Inovio Biomedical Corporation has announced that interim results from an FDA-approved Phase I/II study of 10 patients with recurrent breast cancer treated with Inovio’s Selective Electrochemical Tumor Ablation (SECTA) therapy showed the therapy was safe, well-tolerated, and achieved a 75% complete tumor response rate.
The study results are being presented in a poster presentation titled, “A Safety and Efficacy Study of Bleomycin Sulfate and Electroporation in Patients with Metastatic or Locally Recurrent Breast Cancer,” authored by Viktor Paramanov, MD, Oleh Tyurin, MD, Sergey Polenkov, MD, and Paul M Goldfarb, MD, FACS.
This presentation will be at the VII Madrid Breast Cancer Conference, “Changes in the Treatment of Breast Cancer,” June 20 – 22nd. The open-label, single-treatment trial in patients with recurrent breast cancer following partial or complete mastectomy used intratumoral administration of bleomycin followed by electroporation to significantly enhance uptake of the drug using Inovio’s MedPulser® System.
No treatment-related serious adverse events were observed. Non-serious adverse events were “unremarkable” during a 30-day follow-up period. Of 10 patients enrolled, two patients were not evaluable for tumor response: one patient was lost to follow-up and one patient is still ongoing. Six of eight (75%) evaluable patients and seven of nine (77.8%) evaluable tumors showed complete responses at 24 weeks or last evaluation.
“The result of this first organized study using SECTA to treat breast cancer has important clinical relevance and indicates the potential to use SECTA for an entirely new form of cancer,” stated Dr. Paul Goldfarb, Consulting Medical Director to Inovio.
Dr. Avtar Dhillon, President and CEO, said, “These positive results reaffirm what had been previously indicated by a number of Inovio’s other clinical studies: our SECTA therapy provided clinically beneficial outcomes for patients in those trials without serious adverse events and with nominal non-serious adverse events. We strongly believe in the clinical relevance of the SECTA therapy and believe these results will help prospective partners to better define the potentially broad applicability and market opportunity for this novel treatment.”