Genetronics Announces Successful Introduction of MedPulser? Electroporation Therapy System at European Oral Cancer Conference
May 7, 2001 8:01am
SAN DIEGO, and THE HAGUE, The Netherlands, May 7 /CNW/ --
Genetronics Biomedical Ltd. (Amex: GEB; Toronto) today announced the successful introduction of the MedPulser Electroporation Therapy System (EPT) while presenting at the Seventh International Congress on Oral Cancer (ICOOC) in the Netherlands. As part of the Company's European Access Program (EAP), several surgeons in Europe have reported successful experiences with the MedPulser? system for head and neck cancer treatments.
For instance, Dr. Thomas Plath of the Benjamin Franklin Medical Center (Berlin, Germany) described one of his recent patient cases involving a tumor in the tongue. One day after electroporation therapy, there was some crusting of the patient's tumor and a decrease in pain, said Dr. Plath. Thirteen days after electroporation therapy, we saw massive necrosis of the tumor, and at 20 days almost the entire treated area was necrotic. After a 4-week follow up, the patient's tumor underwent resection, and histological evaluation showed no evidence of tumor.
We are very encouraged by the positive reception of leading European head and neck surgeons of our MedPulser? Electroporation Therapy System, said Babak Nemati, Ph.D., Genetronics Vice-President for Corporate Development. The enthusiastic support of European experts for the MedPulser? System confirms our long-standing belief that electroporation therapy represents a major advancement in the localized treatment of head and neck tumors. Genetronics exhibited its MedPulser? System for the first time at ICOOC, presented two scientific papers on its recent research results on the effect of EPT on tumors and surrounding tissues, and hosted a satellite panel discussion on the use of EPT for the treatment of head and neck cancers. Electroporation involves the use of extremely brief, intense, pulsed
electric fields to temporarily permeabilize cell membranes, creating transient pores, which allow the entry of anti-cancer drugs directly into the cancer cell where the drug is more effective. EPT can potentially represent a tissue-preserving alternative to surgical resection, and offers the potential advantages of significantly shorter hospital stay, improved quality of life following treatment, and efficacy in patients who are refractory to standard of care therapies.
At the ICOOC conference, Dietmar Rabussay, Ph.D., Genetronics
Vice-President for Research and Development, presented two recent non-clinical research projects that demonstrated the efficacy of EPT in treating tumors and the tissue preserving potential of this therapy. Tissue preservation is considered a major potential advantage of EPT compared to traditional surgery, radiation, and certain ablative therapies.
Genetronics also sponsored a panel discussion on the use of
electroporation therapy for the management of head and neck cancers. The panel was chaired by Dr. Nemati, and consisted of Thomas Plath, M.D., Professor Martin Burian, M.D., of the University of Vienna (Vienna, Austria), Gerard Seroussi, M.D., (Paris, France), William Panje, M.D., F.A.C.S., of the Rush-Presbyterian-St. Luke's Medical Center (Chicago, IL, U.S.A.) and Dietmar Rabussay, Ph.D. of Genetronics.
Professor Martin Burian described his experience with two recent patient treatments at the University of Vienna, under the Genetronics sponsored European Access Program. Under this program, tumors of the oral cavity are treated with the MedPulser Electroporation Therapy System and are followed for four weeks, after which the treated tumors are excised surgically. The EPT treated tumor tissue is then evaluated using standard histological methods to assess the effect of electroporation on malignant tumors. The purpose of resecting the cancerous tumors was to see if we could find any viable tumor cells, said Professor Burian. Evaluation of the treated tissues confirmed that for neither of our patients were there any viable tumor cells left.
Dr. Gerard Seroussi summarized the clinical experience to date, of four investigative sites in France, for the treatment of late-stage refractory head and neck cancers. In total, 12 patients were treated at the four French sites, involving 18 tumors. Of these 18 tumors, five (28%) were complete responders, and five (28%) had 50% or greater reduction in total tumor volume. All the tumors responded to the therapy to some degree, said Dr. Seroussi. It is important to remember that these results are achieved in patients that had failed all conventional therapies. Dr. Seroussi reported that in recognition of these results, in December of 2000, the French Hospital Boucicant CCPPRB Ethical Committee has approved the use of EPT as a first intent treatment.
Dr. William Panje reported on the clinical results in the various
late-stage patients that have been treated under the Genetronics sponsored Phase I and Phase II clinical trials at Rush-Presbyterian-St. Luke's Medical Center. One of the cases presented was of an 81-year-old patient with a second primary squamous cell carcinoma of the nasal septum. Dr. Panje reported that this patient's tumor had a complete response, and that the patient lived four years later. Referring to this treatment outcome,
Dr. Panje said: We have saved him a massively debilitating surgical operation, and the [EPT] procedure was all done on an outpatient basis. In summarizing his experience to date, Dr. Panje said: When I first began using EPT I wanted to see if I could treat patients with head and neck tumors without mutilating them. EPT represents an important treatment option for head and neck patients to manage their localized disease.
Genetronics Biomedical Ltd. operates through its wholly owned San Diego subsidiary, Genetronics, Inc and specializes in targeted intracellular delivery of large-molecule therapeutics. Concentrating on oncology and gene therapy, Genetronics is developing its proprietary platform technology, Electroporation Therapy, with the aim of enhancing patients' quality of life and providing safe, effective and comparatively low-cost treatment. In the field of oncology, development programs focus on diseases with high unmet need, including cancers of the head and neck, liver, pancreas and skin. Genetronics BTX® Instrument Division, a leader in molecular delivery, featuring electroporation and electrofusion technology for the research laboratory, markets an extensive line of products for in vitro, ex vivo, and animal in vivo applications worldwide. More information can be found at www.genetronics.com.
This press release contains certain forward-looking statements relating to the Company's plans to develop its electroporation drug delivery system. The availability of resources to support operations and plans for obtaining additional financing cannot be assured. Actual events or results may differ from the Company's expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, capital market conditions, and others set forth in the Genetronics Annual Report, on Form 10-K and other regulatory filings. There can be no assurance that any product in Genetronics product pipeline will be successfully developed or manufactured, or that final results of human pilot studies or clinical studies will be supportive of regulatory approvals required to market products. The American and Toronto Stock Exchanges have not reviewed and do not accept responsibility for the adequacy or accuracy of this release.
-0- 05/07/2001
/For further information: Mervyn McCulloch, CFO of Genetronics
Biomedical Limited, 858-597-6006/
/Web site: http://www.genetronics.com/
(GEB GEB.)
CO: Genetronics Biomedical Ltd.
ST: California
IN: MTC
SU: PDT
-30-
CNW 08:01e 07-MAY-01
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