Aastrom Treats Patients in Adult Stem Cell Clinical Trial for Osteonecrosis
18 January 2007 - 5:07AM
PR Newswire (US)
- Pivotal Bone Regeneration Trial Underway in Spain - ANN ARBOR,
Mich., Jan. 17 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM), a company focused on the use of autologous cells for
regenerative medicine, today announced that the first two patients
have been treated in a pivotal clinical trial utilizing the
Company's Tissue Repair Cells (TRCs) for the treatment of
osteonecrosis (also known as avascular necrosis) of the femoral
head. The pivotal trial sponsored by Aastrom is being conducted at
Centro Medico Teknon (Teknon) located in Barcelona, Spain. Aastrom
initiated patient enrollment and treatment after receiving written
approval from the Spanish Drug Agency (AEMPS) and Teknon's Ethics
Committee for the Company's Investigational Medicinal Product
Dossier (IMPD). (Logo:
http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO ) "The
initiation of this osteonecrosis clinical trial in Spain is an
integral step for our overall bone regeneration program," said
George Dunbar, Chief Executive Officer and President of Aastrom.
"If successful, the patient data from this pivotal trial will
support future registration applications submitted to the
regulatory authorities in the EU, as well as to the FDA in the
U.S." This is Aastrom's first pivotal study evaluating the
Company's TRC stem cell therapy in patients with osteonecrosis of
the femoral head. Initially, ten patients will be accrued into this
trial at Teknon and treated by Principal Investigator, Dr. Lluis
Orozco and Co-Investigators, Dr. Robert Soler-Rich and Dr. Carles
Solano. In general terms, the expected treatment approach will
include the removal of the necrotic tissue from the interior of the
patient's femoral head (top of the femur), followed by the
implantation of TRCs. The expectation is that if the femoral head
is strengthened by the re- growth of healthy bone, marrow and
vascular tissue, the need for a hip replacement could be delayed or
eliminated for patients suffering from this disease. The primary
efficacy endpoint of this trial is to eliminate or delay the
progression of osteonecrosis, which will be measured by MRI and
X-ray. Patients will be followed for a total of 24 months, post
treatment. "The experience we acquired using the TRC cell product
in prior studies of atrophic non-union long bone fractures gave us
the confidence to apply the TRC technology to patients with
osteonecrosis. We hope to demonstrate significant efficacy over
existing therapies," said Dr. Llu�s Orozco, Scientific Director,
Orthopedics, of Institut de Terapia Regenerativa Tisular. The
tissues involved in the osteonecrosis disease process include bone,
bone marrow and blood vessels (vascular), complicating the
development of effective treatments in the past. Aastrom's TRCs, a
proprietary mixture of stem and progenitor cells derived from a
small sample of the patient's own bone marrow, have been used in
separate clinical trials to regenerate all three of these tissues.
With this capability, TRCs may offer a novel means to regenerate
the tissues lost due to osteonecrosis. In 2006, Aastrom's
proprietary TRCs received an Orphan Drug Designation from the U.S.
Food and Drug Administration (FDA) for use in the treatment of
osteonecrosis of the femoral head. Aastrom is preparing a protocol
for a U.S. pivotal osteonecrosis clinical trial with the FDA. About
Osteonecrosis The National Osteonecrosis Foundation indicates that
in the U.S. alone, there are up to 20,000 new people diagnosed with
this debilitating disease each year, and current therapies are of
limited effectiveness. Osteonecrosis is a painful medical condition
where the tissue inside a bone is dying and unable to regenerate
itself through natural processes. Ninety percent of the patients
afflicted by this disease have osteonecrosis at the femoral head --
the ball at the top of the femur bone that rotates inside the hip
socket. Left untreated the femoral head eventually collapses,
leading to the requirement of a total hip joint replacement. In the
U.S., it is estimated that up to 10% of all hip replacements are
performed due to osteonecrosis. There are no established
pharmaceuticals for the prevention or treatment of osteonecrosis.
For more information, visit the National Osteonecrosis Foundation's
website at http://www.nonf.org/. About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. is developing autologous cell products
for the repair or regeneration of multiple human tissues, based on
its proprietary Tissue Repair Cell (TRC) technology. Aastrom's
TRC-based products are a unique cell mixture containing stem and
progenitor cell populations, produced from a small amount of bone
marrow taken from the patient. TRC-based products have been used in
over 230 patients, and are currently in clinical trials for bone
regeneration (osteonecrosis of the femoral head, long bone
fractures and spine fusion) and vascular regeneration (critical
limb ischemia) applications. Aastrom has reported positive interim
clinical trial results for TRCs suggesting both the clinical safety
and the ability of TRCs to promote healing in bone regeneration
applications. The Company is developing plans for TRC- based
therapies to address cardiac and neural regeneration indications.
For more information, visit Aastrom's website at
http://www.aastrom.com/. (astmc) This document contains
forward-looking statements, including without limitation,
statements concerning planned clinical trials, product development
objectives, potential advantages of TRCs, and potential product
applications, which involve certain risks and uncertainties. The
forward-looking statements are also identified through use of the
words "expected," "should," and other words of similar meaning.
Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that
may result in differences are potential patient accrual
difficulties, clinical trial results, potential product development
difficulties, the effects of competitive therapies, regulatory
approval requirements, the availability of financial and other
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 and other filings
with the Securities and Exchange Commission. CONTACTS: Kris M. Maly
Cameron Associates Investor Relations Department Kevin McGrath
Aastrom Biosciences, Inc. Phone: (212) 245-4577 Phone: (734)
930-5777 Deanne Eagle (Media) Phone: (212) 554-5463
http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department of Aastrom
Biosciences, Inc., +1-734-930-5777; or Kevin McGrath,
+1-212-245-4577, or Media, Deanne Eagle, +1-212-554-5463, both of
Cameron Associates, for Aastrom Biosciences, Inc. Web site:
http://www.aastrom.com/ http://www.nonf.org/
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