On January 13, 2025 SciTech Development, a clinical-stage pharmaceutical company specializing in oncology, reported the initiation of the next stage of its clinical trial for their lead drug candidate, ST-001 nanoFenretinide (ST-001) (Press release, SciTech Development, JAN 13, 2025, View Source [SID1234649684]). This milestone follows the successful completion of the accelerated safety and dose-escalation stage, where ST-001 demonstrated exceptional safety, tolerability, and pharmacokinetic performance.
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Advancing the Phase 1a Trial with Clear Clinical Objectives
The continuation of the ST-001 clinical trial aims to achieve several critical clinical objectives:
Confirm that ST-001 achieves previously reported clinical response rates.
Determine the pharmacological profile of intravenous fenretinide delivered using SciTech’s novel nanoparticle delivery system, designed for drugs with poor water solubility.
Determine the recommended treatment dose (RTD) to evaluate disease activity and response rates in the follow-on Phase 1b trial and the planned trial in Small Cell Lung Cancer.
"The success of our accelerated Phase 1a trial marks a pivotal milestone, driving ST-001 into the next critical stage of development," said Earle Holsapple, CEO of SciTech Development. "We are thrilled about the potential of ST-001 nanoFenretinide and its promise to transform treatment outcomes for patients battling cancers such as T-cell Non-Hodgkin Lymphoma."
About ST-001 nanoFenretinide
ST-001 nanoFenretinide is a patented nanoparticle IV formulation that combines the drug fenretinide with biocompatible phospholipids. This groundbreaking new investigational drug overcomes bioavailability challenges, enhances therapeutic efficacy, and minimizes toxicity in cancer patients. Powered by SciTech’s advanced delivery platform, ST-001 enables rapid delivery of effective doses of fenretinide to cancer cells, marking a breakthrough in hard-to-treat cancers.
Encouraging Early Results in Phase 1a Accelerated Trial
During the accelerated stage of the trial, ST-001 achieved significant milestones:
Patient Enrollment is Complete for the accelerated stage of the clinical trial marking a significant accomplishment for patients with this rare disease.
Therapeutic Responses Observed: Patients demonstrated partial responses and stable disease, marking an important step for trial advancement.
Excellent Tolerability for ST-001 across all dose levels to date.
Outstanding Pharmacokinetics: The nanoparticle delivery platform overcame longstanding bioavailability challenges, ensuring efficient delivery of fenretinide to tissues.
Future Direction for ST-001 nanoFenretinide
Building on the success of the accelerated Phase 1a stage, the trial begins detailed evaluation of clinical activity and response rates in T-cell lymphomas. The trial is actively underway at nine renowned medical centers across the country. Click here to learn more about the locations and patient trial criteria. Additionally, a separate trial targeting Small Cell Lung Cancer utilizing ST-001 is scheduled to begin in Q2 2025.