Oncolytics Biotech Inc. (ONCY)

[onco_investor]

FDA Grants Fast Track for Oncolytic Virotherapy Glio

http://www.marketwatch.com/story/fda-grants-fast-track-status-to-dnatrix-drug-dnx-2401-for-recurrent-glioblastoma-2014-06-17

For those keeping score Frank Tufaro is on Oncolytics Advisory Board

http://investing.businessweek.com/research/stocks/people/board.asp?ticker=ONCY

The company is privately held and is only in Phase 1 trials and has treated 35 patients. FDA endorsement of a genetically modified OV is positive for all OV researchers.

http://www.dnatrix.com/science-and-technology/

DNAtrix founders Drs. Juan Fueyo and David Curiel designed and patented DNX-2401, a novel adenovirus that fulfilled the dual requirements of higher potency with excellent safety. To do this, the scientists engineered two stable genetic changes in the adenovirus dsDNA genome that cause it to (1) replicate selectively in retinoblastoma (Rb)-pathway deficient cells and (2) infect cells that express certain RGD-binding integrins more efficiently. Because virtually all tumor cells, including GB, are defective in Rb function and already in the cell cycle, DNX-2401 replicates in and kills these tumor cells selectively and efficiently. DNX-2401 is vastly superior to wild type adenovirus with respect to killing rapidly growing tumor cells, an unprecedented property for an oncolytic virus.

While DNX-2401 should be effective against multiple tumor types, we are initially focused on high-grade gliomas for three reasons: (1) these tumors remain confined to the brain, so patient assessment is not complicated by the presence of metastatic disease, (2) tumor responses can be accurately documented and presented to the FDA to support product approval, and (3), the path to regulatory approval has already been established for high-grade gliomas.