SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Genetronics Biomedical Corporation , a late stage developer of oncology and other therapies using electroporation to deliver drugs, nucleic acids, and genes, has appointed Walter Singleton, B.M., B.Ch. as Vice President of Clinical & Regulatory Affairs. Dr. Singleton has over 25 years experience managing preclinical and clinical drug development programs and has held senior executive roles at leading pharmaceutical and biotechnology companies including Chugai Pharmaceuticals, Gensia and Pfizer.
"Dr. Singleton's extensive skills and expertise in drug development will be invaluable to us over the coming months as we anticipate having six active clinical programs, including two pivotal Phase III trials in the U.S. and a Phase IV trial in Europe for the treatment of head and neck cancer," said Avtar Dhillon, M.D., Genetronics' president and CEO. "Dr. Singleton's proven ability to manage clinical trials has contributed to the commercialization of multiple drug products and supports our goals of advancing the clinical development and initiating the sales launch of our electroporation therapy system."
Dr. Singleton has extensive experience managing preclinical and clinical development in the biotechnology and pharmaceutical industries. Most recently, Dr. Singleton founded and consulted for New Drug Development Services, a company that provides biotechnology and pharmaceutical companies with advice in all areas of drug development and medical affairs. Prior to consulting, Dr. Singleton served as Senior Vice President of New Drug Development at Chugai Pharma U.S.A. and Associate Vice President of International Drug Development at Chugai headquarters in Tokyo. From 1989-1995, Dr. Singleton was Vice President of Medical/Pharmaceutical Development at Gensia. Prior to Gensia, Dr. Singleton held a number of research and executive appointments with Pfizer and ultimately became Senior Vice President of Medical and Pharmaceutical Development for the Pfizer U.S. Pharmaceuticals Division. He supervised or was involved in the management of many successful clinical development programs for drugs including Procardia XL, Cardura, Zyrtec, Zoloft and Feldene. Dr. Singleton received a B.A and M.A. in Animal Physiology, and a B.M., B.Ch. degree (equivalent to an MD in the U.S.) from the Oxford University Medical School (Oriel College).
Background on the MedPulser(R) Electroporation Therapy System
Genetronics is currently conducting a multi-center 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-tumor drug) directly into solid tumors 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 U.S., Genetronics completed a Special Protocol Assessment with the Food and Drug Administration (FDA), which resulted in shifting the primary endpoint being measured to quality of life, and subsequently initiated two pivotal Phase 3 trials for recurrent and second primary squamous cell carcinomas of the head and neck. The FDA has also granted the MedPulser System fast track designation.
About Genetronics Biomedical Corporation
Genetronics Biomedical Corporation is a late stage biomedical company focused on building an oncology franchise based on its proprietary electroporation therapy. The therapy targets a significant unmet clinical need: the selective killing of cancer cells and local ablation of solid tumors while preserving healthy tissue. The company is moving its lead product, the MedPulser(R) Electroporation Therapy System, through pre-marketing studies for head and neck cancer in Europe, where it has CE Mark accreditation, and a U.S. Phase III pivotal study for recurrent head and neck cancer. Merck, Chiron, the US Navy, Vical and other partners are also employing Genetronics' electroporation technology, which enhances local delivery of drugs and DNA, in their development of novel DNA vaccines and gene therapies. Genetronics is a leader in electroporation, with over 240 patents worldwide that are issued, allowed or pending. More information can be obtained at http://www.genetronics.com/.
This press release contains certain forward-looking statements relating to Genetronics' plans to develop its electroporation drug and gene delivery technology and to maximize shareholder value. Actual events or results may differ from Genetronics' 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, the assessment of Genetronics' technology by potential corporate partners, and capital market conditions, and others set forth in the Genetronics Annual Report, on Form 10-K for the 12-month period ending December 31, 2003, and the Form 10-Q for the 3-month period ending June 30, 2004, and other regulatory filings. There can be no assurance that any product in the 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 Licensed Products. The American Stock Exchange has not reviewed and do not accept responsibility for the adequacy or accuracy of this release.
Genetronics Biomedical Corporation