OncoSec Receives ISO 13485 Quality Management System Certification
SAN DIEGO, July 30, 2012 /PRNewswire/ – OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, announced it has received notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices.” The certification confirms the company’s Quality Management System (QMS) and that the company’s manufacturing processes are controlled, documented and compliant with the stringent requirements set by the European Union.
“The ISO certification is a significant accomplishment and an important milestone for OncoSec. Certification affirms that our QMS meets the highest standards and strengthens OncoSec’s commitment to product quality and development,” said Punit Dhillon, President and CEO. “With this certification in place, OncoSec is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe.”
Companies receiving the ISO 13485 certification must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of OncoSec devices, as well as the company’s commitment to continuous improvement. OncoSec’s review was performed by SGS, a world leader among notified bodies in inspection, verification, testing, and certification.
OncoSec’s electroporation device, the OncoSec Medical System (OMS), is currently being used in three on-going clinical trials for the treatment of metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. In addition, the OMS has been used in Europe in Phase IV clinical trials for the treatment of head and neck cancer and cutaneous and subcutaneous skin cancers.
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers and metastatic disease. OMS ElectroOncology therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec’s core technology is based upon its proprietary use of an electroporation platform, the OncoSec Medical System (OMS), to dramatically enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine (OMS ElectroImmunotherapy) or chemotherapeutic agents (OMS ElectroChemotherapy). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy targeting lethal skin cancers. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook, Twitter, and LinkedIn sites.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
University of California Disclaimer: The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.
SOURCE OncoSec Medical Inc.