SAN DIEGO, May 21, 2019 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced the Toca 5 Phase 3 clinical trial
evaluating Toca 511 & Toca FC in patients with recurrent high
grade glioma (HGG) continues without modification following a
planned interim analysis of data conducted by an Independent Data
Monitoring Committee (IDMC). The IDMC completed its analysis and
recommended the trial continue without modification. The global
trial enrolled patients across two periods of time and completed
full enrollment of 403 patients in November
2018.
"We are encouraged by the recommendation from the IDMC to
continue the Toca 5 trial without modification and are looking
forward to reporting the final analysis of the Toca 5 trial by the
end of the year," said Marty Duvall,
chief executive officer of Tocagen. "We believe the longer-term
follow-up of patients in the final analysis, particularly for those
randomized in the second enrollment period, will be important in
assessing both primary and secondary endpoints."
The Toca 5 trial is one of the largest randomized trials
conducted in patients with recurrent high grade glioma. The
international trial is a Phase 3 multi-center trial 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 trial with 85% power to detect a hazard ratio of
0.685. The U.S. Food and Drug Administration (FDA)
granted Toca 511 & Toca FC Breakthrough Therapy Designation for
the treatment of recurrent HGG and the European Medicines
Agency (EMA) 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 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.
About Tocagen
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 (Toca 5) for recurrent high grade glioma (HGG), a
disease with significant unmet medical need. The U.S. Food and
Drug Administration awarded Tocagen an orphan drug grant for
the Toca 5 trial and has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent
HGG. The European Medicines Agency 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 expectations and plans regarding the timing and results 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; our ability
to execute on our strategy; and regulatory developments in
the United States and foreign
countries. 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:
Pete Rahmer
Endurance Advisors
(415) 515-9763
prahmer@enduranceadvisors.com
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SOURCE Tocagen Inc.