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Our therapeutic will make possible the localized treatment of pancreatic cancer by protecting nearby, sensitive body organs, specifically the duodenum, from the detrimental effects of radiotherapy. Radiotherapy can be transformed into a more potent tool for fighting pancreatic cancer and other abdominal cancers
Xerient is conducting a Phase 1/2a, open-label clinical trial evaluating the safety and efficacy of XER-001 in combination with stereotactic body radiotherapy (SBRT) for patients with locally advanced pancreatic cancer.
The study is designed to evaluate the safety and tolerability of XER-001 and to support identification of the appropriate dose for future clinical development. The Phase 2a component will also evaluate the safety and efficacy of XER-001 in combination with SBRT.
The study is currently recruiting at:
City of Hope Duarte and Irvine, California
Karmanos Cancer Institute Detroit, Michigan
CHRISTUS St. Vincent Regional Cancer Center Santa Fe, New Mexico
Oncology Consultants, P.A. Houston, Texas
Pancreatic cancer often occurs in the head of the pancreas, which shares a blood supply with the duodenum, a very radiosensitive portion of the gastrointestinal (GI) tract. Pancreatic cancer is extremely deadly, because patients are rarely surgical candidates, and the tumor is not completely controlled by chemotherapy. Tumors of the pancreatic head require large doses of radiation to achieve local control, but this is often difficult, if not impossible, because the adjacent duodenum can only tolerate minor radiation dosage. Thus, treatment-related GI toxicity may be the single greatest barrier to improving treatment responses for unresectable pancreatic cancer. There are no FDA-approved medications that can selectively protect the stomach and intestines from radiation damage
Less than 20% of patients are candidates for surgical removal of the cancer
The tumor is not controlled by chemotherapy
Tumoricidal radiation (>60Gy) cannot be given to pancreatic tumors that are in proximity to the intestines
Highly focused radiotherapy can act like surgery and eradicate the tumor
Until now, tightly focused, high-dose radiation has only been possible when using highly expensive machines and specialized techniques that are not widely available. Xerient’s technology can make radiotherapy available for all pancreatic cancer patients.
Xerient’s patented solution has repurposed and truly reinvented a known FDA-approved drug to protect the GI tract from radiation injury.
Following over a decade of R&D efforts, our preclinical studies have shown that oral administration of the prodrug enables triple the survival time of animals with pancreatic cancer*.
Our cutting-edge tablet formulation and direct delivery via ND-Tube allow for the target delivery of the drug to the duodenum, with a real-time tracking feature
Oral consumption of the drug at a predetermined time prior to exposure to radiation
Delivering tumoricidal radiation dose of 62.5 Gy
100% of mice survived beyond 10 days with radioprotection vs. 0% of control animals
Survival of mice with pancreatic cancer has tripled!
Utilized for other applications and FDA-approved for intravenous (IV) administration
Administering to the patient orally or via ND-Tube cytoprotective drug at a predetermined time prior to exposure to radiation
The targeted administration of the cytoprotective drug serves as a highly selective intestinal radioprotector
Delivering the appropriate tumoricidal dose of radiation without inducing duodenal destruction
3730 Kirby Drive, Suite 1200, Houston, Texas 77098