SAN DIEGO, March 9 /PRNewswire-FirstCall/ -- Genetronics BioMedical Corporation announced today that it has contracted Quintiles Transnational Corp., a leading global pharmaceutical services organization, as the clinical research organization (CRO) for Genetronics’ clinical trials in the U.S. and Europe for the treatment of head and neck cancer. Quintiles Transnational’s product development group provides a full range of drug development and clinical trial management services, from strategic planning to regulatory submission and approval, focused on helping its customers achieve regulatory success. Quintiles Transnational is a Fortune 1000 company, with 16,000 employees and offices in more than 50 countries.
In the U.S., Genetronics completed the Special Protocol Assessment (SPA) review process with the FDA and has initiated patient enrollment for two Phase III pivotal studies to evaluate the use of Genetronics’ MedPulser(R) Electroporation Therapy System as a treatment for recurrent and second primary squamous cell carcinomas of the head and neck (SCCHN). Both protocols compare the MedPulser(R) Electroporation Therapy System to surgery, where 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.
In Europe, where the MedPulser(R) Electroporation Therapy System has CE Mark regulatory approval, Genetronics has begun a post-approval study treating patients with primary or recurrent SCCHN. This study is designed to support the reimbursement (based on the collection of pharmacoeconomic data) and commercialization of Genetronics’ MedPulser(R) Electroporation Therapy System in the European Union (EU) for the treatment of SCCHN.
“We look forward to working with Quintiles,” said Avtar Dhillon, M.D., President and CEO of Genetronics. “Their ability to provide integrated global services in the oncology sector and first rate CRO capability will be very beneficial to a company like Genetronics. We are excited to have access to Quintiles’ expertise in bringing this important new technology forward for registration in the US, launching commercial sales in Europe, and ultimately achieving success in the marketplace.”
About Quintiles Transnational Corp.
Quintiles helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, and with offices in 50 countries, Quintiles is a leading global pharmaceutical services organization and a member of the Fortune 1000. For more information visit the company’s Web site at http://www.quintiles.com/ .
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 (EPT). EPT enhances local delivery of drugs, genes, and DNA vaccines. The Company is moving its lead product, the MedPulser(R) System, through post regulatory approval clinical studies for head and neck cancer and cutaneous tumors in Europe, where it has received CE Mark certification. It has initiated two pivotal Phase III trials in recurrent SCCHN to support marketing applications in the US. The technology addresses a significant unmet clinical need: highly efficient local ablation of solid tumors and selective killing of cancer cells while preserving healthy tissue. EPT can enhance the delivery of other molecules and the Company is developing other therapies such as cancer DNA vaccines and gene therapies with various biotechnology and pharmaceutical companies. Current partnerships and collaborations include Chiron, the US Navy, Valentis, and Vical. Genetronics is a leader in electroporation with over 240 patents issued, allowed, or pending. More information can be obtained from 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, 2002, and 10-Q for the 3-month period ending September 30, 2003 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
CONTACT: Brook Riggins, CFA, VP Finance and Corporate Communication ofGenetronics BioMedical Corporation, +1-858-597-6006
Web site: http://www.quintiles.com/
Web site: http://www.genetronics.com/
