|Tocagen Achieves Key Development Milestone for Lead Product: Phase 2 Randomized Trial in Patients with Recurrent Brain Cancer Fully Enrolled Top-Line Results Anticipated 1H 2018|
SAN DIEGO – Feb. 23, 2017 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced it has completed patient enrollment in the Phase 2 portion of Toca 5, a randomized, international Phase 2/3 clinical trial of Toca 511 & Toca FC, for the treatment of patients with recurrent brain cancer.
Toca 5 is designed to serve as a potential registrational trial, and top-line results from the Phase 2 portion are anticipated in the first half of 2018. In the trial, patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection are randomized between a cancer-selective virus and oral prodrug, Toca 511 & Toca FC, or standard of care.
"There is an urgent need for effective new treatment options for patients with high grade gliomas, such as glioblastoma and anaplastic astrocytoma," said Tom Mikkelsen, M.D., neuro-oncologist at Henry Ford Hospital, which led enrollment in the Phase 2 trial under the direction of Tobias Walbert, M.D., Ph.D., co-director of the Hermelin Brain Tumor Center at Henry Ford Hospital. "Enrollment in this study was very rapid, which reflects strong interest from patients and their care teams. We look forward to continuing the development of this potential new therapy."
"Completing enrollment in this international, randomized trial brings us an important step closer to a much-needed potential new treatment option for patients with recurrent high grade glioma," said Marty Duvall, chief executive officer of Tocagen. "We sincerely thank the many individuals who have helped advance this study, including patients and their caregivers, site investigators and coordinators, and non-profit organizations, for their tremendous support in our shared fight against brain cancer."
The primary endpoint of the Toca 5 clinical trial is overall survival. Secondary endpoints include objective response rate and duration of response. Immune monitoring is being performed to evaluate evidence of immunologic mechanisms of disease control. A total of 67 clinical sites around the world are participating in the trial. Investigators chose between chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for the control arm.
The lead investigators of the Toca 5 trial are as follows: United States: Tim Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program; Canada: Gelareh Zadeh, M.D., Ph.D., associate professor at the Department of Surgery University of Toronto; Israel: Rachel Grossman, M.D., attending neurosurgeon at Tel-Aviv Sourasky Medical Center; South Korea: Sin-Soo Jeun, M.D., professor of neurosurgery at Seoul St. Mary's Hospital.
High grade gliomas are among the most common and aggressive primary brain cancers. The total number of patients with high grade glioma (HGG) expected to be diagnosed in 2017 is about 160,000 worldwide and about 14,000 in the United States. The two most common forms of HGG are glioblastoma and anaplastic astrocytoma. Standard treatment for newly diagnosed HGG includes surgical removal of as much of the tumor as possible, followed by radiation therapy and chemotherapy. However, HGG recurs in most patients, even after maximal treatment. After recurrence, median survival is typically seven to nine months.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC, designed to be used together. The Toca 511 & Toca FC combination is designed to directly kill cancer cells and immune-suppressive myeloid cells resulting in activation of the immune system against cancer. Toca 511 & Toca FC is currently being evaluated in multiple clinical trials. The ongoing Toca 5 trial is an international, randomized, Phase 2/3 clinical trial for the treatment of patients with recurrent HGG. The ongoing Toca 6 study is a Phase 1 trial for the treatment of patients with metastatic cancer. Tocagen plans to expand the Toca 6 trial to include patients with recurrent HGG and to initiate Toca 7, a Phase 1 trial in patients with newly diagnosed HGG. The FDA has granted Toca 511 & Toca FC Breakthrough Therapy Designation and Fast Track designation for the treatment of patients with recurrent HGG, and Orphan-Drug designation for the treatment of glioblastoma multiforme (GBM).
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 & Toca FC, initially for the treatment of recurrent high-grade glioma, a disease with significant unmet medical need. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.