The FDA has granted orphan drug designation to LSTA1 as a treatment option for patients with advanced solid tumors.
LSTA1 is an experimental targeting agent called CEND-1, created to synergize with anti-cancer drugs to invade solid tumors with greater efficiency. This makes immunotherapies more effective when employed within these tumor masses.
Evaluations through clinical trials that encompassed individuals with pancreatic cancer have underscored the safety and tolerability of LSTA1.
The phase 1 trial (NCT03517176) assessed CEND-1 targeted therapy combined with nab-paclitaxel and gemcitabine for pancreatic ductal adenocarcinoma (PDAC) patients and showed promising activity and safety.
Lisata Therapeutics, the creator of LSTA1, plans to investigate its application in glioblastoma multiforme. A new clinical study aimed at this group of patients is set to start in the fourth quarter of 2023.
Dr. Kristen K. Buck, MD, Lisata’s EVP of Research and Chief Medical Officer, noted in an official release the severity of malignant glioma, an aggressive and fatal malignancy. She stated that the orphan drug status acknowledged the unmet medical needs of this cohort and LSTA1’s potential to address these needs effectively.
Source: Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Malignant Glioma.
https://www.biospace.com/article/releases/lisata-therapeutics-announces-u-s-fda-orphan-drug-designation-granted-to-lsta1-for-the-treatment-of-malignant-glioma/?s=62
