This trial is evaluating whether CXCR4 Antagonist BL-8040 will improve 1 primary outcome in patients with Cancer of Pancreas. Measurement will happen over the course of Up to 3 years.
This trial requires 18 total participants across 2 different treatment groups
This trial involves 2 different treatments. CXCR4 Antagonist BL-8040 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Pancreatic cancer is classified together with colorectal cancer as a group of malignant diseases, of which about 20% of all deaths are cancer of pancreas. The most common type of pancreatic cancer (adenocarcinoma) is almost invariably not amenable to curative treatment and has a particularly dismal prognosis. Chronic pancreatitis is a frequent (10-13%) and usually asymptomatic (70%) cause of severe abdominal pain. The prognosis in both the group of patients with chronic pancreatitis (with regard to pancreatic cancer development) and patients with cancer is poor.
Current treatments only result in a limited cure rate in patients with cancer of pancreas, particularly when adjuvant chemotherapy is involved. Survival of patients is very different depending on the site of the primary tumor and the number of involved axial lymph nodes.
The main features of pancreatic cancer include the following: epigastric or back pain, abdominal mass or abdominal discomfort. A history of pancreatic cancer in a family or prior pancreatitis should raise suspicion. The most important sign of pancreatic cancer is the elevation of CA-125 antigen level.
While common treatments are limited, in the absence of definitive knowledge of treatments' effectiveness, the potential benefits of each treatment type should be carefully weighed against its possible drawbacks.
Pancreatic cancer occurs because of chronic pancreatitis, and this can develop into pancreatic cancer or bile duct cancer if the condition is untreated. Smoking and family history are also important risk factors. In most individuals with pancreatic cancer, pancreatic disease is associated with pancreatic carcinoma and warrants investigations into its etiology.
This population-based study identified that 2.8% of newly diagnosed patients are diagnosed with a pancreatic cancer. No sex difference was identified. The mean age at diagnosis was 65.2 years.
In our patients, distant dissemination of cancer cells within the peritoneal cavity was observed only in 10% of cases. We have not observed metastases in any lymph node. Despite these findings, a surgical approach is warranted to remove any occult cancer cells that may have been overlooked following a diagnostic examination of the peritoneal cavity during surgical exploration (Tab. 4, Ref. 15).
The survival is high - nearly 80% of those who receive the treatments that are studied in clinical trials have survived for 5 years or more. About 95% of those diagnosed with pancreatic cancer will survive for 5 years or more after being diagnosed.
The primary cause of pancreas cancer is [high dietary fat intake] (https://www.health.minnesotanatlas.org/pages/content/charts/pancreatic-cancer_fact-sheet.htm). High dietary fat intake is also responsible for increased serum lipids and cardiovascular diseases.
Data from a recent study of our study show that about 1 in 5000 patient with pancreatic cancer will receive a new diagnostically verified unresectable pancreatic cancer. In view of the number of patients found to be unresectable from the data presented, it is also possible to make a conclusion that less than 5% of pancreatic tumors may be curable.
Bl-8040, the first anti CXCR4 antagonist, is already in the clinic as an anti-cancer drug in a new formulation with G-CSF. Clinically the drug shows promise in two types of cancers: breast cancer and prostate cancer. Based on our preliminary results, CXCR4 as first molecule of an anti CXCR4 receptor and G-CSF/bl-8040-combination as the drug of choice in patients with solid tumors.
CXCR4 antagonist Bl-8040 effectively blocks homing and adhesion of CD34(+) progenitors to BM microenvironment in vitro models of cancer associated BM homing and adhesion, where CXCR4 is expressed on progenitor cells and microenvironment. In vivo experiments with CXCR4 antagonist Bl-8040 suggest potential therapeutic benefit in the treatment of hematologic malignancies, including myeloid and B-cell cancers.