Rexin-G Efficient For Metastatic Pancreatic Cancer
Epeius Biotechnologies Corporation announced that Interim Analysis of 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. The clinical trial design includes 5 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 4 weeks. Treatment cycles are repeated if the patient exhibits Grade 1 or less toxicity.
Interim analysis showed no dose limiting toxicities in 9 evaluable patients who received Dose Levels 1-3. Furthermore, the analysis showed decrease in tumor size or disease stabilization (by RECIST), 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.
According to Dr. Sant P. Chawla, Principal Investigator of the Phase I/II study, "I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G." Dr. Chawla is currently conducting three Los Angeles-based Phase I/II clinical trials using Rexin-G in sarcoma, pancreatic cancer, and breast cancer, and a Phase II study of Rexin-G for osteosarcoma.
Rexin-G is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body.
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.