Drugs / CEND-1
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03517176 | Jul 2018 → Jun 2020 | pancreatic ductal adenocarcinoma | Lisata Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06592664 | Jan 2030 → Jan 2035 | pancreatic ductal adenocarcinoma | Lisata Therapeutics, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05052567 | Oct 2021 → Jun 2024 | malignant pancreatic neoplasm | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT05121038 | Oct 2021 → Sep 2025 overdue | colon carcinoma, malignant pancreatic neoplasm | Anup Kasi | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06261359 | Mar 2024 → Apr 2025 overdue | pancreatic ductal adenocarcinoma | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05712356 | May 2023 → Apr 2026 | gallbladder carcinoma, intrahepatic cholangiocarcinoma | Lisata Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-11-04 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics Highlights Positive Preclinical Data of Certepetide as Part of Antibody-Drug Conjugate Combinations as Reported by Licensing Partner Catalent lisata.com ↗
Specifically, Catalent reported preclinical results showing that using certepetide as a non-cytotoxic ADC payload not only improved ADC efficacy but also broadened the distribution of the cytotoxic payload within the tumor microenvironment. |
| 2025-09-29 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics Announces Encouraging Preliminary Results from the Pancreatic Cancer Cohort of the CENDIFOX Trial lisata.com ↗
today announced encouraging preliminary data from the pancreatic ductal adenocarcinoma (“PDAC”) cohort of the Phase 1/2a CENDIFOX trial ( NCT05121038 ). |
| 2025-07-17 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics and WARPNINE Announce iLSTA Trial Enrollment Completion and Provide Preliminary Data Update lisata.com ↗
Compelling new preliminary data consistent with previously reported preclinical findings demonstrating certepetide’s potential ability to enhance the effectiveness of immunotherapy |
| 2025-06-26 | Lisata Therapeutics, Inc. | Results Positive Preliminary Cohort B Results from the AGITG-led ASCEND Trial to be Presented at ESMO GI Evaluating Lisata’s Certepetide in Combination with Standard-of-Care Chemotherapy in Metastatic Pancreatic Cancer lisata.com ↗
Positive signal in progression-free survival and objective response rate observed in certepetide-treated group compared to placebo-treated group |
| 2025-01-23 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics and WARPNINE Announce Encouraging Preliminary Results from the Phase 1b/2a iLSTA Trial Evaluating Certepetide in Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma lisata.com ↗ |
| 2025-01-22 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics Reports Encouraging Preliminary Cohort A Data from the AGITG-led Phase 2 ASCEND Trial Evaluating Certepetide with Standard-of-Care Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma lisata.com ↗
Data reported positive trend in overall survival, including 4 complete responses observed in the certepetide treatment group compared to none in placebo group |
| 2024-09-05 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma lisata.com ↗
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 that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to certepetide for the treatment of cholangiocarcinoma. |
| 2024-07-10 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics’ Certepetide Shows Promise in Improving Standard Treatment for Intrahepatic Cholangiocarcinoma in a Preclinical Model lisata.com ↗
The data, presented in a poster by Dr. Dan G. Duda of Massachusetts General Hospital at the 2024 Cholangiocarcinoma Foundation Annual Conference, showed that certepetide combined with standard-of-care chemotherapy and immunotherapy improved survival in mice with intrahepatic cholangiocarcinoma. |
| 2024-05-20 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics Receives Paediatric Investigation Plan Waiver from the European Medicines Agency for Certepetide in Pancreatic Cancer lisata.com ↗
The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer. |
| 2024-04-09 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma lisata.com ↗ |
| 2024-03-21 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics Announces U.S. FDA Rare Pediatric Disease Designation Granted to LSTA1 for the Treatment of Osteosarcoma lisata.com ↗ |
| 2024-01-04 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics Announces Publication of Case Report on a Complete Response in a Metastatic Gastroesophageal Adenocarcinoma Patient Treated with LSTA1 in Combination with Standard-of-Care Therapy lisata.com ↗
Upon subsequent addition of LSTA1 to such SoC therapeutic regimen, the subject achieved a complete response, confirmed both radiographically and surgically. |
| 2023-10-17 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics Announces European Medicines Agency Has Granted LSTA1 Orphan Drug Designation for the Treatment of Pancreatic Cancer lisata.com ↗
today announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products has granted orphan drug designation to LSTA1, the Company’s lead product candidate for the treatment of pancreatic cancer. |
| 2023-09-06 | Lisata Therapeutics, Inc. | Results Lisata Therapeutics Announces Outcome of Interim Futility Analysis for its Phase 2b ASCEND Trial of LSTA1 in Metastatic Pancreatic Ductal Adenocarcinoma lisata.com ↗
Based on the results of the interim futility analysis, which was reviewed by the study’s Independent Data Safety Monitoring Committee (“IDSMC”), the ASCEND trial will continue as planned without modification. |
| 2023-08-08 | Lisata Therapeutics, Inc. | Regulatory Lisata Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Malignant Glioma lisata.com ↗ |
| 2022-07-06 | Lisata Therapeutics, Inc. | Results Caladrius Biosciences and Cend Therapeutics Announce Publication of Pancreatic Cancer Trial Data in The Lancet Gastroenterology and Hepatology lisata.com ↗
today announced that The Lancet Gastroenterology and Hepatology has published data from the Phase 1b study of CEND-1, Cend’s lead investigational drug, in combination with gemcitabine and nab-paclitaxel for the treatment of first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). |
All press releases naming this drug 23 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CEND-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03517176 ↗ |
| Known as | certepetide | “Drug: certepetide” NCT05712356 ↗ |
| Modality | Peptide | “CEND-1 is a novel cyclic peptide” PMID 35803294 ↗ Jul 2022 |
| Route | Intravenous | “CEND-1 will be provided as concentrate for solution to be administered via IV injection.” NCT03517176 ↗ |