ERASE - A new dual thermal ablation/SCN device system for treating pancreatic cancer

CPSI Biotech is a medical device company that specializes in thermal ablation systems for treating
a variety of cancers The SCN systems developed by CPSI are now in prototype form and have
been animal tested at a variety of venues including Johns Hopkins School of Medicine CPSI also
specializes in novel probes and catheters designed for the cryoablation of cancers for use with the
SCN system This Phase SBIR application proposes to develop a new device and treatment
regime for treating pancreatic cancer PaCa CPSI has named this new approach ERASE
Endoscopic based combinatoRial Ablative and Sensitization therapeutic procedurE The project
includes the development of a next gen dual thermal ablation DTA catheter with an integrated
intertumoral drug delivery channel QuadProbe and requisite re engineering of the SCN system as
well as identifying thermal sensitizers that will make DTA more effective Under Phase studies
the investigational team will identify and test the effectiveness of the targeted chemical molecular
sensitizers in conjunction with the SCN and QuadProbe catheter to develop ERASE to more
effectively treat resectable and nonresectable PaCa Further through the incorporation of select
site directed drug therapy the combinatorial ERASE protocol will help address the challenges with
the management of metastatic disease targeting undetected satellite cancer populations The
intent of this project is to develop and characterize a next generation flexible closed loop needle
catheter based endoscopic device QuadProbe for the treatment of PaCa employing a minimally
invasive outpatient procedure The prototype device and preliminary data collected to date strongly
support the potential of this approach The major goals of this Phase proposal are to develop
the QuadProbe DTA catheter identify a series of drugs that when used with DTA increase the
destruction of PaCa cells develop the combinatorial drug ablation ERASE protocol optimize
ERASE in an ex vivo tissue model and conduct a pilot in vivo study for validation and
technology procedural development Phase studies will be dedicated to optimizing the four way
function of the QuadProbe freezing heat thermal sentizer ejection biopsy tissue aspirate
collection as well as working with our Johns Hopkins colleagues analyzing and modulating the
immune response triggered in patients who have undergone the ERASE protocol so that patient
outcome can be improved The successful completion of this project will lead to new technology
and therapy for the management of PaCa as well as provide data in support of establishing the
thermal dose parameters necessary for optimal clinical application of the proposed as well as
other ablation devices for the treatment of PaCa This project will leverage and combine the
expertise of researchers from CPSI Binghamton University and Johns Hopkins School of Medicine
to develop a new surgical sensitizer approach to more effectively treat PaCa Once completed this
project will provide for an effective minimally invasive treatment option for individuals suffering from
PaCa contributing to efforts for improving patient survival and quality of life CPSI Biotech is a medical device company that has developed a surgical instrument that
freezes cancer tissue so that it is destroyed This grant application proposes to test the concept
that both heat and freezing are more effective at ablating killing pancreatic cancer one of the
most lethal cancers CPSI hypothesizes that the application of agents called andquot thermal
sensitizersandquot will make the dual thermal ablation device more effective by killing more pancreatic
cancer cells The key invention will be CPSIandapos s QuadProbe the first probe that can freeze heat
freeze heat eject thermal sensitizers and remove biopsy debris from the pancreatic cancer site
CPSIandapos s partners are from Johns Hopkins School of Medicine and they will do the necessary
animal human studies Finally both CPSI and Johns Hopkins hypothesize that this new dual
thermal ablation technology may trigger an immune response in patients that can be leveraged
so that the metastatic nature of the disease can be more effectively treated resulting in better
patient outcome