Lisata Therapeutics Inc (NASDAQ:LSTA) announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, certepetide, for the treatment of cholangiocarcinoma. Cholangiocarcinoma, a rare and aggressive form of cancer affecting the bile ducts, presents a significant challenge due to the limited effectiveness of current treatment options, particularly in advanced stages.
Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo told shareholders that the company is coming off a quarter with “strong momentum” to advance clinical studies on its investigational product, certepetide. The biotech firm is looking forward to crucial data readouts from ongoing trials, particularly the Phase 2b ASCEND trial, which could lead to transformative outcomes and potential regulatory approvals.
Lisata Therapeutics Inc (NASDAQ:LSTA) chief medical officer Kristen Buck joined Proactive to discuss the company's new research collaboration with Haystack Oncology which will evaluate the efficacy of its drug candidate certepetide as a therapy for pancreatic cancer. She detailed the collaboration, which will leverage Haystack's minimal residual disease (MRD) technology to detect circulating tumor DNA in blood, which can indicate cancer recurrence or progression.
Lisata Therapeutics Inc (NASDAQ:LSTA) has announced a research collaboration with Haystack Oncology using Haystack's MRD technology to evaluate the efficacy of its investigational pancreatic cancer therapy certepetide. Per the research agreement, Lisata will deploy the Haystack MRD technology for the detection of circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide plus chemotherapy as an investigational treatment for metastatic pancreatic cancer.
Lisata (LSTA) is progressing well with developing its lead investigational pipeline candidate, certepetide, which is being studied for various cancer indications.
Lisata Therapeutics Inc (NASDAQ:LSTA) said it has completed enrollment in its Phase 2a BOLSTER trial for certepetide, a promising investigational treatment for first-line cholangiocarcinoma (CCA). The BOLSTER trial, a Phase 2a double-blind, placebo-controlled study conducted across multiple centers in the United States, evaluates certepetide in combination with standard-of-care versus standard-of-care alone for patients with first-line CCA.
Lisata Therapeutics Inc (NASDAQ:LSTA) chief medical officer Kristen Buck talked with Proactive about encouraging preclinical results for their drug candidate, certepetide, in treating intrahepatic cholangiocarcinoma, otherwise known as bile duct cancer. Preclinical results support certepetide's potential to enhance chemotherapy and immunotherapy, which is expected to translate into improved patient survival.
Lisata Therapeutics Inc (NASDAQ:LSTA) has unveiled encouraging preclinical results for its drug candidate, certepetide, in intrahepatic cholangiocarcinoma, a cancer found inside the bile ducts. The results, presented at the 2024 Cholangiocarcinoma Foundation Annual Conference, support advancing clinical development efforts for the drug.
Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo joined Proactive to discuss a recent milestone for the company: the completion of patient enrollment in the pancreatic cancer cohort of its Phase 1b/2a CENDIFOX trial. The trial is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
Lisata Therapeutics Inc (NASDAQ:LSTA) announced it has completed enrollment in the pancreatic cancer cohort of its Phase 1b/2a CENDIFOX trial. The trial evaluates the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
Lisata Therapeutics Inc (NASDAQ:LSTA) finds itself in an extraordinary but not unusual position emblematic of the challenges faced by small-cap biotech companies over the past three years as they seek recognition in a market that has performed ‘a 180' turn since the peak of Covid vaccines interest in the sector in 2021. Risk capital has been sidelined during this politically and economically volatile period, not just in life sciences, but across microcap markets internationally.
Lisata Therapeutics Inc (NASDAQ:LSTA) has received a Paediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for its lead investigational product, certepetide, in pancreatic cancer. The waiver, recommended by the Paediatric Committee (PDCO) and granted by the EMA, confirms that pediatric studies for certepetide in pancreatic cancer are not required.