While melanoma rates have been rising over the last 30 years, advancements in treatment and early detection are providing new hope for patients everywhere. In this edition of Guided By Science, we explore melanoma prevention, early detection, and new treatments that are changing the way we treat this deadly disease.
While skin cancer is well-known and well-documented, in most communities, few people differentiate between the various types. Melanoma, basal cell carcinoma and squamous cell carcinoma are, unfortunately, quite prevalent (and on the rise). It is important to understand the risk factors and preventative measures for these cancer types. However, there is one rare type of skin cancer called Merkel cell carcinoma: a deadly type of skin cancer with a low survival rate that still has no approved, specialized treatment method.
OncoSec is continuing to execute on its corporate milestones, which were laid out for our investors at the beginning of 2012. The fourth quarter of 2012 will mark an important achievement for OncoSec – the announcement of preliminary data from our Phase II ImmunoPulse clinical trials, the first of which will be presented at this years annual meeting for the Society of Immunotherapy of Cancer (SITC) later this week. Here, we will be presenting data from 5 patients treated in our Merkel cell carcinoma (MCC) program. Merkel cell carcinoma is an aggressive cancer that starts in the skin and Merkel cells. If you’d like to know more about this cancer, you can read our previous blog post titled, “What is Merkel Cell Carcinoma“.
SAN DIEGO, CA — July 30, 2012 — 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.