Tocagen Inc (Nasdaq:TOCA) has completed the planned enrolment of 380 patients in a pivotal Phase 3 trial of its lead product candidate, a potential new treatment for an aggressive form of brain cancer, the gene therapy company reported on Wednesday.
This randomised, multi-centre study, known as Toca 5, will evaluate the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma (HGG), one of the most common and aggressive primary brain cancers.
Toca 511 & Toca FC is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC.
Completing enrolment in Toca 5 triggers the next milestone payment of USD2m from ApolloBio, the licensor of Toca 511 & Toca FC within the greater China region.
Tocagen announced in August that the Toca 5 study would continue without modification after an independent data monitoring committee completed the first interim analysis. The second interim analysis is expected in the first half of 2019, followed by the final planned safety and efficacy analyses by the end of 2019.
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
ELIAS Animal Health names new chief revenue officer
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval