An on-going Phase I/II study of Rexin-G for pancreatic cancer confirmed Rexin-G's anti-tumor activity with no major toxicity in patients with metastatic chemotherapy-resistant pancreatic cancer, according to an interim analysis from Epeius Biotechnologies, which manufactures Rexin-G.
Sant P. Chawla, MD, lead investigator of the Phase I/II study, said that Rexin-G, which is injected intravenously, has targeted nanoparticles designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body.
The clinical trial design includes five escalating doses of intravenous Rexin-G ranging from 1 x 10e11 cfu twice a week to 4 x 10e11 cfu three times a week for four weeks. Treatment cycles are repeated if the patient exhibits grade 1 or less toxicity, the company said.
Interim analysis showed no dose limiting toxicities in nine evaluable patients who received dose levels 1-3. Furthermore, the analysis by response evaluation criteria in solid tumors (RECIST) showed decrease in tumor size or disease stabilization, decreased metabolic activity in tumors (by PET-CT scan), reduction in tumor marker levels, and clinical benefit in patients receiving dose level 3.
The second phase of the Rexin-G study has now opened wherein six patients will receive dose levels 4 and 5, respectively, as the Phase I/II adaptive study design continues to evaluate the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the clinical benefits required to support a Phase II/III pivotal trial, the San Marino, Calif.-based company said.
The FDA has granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.