Cotara® Oncology PDF Print E-mail

Novel Brain Cancer Therapy Cotara®

The lead candidate from our Tumor Necrosis Therapy (TNT) platform, Cotara is a novel therapy positioned for Phase III clinical development for the treatment of glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered in a single dose using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor site in the brain.

Clinical Data

Interim median overall survival data presented in October 2011 at the CNS Annual Meeting from our fully enrolled Phase II 41-patient trial of Cotara in recurrent GBM has been promising at 9.3 months (40.6 weeks). Additionally, patients alive at six-months, 12-months and 24-months were 73%, 38% and 19%, respectively, and two patients had survived three years after a single treatment with Cotara. With this positive data in hand, we have opened a dialogue with the FDA to determine the critical elements of a pivotal trial protocol, which we expect will support our partnering discussions to advance Cotara’s development.

Global Phase III Pivotal Trial Design

In December 2012, we announced that we had made significant progress in advancing the Cotara program into late-stage development through an agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM).  The FDA agreed with our proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The advancement of this program is dependent upon securing a licensing or funding partner to further advance Cotara into Phase III development.