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Biotech / Medical : ASTM-AASTROM BIOSCIENCES: STEM CELL RESEARCH -- Ignore unavailable to you. Want to Upgrade?

To: Probart who wrote (533)	2/2/1999 8:51:00 AM
From: Hope	Read Replies (1) \| Respond to of 1084

Aastrom Biosciences Announces CE Mark Approval For Cord Blood Therapy Kit -- Cord Blood Transplantation Offers New Therapy Options for Patients with Cancer and Other Diseases-- ANN ARBOR, Mich., Feb. 2 /PRNewswire/ -- Aastrom Biosciences, Inc. (Nasdaq: ASTM - news), today announced that it has obtained approval to affix the CE Mark to the final components of the AastromReplicell(TM) Cell Production System (System) CB-I Therapy Kit for the production of cord blood cells used in stem cell therapy. This announcement follows earlier approvals received by Aastrom to affix the CE Mark to the AastromReplicell(TM) System instrumentation platform and SC-I therapy kit for the production of bone marrow cells used in stem cell therapy. These approvals allow marketing activities to begin for each of these products in the European Community upon Aastrom's final product release. ''This most recent CE Mark approval demonstrates continued and steady progress at the Company to bring the AastromReplicell(TM) System to the market in Europe and to enable new therapy approaches in the treatment of cancer and other diseases,'' said R. Douglas Armstrong, Ph.D., President and Chief Executive Officer of Aastrom. Dr. Armstrong continued, ''Importantly, the regulatory approval provided to the AastromReplicell(TM) System may set a standard for the way cell therapy applications are regulated in Europe. This regulatory process is directed at the manner in which the cells are manufactured rather than the cells themselves. The therapy-specific kit approach offered by the AastromReplicell(TM) System not only enables hospitals to have access to needed cells, but also provides both a standardized mechanism and increased reliability for different treatment centers to carry out cell production for a variety of therapies.'' By being able to produce cord blood cells to larger quantities using the AastromReplicell(TM) System, patients with blood cancers and diseases may have a new treatment option when an acceptable bone marrow donor cannot be found, thereby yielding a new therapeutic approach for adult and pediatric patients with otherwise incurable hematologic disorders. Cord blood, which remains in the umbilical cord and placenta after childbirth, is a rich source of stem cells that can be used to restore tissue destroyed by aggressive chemotherapy or radiation therapy used in the treatment of cancer and other diseases. While cord blood is emerging as a promising new source of stem cells for use in therapy, there is unfortunately a limited quantity of cells available from a standard cord blood collection, restricting the effectiveness of cord blood transplants. Low transplantation cell dose is particularly problematic for larger and older patients where cord blood transplantation is generally not attempted. The AastromReplicell(TM) System CB-I Therapy Kit is designed to address this limitation. The Company recently reported positive clinical results at the Annual Meeting of the American Society of Hematology from multi-center trials using the AastromReplicell(TM) System CB-I Therapy Kit to produce cord blood cells used in the treatment of patients with cancer and other blood diseases. The AastromReplicell(TM) System consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits for a broad range of cell therapy applications. In addition to the currently used stem cell therapies, many emerging cell therapies are being developed at academic centers and other companies. The AastromReplicell(TM) System, an automated clinical system designed for the production of therapeutic cells from small starting quantities, is designed to enable the transition of these laboratory procedures to a standard medical treatment. Once established for use in stem cell therapy, Aastrom plans to leverage the cell manufacturing capabilities of the AastromReplicell(TM) System across multiple cell therapy opportunities by providing a commercialization outlet for these therapies through the AastromReplicell(TM) System product line. 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.