SciTech Development Celebrates Second FDA Approval for New Lung Cancer Treatment

SciTech Development Receives FDA Approval for ST-001

SciTech Development, Inc., a pioneering oncology company based in Grosse Pointe Farms, Michigan, is making headlines with its recent FDA approval for its innovative drug ST-001, which targets relapsed and refractory small cell lung cancer (SCLC). This represents a significant milestone for the company, which is on a mission to provide groundbreaking treatments for various types of cancer.

On April 8, 2025, SciTech announced that the U.S. Food and Drug Administration (FDA) greenlit its Investigational New Drug (IND) application for a Phase 1a/b trial of ST-001. This drug, a fenretinide phospholipid suspension administered intravenously, is designed to tackle the dire treatment landscape surrounding SCLC, a particularly aggressive form of lung cancer that currently presents limited treatment options.

The FDA's decision follows a comprehensive safety assessment of the application. In the agency's statement regarding the IND approval, it emphasized that there are significant unmet medical needs within the SCLC patient population, making this trial both timely and crucial. Principal Investigator Dr. Greg Kalemkerian, a noted expert in thoracic oncology at the University of Michigan, will lead the clinical trial. "Small cell lung cancer remains a formidable challenge with few effective therapies for patients who relapse or don't respond to initial treatment," Dr. Kalemkerian stated, expressing hope that ST-001 could provide new avenues for patients in need.

The ST-001 formulation cleverly uses nanotechnology to resolve fenretinide's bioavailability challenges. It capitalizes on a unique drug delivery platform developed by SciTech, which allows for enhanced efficacy through high-dose intravenous delivery while minimizing potential toxicity to patients. In this upcoming trial, researchers will evaluate the safety profile, pharmacological properties, and maximum tolerated dose of ST-001, setting the path for future studies.

Previously, ST-001 showed promising results in a Phase 1 trial targeting T-cell non-Hodgkin lymphoma, achieving favorable pharmacokinetics and early signs of efficacy. The forthcoming trial for SCLC is anticipated to commence between the second and third quarters of 2025, as SciTech aims to build on its earlier successes.

"We are ecstatic about the FDA's approval of the IND for ST-001 in SCLC," said Earle T. Holsapple, CEO of SciTech Development. This marks a pivotal moment in the ongoing journey to find effective cancer treatments. Holsapple added, "Our unwavering commitment to harnessing the power of nanotechnology is yielding encouraging results, and we are eager to observe the drug's impact on patients in clinical settings."

SciTech Development is no stranger to the oncology landscape, emerging as a key player focused on revolutionary cancer therapeutics. With their lead candidate ST-001, the company aims to change the treatment trajectory for several challenging cancers. Patients and caregivers looking for information about this new development may keep an eye on their website at www.scitechdevelopment.com.

As SciTech prepares for this critical trial, the oncology community watches closely, hoping for groundbreaking advancements in the fight against cancer.