French clinical-stage biopharmaceutical company ERYTECH Pharma has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for Eryaspase.
The approval will enable the company to enrol patients for the Phase III TRYbeCA1 trial to evaluate Eryaspase in second-line pancreatic cancer.
Enrolment of US patients at trial sites is expected to commence in the third quarter of 2019. With FDA approval, the company has secured clinical trial authorisations in all 12 participating countries.
Eryaspase consists of enzyme L-asparaginase encapsulated inside donor-derived red blood cells.
Around 500 patients with second-line metastatic pancreatic cancer are expected to be enrolled under TRYbeCA1 at more than 120 clinical sites in Europe and the US.
During the trial, patients are randomised to receive Eryaspase in combination with standard chemotherapy using gemcitabine/nab-paclitaxel or an irinotecan-based regimen, or chemotherapy alone and the primary endpoint is overall survival.
An interim efficacy analysis is planned for when two-thirds of events have occurred.
Erytech chief medical officer Iman El Hariry said: “There is a high unmet need for therapeutic options in pancreatic cancer, particularly in metastatic patients who have progressed on first-line chemotherapy.
“With the FDA’s acceptance of the eryaspase IND, we are excited to initiate US trial sites and to begin enrolling patients in TRYbeCA1.
“We anticipate that the first US patient enrolled in TRYbeCA1 will be in the third quarter of 2019.”
Enrolment of patients under the trial commenced in Spain in September and the company is enrolling patients in several European countries.
Weill Cornell Medicine and New York Presbyterian Hospital chief of division of haematology and medical oncology Dr Manuel Hidalgo said: “We are very pleased to learn that the FDA has reviewed our IND and is allowing ERYTECH to proceed with the initiation of the TRYbeCA1 study in the United States.
“This is good news for patients with pancreatic cancer in the USA that now have another clinical trial opportunity to combat this deadly disease.”
The company’s Erycaps platform uses a novel technology to encapsulate drug substances inside red blood cells to develop innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases.
Erytech manufactures product candidates at its site in Lyon, France, and at the American Red Cross in Philadelphia, US. The company has recently constructed a manufacturing facility in Princeton, New Jersey, US.