Plasmid IL-12 and Electroporation Combination Against Metastatic
Melanoma Achieves Systemic Response in Untreated Lesions Without
Reaching Dose-Limiting Toxicity
Pioneering Results Published in Journal of Clinical Oncology
Inovio
Biomedical Corporation (AMEX:INO), a
leader in enabling the development of DNA
vaccines using electroporation-based
DNA delivery, announced today the final results of a Phase I clinical
study demonstrating safe and effective treatment of metastatic melanoma
in the first-in-man trial of a DNA-based therapy designed to express a
therapeutic protein through in vivo delivery using electroporation. The
data was presented in the peer-reviewed Journal of Clinical Oncology
in a paper prepared by Drs. Adil Daud, Richard Heller et al, titled,
“Phase I Trial of Interleukin-12 Plasmid Electroporation in Patients
With Metastatic Melanoma.”
The paper presented results of a Phase I clinical study sponsored by the
Moffitt Cancer Center in Tampa, Florida. The study was designed to
assess the use of electrical pulses generated by Inovio's proprietary
electroporation technology to deliver into tumor cells a plasmid DNA
encoding a cytokine, interleukin-12, which stimulates adaptive and
innate immunity. The paper concluded: “This first human trial, to our
knowledge, of gene transfer utilizing in vivo DNA electroporation in
metastatic melanoma showed that it is safe, effective, reproducible, and
titratable.” The findings showed not only regression of treated melanoma
skin lesions, but also regression of distant untreated lesions,
suggesting a systemic immune response to the localized treatment.
Dr. Adil Daud, principal investigator of the study at the Moffitt Cancer
Center and now Associate Professor, Director, Melanoma Clinical
Research, UCSF Medical Center, stated: “The fact that more than half of
the patients showed stabilization or regression of their melanoma
lesions is encouraging. What is particularly compelling is the
regression of untreated tumors, with 10% of patients treated with IL-12
and electroporation showing complete tumor regression of both treated
and untreated tumors. These results have opened a door to greater hope
for finding a better treatment for cancers such as melanoma.”
Richard Heller, PhD, Executive Director, Frank Reidy Research Center for
Bioelectrics, Old Dominion University, a former University of South
Florida professor of Molecular Medicine and Dr. Daud's co-researcher on
the study, stated: “In prior studies of DNA-based immunotherapies,
direct injection of DNA into tissue suffered from a low rate of gene
transfer. Other delivery methods, particularly viral vectors, have
safety considerations. Now, for the first time in human trials, our
study demonstrates in vivo electroporation’s vital role in facilitating
gene transfer in a safe and reproducible manner. These results suggest
that electroporation-mediated plasmid delivery is a powerful new tool
for effective gene transfer with implications for the clinical arena.”
Avtar Dhillon, MD, Inovio's president and CEO, stated: “The life-saving
potential of DNA-based immunotherapies and vaccines for cancer has
always been tempered by the lack of a safe and efficient delivery
method. These results represent an important advance in stepping over
that barrier.
