On April 8, 2025 SciTech Development, Inc., a clinical-stage oncology company pioneering innovative cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for "A Phase 1a/b Trial in Relapsed/Refractory Small Cell Lung Cancer (SCLC) to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension for Intravenous Infusion (Press release, SciTech Development, APR 8, 2025, View Source [SID1234651839])." This milestone greenlights SciTech to begin recruiting patients and initiates another Phase 1a/b clinical trial of ST-001, a novel nanoparticle drug designed to deliver fenretinide effectively to cancer cells.
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The FDA’s approval follows a thorough safety review, with the agency stating, "We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of fenretinide phospholipid suspension (ST-001) for small cell lung cancer." This decision marks a significant step forward in SciTech’s mission to address unmet needs in oncology, particularly for patients with relapsed or refractory SCLC, a notoriously aggressive disease with limited treatment options.
Leading the trial, as Principal Investigator, is Greg Kalemkerian, MD, a renowned thoracic oncologist at the University of Michigan. "Small cell lung cancer remains a formidable challenge with few effective therapies for patients who relapse or don’t respond to initial treatment," said Dr. Kalemkerian. "ST-001 represents a promising approach, and I’m excited to oversee this trial to evaluate its safety and potential for SCLC patients who desperately need new options."
ST-001 nanoFenretinide leverages SciTech’s patented drug delivery platform to overcome fenretinide’s historical bioavailability challenges, delivering high doses intravenously with enhanced efficacy and reduced toxicity. The Phase 1a/b trial will assess the drug’s safety, pharmacology, and maximum tolerated dose, paving the way for further development in SCLC and potentially other cancers.
Building on prior success in a Phase 1a trial for T-cell non-Hodgkin lymphoma – where ST-001 demonstrated favorable pharmacokinetics and early signs of efficacy – SciTech is preparing to launch the SCLC trial in Q2/3 2025. The company anticipates that this trial will further validate the drug’s broad therapeutic potential.
"We are thrilled about the FDA’s approval of our IND for ST-001 in SCLC," said Earle T. Holsapple, CEO of SciTech Development. "This is a pivotal moment that brings us closer to offering a transformative treatment option for patients facing this devastating disease. "Our team’s dedication to advancing ST-001’s potential through innovative nanotechnology is showing promising results, and we’re eager to see its impact in the clinic."