SAN DIEGO, Sept. 12, 2019 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced that the Toca 5 Phase 3, randomized, multi-center clinical trial evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma (HGG) undergoing resection missed the primary endpoint of overall survival compared to standard of care treatment (11.1 months median compared to 12.2 months, HR=1.06, p=0.6154). In addition, all secondary endpoints showed no meaningful difference between the arms of the trial. The safety, tolerability and adverse event profile of Toca 511 & Toca FC was as expected for this patient population.
Further analysis of the Toca 5 trial data is currently underway and presentation of the results is planned at an upcoming medical conference.
"Recurrent brain cancer represents a very high unmet medical need and patients with this disease have very few treatment options," said Marty Duvall, chief executive officer of Tocagen. "While the Toca 5 trial results are disappointing, we will be conducting a thorough analysis of the data including molecular analyses and pre-planned subgroups. In addition, we will be conducting an operational review. We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of Toca 511 & Toca FC in the Toca 5 trial."
Conference Call and Webcast
Tocagen will host a conference call today, September 12, at 8:30 a.m. Eastern (5:30 a.m. Pacific) to discuss the Toca 5 clinical trial. The live call may be accessed by dialing 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers. A live webcast of the conference call will be available online from the Investors section of Tocagen's website at www.tocagen.com. The webcast will be archived on Tocagen's website for 60 days.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.
More information about the Toca 5 trial can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165. The Toca 5 trial was funded in part by a grant awarded by the FDA Office of Orphan Products (FD-R-5732).
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. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a Phase 2/3 trial for patients newly diagnosed with glioblastoma, sponsored by the NCI and conducted by NRG Oncology, and a Phase 1 trial in patients with non-muscle invasive bladder cancer. Tocagen is advancing preclinical programs from its versatile gene therapy platform that represents a new approach in cancer immunotherapy. For more information about Tocagen, visit www.tocagen.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our expectations and plans regarding further data analysis and regulatory agency engagement. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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SOURCE Tocagen Inc.