On December 23, 2019 SciTech Development reported that the U.S. Food and Drug Administration (FDA) has accepted Investigational New Drug (IND) Application for ST-001 nanoFenretinide, an experimental treatment for T-cell non-Hodgkin’s lymphoma (NHL) (Press release, SciTech Development, DEC 23, 2019, View Source [SID1234552595]).
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The FDA approved IND provides clearance for ST-001 nanoFenretinide to enter the clinic. SciTech’s Phase I clinical trial will be conducted at the Rush University Medical Center (Chicago, IL) under the guidance and direction of Timothy M. Kuzel, MD, FACP, Samuel G Taylor III MD Professor of Oncology, Chief, Division of Hematology/Oncology/Cell Therapy; Deputy Director, Clinical Affairs, Rush University Cancer Center (Principal Investigator, PI). The study is planned to enroll patients with relapsed/refractory (R/R) T-Cell NHL and is scheduled to begin in mid-2020 with the potential to advance to a registration trial in late 2021.
"The IND approval is an important step to enabling the collection of first-in-human safety data for nanoFenretinide. We hope to provide required data for eventual full registration of this potential treatment for cutaneous T-cell lymphoma to meet the continuing unmet needs of this rare disease population," said Dr. Kuzel.
SciTech’s ST-001 nanoFenretinide technology is a cancer drug employing a nanoparticle suspension for intravenous administration. ST-001 is comprised of nanoparticle-sized fenretinide in a patented combination with carefully selected phospholipids. SciTech’s product pipeline includes nanoFenretinide formulations for the treatment of several cancer indications.
"FDA approval of our IND for ST-001 is a significant milestone in the development of our SciTech Drug Delivery Vehicle (SDV) program," said Earle Holsapple, President of SciTech Development. "Moving forward, and in addition to the previously granted Orphan Drug Status (Feb. 1, 2018) for the treatment of peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), we intend to make use of other FDA expedited programs including fast track designation, priority review and expedited new drug application (NDA) approval in bringing ST-001 nanoFenretinide to market."
SciTech Development will present an update at the Biotech Showcase on Monday, January 13, 2020 at 11:15am (PST) at the Hilton San Francisco Union Square Hotel (Room: Franciscan B), 333 O’Farrell Street, San Francisco, CA. Qualified investors can register to attend Biotech Showcase free of charge and SciTech personnel will be available during the annual JPMorgan Healthcare Conference in San Francisco. For ST-001 nanoFenretinide investment and partnering opportunities contact Earle Holsapple | +1-313-263-4887 | [email protected]