Tocagen Expands Toca 5, Phase 2/3 Clinical Trial for Recurrent Brain Cancer, to South Korea

14-Jan-2017 Intellasia | BusinessWire | 6:32 AM Print This Post

SAN DIEGO–(BUSINESS WIRE)–Tocagen Inc., a clinical-stage, cancer-selective gene therapy company,
today announced its randomized, controlled Phase 2/3 clinical trial,
called Toca
5
, is now enrolling patients in South Korea. The trial is ongoing in
the United States, Canada and Israel. The study compares a
cancer-selective virus, Toca
511 (vocimagene amiretrorepvec), in combination with Toca FC
(extended-release 5-fluorocytosine)
, to standard of care in patients
with first or second recurrence of glioblastoma or anaplastic
astrocytoma who are undergoing resection.

Brain tumors are among the deadliest of all cancers and there are very
few treatment options available,” said Do Hyun Nam, M.D., professor,
department of neurosurgery, Samsung
Medical Center
, Sungkyunkwan University School of Medicine, which
enrolled the first patient in South Korea. “Data from Phase 1 studies of
this investigational agent showed very promising safety, survival and
durable tumor response data so we are excited to continue evaluation of
this therapy in the Toca 5 trial.”

Sin-Soo Jeun, M.D., professor of neurosurgery at Seoul St. Mary’s
Hospital, is the principal investigator for the Toca 5 clinical trial in
South Korea.

The primary endpoint for the Toca 5 clinical trial is overall survival
with secondary endpoints including objective response rate.
Investigators may choose chemotherapy (lomustine or temozolomide) or
antiangiogenic therapy (bevacizumab) for the control arm. More
information about the clinical trial can be found at www.tocagen.com/toca5.

High grade gliomas are among the most common and aggressive primary
brain cancers. The two most common forms of high grade glioma are
glioblastoma and anaplastic astrocytoma. Standard treatment for newly
diagnosed high grade glioma includes safe surgical removal of as much of
the tumor as possible followed by radiation therapy and chemotherapy.
Despite these treatments, the tumor typically recurs. Median survival
after recurrence is approximately seven to nine months.

A total of 126 patients have been treated in Tocagen’s Phase 1,
ascending-dose studies. Clinical data were recently published in Science
Translational Medicine
. In the subset of patients in the higher
dose cohorts that mirror the patient population under evaluation in the
ongoing Toca 5 trial, a clinical benefit rate of 41.7% was reported at
the 21st
Annual Scientific Meeting and Education Day of the Society for
Neuro-Oncology
. This included 3 complete responses, 2 partial
responses and 5 patients with stable disease (N=24). All patients with
an objective response remain alive and in response. The median duration
of response is at least 26.7 months. A summary of clinical data from
Tocagen’s ongoing Phase 1 clinical trials can be found on Tocagen’s website.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a combination of an investigational
biologic, Toca 511, and an investigational oral tablet, Toca FC. Toca
511 encodes a prodrug activator enzyme, CD. Its selective delivery to
cancer cells means that the infected cancer cells carry the CD gene and
produce CD protein. Toca FC is an orally administered, proprietary
extended-release formulation of 5-fluorocytosine (5-FC), a prodrug that
is inactive as an anti-cancer drug. Within Toca-511-infected cancer
cells that are producing CD, Toca 511 is designed to convert Toca FC
into the anti-cancer drug, 5-fluorouracil (5-FU) at local high
concentrations. In addition to the direct killing of Toca 511-infected
cancer cells, 5-FU kills neighboring uninfected cancer cells and
immunosuppressive myeloid cells including myeloid derived suppressor
cells (MDSCs) and tumor associated macrophages (TAM) in the tumor.

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.
The company is developing its lead investigational product candidate,
Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release
5-fluorocytosine), initially for the treatment of recurrent high grade
glioma (HGG), a disease with significant unmet medical need. Tocagen has
initiated the Phase 2 portion of a randomized, controlled Phase 2/3
clinical trial of Toca 511 & Toca FC in patients with recurrent HGG,
which is designed to serve as a potential registrational trial. More
information about the clinical trial can be found at www.tocagen.com/toca5.
Tocagen has initiated a clinical trial of Toca 511 & Toca FC in
metastatic cancers, including colorectal, pancreatic, lung, breast,
renal and melanoma. Tocagen obtained Fast Track designation from the
U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment
of recurrent HGG and Orphan drug designation for the treatment of
glioblastoma multiforme (GBM), a subset 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). For more information, visit www.tocagen.com or
follow @Tocagen.

Contacts

Canale Communications
Monica May, 619-849-5383
[email protected]

 


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