Cambridge, MA (January 5, 2023) - Salspera is announcing positive results from its Phase 2 study in patients diagnosed with Stage 4, metastatic pancreatic cancer. Salspera’s lead program, orally bioavailable Saltikva®, when administered together with standard of care FOLFIRINOX, provides a statistically significant increase in overall survival.
Patients receiving Saltikva® in conjunction with standard of care FOLFIRINOX showed a median survival of 24 months compared with historical, published survival of 11.1 months in patients treated with standard of care FOLFIRINOX alone. The increase in overall survival was accompanied by a host of supporting data from biomarkers and imaging, showing marked improvement and benefits.
Saltikva® has been shown to be safe. No adverse event occurring in the study were attributed to Saltikva®. Unlike many other agents which are administered intravenously, Saltikva® is orally administered thus reducing patient discomfort.
Dr. Eddie Moradian, Chief Executive Officer of Salspera expressed, “We are excited about the hope and promise of Saltikva® for patients who are diagnosed with this deadly disease. The success to date with our program obligates us to move rapidly ahead into next steps and towards approval.” This statement was echoed by Dr. Daniel Saltzman, Chief Medical Officer, who added, “The unsurpassed safety of Saltikva® and evidence of its efficacy is introducing a new armament into the battle against Stage 4 pancreatic cancer. We are working diligently in evaluating other disease targets for Saltikva®.”
The Food and Drug Administration (FDA) granted Orphan Drug Status to Saltikva® in May 2022 followed by Fast Track status in June 2022. Both recognitions by the FDA indicate the need for important new therapeutics like Saltikva® that treat serious or life-threatening conditions and potentially address an unmet medical need.
About Stage 4, metastatic pancreatic cancer
Pancreatic cancer is classified as a rare disease affecting fewer than 200,000 patients per year in the United States. Stage 4 indicates the metastatic spread of the disease to other organs. Approximately half of pancreatic cancer patients are diagnosed with the disease when the cancer has already spread to other organs such as the stomach, liver, colon, lungs, bone, or other organs. The overall five-year survival of patients with Stage 4 metastasized pancreatic cancer is at 1%. This disease is primarily treated with aggressive chemotherapy as standard of care. Modified FOLFIRINOX is one of the main chemotherapeutic combinations used in such treatments that has the best outcomes, until now.
About Salspera
Salspera is a privately held, late-stage immuno-oncology company focused on solid cancer therapy based on its microbiological platform. Salspera operates research and development laboratories in Oakdale, MN with offices in Cambridge, MA. The company was established in 2017 based on 20+ years of academic research. Salspera is expanding activities related to the anticipated Phase 3 trial and is engaging in talks with interested strategic collaboration partners.