SAN DIEGO, Aug. 23, 2018 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced the Toca 5 pivotal Phase 3 trial continues
without modification following a planned first interim analysis of
data conducted by an Independent Data Monitoring Committee (IDMC).
The IDMC completed its analysis at 50% of events occurring in
patients with brain cancer and recommended the trial continue
without modification. The global trial is enrolling robustly and
nearing full enrollment.
"We are pleased with the outcome of the interim analysis of the
Toca 5 trial by the independent Data Monitoring Committee and the
global trial continues. The Toca 5 trial is nearing completion of
full enrollment of patients ahead of the projected schedule. We
plan to conduct the second interim analysis in the first half of
2019 after 75% of events have occurred," said Asha Das, M.D., senior vice president and chief
medical officer of Tocagen.
Toca 5 is a Phase 3, randomized, multi-center study evaluating
the safety and efficacy of Toca 511 & Toca FC compared to
standard of care in patients undergoing resection for recurrent
high grade glioma (HGG). The primary endpoint of the trial is
overall survival (OS). The statistical plan for 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. The U.S. Food and Drug
Administration (FDA) has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent HGG
and the European Medicines Agency (EMA) has granted Toca
511 PRIME (PRIority MEdicines) designation for the treatment of
glioma. More information about the Toca 5 trial can be found on
ClinicalTrials.gov using the clinical trial identifier
NCT02414165.
About Toca 511 & Toca FC
Tocagen's lead
product candidate is a two-part cancer-selective immunotherapy
comprised of an investigational biologic, Toca 511 and an
investigational small molecule, Toca FC. Toca 511 (vocimagene
amiretrorepvec) 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,
infected cancer cells carry the CD gene and produce CD. Toca FC is
an orally administered, extended-release formulation of the
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 in the
tumor microenvironment resulting in anti-cancer immune activation
and subsequent tumor killing.
About Tocagen Inc.
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 pivotal Phase 3
trial for recurrent high grade glioma (HGG), a disease with
significant unmet medical need. The U.S. Food and Drug
Administration (FDA) has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent HGG
and the European Medicines Agency (EMA) has granted Toca
511 PRIME (PRIority MEdicines) designation for the treatment of
glioma. For more information about Tocagen,
visit www.tocagen.com.
Forward-Looking Statements
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 and
expectations regarding the enrollment, timing and success of 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 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.
Media Contact:
Pam
Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com
Investor Contact:
Elizabeth
Broder
Endurance Advisors
ebroder@enduranceadvisors.com
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SOURCE Tocagen Inc.