Aastrom Biosciences Appoints Dr. LaVonne Lang as Head of Regulatory Affairs
ANN ARBOR, Mich., March 14, 2012 (GLOBE NEWSWIRE) -- 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.
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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.
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