“2007 was our most productive year to date, marking a significant expansion of the Company’s clinical trial program for REOLYSIN® with Phase II studies and combination drug therapy studies being expanded and initiated,” said Dr. Brad Thompson, President and CEO of Oncolytics. “This activity was supported by further advances in our preclinical development program, manufacturing, and intellectual property.”
Selected Highlights:
Clinical Trial Results Presented
- Final results from our Phase I U.K. systemic administration trial, and our U.S. Phase I systemic administration trial at ASCO;
- Positive interim results from our U.K. Phase Ia/Ib combination REOLYSIN® and radiation trial;
Clinical Trial Progress
- Commenced patient enrolment in three combination REOLYSIN® and chemotherapy trials in the U.K.;
- Commenced patient enrolment in a U.S. Phase II trial for patients with various sarcomas that have metastasized to the lung;
- U.S. National Cancer Institute (NCI) filed a protocol with the U.S. Food and Drug Administration (FDA) to conduct a Phase II melanoma trial with REOLYSIN®;
- Approval to begin a Phase I combination REOLYSIN® and cyclophosphamide trial in the U.K.;
- In January 2008, the NCI filed a protocol with the U.S. FDA to conduct a Phase I/II ovarian, peritoneal and fallopian tube cancer trial;
- In January 2008, met the criteria to expand to full enrolment of 52 patients in our U.S. Phase II sarcoma trial;
Manufacturing
- Completed scale up of our manufacturing process to the 40-litre level and investigated further increases in scale to the 100-litre level;
Financial and Intellectual Property
- Completed a public offering that added gross proceeds of $13.8 million to our financial reserves; and,
- Secured an additional eight U.S, patents and one Canadian patent, bringing our current total to more than 165 patents issued worldwide;
“We expect 2008 to be an outstanding year as we move ahead with our Phase II program and begin to focus our efforts in the clinical program in key indications,” said Thompson. “With solid preclinical and Phase I results, a scalable manufacturing process, a comprehensive intellectual property portfolio and the financial resources to support our Phase II program, we are well positioned for an exciting and productive 2008.”
View the complete report here.
No comments:
Post a Comment