We carefully planned for, designed, and now are executing our Phase III clinical trial to the highest standard because we recognize that this is what it takes to succeed. We built a fully validated manufacturing facility near Baltimore, Maryland, USA, to ensure that the Multikine used in our Phase III trial would be consistent from lot to lot. Our study was intentionally designed to be very large and international in scope to improve our chances that the study results would be sufficiently robust so that it would not be required by the regulatory authorities that we conduct multiple studies to achieve approval of Multikine for commercial distribution. The international scope of the study will also increase rate of enrollment in the study so the study may be completed more rapidly, and allow us to submit applications for approval in multiple countries around the world. It is our strong belief that this study will prove that Multikine treatment will increase the overall survival of head and neck cancer patients.
The following is a brief summary of the key operational successes in 2011:
- Our Phase III study for Multikine started in one US cancer center in the final days of 2010. During 2011 we initiated 36 additional hospitals in 8 countries on three continents. That is a very fast pace for adding clinical sites to an international study.
- Patients were enrolled in the study on all three continents (North America, Europe and Asia).
- Our partners Teva Pharmaceuticals Industries (Israel) and Orient Europharma (Taiwan) enrolled patients in their respective territories.
- We produced multiple lots of Multikine in our manufacturing facility near Baltimore, Maryland, USA and provided drug in sufficient amounts at all clinical sites.
I am constantly being asked how the study is going. As you may know, I am not allowed to discuss the study results at this early stage. However, that being said, our confidence may be best expressed by the decision made to expand the trial into four extra territories at additional expense and effort, with the help of our partner Teva in certain areas. We are doing so because we want to complete the study to prove Multikine’s effectiveness as quickly as possible and hopefully receive marketing approval from the regulators.
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