Pancreaze (pancrelipase delayed-release) / IEH Biopharma - LARVOL DELTA

PANCAX-3: Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Andrew Hendifar, MD | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jan 2027

Enrollment closed • Trial completion date • Cachexia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Mitigating Financial Toxicity of Pancreatic Enzyme Replacement Therapy in Medicare Part D (ACG 2024) - "Total MPD PERT spending was $1.67 billion; Creon spending was $1.31 billion (78%). Alternative supply at Amazon and GoodRx price-point was constitutively unfavorable, mean relative cost 1.34 and 1.38 respectively. Zenpep was also unfavorable at VHA price-point; although others yielded potential cost savings."

Medicare • Reimbursement • US reimbursement • Gastroenterology • Pancreatitis

Pancreatic-enzyme replacement therapy with pancrelipase plus chemotherapy for patients with pancreatic adenocarcinoma with cachexia and exocrine pancreatic insufficiency (PANCAX-3). (ASCO 2024) - P2 | "PERT plus SOC chemotherapy for PDAC patients with cachexia and EPI is feasible and well-tolerated. Patients taking PERT experienced weight stability. PERT may aid in reducing stool frequency and further analysis is warranted into how PERT affects stool consistency."

Clinical • Cachexia • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Infectious Disease • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Clinical Data Published at ASCO Support the Potential of VIVUS’ PANCREAZE to Stabilize Weight and Improve Gastrointestinal Outputs in Patients with Pancreatic Cancer (GlobeNewswire) - P2 | N=36 | NCT0409823 | "VIVUS LLC...announces the publication of new clinical trial data demonstrating that PANCREAZE (pancrelipase) helped to stabilize weight in patients undergoing chemotherapy for the treatment of pancreatic ductal adenocarcinoma (PDAC) who have cachexia (wasting syndrome) and exocrine pancreatic insufficiency (EPI)...The poster published at ASCO (Abstract # e24059) describes the results of single-site phase 2 trial (NCT0409823) for pancreatic-enzyme replacement therapy (PERT) with PANCREAZE plus standard of care (SOC) chemotherapy in PDAC patients with cachexia and EPI...The adherence rate was 96.7% (29/30); Weight remained stable (-0.01±0.07 kg/BMI, p=0.511)....There were no Grade 3/4 adverse events associated with PANCREAZE."

P2 data • Cachexia • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

PANCAX-3: Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Andrew Hendifar, MD | N=30 ➔ 40 | Trial primary completion date: May 2023 ➔ Dec 2023

Enrollment change • Metastases • Trial primary completion date • Cachexia • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer