Fenretinide

GROSSE POINTE FARMS, Mich., April 8, 2025 /PRNewswire/ -- SciTech Development, Inc., a clinical-stage oncology company pioneering innovative cancer therapeutics, is thrilled to announce 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." 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. 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." About SciTech Development, Inc. SciTech Development, Inc., headquartered in Grosse Pointe Farms, Michigan, is a clinical-stage pharmaceutical company focused on revolutionizing cancer treatment through its proprietary drug delivery platform. ST-001 nanoFenretinide, its lead candidate, combines fenretinide with biocompatible phospholipids to target hard-to-treat cancers, offering hope to patients worldwide. For more information, please visit or contact: Media Contact: David Schaffer | +1-727-278-8188 | [email protected] Disclaimer: This press release contains forward-looking statements based on current expectations. Actual results may differ due to risks and uncertainties. SciTech undertakes no obligation to update these statements beyond legal requirements. SOURCE SciTech Development, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

**Encouraging Data from Accelerated Trial Supports Progress for T-cell Non-Hodgkin Lymphoma.** DETROIT, Jan. 13, 2025 /PRNewswire/ -- SciTech Development, a clinical-stage pharmaceutical company specializing in oncology, is pleased to announce the initiation of the next stage of its clinical trial for their lead drug candidate, ST-001 nanoFenretinide (ST-001) . This milestone follows the successful completion of the accelerated safety and dose-escalation stage, where ST-001 demonstrated exceptional safety, tolerability, and pharmacokinetic performance. 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. About SciTech Development, Inc. SciTech Development, Inc., headquartered in Michigan, is an oncology focused, clinical-stage pharmaceutical company led by a world-class team. SciTech is committed to developing innovative, effective, and affordable cancer therapeutics that address unmet medical needs to bring hope to patients around the globe. To learn about SciTech and our latest advancements, please visit . Read the latest Press Release announcing "Promising Preliminary Results from the Phase 1a Accelerated Trial". Company Contact: David Schaffer Investor Relations [email protected] (727) 278-8118 SOURCE SciTech Development, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED