INNOVATIVE DRUG DELIVERY SYSTEM SHOWS PROMISE IN ADVANCED PANCREATIC CANCER TREATMENT
California-based RenovoRx, Inc.’s RenovoCath™ System is expected to complete enrollment in the crucial clinical trial before June 2021.
A Quick Overview of Pancreatic Cancer and Its Treatment
Pancreatic cancer causes an uncontrolled multiplication of the cells in the pancreas. Healthy pancreatic cells produce enzymes and hormones that help in digestion and sugar metabolism.
According to a 2016 study, pancreatic cancer is one of the leading causes of death across the world. It causes over 300,000 deaths each year and in 2012, it was the 11th most common type of cancer.
Even worse, it has a poor survival rate. After the diagnosis, the average survival time is less than a year.
Sadly, the diagnosis and treatment of pancreatic cancer remain a major challenge for clinicians worldwide. The main reason for the delayed diagnosis is that the symptoms are often vague. Moreover, routine examinations usually fail to detect the tumor and treatment options are limited.
Problems with Current Pancreatic Cancer Treatment
Treating pancreatic cancer with drugs has two major problems both involving the fact that pancreatic tumors do not have a high level of blood supply like other tumors.
First, systemic drug delivery (generally given through a vein in the arm) circulates and affects most cells in the body, but cannot penetrate the tumor tissues. Poor drug penetration drastically reduces the efficacy of the drugs.
Second, due to this lack of blood supply to the tumor, there are not visible blood vessels doctors can use for targeted catheter-based therapy like in other tumors.
RenovoRx has developed a catheter-based device called RenovoCath which has been cleared by the FDA. It delivers Gemcitabine (a well-profiled anti-cancer drug) through isolated segments of the blood vessels next to the tumor to overcome the barriers described earlier. A catheter is a long, thin tube made of a soft material.
RenovoCath contains two balloons attached to the catheter. The balloons allow the drug to be delivered to specific cancer tissues in the pancreas. A doctor inserts the catheter into one of the arteries in the thigh.
Three Major Benefits of RenovoCath
Compared to conventional systemic administration, RenovoCath delivers higher concentrations of the drug directly to the tumor.
Only a small amount of the drug reaches the bloodstream. As a result, a patient experiences fewer side effects. Notably, severe side effects limit the use of the drug in large doses, which might be necessary for treating pancreatic cancer.
Because the drug directly reaches the tumor, its effects do not depend on the nature of the blood vessels that supply the tumor.
A 2017 study found that delivery of the anti-cancer drug gemcitabine using RenovoCath increased the survival rate. Moreover, the approach caused a reduction in tumor markers in more than 50 percent of the participants. The findings of the study appear in the Journal of Pancreatic Cancer.
Most notably, the researchers concluded that the use of RenovoCath to administer gemcitabine was safe.
What Lies Ahead for RenovoRx and RenovoCath?
RenovoCath has already obtained Orphan Drug Status from the FDA. The FDA approves a medical product as an orphan drug only if the product has shown promise for the diagnosis and/or treatment of rare diseases or conditions.
Moreover, the FDA has approved an Investigational New Drug (IND) application for the makers. It means they can directly test RenovoCath in the Phase III clinical study. A Phase III study evaluates the safety and efficacy of a product against currently available therapies before it gets approval as a new medication. The study involves hundreds of participants and it can many last years.
The makers of RenovoCath have received significant investment from prominent healthcare companies and investors to continue the product development process.
Interestingly, the use of RenovoCath may just not be limited to treating pancreatic cancer. Other cancers with a solid tumor near a major blood vessel may also be a potential indication for the system. Lung cancer is the most notable example of such tumors. Moreover, doctors may be able to use it to give other anticancer drugs and diagnostic substances.
The future seems bright for pancreatic cancer patients and the makers of RenovoCath.
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