Tocagen to Accelerate Toca 511 & Toca FC Development into Pivotal Phase 3 Trial
"We are pleased with the outcome of our discussions with
Highlights of the revised trial design are as follows:
- An additional 193 patients with recurrent HGG will be enrolled and pooled with 187 already enrolled patients, for a total target enrollment of 380 patients.
- The primary endpoint of the trial is overall survival (OS). The primary endpoint assumes a median OS of 9.8 months for the control arm versus 14.3 months for the Toca 511 & Toca FC arm. A total of 257 events will provide the study with 85% power to detect a hazard ratio of 0.685.
- Secondary endpoints of the trial include durable response rate, defined as complete or partial responses lasting at least 24 weeks, which is being assessed as a novel endpoint in the post-surgical setting of recurrent HGG.
- The updated protocol includes planned interim analyses at 50% and 75% of events, estimated to occur in the second half of 2018 and first half of 2019, respectively. Due to this transition to a seamless trial design, a previously planned data analysis of the Phase 2 portion of the original Phase 2/3 trial will no longer occur.
- Additionally, the
FDAawarded Tocagena $2 millionorphan drug grant, payable over four years, to support the Toca 5 trial. More details on the grant are available at FDA.gov.
"The maturing data from our Phase 1 resection trial in patients with recurrent brain cancer gives us confidence to move forward with a seamless pivotal trial rather than waiting to initiate a separate Phase 3 study," said
About Toca 511 & Toca FC
About the Toca 5 trial
Toca 5 is a Phase 3, pivotal, randomized, double-blind study of Toca 511 & Toca FC in patients with recurrent high-grade glioma, a type of brain tumor. The study is being conducted at 167 sites globally and is expected to enroll 380 patients. Patients will be randomized following surgical resection 1:1 to receive either the Toca 511 & Toca FC regimen or chemotherapy. The primary endpoint of the trial is overall survival (OS). The primary endpoint assumes a median OS of 9.8 months for the control arm versus 14.3 months for the Toca 511 & Toca FC arm. A total of 257 events will provide the study with 85% power to detect a hazard ratio of 0.685. Interim analyses are planned at 50% and 75% of events. More information can be found at www.tocagen.com/toca5 or by searching clinicaltrials.gov using the clinical trial identifier NCT02414165.
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 business plans and objectives, expectations regarding the timing of our clinical trials, including the timing of enrollment, interim analyses and results from our clinical trials. 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
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Monica May, Canale Communications, (619) 849-5383, firstname.lastname@example.org, or Investor Contact: Elizabeth Broder, The Trout Group , (646) 378-2945, email@example.com