WICHITA, Kan., May 10, 2017 (GLOBE NEWSWIRE) -- NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, reported the results of a pre-clinical porcine study that demonstrated the safe and effective heating of the pancreas with a prototype version of its Vectron TTx device.
Key Findings and Conclusions:
- Safety demonstrated by the absence of injury to skin, internal organs or blood chemistries from repeated thermal treatments in a preclinical animal model.
- Effectiveness shown by heating of the pancreas to therapeutic temperatures without aid of an external water bolus to cool skin and subcutaneous fat.
- These successful pre-clinical results support submissions of an IDE to FDA for permission to conduct first-in-human studies in patients with pancreatic cancer
A reproduction of the abstract is available at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/d5693c6e-fa4e-4145-b3ec-0fd8ae3a87d7
These results reported the safety, based on analysis of gross pathology and blood serum biomarkers, and the efficacy of deep tissue heating, determined with surgically placed temperature probes, in a cohort of Yucatan mini-pigs treated with the device. “The NTO design and the experimental in vivo results are promising and demonstrate evidence that the Vectron TTx delivers energy to produce deep therapeutic temperature elevations which could be extremely effective for treating pancreatic cancer and other disease within the pelvis and abdomen,” commented Dr. Chris Diederich, Professor and Director of Clinical Hyperthermia, UCSF Radiation Oncology. He continued, “this promising approach should provide a practical and accurate means to produce heat deep within the body as an effective adjuvant to radiation therapy, immunotherapy, and/or nanoparticle and chemotherapy.”
Dr. Michael Wandell, CEO of NTO said “Our team was pleased with the successful outcome of this study and we were pleased to present the results to the experts at STM. We could not be happier with these data as they allow to move to device development for human use. Also, these data were key elements of the information submitted to FDA that lead to their designation of our Vectron TTx device as Breakthrough Status within the Expedited Access for Premarket Approval Program.” Further positive impressions came from clinicians with experience in the delivery of hyperthermia such as Dr. Mark Hurwitz, Director of Thermal Oncology, Professor of Radiation Oncology, Thomas Jefferson University Hospital who commented, “I believe NeoTherma Oncology's evidence-based medicine approach to clinically validating the Vectron device will not only drive adoption by the medical community, but further corroborate the effectiveness of hyperthermia as a new pillar of cancer therapy.”
About Pancreatic Cancer
The American Cancer Society1 estimates that 53,670 new cases of pancreatic cancer will be diagnosed in 2017. Pancreatic cancer is the fourth leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Less than 20% of patients are candidates for surgery. Radiation therapy and chemotherapy are treatment options but rarely produce a cure. For all stages combined, the 5-year relative survival rate is 8%.
About Neotherma Oncology
NeoTherma Oncology is a private, developmental stage medical device company developing the proprietary Vectron Thermal Treatment (TTx) system for solid tumors. Our technology is based on the non-invasive application of safe, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue. This energy has been shown to significantly increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. More information is available at www.neothermaoncology.com
CAUTION: The Vectron device is investigational medical device and is not yet eligible for human clinical studies nor available for sale.
1 American Cancer Society – Cancer Facts and Figures 2017.
