifola frondosa), an edible mushroom, whose immunological effects and safety have been demonstrated in two Phase I/II clinical studies performed at Memorial Sloan Kettering Cancer Center (MSKCC) with breast cancer and myelodysplastic syndromes (MDS) patients.
“We are pleased the US FDA approved IND 161602 within the 30-day review period. As a result of that approval, our BioKey subsidiary has earned a milestone payment of $600,000 from Rgene, our development partner,” said Dr. Howard Doong, Chief Executive Officer of the Company; “RGC-1501 is the first of three co-development projects with Rgene and will initially be conducted at Taipei Veterans General Hospital in Taiwan.”
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