UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): February
24, 2015
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California
|
1-12830
|
94-3127919
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer
Identification No.)
|
1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
Any statements that are not historical fact (including, but not
limited to statements that contain words such as “may,” “will,”
“believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”)
should also be considered to be forward-looking statements. Additional
factors that could cause actual results to differ materially from the
results anticipated in these forward-looking statements are contained in
BioTime’s periodic reports filed with the Securities and Exchange
Commission (“SEC”) under the heading “Risk Factors” and other filings
that BioTime may make with the SEC. Undue reliance should not be placed
on these forward-looking statements which speak only as of the date they
are made, and the facts and assumptions underlying these statements may
change. Except as required by law, BioTime disclaims any intent or
obligation to update these forward-looking statements.
This Report and the accompanying Exhibit 99.1 shall be deemed
“furnished” and not “filed” under the Securities Exchange Act of 1934,
as amended.
Section 7 - Regulation FD
Item 7.01 - Regulation FD Disclosure
On February 24, 2015, we issued the press release furnished as Exhibits
99.1 to this report, which is incorporated by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
Exhibit Number Description
99.1 Press release dated February 24,
2015
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
|
BIOTIME, INC.
|
|
|
|
|
|
|
|
|
|
|
Date:
|
February
24, 2015
|
By:
|
s/Robert W. Peabody
|
|
|
|
|
Senior Vice President and
|
|
|
|
|
Chief Financial Officer
|
|
Exhibit Number
|
Description
|
99.1
|
Press release dated February 24, 2015
|
Exhibit 99.1
BioTime
Announces First Patient Treated in Pivotal Clinical Trial of Renevia™
for HIV-Associated Lipoatrophy
ALAMEDA, Calif.--(BUSINESS WIRE)--February 24, 2015--BioTime, Inc. (NYSE
MKT: BTX) today announced that the first patient was successfully
treated in the Company’s pivotal clinical trial in Europe assessing the
efficacy of Renevia™ for the treatment of HIV-associated
lipoatrophy. HIV-associated lipoatrophy is a disorder characterized by
abnormal loss of body fat from under the skin that occurs in almost half
of the approximately three million people on anti-retroviral therapy in
the U.S. and Europe. Renevia is a proprietary injectable matrix
designed to facilitate the stable engraftment of transplanted cells. The
uniqueness of Renevia is that it allows the mixture of cells with the
matrix in a liquid form such that the cells and matrix can be injected
easily and safely through a small gauge syringe, and then the matrix can
polymerize around the cells to create a three-dimensional tissue within
the body.
In the trial, Renevia is being tested as a delivery matrix for
the patient’s own fat-derived cells and injected into portions of the
patient’s face where there is facial lipoatrophy in order to promote
facial tissue reconstruction. The first treatment marks the beginning of
enrollment for this pivotal trial and follows the previous successful
safety trial of Renevia, the completion of which was announced in
2014. The procedure was performed at The Stem Center in Palma de
Mallorca, Spain, an innovative patient therapy center and a global
leader in clinical research aimed at the use of a patient’s adipose
derived stem cells for cosmetic and regenerative therapies. The clinical
site is located within the Clinica USP Palma Planas hospital in Palma.
“The current options for patients with facial lipoatrophy do not provide
a natural long lasting result, so I am excited to be leading this
important clinical trial to bring Renevia to this community,”
said Ramon Llull, MD, PhD, Medical Director of The Stem Center and
Principal Investigator for the Renevia studies. Dr. Llull is a
leading expert on advanced regenerative therapies based on lipotransfer.
“The first subject treated in our Renevia pivotal trial is
a significant clinical milestone for an important BioTime pipeline
product,” said Adi Mohanty, BioTime’s Chief Operating Officer. “Renevia
is based on our proprietary HyStem® technology
platform for cell and molecule transfer, and has the potential to be the
first CE-marked injectable delivery vehicle for safe transplantation of
therapeutic cells. We are optimistic about the promise of this
technology platform because of the potential to solve a major hurdle in
the development of effective cell transplant therapies. We believe that
meeting the endpoint in our Renevia pivotal trial could lead to
submission for CE Mark approval in 2016 for HIV related facial
lipoatrophy, and could pave the way for other future applications in
transplanting other types of cells to address unmet medical needs.”
On November 4, 2014, the Spanish Agency of Medicines and Health Products
(“AEMPS”) authorized BioTime to conduct a randomized, evaluator-blinded,
delayed-treatment-controlled study of the effectiveness and safety of Renevia
as a resorbable matrix for the delivery of autologous adipose-derived
cells to treat subcutaneous facial lipoatrophy defects associated with
antiviral therapy for HIV infection. The pivotal study will include a
minimum of 56 and up to 92 HIV positive males and females between 18-65
years of age. Subjects will be randomized with half in the treatment
group and half in a delayed-treatment cohort, each receiving a single
treatment procedure of Renevia™ with autologous adipose cells
harvested by liposuction and implanted in the mid-facial region. The
primary effectiveness measure will be the comparison of the change in
skin thickness between the treatment and delayed treatment groups. A
secondary endpoint will be mid-face volume deficit and global aesthetic
improvement scores. Patients will be monitored at one, three, and
six-month intervals after treatment. Additional information on the trial
will be made available on BioTime’s website at www.biotimeinc.com.
About Facial Lipoatrophy and HIV-related Facial Lipoatrophy
Facial lipoatrophy is the loss of facial fat tissue, which is a key
component for an overall youthful facial appearance. Facial lipoatrophy
is an unfortunate, but inevitable, condition that typically develops as
we age but is dramatically accelerated in those HIV-infected individuals
being treated with antiretroviral therapy (ART). Indeed the loss of
facial fat can be nearly complete in these individuals on ART.
In HIV-infected patients on antiretroviral therapy (ART) facial
lipoatrophy is common and particularly devastating. The resulting facial
wasting ages the individual’s appearance prematurely and, along with a
thinning of the skin, allows musculature and vasculature to be easily
seen, resulting in what is commonly known as “the face of AIDS.”
Treatment of the condition has been determined to be medically advisable
to improve the individual’s self-esteem and quality of life.
Because ART has greatly increased long term survival in HIV-positive
patients the incidence of associated lipoatrophy has risen dramatically.
According to statistics published by AVERT (www.avert.org),
worldwide there were 34 million people living with HIV/AIDS in 2011.
According to the World Health Organization (WHO) 10 million of these are
receiving ART. That number is expected to grow to 15 million people by
the end of 2015.
HyStem® Technology and Renevia™
BioTime’s HyStem® hydrogels, including Renevia,
are a family of unique and proprietary biomaterials that are designed to
function as adhesion matrices for the stable attachment and survival of
cells. The failure rate in many applications of cell grafts without such
a matrix is high because of difficulties in achieving cell attachment
and survival. The achievement of high success rates for cell grafts
would create opportunities to develop cell therapies for many high unmet
medical needs. A unique feature of the proprietary technology is that it
allows the mixture of cells with the matrix in a liquid form such that
the cells and matrix can be injected easily and safely through a small
gauge syringe, and then the matrix can polymerize around the cells to
create a three-dimensional tissue within the body. The matrix is then
resorbed by the body over a few months. HyStem hydrogels are
currently sold worldwide by BioTime and its distributors for
pre-clinical research for a wide array of applications in regenerative
medicine including the engraftment of cells in the brain, liver,
cartilage and bone, heart, and vocal cords. Premvia™, a HyStem
based hydrogel, is a recently FDA-cleared medical device indicated for
the management of wounds. BioTime’s HyStem technology is
covered by two issued US patents with applications pending in the EU,
Canada, Japan, and Australia.
About BioTime
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem®
progenitors, HyStem® hydrogels, culture media,
and differentiation kits. Renevia™ (a HyStem
product), is now in a pivotal trial in Europe as a biocompatible,
implantable hyaluronan and collagen-based matrix for cell delivery in
the treatment of HIV-related lipoatrophy. In addition, BioTime has
developed Hextend®, a blood plasma volume
expander for use in surgery, emergency trauma treatment and other
applications. Hextend is manufactured and distributed in the U.S.
by Hospira, Inc. and in South Korea by CJ HealthCare Corporation, under
exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
-
Asterias Biotherapeutics, Inc. is developing pluripotent stem-cell
based therapies in neurology and oncology, including AST-OPC1
oligodendrocyte progenitor cells in spinal cord injury, multiple
sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based
cancer vaccine. Asterias Series A common stock is traded on the NYSE
MKT under the symbol AST.
-
BioTime Asia, Ltd., a Hong Kong company, may offer and sell products
for research use for BioTime’s ESI BIO Division.
-
Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological disorders. OpRegen® is currently
in a Phase I/IIa clinical trial for the treatment of the dry-form of
age-related macular degeneration.
-
ESI BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem®
progenitors and HyStem® hydrogels.
-
LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®,
the leading human gene database, as part of an integrated database
suite that also includes the LifeMap Discovery®
database of embryonic development, stem cell research, and
regenerative medicine, and MalaCards, the human disease
database.
-
LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
-
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer, including PanC-Dx™, with four
clinical studies currently underway.
-
OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
-
ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For
more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube, and
Google+.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for BioTime and its subsidiaries, 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
business of BioTime and its subsidiaries, particularly those mentioned
in the cautionary statements found in BioTime's Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com
or
Investor
Contact:
EVC Group, Inc.
Gregory Gin, 862-236-0673
ggin@evcgroup.com
Jim
Dawson, 646-445-4800
jdawson@evcgroup.com
Doug Sherk,
415-652-9100
dsherk@evcgroup.com
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Apr 2023 to Apr 2024