Aastrom Biosciences Announces Appointment of Joyce L. Frey-Vasconcells, Ph.D. to Scientific Advisory Board
30 October 2012 - 7:05AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
announced that cell therapy regulatory and development expert Joyce
L. Frey-Vasconcells, Ph.D. has been appointed to the company's
Scientific Advisory Board (SAB). Dr. Frey-Vasconcells is considered
one of the foremost regulatory experts for cell therapies, tissues
and gene therapies.
Dr. Frey-Vasconcells is founder and president of
Frey-Vasconcells Consulting LLC and previously served as a
regulatory consultant for Pharmanet where she advised on the
development of multiple cell therapy, gene therapy, tissue and
tissue engineered products. Prior to joining Pharmanet, Dr.
Frey-Vasconcells spent more than 12 years at the FDA as deputy
director, Office of Cellular, Tissue, and Gene Therapies (OCTGT)
with the Center for Biologics Evaluation and Research (CBER). In
2001, Dr. Frey-Vasconcells was named the Regulatory Expert for Cell
Therapies at FDA.
"We are honored to have Dr. Frey-Vasconcells join as a member of
our SAB as our team advances ixmyelocel-T through the final stages
of development and regulatory review. Her broad range of scientific
and regulatory experience, including expertise derived from her
work at the Office of Cellular, Tissue and Gene Therapies, will be
an invaluable resource for us," said Tim Mayleben, Aastrom's
president and chief executive officer.
"I am very pleased to welcome Dr. Frey-Vasconcells to the
Aastrom SAB and am grateful for the opportunity to work with her to
advance Aastrom's clinical programs. Her senior-level insight and
wealth of experience working with a variety of biologics products
will make a positive addition to our board," said Daniel R.
Salomon, M.D., chairman of Aastrom's SAB and program medical
director, Scripps Center for Organ Transplantation.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular
diseases. The company's proprietary cell-processing technology
enables the manufacture of ixmyelocel-T, a patient-specific
multicellular therapy expanded from a patient's own bone marrow and
delivered directly to damaged tissues. Aastrom has advanced
ixmyelocel-T into late-stage clinical development, including a
Phase 3 clinical program studying patients with critical limb
ischemia and a Phase 2b clinical trial in patients with ischemic
dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com. For more information on
the pivotal REVIVE Phase 3 clinical trial, please visit the trial
website at www.revivecli.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, all of which involve certain risks and
uncertainties. These statements are often, but are not always, made
through the use of words or phrases such as "anticipates,"
"intends," "estimates," "plans," "expects," "we believe," "we
intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could,"
"may," or similar expressions. Actual results may differ
significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with clinical
trial and product development activities, regulatory approval
requirements, competitive developments, and the availability of
resources and the allocation of resources among different potential
uses. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q and other filings with the Securities and Exchange
Commission. These forward-looking statements reflect management's
current views and Aastrom does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
CONTACT: Media contact
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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