XBiotech Announces Successful Completion of Phase I portion of Pancreatic Cancer Study
AUSTIN, Texas, June 20, 2022 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer. Enrollment in the Phase II portion is commencing immediately.
Thirty leading cancer centers across the United States are involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022 about 50,000 people will die from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy—with the aim to of reducing treatment related toxicity of chemotherapy while also blocking the tumor-associated signals that spurn growth and spread of tumors.
The key is Natrunix’s ability to specifically target the body’s response to injury. Chemotherapy and tumors both elicit an injury response from the body, and this response may counteract some of the beneficial effects of therapy while at the same time cause substantial morbidity. This injury response plays a crucial role in the growth, spread and morbidity of cancer. Natrunix targets this common pathway activated by cytotoxic therapy and paraneoplastic inflammation. Used in combination with chemotherapy, Natrunix is therefore being assessed for its ability to reduce the side effects of chemotherapy treatment and mediate anti-tumor effects.
The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of “possibly, probably, or definitely related dose limiting toxicity (DLT)” associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continue to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects.
Dr. David Park, Medical Director, Hematology, Medical Oncology, St Jude Crosson Cancer Institute, Providence OC Cancer Institute stated, "Natrunix has shown to be well-tolerated when administered concurrently with chemotherapy. We are seeing early encouraging signs that this investigational agent may have a salutary effect in patients via its action in the inflammatory pathway(s).”
The Phase II portion of the study is commencing immediately. Key endpoints in the Phase II portion will be progression-free survival, overall survival and time-to-treatment-failure. The Phase II portion is enrolling 60 subjects that will be randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Subjects will receive the treatment for up to 12 cycles and will be allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent.
Cautionary Note on Forward-Looking Statements