On December 3, 2024 SciTech Development, a clinical-stage pharmaceutical company focused on advancements in cancer treatment, reported promising updates from its clinical trial of ST-001 nanoFenretinide (ST-001) (Press release, SciTech Development, DEC 3, 2024, View Source [SID1234648770]).

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Preliminary Trial Findings
Preliminary data from the accelerated Phase 1a trial in patients with Cutaneous T-cell Lymphoma indicates favorable clinical improvements to ST-001 treatment, including earlier-than-anticipated stable disease and partial responses – one initial and one confirmed.

In addition, results from patients treated with ST-001 demonstrate that the advanced nanoparticle delivery system successfully achieves the desired pharmacokinetic profile. It enables rapid and targeted delivery of fenretinide directly to tissues while minimizing side effects and toxicity. These findings exceed expectations and mark a significant milestone in the continued development of ST-001.

ST-001 Clinical Trial Information
SciTech’s initial trial is targeting T-cell non-Hodgkin lymphoma (T-cell NHL) indications including all sub-types of Cutaneous T-cell lymphoma (CTCL), Mycosis Fungoides (MF), Sézary Syndrome (SS), Angioimmunoblastic T-cell lymphoma (AITL), and other types of systemic T-cell lymphomas. The trial is activated and enrolling at 8 prestigious cancer institutions across the U.S., supported by world-renowned scientific advisors and principal investigators specializing in T-cell NHL. View Source

"The early findings from the Phase 1a trial of ST-001 nanoFenretinide are incredibly promising. Achieving a partial response at this stage is a remarkable step forward and highlights the potential of this innovative treatment to address significant gaps in care for patients with Cutaneous T-cell Lymphoma (CTCL)," said Dr. Larisa Geskin, Director of the Comprehensive Cutaneous Oncology Center at Columbia University. "Fenretinide has shown an excellent safety profile so far, with minimal side effects, including no reported thyroid abnormalities or significant lipid issues. If responses continue to improve as doses are escalated, this trial could mark a turning point in CTCL therapy and bring renewed hope to patients."

"We are extremely encouraged by the preliminary data from the ST-001 trial," said Earle Holsapple, CEO of SciTech Development. "The findings to date strengthen our resolve to gather additional data and advance to the next phase of the trial, as we work toward bringing a new therapeutic option to oncology patients."

Trial Design and Advancements
The FDA approved the Phase 1a accelerated dose-escalation design based on extensive research, prior clinical testing, and the safety profile of fenretinide in more than 3,000 patients. This accelerated portion of the trial is designed to achieve early clinical development objectives including confirming safety, assessing pharmacokinetics, pharmacodynamics, and determine the optimal therapeutic dosing in patients with T-cell NHL.

Upcoming Trial Milestones
The accelerated Phase 1a portion is nearing completion. SciTech is preparing to progress to the next phase of the T-cell NHL study and plans to enroll approximately 45 additional patients. An upcoming clinical trial for ST-001 targeting small cell lung cancer (SCLC) is anticipated to commence in Q2 2025.

About ST-001
SciTech’s lead drug candidate, ST-001 nanoFenretinide, is a patented nanoparticle formulation of fenretinide and biocompatible phospholipids, allowing for the rapid infusion (IV) of high-dose fenretinide. ST-001 solves bioavailability challenges, avoids triglyceride toxicity of prior formulations, and optimizes therapeutic efficacy. ST-001 represents a novel therapeutic approach for targeting difficult-to-treat cancers, utilizing patented methods to improve drug safety and efficacy profiles while optimizing treatment outcomes.