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Lisata Therapeutics Achieves Orphan Drug Designation from U.S. FDA

Lisata Therapeutics, a clinical-stage pharmaceutical company dedicated to pioneering innovative treatments for advanced solid tumors and other severe illnesses, has announced a significant milestone. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to their lead product candidate, LSTA1, specifically for the treatment of malignant glioma.

Malignant glioma is a highly aggressive and deadly form of cancer, making this Orphan Drug Designation a recognition of the urgent medical need within this patient community. It also acknowledges the potential of LSTA1 to address this critical need effectively.

Orphan Drug Designation is an FDA designation given to drugs or biologics intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation provides essential financial incentives to support clinical development efforts and, upon FDA approval for the specific indication, grants a seven-year exclusive presence in the U.S. market.

Presently, LSTA1 is undergoing multiple Phase 1b/2a and 2b clinical trials worldwide, examining its potential in a variety of solid tumor types in combination with different anti-cancer treatment approaches. In the near future, in partnership with researchers from the University of Tartu in Estonia, the company intends to commence a clinical study to evaluate LSTA1's effectiveness in treating previously untreated glioblastoma multiforme (GBM).

LSTA1 is an investigational drug designed to activate an innovative uptake pathway, enabling more efficient penetration of co-administered or tethered anti-cancer drugs into solid tumors. Importantly, this mechanism operates in a tumor-specific manner, ensuring targeted delivery and accumulation of anti-cancer drugs within the tumor. Additionally, LSTA1 has the potential to modify the tumor microenvironment, enhancing its responsiveness to immunotherapies.

Lisata, in collaboration with its partners, has amassed substantial preclinical evidence showcasing improved delivery of a wide range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics. Furthermore, clinical trials have demonstrated the safety, tolerability, and effectiveness of LSTA1 in enhancing the delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata Therapeutics is actively exploring how LSTA1 can facilitate various treatment modalities, offering more effective strategies for combatting various solid tumors.

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