SAN DIEGO, Sept. 19, 2018 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced that it has completed the planned
enrollment of 380 patients in the global Toca 5 pivotal Phase 3
trial approximately three months ahead of schedule. Toca 5 is a
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
principal investigator is Timothy
Cloughesy, M.D., director of the University of California, Los Angeles
Neuro-Oncology Program.
"Achieving our enrollment goal ahead of schedule is a testament
to the enthusiasm and dedication of our investigators
and study coordinators as well as the participating patients,
families and patient advocates," said Asha
Das, M.D., senior vice president and chief medical officer
of Tocagen. "Achieving this enrollment goal takes us one step
closer towards a potentially transformative new treatment option
for patients with brain cancer."
"Completing enrollment in Toca 5 is the latest example of our
recent progress as we continue to execute against our goals," said
Marty Duvall, chief executive
officer of Tocagen. "This important milestone also triggers the
next milestone payment of $2 million
from ApolloBio, our licensor of Toca 511 & Toca FC within the
greater China region."
On August
23rd, Tocagen announced the Toca 5 study
would continue without modification after an Independent Data
Monitoring Committee completed the first interim analysis. Tocagen
estimates the second interim analysis in the first half of 2019 and
the final planned safety and efficacy analyses by the end of 2019.
More information about Toca 5 can be found on ClinicalTrials.gov
using the clinical trial identifier NCT02414165.
About High Grade Glioblastoma
Recurrent HGG is among the most common and aggressive primary
brain cancers and often strikes in the prime of life. The two most
common forms of HGGs are glioblastoma and anaplastic astrocytoma.
The total number of new diagnoses of HGG expected in 2018 is about
188,000 worldwide. Unfortunately, HGG recurs in most patients after
frontline treatment, and standard of care treatment typically
offers a median survival of only seven to nine months.
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.