Prima BioMed Ltd engages in the development of personalized bio-therapeutic products for cancer. Products The company’s major product candidate in development is CVac, an autologous dendritic cell based product in clinical trials for late stage ovarian cancer patients in complete remission. CVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission The company’s major program is the treatment of epithelial ovarian cancer patients who are in complete remission. It is targeting patients in second remission. The company has obtained orphan indication designation in both the United States and Europe. In October and November 2012, the company reported positive interim data from its ongoing phase 2 trial of CVac as maintenance treatment of epithelial ovarian cancer (the CAN-003 study). In September 2013, the company announced top-line results of its CAN-003 trial. Intellectual Property CVac is protected in the major markets and various other countries by two patent families licensed from the Burnet Institute in Melbourne, Australia, including composition of matter patents on mucin-mannan conjugates and method of composition patents of producing dendritic cells treated with mannosylated fusion protein. CVac is a registered trademark in Australia, the United States, Europe, New Zealand, China, and the UAE. Regulatory Authorities The company, and any manufacturers of its products, is required to comply with applicable U.S. Food and Drug Administration manufacturing requirements contained in the U.S. Food and Drug Administration’s GMP regulations.
prima biomed ltd
(PRR:Australian Stock Exchange Ltd)
151 Macquarie Street
Sydney, NSW 2000
Phone: 61 2 9276 1224
Fax: 61 2 9276 1284www.primabiomed.com.au
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