Aastrom Biosciences Awarded NIH Grant to Support Cord Blood Transplant Program
To Date, Company Has Received Nearly $1 Million in NIH Grant Awards For
Advancements in Cord Blood Therapy
ANN ARBOR, Mich., March 8 /PRNewswire/ -- Aastrom Biosciences, Inc. (Nasdaq: ASTM) announced today that it was awarded a grant providing funding of up to $105,000 over a six-month period to support further development of the AastromReplicell(TM) Cell Production System (System) to produce umbilical cord blood (UCB) derived cells used in stem cell transplantation. The Phase I Small Business Innovation and Research (SBIR) grant is from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH). Aastrom will collaborate with investigators at Duke University Medical Center (Duke) to perform this research.
"Aastrom continues to receive substantial funding support from the NIH for this program reflecting the clinical need for efficient, reliable and cost- effective access to cord blood cells to treat patients who require a stem cell transplant," said R. Douglas Armstrong, Ph.D., President and CEO of Aastrom. Dr. Armstrong continued, "Use of cord blood in the transplant setting has demonstrated that clinical outcome appears to be linked to transplantation cell dose. By increasing the number of available cells for transplant using the AastromReplicell(TM) System, we hope to improve recoveries in pediatric patients and to enable transplants to occur in adult patients that might not otherwise be transplant candidates."
The AastromReplicell(TM) System is a clinical system that consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits for a broad range of cell therapy applications. Aastrom recently announced the receipt of approval to affix the CE Mark to the AastromReplicell(TM) System instrumentation platform, the CB-I Therapy Kit for the production of cord blood cells and the SC-I Therapy Kit for the production of bone marrow stem cells. CE Mark approval is necessary for commercialization of the product line in Europe. Aastrom is now completing its final product release procedures and is working with transplant physicians in preparation for European product launch.
Research to be performed under this grant will evaluate conditions for stromal cells to serve as "feeder cells" in cord blood expansions. These feeder cells have been shown by the Company to enable the production of stem cells in bone marrow cultures. Under this program, scientists at Aastrom and Duke will evaluate how cord blood cells interact with bone marrow or placental tissue derived stromal cells added to the culture to increase overall expansion productivity. Research will also be performed to evaluate the addition of exogenous growth factors to these cultures to further augment expansion results.
Dr. Alan K. Smith, Vice President Research at Aastrom, commented, "By understanding the interactions between cord blood cells, stromal feeder cells and various endogenous and exogenous growth factors, we hope to develop methods of increasing the proliferative capabilities of our cord blood cell cultures. This may have broad clinical benefit by being able to provide greater numbers of cells in a transplant setting."
Umbilical cord blood, which remains in the umbilical cord and the placenta after childbirth, contains high concentrations of stem cells that can be used to restore tissue destroyed by aggressive chemotherapy or radiation therapy and represents a viable alternative to traditional stem cell collection procedures. This new technique may overcome the problem of transplant incompatibility, as donor tissue matching for transplants is comparatively easier for umbilical cord blood than for bone marrow derived stem cells. Due to the relatively small number of cells available from a standard collection, cord blood stem cell transplants have been used primarily in smaller patients, and recovery times are often long. The AastromReplicell(TM) System, an automated system that enables the production of larger quantities of cells from small starting samples, is being evaluated to alleviate this cell dose limitation, increasing the number of patients who may benefit from UCB transplantation. The growing UCB banking infrastructure, together with the expansion capabilities of the AastromReplicell(TM) System, should expand the use of cord blood transplantation in patients with cancers, leukemias and other blood diseases such as Wiskott-Aldrich Syndrome, Congenital Immunodeficiency Syndrome and Fanconi's Anemia.
Aastrom Biosciences, Inc. is pioneering the development of proprietary clinical systems including the AastromReplicell(TM) System, a first of its kind product, to enable physicians and patients greater accessibility to cells used for therapy. The AastromReplicell(TM) System product line consists of an instrumentation platform that can operate a growing number of patient-specific therapy kits tailored to each cell therapy application. Aastrom has received patents covering methods and devices for the ex vivo production of human stem and other types of cells, as well as for the genetic modification of stem cells. The AastromReplicell(TM) System is under development, and is not available for sale at this time in the U.S.
This document contains forward-looking statements, including without limitation, statements concerning product development objectives, clinical trial results, commercial introduction, and potential advantages of the AastromReplicell(TM) System, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "anticipates," "believes," "expects," "plans," 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 the results obtained from clinical trial and development activities, regulatory approval requirements, the availability of resources and the degree to which the Company's products achieve market acceptance. These and other significant factors are discussed in greater detail in Aastrom's Annual Report on Form-10K and other filings with the Securities and Exchange Commission.
SOURCE Aastrom Biosciences, Inc.
CO: Aastrom Biosciences, Inc.
ST: Massachusetts
IN: MTC
SU:
03/08/99 08:29 EST prnewswire.com
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