Selvita Initiates IND-enabling Studies for its First-In-Class PIM/FLT3 Inhibitor
News Apr 04, 2015
Selvita has announced that it is commencing IND-enabling studies for SEL24 project, the company’s first oncology drug candidate.
SEL24 is a novel, orally-available small molecule, selective inhibitor of PIM and FLT3 kinases, with potential application in the treatment of acute myeloid leukemia (AML), non-Hodgkin’s lymphoma, multiple myeloma and other neoplastic disorders.
SEL24 compound has shown significant activity in multiple hematological xenograft models as a single agent and has demonstrated synergistic effects with marketed standard of care compounds and therapies in advanced clinical development, such as cytarabine.
The compound has also favorable therapeutic window in non-GLP toxicology studies. These Investigational New Drug (IND) enabling studies are integral to the submission of the application for First-In-Humans (FIH) clinical trials.
On March 31st, Selvita signed a service agreement with Aptuit, the leader in early to mid-phase drug development support, for the preparation of selected studies for the IND/CTA data package. This includes both the regulatory and GLP (Good Laboratory Practice) toxicology and safety pharmacology testing in rodents and dogs, as well as large-scale GMP (Good Manufacturing Practice) synthesis of the test compound.
“Initiation of the IND-Enabling Studies is a major milestone in our development of SEL24 and Selvita”, said Dr. Krzysztof Brzozka, Chief Scientific Officer at Selvita. “We are very excited to be at this point, the last step before Phase I clinical trials, when we’ll be able to offer a potentially breakthrough treatment to oncohematology patients”, he added.
Dr. Jonathan Goldman MD, Chief Executive Officer at Aptuit added: “Aptuit is a leading provider of integrated IND enabling development programs. We are delighted to support Selvita at this time with our expert scientists and world class GMP and GLP capabilities”.
Selvita expects to incur also other costs related to SEL24 pre-clinical development in addition to the contract with Aptuit.