California Stem Cell Announces U.S. FDA Approval of Phase II Cancer Stem Cell Clinical Trial for Ovarian Cancer

IRVINE, Calif.--(BUSINESS WIRE)--
California Stem Cell, Inc. (CSC) announced today that the U.S. Food and
Drug Administration (FDA) has approved the Company’s application to
begin a Phase II clinical trial exploring the potential of a
patient-specific cancer immunotherapy in women with Stage III or IV
ovarian, fallopian tube or primary peritoneal cancer. The randomized,
double-blind study is the Company’s second cancer therapy approved for
clinical trials by the FDA, bolstering its platform approach to treating
late stage solid-tumor cancers. The Company’s patient-specific approach
to treating metastatic melanoma, recently approved to begin a Phase III
trial, provided sufficient safety data to proceed directly to a Phase II
study in ovarian cancer.

Led by Chief Medical Officer Robert Dillman, M.D., the study design
randomizes an estimated 99 adult female patients to two treatment arms.
The treatment group will receive Ovapuldencel-T, which is a combination
of autologous dendritic cells loaded with irradiated autologous tumor
cells in GM-CSF. Ovapuldencel-T is created by first isolating cancer
stem cells from the patient's resected tumor sample, then enriching,
inactivating and combining these cells with dendritic cells – or
antigen-presenting immune cells – which are harvested from the patient’s
blood.

The control group will receive the “MC” treatment, harvested from the
patient’s blood (autologous peripheral blood mononuclear cells) combined
with GM-CSF, granulocyte-macrophage colony-stimulating factor, a white
blood cell growth factor.

The trial design calls for both groups to receive subcutaneous
injections of their respective treatment weekly for three consecutive
weeks, then monthly for the following five months. The trial is expected
to last approximately sixty months, including enrollment, treatment, and
long-term patient follow-up.

“We are very pleased with the recent news and what it could mean to
women suffering from late stage ovarian cancer, a disease in which very
little progress has been made,” said CSC President and CEO Hans
Keirstead. “We are also excited at what this approval represents for our
platform cancer program and our potential to pursue similar clinical
studies in additional cancer types.”

The MC treatment is based on findings in recent years that the rapid
proliferation and subsequent spreading of cancer throughout a patient’s
body may be fueled by a small number of cancer stem cells. Through
proprietary processes developed at CSC, researchers have refined their
ability to isolate and expand these cancer stem cells to clinically
useful numbers, combine them with autologous dendritic cells, and
reintroduce them into the patient with the intention of training and
bolstering the patient’s immune system to target the cells that have
ability to form new tumors.

California Stem Cell, Inc. (CSC) is an Irvine, CA-based company focused
on the development of stem cell-based therapies for metastatic cancers
and neuromuscular disorders such as spinal muscular atrophy (SMA),
amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease) and spinal
cord injury.

CSC has proprietary methods to generate human stem cell lines, expand
them to clinically and commercially useful numbers, and differentiate
them at extremely high purity using fully-defined, proprietary media and
cGMP processes.

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California Stem Cell, Inc.Matt Bayless, +1 949-725-1750press@californiastemcell.com

Source: California Stem Cell, Inc.