FREMONT, Calif., April 26, 2017 /PRNewswire/ -- Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company
focused on the emerging field of regenerative medicine, today
announced that the results from its completed Phase 2 clinical
trial of AST-VAC1 are now available online in Cancer,
a leading peer-reviewed journal of the American Cancer
Society. The study publication is available at
http://onlinelibrary.wiley.com/doi/10.1002/cncr.30696/full.
"This important publication in the journal Cancer shows
why AST-VAC1 has the potential to become an important new therapy
for AML patients by safely prolonging the duration of remission in
patients with high-risk AML," said Steve
Cartt, President and Chief Executive Officer of Asterias.
"We believe these Phase 2 results also demonstrate the potential of
our AST-VAC2 allogeneic (non-patient specific) dendritic cell
cancer vaccine to achieve promising results in its upcoming Phase
1/2a study in non-small cell lung cancer and to potentially be
developed for the treatment of other types of cancer, as well."
The publication, titled "Immune Responses and Long-Term Disease
Recurrence Status After Telomerase-Based Dendritic Cell
Immunotherapy in Patients With Acute Myeloid Leukemia," describes
the previously reported results of the Phase 2 study of AST-VAC1,
Asterias' patient-specific dendritic cell cancer vaccine, in which
57% of patients who received AST-VAC1 had prolonged relapse-free
survival, including high-risk patients over 60 years old or in
second remission.
The Phase 2 multicenter, open label trial was designed to
evaluate the safety and tolerability of the AST-VAC1 vaccination
regimen in patients with intermediate or high risk AML who were in
complete clinical remission. Additional objectives of the study
were to evaluate the immune responses to AST-VAC1 and to explore
the effects of vaccination on relapse in this patient population.
Long-term follow-up results showed that 11 out of 19 patients (58
percent) receiving AST-VAC1 during complete remission were
relapse-free with a median follow-up of 52 months. In addition,
four out of seven patients (57 percent) over the age of 60 remained
in remission after a median 54 months of follow-up. Such prolonged
relapse-free survival was favorable compared to that previously
reported for these patient groups (20-40% overall group and 10-20%
for subjects over 60 years old). AST-VAC1 was found to be safe and
well-tolerated in this study over multiple vaccinations.
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a cancer of the blood and bone
marrow. AML is the most common type of acute leukemia and has the
potential for rapid progression, if untreated. In AML, the bone
marrow produces an excess number of immature cells known as blasts.
In AML, these blasts fail to mature into normal red and white blood
cells. Instead, the blasts proliferate and accumulate in the bone
marrow and peripheral blood, leading to deficiencies in normal
mature cells. These deficiencies, often referred to as cytopenias,
can induce several adverse effects including anemias and
susceptibility to infections. Current treatment strategies for AML
are associated with significant morbidities and in most instances,
AML leads to death.
Approximately 20,500 new cases of AML are diagnosed in the U.S.
annually. AML remains a high unmet clinical need, particularly in
patients over the age of 60 years who face poor outcomes and have
limited therapeutic options. Treatment and prognosis in AML is
strongly influenced by a patient's age and tumor profile.
Successful treatment and survival of advanced age patients or those
with a high risk profile is very poor, with a four year
relapse-free survival of 10% – 20% (Rolig et al, 2011). Detailed
characterizations of genetic abnormalities associated with AML have
elucidated their high number and relative complexity, making
development of targeted therapeutics to these mutations very
challenging. For this reason, broad immunotherapy approaches such
as autologous cell vaccines are particularly promising.
About AST-VAC1
AST-VAC1 is a cancer immunotherapy, consisting of autologous
mature antigen-presenting dendritic cells pulsed with a messenger
RNA for the protein component of human telomerase (hTERT) and a
portion of a lysosomal targeting signal (LAMP). hTERT is a common
protein in tumor cells and is responsible for the increased
proliferative lifespan of cancer cells. In AST-VAC1, the dendritic
cells present telomerase to the immune system to induce T cells to
target and kill hTERT-expressing tumor cells. The LAMP signal
allows AST-VAC1 to stimulate both cytotoxic and helper T cell
responses to telomerase, critical elements to induce and maintain
immune responses that kill tumor cells. Because of the widespread
expression of telomerase in the majority of cancers, AST-VAC1 is a
platform immunotherapeutic that could be used alone or in
conjunction with other therapeutics such as immune checkpoint
inhibitors to target immune-based destruction of tumors.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company
pioneering the field of regenerative medicine. The company's
proprietary cell therapy programs are based on its pluripotent stem
cell and immunotherapy platform technologies. Asterias is presently
focused on advancing three clinical-stage programs which have the
potential to address areas of very high unmet medical need in the
fields of neurology and oncology. AST-OPC1 (oligodendrocyte
progenitor cells) is currently in a Phase 1/2a dose escalation
clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting
autologous dendritic cells) is undergoing continuing development by
Asterias based on promising efficacy and safety data from a Phase 2
study in Acute Myeloid Leukemia (AML), with current efforts focused
on streamlining and modernizing the manufacturing process. AST-VAC2
(antigen-presenting allogeneic dendritic cells) represents a second
generation, allogeneic cancer immunotherapy. The company's research
partner, Cancer Research UK, plans to begin a Phase 1/2a clinical
trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional
information about Asterias can be found at
www.asteriasbiotherapeutics.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating
and/or clinical research results, future growth in research,
technology, clinical development, and potential opportunities for
Asterias, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as "will," "believes," "plans,"
"anticipates," "expects," "estimates") should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the businesses of Asterias,
particularly those mentioned in the cautionary statements found in
Asterias' filings with the Securities and Exchange Commission.
Asterias disclaims any intent or obligation to update these
forward-looking statements.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/asterias-announces-publication-of-positive-phase-2-data-on-ast-vac1-for-the-treatment-of-acute-myeloid-leukemia-aml-in-cancer-300445721.html
SOURCE Asterias Biotherapeutics, Inc.