On September 12, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("OTLC" or the "Company"), a clinical-stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, reported a summary of its major accomplishments over the past two years (Press release, Oncotelic, SEP 12, 2025, View Source [SID1234655949]). These milestones underscore meaningful clinical progress and regulatory validation across the Company’s lead drug candidates.
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Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant clinical milestones
Two-Year Clinical Progress Snapshot
OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19
OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design
CA4P / Fosbretabulin: Late-stage oncology asset currently under repositioning
AL-101 (intranasal apomorphine): Phase 2 for Parkinson’s disease and sexual dysfunctions
AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s disease
Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)
Nanomedicine Pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway-a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA).
"OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential. Our pipeline addresses multi-billion-dollar markets with high unmet medical need," said Dr. Vuong Trieu, Chairman and CEO of Oncotelic.