SAN DIEGO, July 24, 2017 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced the European Medicines Agency (EMA) has
granted Toca 511 (vocimagene amiretrorepvec) PRIME (PRIority
MEdicines) designation for the treatment of patients with high
grade glioma (HGG), a type of brain tumor. Toca 511 & Toca FC
is currently under evaluation in an international, randomized Phase
2/3 clinical trial, which is designed to serve as a potential
registrational study. The trial involves patients with first or
second recurrence of glioblastoma or anaplastic astrocytoma who are
undergoing resection.
The PRIME designation application was based on clinical data
from a Phase 1 resection study in patients with recurrent brain
cancer and results from various preclinical models. Clinical data
include results published in Science Translational Medicine,
including safety data, patient survival data and durable, complete
or partial tumor shrinkage determined by independent radiology
review. Preclinical data include results published in
Neuro-Oncology detailing proposed mechanisms of action for Toca 511
& Toca FC. These clinical and preclinical data were also
reviewed by the U.S. Food and Drug Administration (FDA) and
resulted in the granting of Breakthrough Therapy Designation for
Toca 511 & Toca FC in recurrent high grade glioma in
February 2017.
"The EMA's granting of PRIME designation for Toca 511
underscores the urgent need for new treatments for high grade
glioma, one of the deadliest cancers," said Marty Duvall, chief executive officer of
Tocagen. "We are committed to working closely with the EMA to
expedite the advancement of our product candidate, and bringing a
potentially transformative treatment option for high grade glioma
to European patients and physicians as quickly as possible."
The PRIME program was launched by the EMA in 2016 to increase
support for the development of medicines that target an unmet
medical need. Under PRIME designation, drug developers receive
enhanced interaction and early dialogue with the goal of optimizing
development plans and accelerating evaluation so medicines can
reach patients earlier. To be accepted, an investigational medicine
must show the potential to benefit patients with unmet medical
needs based on early clinical data. Medicines accepted into the
PRIME program are considered priority medicines within the European
Union (EU).
HGGs are among the most common and aggressive primary brain
cancers. The total number of patients with HGG expected to be
diagnosed in 2017 is approximately 160,000 worldwide and
approximately 36,000 in Europe.
The two most common forms of HGG are glioblastoma and anaplastic
astrocytoma. Standard treatment for newly diagnosed HGG includes
safe surgical removal of as much of the tumor as possible followed
by radiation therapy and chemotherapy. However, HGG recurs in most
patients even after maximal treatment. After recurrence, median
survival is typically seven to nine months.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a cancer-selective
immunotherapy comprised of an investigational biologic, Toca 511,
and an investigational small molecule, Toca FC, that are designed
to be used together. Toca 511 is an injectable retroviral
replicating vector (RRV) that encodes a prodrug activator enzyme,
cytosine deaminase (CD). CD is derived from yeast, and humans do
not naturally have this gene. Its selective delivery to cancer
cells means that the infected cancer cells selectively carry the CD
gene and produce CD protein. Toca FC is an investigational orally
administered prodrug, 5-fluorocytosine (5-FC) that is inactive as
an anti-cancer drug. In animal models, Tocagen has shown that 5-FC
is converted into the anticancer drug, 5-FU, at high concentrations
in Toca 511-infected cancer cells that are producing CD protein.
Together, the Toca 511 & Toca FC combination directly kills
cancer cells and immune-suppressive myeloid cells resulting in
activation of the immune system against cancer.
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 is developing its lead investigational
product candidate, Toca 511 & Toca FC, initially for the
treatment of 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 HGG. Tocagen
has received grant support from leading brain cancer foundations,
including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor
Society (NBTS), American Brain Tumor Association (ABTA), Musella
Foundation and Voices Against Brain Cancer (VABC).
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, expectations regarding timing
and success of our clinical trials and planned clinical trials,
timing and substance of communications with the FDA and
EMA, a commercialization of our product candidates. Risks
that contribute to the uncertain nature of the forward-looking
statements include: risks associated with
our product candidate development activities including
the risks of clinical trials; the risk that our product
candidates will cause serious adverse events or otherwise fail to
prove effective and safe; the risk that we are unable to execute on
our strategy; and the risks associated with commercialization of
our product candidates if approved for sale. 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/tocagen-receives-european-medicines-agency-priority-medicines-prime-designation-for-toca-511-in-high-grade-glioma-300492648.html
SOURCE Tocagen Inc.