Feature

Dual thermal ablation technique may offer novel treatment approach for pancreatic cancer

John M. Baust

Researchers at Binghamton University and CPSI Biotech have developed a novel technique that uses cryotherapy and hyperthermia therapy to attack pancreatic cancer cells.

The technique, called dual thermal ablation (DTA), involves a 5-minute heat exposure to cancer cells, followed by a 5-minute freezing of the cells.

“Pancreatic cancer is one of the leading causes of cancer-related deaths in the world today. It is estimated that 95% of patients diagnosed with pancreatic cancer will die because of limited treatment options,” John M. Baust, PhD, president and founder of CPSI Biotech, and colleagues wrote in a study published in Liver and Pancreatic Sciences. “As standard treatments have not yielded an improvement in patient outcome, alternative approaches, such as thermal ablation, may offer a new treatment path.”

HemOnc Today spoke with Baust about how the technique works, the efficacy and safety observed so far, and what additional research must be conducted to validate the potential benefits of this approach.

 

Question: How does the technique work?

Answer: We have been exploring different ways to enhance cancer ablation therapy treatment. Two standard therapies utilized today are cryotherapy for freezing tumors and hyperthermia, or heat-based therapy, for heating and boiling tumors in place. We are working on combining the two approaches to improve therapeutic outcomes.

With this technique, we apply an ablative heat temperature, followed by a freezing temperature. In our most recent study, we used a 5-minute heat exposure, then a 1-minute pause, followed by freezing the tissue for 5 minutes.

 

Q: Can you describe the early efficacy and safety observations?

A: By combining the two approaches of cryotherapy and hyperthermia, we found we were able to obtain an enhanced level of kill of the pancreatic cancer cells. However, it is important to note that this approach is in the investigational stage. Our specific study was conducted in the lab using a pancreatic cancer cell tumor model. Both cryotherapy and hyperthermal ablation themselves alone are procedures that are cleared by the FDA and used quite often to treat a number of different cancers. Yet, the combined treatment approach is still in the investigational stage, and it will most likely be a number of years before it successfully goes through the necessary safety and efficacy testing to become a standard of care.

 

Q: What is the anticipated timeline for subsequent research?

A: We are looking to start phase 1 trials within the next 2 years. We are in the process of transitioning from the investigational and engineering stage into preclinical research and hope to move into phase 1 trials soon after.

Q: What are the potential clinical implications if the validity of the technique is confirmed?

A: There are a number of clinical implications. First, the immediate potential impact we are looking for is to develop an enhanced therapy for pancreatic cancer. With pancreatic cancer being a very lethal disease with few treatment options available, this approach has the potential to provide a more effective treatment option that can be applied in place within the body and yield improved clinical outcome. Beyond that, we also believe that this approach will have a spin-off application in a number of other cancer areas, such as liver, kidney or breast cancers, by providing a more efficient way to ablate tumors. One of the interesting aspects of this technique is by combining the heat and the freezing together, we are able to deliver two very destructive events to the cancer that activate different stress pathways and other cell response mechanisms on the molecular level, therefore enhancing therapeutic outcome. There are a lot of different things going on with this combination procedure that could have a lot of therapeutic benefit in many other cancer areas.

 

Q: Can you describe the development of the new catheter technologies to deliver this ablative therapy to patients?

A: In order to deliver this new approach clinically, we are in the process of developing a new catheter-based device. The novel catheter, known as Frostbite, is being developed to support the growing field of natural orifice transluminal endoscopic surgery (NOTES) in which ‘scarless’ abdominal operations can be performed with an endoscope passed through the mouth, thereby enabling the introduction of surgical tools into the stomach to target various tissues via the stomach wall, avoiding the need for invasive external surgical procedures. In this manner, the catheter is designed to be introduced into the stomach via an endoscopic ultrasound (EUS) device and then the ablation needle tip of the catheter passes directly through the stomach wall into a tumor in the pancreas. The use of EUS allows for the real-time visualization of the tumor and positioning of the ablation needle prior to treatment. The ability to target and ablate tissues in situ under EUS will provide for a more precise and minimally invasive strategy to treat cancer. Ultimately, our goal is to provide a powerful ablation catheter to effectively treat pancreatic cancer, reducing the need for more traditional highly invasive and toxic approaches such as chemotherapy, radiation or major surgery thereby reducing the negative side effects experienced by a patient.

 

Q: Is there anything else that you would like to mention?

A: We are looking to move this novel treatment approach into the clinical arena soon and will be launching a funding initiative to help move this research forward. As discussed above, ongoing efforts are focused on developing new catheter-based devices to allow for this new thermal ablation treatment technique to be delivered via a minimally invasive endoscopic-based approach. These activities are being funded in part by a grant from NCI. We are very excited about this technique and even though it is in the early stages, we are hoping to advance it quickly and provide a therapeutic option for patients who do not have a lot of options right now. – by Jennifer Southall

 

Reference:

Baumann KW, et al. Liver Pancreat Sci. 2017;doi:10.15761/LPS.1000115.

 

For more information:

John M. Baust, PhD, can be reached at CPSI Biotech, 2 Court St., Owego, NY 13827; email:jmbaust@cpsibiotech.com.

 

Disclosure: Baust is founder and president of CPSI Biotech.

John M. Baust

Researchers at Binghamton University and CPSI Biotech have developed a novel technique that uses cryotherapy and hyperthermia therapy to attack pancreatic cancer cells.

The technique, called dual thermal ablation (DTA), involves a 5-minute heat exposure to cancer cells, followed by a 5-minute freezing of the cells.

“Pancreatic cancer is one of the leading causes of cancer-related deaths in the world today. It is estimated that 95% of patients diagnosed with pancreatic cancer will die because of limited treatment options,” John M. Baust, PhD, president and founder of CPSI Biotech, and colleagues wrote in a study published in Liver and Pancreatic Sciences. “As standard treatments have not yielded an improvement in patient outcome, alternative approaches, such as thermal ablation, may offer a new treatment path.”

HemOnc Today spoke with Baust about how the technique works, the efficacy and safety observed so far, and what additional research must be conducted to validate the potential benefits of this approach.

 

Question: How does the technique work?

Answer: We have been exploring different ways to enhance cancer ablation therapy treatment. Two standard therapies utilized today are cryotherapy for freezing tumors and hyperthermia, or heat-based therapy, for heating and boiling tumors in place. We are working on combining the two approaches to improve therapeutic outcomes.

With this technique, we apply an ablative heat temperature, followed by a freezing temperature. In our most recent study, we used a 5-minute heat exposure, then a 1-minute pause, followed by freezing the tissue for 5 minutes.

 

Q: Can you describe the early efficacy and safety observations?

A: By combining the two approaches of cryotherapy and hyperthermia, we found we were able to obtain an enhanced level of kill of the pancreatic cancer cells. However, it is important to note that this approach is in the investigational stage. Our specific study was conducted in the lab using a pancreatic cancer cell tumor model. Both cryotherapy and hyperthermal ablation themselves alone are procedures that are cleared by the FDA and used quite often to treat a number of different cancers. Yet, the combined treatment approach is still in the investigational stage, and it will most likely be a number of years before it successfully goes through the necessary safety and efficacy testing to become a standard of care.

 

Q: What is the anticipated timeline for subsequent research?

A: We are looking to start phase 1 trials within the next 2 years. We are in the process of transitioning from the investigational and engineering stage into preclinical research and hope to move into phase 1 trials soon after.

 

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Q: What are the potential clinical implications if the validity of the technique is confirmed?

A: There are a number of clinical implications. First, the immediate potential impact we are looking for is to develop an enhanced therapy for pancreatic cancer. With pancreatic cancer being a very lethal disease with few treatment options available, this approach has the potential to provide a more effective treatment option that can be applied in place within the body and yield improved clinical outcome. Beyond that, we also believe that this approach will have a spin-off application in a number of other cancer areas, such as liver, kidney or breast cancers, by providing a more efficient way to ablate tumors. One of the interesting aspects of this technique is by combining the heat and the freezing together, we are able to deliver two very destructive events to the cancer that activate different stress pathways and other cell response mechanisms on the molecular level, therefore enhancing therapeutic outcome. There are a lot of different things going on with this combination procedure that could have a lot of therapeutic benefit in many other cancer areas.

 

Q: Can you describe the development of the new catheter technologies to deliver this ablative therapy to patients?

A: In order to deliver this new approach clinically, we are in the process of developing a new catheter-based device. The novel catheter, known as Frostbite, is being developed to support the growing field of natural orifice transluminal endoscopic surgery (NOTES) in which ‘scarless’ abdominal operations can be performed with an endoscope passed through the mouth, thereby enabling the introduction of surgical tools into the stomach to target various tissues via the stomach wall, avoiding the need for invasive external surgical procedures. In this manner, the catheter is designed to be introduced into the stomach via an endoscopic ultrasound (EUS) device and then the ablation needle tip of the catheter passes directly through the stomach wall into a tumor in the pancreas. The use of EUS allows for the real-time visualization of the tumor and positioning of the ablation needle prior to treatment. The ability to target and ablate tissues in situ under EUS will provide for a more precise and minimally invasive strategy to treat cancer. Ultimately, our goal is to provide a powerful ablation catheter to effectively treat pancreatic cancer, reducing the need for more traditional highly invasive and toxic approaches such as chemotherapy, radiation or major surgery thereby reducing the negative side effects experienced by a patient.

 

Q: Is there anything else that you would like to mention?

A: We are looking to move this novel treatment approach into the clinical arena soon and will be launching a funding initiative to help move this research forward. As discussed above, ongoing efforts are focused on developing new catheter-based devices to allow for this new thermal ablation treatment technique to be delivered via a minimally invasive endoscopic-based approach. These activities are being funded in part by a grant from NCI. We are very excited about this technique and even though it is in the early stages, we are hoping to advance it quickly and provide a therapeutic option for patients who do not have a lot of options right now. – by Jennifer Southall

 

Reference:

Baumann KW, et al. Liver Pancreat Sci. 2017;doi:10.15761/LPS.1000115.

 

For more information:

John M. Baust, PhD, can be reached at CPSI Biotech, 2 Court St., Owego, NY 13827; email:jmbaust@cpsibiotech.com.

 

Disclosure: Baust is founder and president of CPSI Biotech.