prr and the other three cancer trials

Guys read the last line, more good news coming up...


Exploratory CVac trials in triple-negative breast, colorectal, and pancreatic cancers
In addition to ovarian cancer, and based on early data that demonstrate the safety and immunological activity of CVac, Prima believes there are multiple potential applications for CVac to stimulate the immune system to target and kill mucin 1 overexpressing cells identified in a variety of cancers
As announced, Prima will conduct three separate phase 2 clinical trials to evaluate the potential of CVac for the treatment of triple-negative breast cancer (protocol CAN-101), metastatic colorectal cancer (protocol CAN-201), and resectable pancreatic cancer (protocol CAN-301).

These indications were chosen for exploration because there is reliable data on mucin 1 overexpression in these cancer types, patients generally have a median survival period long enough that would allow potential clinical benefit from CVac, the patient populations are reasonably well defined for consistent clinical trial analysis, and all three indications represent areas of unmet medical needs for new treatment modalities.
The approximate incidence (in the United States and the European Union) for triple-negative breast cancer is approximately 100,000 per year; for metastatic colorectal cancer it is approximately 180,000 per year; for resectable pancreatic cancer it is approximately 18,000 per year.

The new trials will be co-funded by Prima and the Saxony Development Bank in Germany (“SAB”). The Fraunhofer Institute of Cell Therapy and Immunology in Leipzig is Prima’s collaboration partner for manufacturing of CVac for these clinical trials. As of the end of the financial year, Prima is finalizing trial protocols and we plan to make regulatory and ethics committee submissions for trial approval in September and October 2013.