Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Malignant Glioma
BASKING RIDGE, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to LSTA1, the Company’s lead product candidate, for the treatment of malignant glioma.
- BASKING RIDGE, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to LSTA1, the Company’s lead product candidate, for the treatment of malignant glioma.
- “Malignant glioma is one of the most aggressive and deadly malignancies,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata.
- Orphan Drug Designation provides certain financial incentives to support clinical development as well as a seven-year period of U.S. market exclusivity if the product receives FDA approval for such indication.
- It will be conducted at several sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 LSTA1 + SoC versus placebo + SoC.