Aastrom Biosciences Appoints Dr. LaVonne Lang as Head of Regulatory Affairs
March 14 2012 - 8:21AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
announced the appointment of Dr. LaVonne Lang as head of regulatory
affairs.
Most recently, Dr. Lang consulted on various
investigational drugs and biologics for United BioSource
Corporation. Previously, she was a therapeutic area regulatory
lead at Pfizer. She also served as a worldwide regulatory lead for
the CAD/PAD gene therapy development program, and was involved with
various marketed wound care biologic products while at Parke-Davis.
Dr. Lang has over 20 years of industry
experience and holds B.S. degrees in psychology
and nursing, an MPH in environmental
and industrial health with a subspecialty
in toxicology, and a doctorate
in public health policy from the University of
Michigan.
"We are very pleased to have LaVonne join the Aastrom team at an
especially important and exciting time for our company. With
ixmyelocel-T recently advancing into pivotal phase 3 clinical
testing, we are preparing for the final stages of regulatory
review. Her considerable regulatory experience, including
extensive work with the Center for Biologics Evaluation and
Research (CBER), will be a critical resource for us as we continue
to work closely with the FDA and other regulatory agencies to
position ixmyelocel-T for review and approval," said Tim Mayleben,
Aastrom Biosciences president and chief executive officer.
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 to study patients with critical limb
ischemia and a planned 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 or Transition Report on Form 10-K or
10-K/T, 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
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jun 2024 to Jul 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Jul 2023 to Jul 2024