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): October
20, 2014
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 SEC under the heading “Risk
Factors” and other filings that BioTime may make with the Securities and
Exchange Commission. 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.
Section 8 – Other Events
Item 8.01 Other Events
We have received authorization from the Spanish Agency of Medicines and
Medical Devices (AEMPS) to begin a pivotal human clinical trial of Renevia™
in Spain. In the trial, Renevia will be used in combination
with the patient’s own fat-derived cells and injected into portions of
the patient’s face where there has been a loss of fat from under the
skin (lipoatrophy). Lipoatrophy is estimated to occur in 35-50% of the
10 million HIV patients on antiretroviral therapy.
About the Renevia Clinical Trial
We will 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 arising from HIV
infection. The 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 course 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.
Patient enrollment, which has begun, is expected to be completed in
2015. Additional information on the trial will be made available on
BioTime’s website at www.biotimeinc.com.
The trial will be conducted at The Stem Center in Palma de Mallorca,
Spain, an innovative patient therapy center, laboratory, and
professional research facility located within the Clinica USP Palma
Planas hospital in Palma. The Medical Director of The Stem Center and
Principal Investigator for the Renevia studies, Ramon Llull, MD,
PhD, is a leading expert on advanced regenerative therapies based on
adipose technology.
About Facial Lipoatrophy
Facial lipoatrophy is a condition characterized by localized loss of fat
under the skin. It is common in HIV-infected patients on antiretroviral
therapy (ART), and 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.
While the use of highly active ART in the treatment of HIV-positive
patients has greatly increased longevity, the reported incidence of
HIV-associated lipoatrophy has correspondingly risen. According to
statistics published by AVERT (www.avert.org), worldwide there were 34
million people living with HIV/AIDS in 2011 with 900,000 of these in
western and central Europe and 1.4 million in North America. UNICEF,
UNAIDS, and the World Health Organization (WHO) reported in 2013 that
the number of people receiving ART has tripled in five years to
approximately 10 million people. A substantial effort is underway to
reach a global target of 15 million people receiving ART by the end of
2015.
At present, commonly-used products for the treatment of HIV-related
lipoatrophy include dermal fillers or products that trigger fibrotic
reactions which create fibrous tissue that has an effect of bulking the
skin, but not a restoration of natural subcutaneous fat with its
associated texture and appearance. A full course of treatment of those
products can require multiple injections over a period of several
months. We expect that a single treatment of Renevia
with adipose-derived cells when injected with a small gauge cannula will
result in a reconstitution of normal subcutaneous fat and restoration of
skin contour.
Section 9-Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
Exhibit Number
|
Description
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99.1
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Press Release dated November 4, 2014
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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:
|
November
4, 2014
|
By:
|
/s/ Michael D. West
|
|
|
|
|
Chief Executive Officer
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Exhibit Number
|
Description
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99.1
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Press Release dated November 4, 2014
|
4
Exhibit 99.1
BioTime
Receives Authorization to Begin Pivotal Human Clinical Trial of Renevia™
in
Europe
-
Renevia™
to be utilized in the treatment of HIV-related lipoatrophy, a disorder
estimated to afflict more than 3.5 million patients globally
-
Patient
enrollment initiated; expected to be completed in 2015
ALAMEDA, Calif.--(BUSINESS WIRE)--November 4, 2014--BioTime, Inc. (NYSE
MKT:BTX) today reported that it has received authorization to begin its
pivotal human clinical trial of Renevia™ in Europe. In the
trial, Renevia will be used in combination with the patient’s own
fat-derived cells and injected into portions of the patient’s face where
there has been a loss of fat from under the skin (lipoatrophy).
Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV
patients on antiretroviral therapy. This pivotal trial follows the
previous successful safety trial of Renevia, the completion of
which was announced earlier in 2014.
“Renevia has the potential to be the first approved product
that allows cells to be easily transplanted through a syringe and then
safely polymerized into three-dimensional tissue constructs within the
human body,” said William Tew, Ph.D., BioTime’s Chief Commercial
Officer. “We are excited to enter this last phase of clinical trials for Renevia
as well as by the promise of this technology for the transplantation of
other types of cells to address unmet medical needs. BioTime considers Renevia
a key strategic asset for its future regenerative medicine programs
which are focused on the development of human embryonic stem
cell-derived brown adipocytes, vascular, and osteochondral cells to
treat tissues afflicted with degenerative disease. If the pivotal trial
meets its primary end points, then we would expect to submit Renevia
for CE Mark approval in 2016.”
About the Renevia Clinical Trial
The Spanish Agency of Medicines and Medical Devices (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 arising from HIV
infection. The 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 course 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.
Patient enrollment, which has begun, is expected to be completed in
2015. Additional information on the trial will be made available on
BioTime’s website at www.biotimeinc.com.
The trial will be conducted at The Stem Center in Palma de Mallorca,
Spain, an innovative patient therapy center, laboratory, and
professional research facility located within the Clinica USP Palma
Planas hospital in Palma. The Medical Director of The Stem Center and
Principal Investigator for the Renevia studies, Ramon Llull, MD,
PhD, is a leading expert on advanced regenerative therapies based on
adipose technology.
About Facial Lipoatrophy
Facial lipoatrophy is a condition characterized by localized loss of fat
under the skin. It is common in HIV-infected patients on antiretroviral
therapy (ART), and 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.
While the use of highly active ART in the treatment of HIV-positive
patients has greatly increased longevity, the reported incidence of
HIV-associated lipoatrophy has correspondingly risen. According to
statistics published by AVERT (www.avert.org), worldwide there
were 34 million people living with HIV/AIDS in 2011 with 900,000 of
these in western and central Europe and 1.4 million in North America.
UNICEF, UNAIDS, and the World Health Organization (WHO) reported in 2013
that the number of people receiving ART has tripled in five years to
approximately 10 million people. A substantial effort is underway to
reach a global target of 15 million people receiving ART by the end of
2015.
At present, commonly-used products for the treatment of HIV-related
lipoatrophy include dermal fillers or products that trigger fibrotic
reactions which create fibrous tissue that has an effect of bulking the
skin, but not a restoration of natural subcutaneous fat with its
associated texture and appearance. A full course of treatment of those
products can require multiple injections over a period of several
months. BioTime expects that a single treatment of Renevia with
adipose-derived cells when injected with a small gauge cannula will
result in a reconstitution of normal subcutaneous fat and restoration of
skin contour.
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. 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,TM
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 trades publicly 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. OpRegenTM 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 stock is traded on the NYSE MKT, ticker 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.
Brian Moore, 310-770-0389
bmoore@evcgroup.com
Gregory
Gin, 862-236-0673
ggin@evcgroup.com
Doug Sherk, 415-652-9100
dsherk@evcgroup.com
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