title: Maintaining therapeutic activity in the operating room: compatibility of a gamma-retroviral replicating vector with clinical materials and biofluids.
abstract: Toca 511 is a novel retroviral replicating vector, encoding a modified yeast cytosine deaminase, administered to recurrent high grade glioma patients in Phase 1 trials by stereotactic, transcranial injection into the tumor or into the walls of the resection cavity. A key issue, with little published data, is vector biocompatibility with agents likely to be encountered in a neurosurgical setting. We tested biocompatibility of Toca 511 with: delivery devices; MRI contrast agents, including ProHance supporting coinjection for real time MRI-guided intratumoral delivery; hemostatic agents; biofluids (blood and cerebrospinal fluid); potential adjuvants; and a needleless vial adapter that reduces risk of accidental needle sticks. Toca 511 is stable upon thawing at ambient temperature for at least 6 hours, allowing sufficient time for administration, and its viability is not reduced in the presence of: stainless steel and silica-based delivery devices; the potential MRI contrast agent, Feraheme; ProHance at several concentrations; the hemostatic agent SURGIFOAM; blood; cerebrospinal fluid; and the needleless vial adapter. Toca 511 is not compatible with the hemostatic agent SURGICEL or with extended exposures to titanium-based biopsy needles.
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Burnett
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ibañez
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Pär L
authors.initials: PL
authors.lastname: Pettersson
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Ching-I
authors.initials: CI
authors.lastname: Chen
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Shraddha
authors.initials: S
authors.lastname: Parab
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Tiffany
authors.initials: T
authors.lastname: Huang
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Robbins
authors.affiliation: Department of Neurological Surgery, University of California San Francisco (UCSF) , San Francisco, CA, USA.
authors.forename: Krystof
authors.initials: K
authors.lastname: Bankiewicz
authors.affiliation: Department of Neurological Surgery, University of California San Francisco (UCSF) , San Francisco, CA, USA.
authors.forename: Manish
authors.initials: M
authors.lastname: Aghi
authors.affiliation: Department of Medicine, University of California Los Angeles (UCLA) , Los Angeles, CA, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Logg
authors.affiliation: Department of Medicine, University of California Los Angeles (UCLA) , Los Angeles, CA, USA.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Kasahara
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Pertschuk
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Harry E
authors.initials: HE
authors.lastname: Gruber
authors.affiliation: Tocagen Inc., Bunker Hill St. , San Diego, CA, USA.
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Jolly