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Ortec Announces Formation of Stem Cell and Regenerative Medicine
Scientific Advisory Board
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http://www.arizonabiotech.com/
Appoints Noted Stem Cell Expert Daniel Marshak, Ph.D. as
Chairman
NEW YORK, April 24 -- Ortec
International, Inc.
(OTC Bulletin Board: ORTN), a company focused on development and
commercialization of products applicable to regenerative medicine
and stem
cell therapy, today announced the formation of its Stem Cell and
Regenerative Medicine Scientific Advisory Board, focused on
advancing the
clinical development of the Company's newly acquired proprietary
fibrin
derived advanced biomaterial technologies: Fibrin Micro Beads
(FMB's) and
Fibrin based peptides, (Haptides(TM)). FMB's have demonstrated the
ability
to efficiently recover adult stem cells from mixed cell populations
as well
as allow for their growth, proliferation and potential
reimplantation into
the patient, and Haptides(TM) have demonstrated the ability to
enhance cell
attraction and attachment allowing for the potential development of
products for tissue regeneration and cosmetic tissue augmentation.
Daniel
R. Marshak, Ph.D., highly accomplished in the field of stem cell
biology
and human cell research, has been appointed as the Board's Chairman.
Over
the coming months, Ortec expects to expand the Board.
Commenting on the appointment, Ron Lipstein, Vice Chairman and
CEO of
Ortec, stated, "We are quite fortunate that Dr. Marshak has agreed
to chair
our stem cell and regenerative medicine Scientific Advisory Board.
We look
forward to Dr. Marshak's guidance in charting the development and
commercialization pathway for our newly acquired advanced
biomaterials and
in generating products that can make a significant contribution to
stem
cell therapy and regenerative medicine."
Dr. Marshak added, "I am excited to help build Ortec
International's
Stem Cell and Regenerative Medicine Advisory Board, which will play a
guiding and directing role in the clinical development of novel
technology
in biomaterials and stem cells."
From 1994 through 2000, Dr. Marshak was Senior Vice President
and Chief
Scientific Officer for Osiris Therapeutics, Inc., a U.S.
biotechnology
company developing adult stem cell products for the regeneration of
diseased or damaged tissues. From 1986-1995, he was Senior Staff
Investigator at the Cold Spring Harbor Laboratory in Long Island,
New York,
where he and the members of his laboratory conducted research in
signal
transduction, cellular growth control and differentiation.
Concurrent with
that appointment, he was Assistant Professor, School of Medicine,
State
University of New York at Stony Brook, where he taught graduate
biochemistry.
Dr. Marshak currently serves as Vice President and Chief
Technology
Officer, Biotechnology, for Cambrex Corporation (NYSE: CBM), where he
coordinates technology licensing and corporate collaborations in the
biosciences, and participates in strategic planning for the
corporation.
Dr. Marshak joined Cambrex in 2000, and through 2001, led R&D
worldwide for
the Bioscience sector. Cambrex provides products and services in Life
Sciences, with 13 operating sites in the U.S. and Europe and offices
worldwide. Cambrex is a leader in providing human cells, cell
culture media
and reagents, ararose, endotoxin tests and bioassays, contract
production
and other custom services to the pharmaceutical industry and the
biological
research markets. Concurrent with his position at Cambrex, Dr.
Marshak also
holds an appointment as Adjunct Associate Professor at the Johns
Hopkins
University School of Medicine in Baltimore, Maryland.
Dr. Marshak has extensive research experience in the growth
control of
human cells. He has authored more than 100 scientific publications,
including one textbook, and he has been editor of five monographs.
The most
recent monograph, Stem Cell Biology, was published in 2001 by The
Cold
Spring Harbor Laboratory Press. Dr. Marshak is a graduate of Harvard
University where he earned a B.A. in Biochemistry & Molecular
Biology. He
earned his Ph.D. from The Rockefeller University in Biochemistry and
Cell
Biology and conducted postdoctoral research in Pharmacology at
Vanderbilt
University School of Medicine and at the National Institutes of
Health. Dr.
Marshak has received several awards for scientific and academic
achievements, and is an inventor on five issued U.S. patents.
About Ortec International, Inc.
Ortec International, Inc. (ORTN) is a company focused on
advancing
regenerative medicine and stem cell therapy through the development
and
commercialization of innovative products by combining advanced cell
technology and advanced biomaterials. Ortec's lead product is OrCel
(R)
(Bilayered Cellular Matrix). Ortec's current focus is the
application of
OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a
collagen sponge seeded with allogeneic epidermal and dermal cells.
These
cells secrete growth factors and cytokines normally found in acute
human
wounds and are believed to have a beneficial role in promoting tissue
repair.
A pivotal clinical trial evaluating a cryopreserved version of
OrCel(R)
in the treatment of venous leg ulcers has been completed and a Pre
Market
Approval (PMA) application has been filed. Ortec is currently near
completion of patient enrollment in a confirmatory trial as a
clinical
supplement to its PMA filing. Ortec has already obtained FDA
approvals for
use of a non-frozen version of OrCel(R) in the treatment of
Epidermolysis
Bullosa and donor sites in burn patients. In addition, the FDA has
granted
Ortec approval to initiate a pivotal (Phase III) trial evaluating
OrCel(R)
for the treatment of diabetic foot ulcers.
Through its recent merger with Hapto Biotech, Ortec acquired two
fibrin
derived advanced biomaterial technologies, Fibrin Micro Beads
(FMB's) and
Haptides(TM). FBM's have the potential to play a significant role in
advancing stem cell therapy having demonstrated the ability to
efficiently
recover adult stem cells and allow for their growth, proliferation,
and
potential reimplantation into the patient. Haptides(TM) utilize
proprietary
synthetic peptides that mimic the mechanism of cell attachment to
fibrin.
These peptides have demonstrated the ability to significantly
enhance cell
attraction and attachment providing the potential to use Haptides
(TM) in
the development of product opportunities applicable to the cosmetic
tissue
augmentation, wound healing, orthopedics, and drug delivery markets.
For more information, visit Ortec's website at
http://www.ortecinternational.com .
This news release may contain "forward-looking statements" for
the
purposes of the United States Securities and Exchange
Commission's "safe
harbor" provisions under the Private Securities Litigation Reform
Act of
1995 and Rule 3B-6 under The Exchange Act. Without limitation,
statements
regarding expected FDA approvals, clinical trial results, product
performance, expectations with respect to sales, gross margins,
research
and development expenditures, earnings per share, capital
expenditures,
collaborations, or other expansion opportunities would be "forward-
looking
statements." These statements may be identified by words such
as "expects",
"anticipates", "intends", "estimates", "believes" or similar
expressions in
connection with any discussion of future financial and operating
performance. The forward- looking statements contained herein
involve risks
and uncertainties that may cause results to differ materially from
the
Company's expectations including but not limited to, global economic
trends, competitive pricing or product developments, government
legislation
and/or regulations, technology, manufacturing, legal and patent
issues,
suppliers, capital availability, personnel changes, cancellation or
delays
in renewal of contracts, and lack of suitable raw materials or
packaging
materials. Investors are cautioned to review risk factors in the
Company's
filings with the United States Securities and Exchange Commission.
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