Electroporation data reported

Two studies in the use of electroporation have been presented at the 5th European Congress of Oto-Rhino-Laryngology (ORL) Head and Neck Surgery (EUFOS) in Rhodes, Greece. The studies were commissioned by San-Diego, US-based Genetronics Biomedical, a late stage developer of therapeutic oncology and other therapies using electroporation to deliver drugs, nucleic acids, and genes.

The presentations, entitled: 'Treatment of Stage T1 and T2 Head and Neck Cancer in Germany' and 'Adverse Events in the Treatment of Head and Neck Cancer' were given by Dr Thomas Plath, a surgeon and researcher in the department of Maxillofacial and Plastic Facial Surgery of the University Clinic Benjamin Franklin/Charite located in Berlin, Germany.

'Surgical removal of a tumour is considered the standard of care for the treatment of stage T1 and T2 head and neck cancer. However, a high percentage of patients suffer from adverse events that not only impact quality of life, but are also expensive to treat,' said Dr Avtar Dhillon, Genetronics, president and ceo. 'As we progress on our post regulatory approval study in Europe for the treatment of head and neck solid tumours, data gathered from the studies presented at this conference will provide an important baseline against which we can measure the effectiveness of the MedPulser electroporation therapy in improving the quality of life for patients, as well as pharmacoeconomic outcomes.'

In 2003, approximately 16,000 individuals in Germany were diagnosed with head and neck cancer, 60% at T1 or T2 stage (< 4cm tumor size). In the US, nearly 40,000 people are diagnosed with head and neck cancer, and 12,000 will die of the disease each year. Nearly all patients undergo surgery and/or chemotherapy and/or radiation. Whatever the treatment, adverse events negatively impacting patient quality of life are common, and treatment is expensive. In the two studies presented in Greece, the researchers noted that the average cost per patient for treatment, including a 10-year follow-up, was e28,493 and the average cost in the US for 21.8 days of in-hospital treatment was $54,127.

The 'Treatment of Stage T1 and T2 Head and Neck Cancer in Germany' was designed to obtain an understanding of the alternatives to head and neck surgery in Germany and Austria. 'If new ablation technologies are to be introduced, their efficacy and pharmacoeconomic benefits will need to be assessed relative to surgery,' according to lead author, Dr Thomas Plath.' Although surgery provides effective local tumour control in T1 and T2 head and neck carcinomas (HNC), patients may suffer morbidity associated with resection, impacting quality of life,' said Dr Plath.

'This study demonstrated the need for treatments with an improved profile in quality of life and pharmacoeconomic outcomes.'

The second presentation: 'Adverse Events in the Treatment of Head and Neck Cancer,' studied how patients in Germany and Austria diagnosed with stage T1 or T2 head and neck cancer are treated from diagnosis through one-year post surgery. 'Overall, nearly all patients suffer from an adverse event due to surgery,' according to lead author Professor Martin Burian, vice chairman of the department of ORL, Vienna Medical School, Vienna, Austria. 'If new ablation technologies (such at the MedPulser) are to be introduced, their efficacy and pharmacoeconomic benefits will need to be assessed relative to surgery,' added Dr Burian.

MedPulser Electroporation Therapy System

Genetronics is currently conducting a multi-centre pre-sales clinical trial in Europe to study the Genetronics MedPulser in treatment of newly-diagnosed primary and recurrent head and neck cancers. The MedPulser Electroporation Therapy System is an electroporation device that significantly enhances the uptake of bleomycin (an approved anti-tumour drug) directly into solid tumours via short electrical pulses. The MedPulser has received the European CE Mark, and Genetronics anticipates launching the product in Europe in the second half of 2005. The European MedPulser study is measuring quality of life and pharmacoeconomic outcomes in the treatment of head and neck cancer. In the US, Genetronics completed the Special Protocol Assessment process with the FDA and subsequently initiated two pivotal Phase III trials for recurrent and second primary squamous cell carcinomas of the head and neck. The FDA also granted the MedPulser System fast track designation.