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Patient Enrollment Begins in Phase III Studies Involving Electroporation Therapy System
SAN DIEGO, Feb. 23 /PRNewswire-FirstCall/ -- Genetronics BioMedical Corporation announced today that it has completed the Special Protocol Assessment review process with the FDA for two Phase III pivotal studies to evaluate the use of Genetronics' MedPulser® Electroporation Therapy System as a treatment for recurrent and second primary squamous cell carcinomas of the head and neck (SCCHN). Three Institutional Review Boards (IRB's) in the U.S. have approved the two protocols to date, Genetronics has initiated patient enrollment.
Both protocols will compare Genetronics' MedPulser® Electroporation Therapy System to surgery, in patients that have resectable recurrent or second primary SCCHN. The primary endpoint is to demonstrate that patients treated with electroporation therapy have superior preservation of function (e.g. eating, swallowing, and talking) when compared to surgery. The secondary endpoints include comparing quality of life, safety, and pharmacoeconomics; in addition to showing local tumor control and survival that are equivalent to surgery.
"We are delighted that Genetronics has received approval from three IRB's to proceed with patient enrollment in our pivotal Phase III clinical trials," said Avtar Dhillon, M.D., President and CEO. "These are major milestones for the Company, because they allow Genetronics to perform clinical trials that compare electroporation to surgery and demonstrate the core benefit of the technology." Paul Goldfarb, M.D., Genetronics' Consulting Medical Director, said, "Electroporation therapy could be the next generation ablation therapy for many solid tumors, because it is has the potential to be highly specific in the killing of local tumor cells while preserving adjacent healthy tissue."
The MedPulser® Electroporation System
The MedPulser® System is intended for electroporation therapy (EPT) of cancerous lesions by applying a defined electric field to the target cells that induce transient cell membrane pores, thereby allowing previously administered therapeutic agents to easily transfer into the cell interior. In Europe, the MedPulser® System when used with the chemotherapeutic drug bleomycin has been shown to be effective and safe for the local treatment of head and neck cancers and for cutaneous and subcutaneous cancers, as evidenced by its CE Mark certification. In the U.S., The MedPulser® System has demonstrated promising safety and efficacy in Phase II clinical trials, where it was used for local treatment of head and neck cancer.
Source: Genetronics BioMedical Corporation