ASTM news,
Aastrom Biosciences Completes Second CE Marked Dendritic Cell Therapy Product
- Product to Provide Foothold in Novel Cancer Therapy Field -
ANN ARBOR, Mich., Feb. 14 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (Nasdaq: ASTM), announced today that it obtained approval to affix the CE Mark to the new DCV-I Cell Therapy Kit (DCV-I), permitting its marketing and sale in Europe. The DCV-I product provides the automated, GMP-compliant production of a complete antigen-loaded dendritic cell vaccine, based on Aastrom's proprietary cultured dendritic cell, the Dendricell(TM). The DCV-I joins the Company's lead dendritic cell product, the DC-I, in providing a unique business capability for cell-based vaccines that are being broadly investigated for the treatment of certain cancers.
The DCV-I product will be immediately available through commercial relationships to clinical investigators and companies active in dendritic cell vaccine research and development. Zellera AG, Aastrom's German subsidiary, will lead the sales and marketing efforts in Europe, while Aastrom directs commercial activity in the U.S. In addition to expanding the Company's new product base, this recent milestone enables Aastrom to formally initiate its own clinical vaccine program using soluble antigens. With this progress, the Company also announced today that it is planning its first clinical studies with DCV-I based vaccines.
"While there are numerous antigen approaches being explored to create vaccines, all require a highly active dendritic cell produced under conditions required by regulatory authorities," said R. Douglas Armstrong, Ph.D., President and Chief Executive Officer of Aastrom. "The DCV-I and DC-I products specifically address this market need, and may be used in virtually all cultured dendritic cell vaccine approaches. These two products give Aastrom an important strategic position in the field as both a commercial enabler and a developer of cell-based vaccines."
Dendritic cells are found in the skin, lymphoid tissues and the blood, and are the most potent antigen-presenting cell serving to initiate an immune reaction. Antigens are biological molecules that combine with dendritic cells. These antigen-loaded dendritic cells "educate" immune system T-cells to recognize antigens on target cells. This approach can be used to form a tumor-specific vaccine, by first producing a specific class of dendritic cells using cell culture, and then loading these cells with antigen that is specific to a patient's tumor. Once administered to cancer patients, these dendritic cell vaccines are intended to work by triggering a T-cell immune system response against the patient's tumor cells. Recent research publications have shown encouraging data and results with these new therapeutic vaccines in renal cell carcinoma, melanoma, prostate and other cancers.
The Dendricell(TM) is produced using the Company's patented single-pass perfusion technology and automation platforms. The DCV-I and DC-I products are both used to produce the Dendricell(TM), and are packaged as single-use kits to be sold and used with the AastromReplicell(TM) System. Aastrom's DCV-I product addresses the majority of current dendritic cell vaccine approaches, by combining the production of cultured dendritic cells with the introduction of soluble tumor antigen in one automated, closed-system biological process. The Company's other CE Marked dendritic cell product, the DC-I, also provides a robust cultured dendritic cell that may then be utilized in a separate mechanical or chemical process to transfer tumor antigens.
About Zellera AG
Zellera AG is a wholly-owned subsidiary of Aastrom Biosciences, Inc., located in Berlin, Germany. Zellera serves as the sales and marketing operational base for Aastrom's products in Europe.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of proprietary cell therapeutic products based on its dual-technology platforms: patented "single-pass perfusion" providing cells with excellent biological function, and patented GMP-compliant system automation facilitating the delivery of cells for therapeutic use into medical practice. These technologies are integrated into the AastromReplicell(TM) System that is designed to uniquely standardize and automate the processes involved in producing high quality therapeutic cells. Aastrom is developing a range of cell therapeutic products, including the Dendricell(TM) products for use in the dendritic cell-based cancer vaccine market, and the OC-I bone progenitor cell production product for the treatment of degenerative bone diseases such as osteoporosis. The AastromReplicell(TM) System, the SC-I bone marrow and the CB-I cord blood cell production products have previously received CE Mark approval necessary for European marketing, and are in late-stage U.S. clinical trials. These products are not available for sale at this time in the U.S., except for research or investigational use. In addition, the DC-I and DCV-I dendritic cell production products have recently received CE Mark approval necessary for European marketing, and are available for sale to the research market in the U.S.
This document contains forward-looking statements, including without limitation, statements regarding product development objectives, planned clinical trials and their results, potential product applications and potential advantages of the AastromReplicell(TM) System and related cell therapy kits, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "intend," "may," "plan," "seek," 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, research activities being conducted by others, regulatory approval requirements, the availability of resources, competitive developments 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 Noonan/Russo Communications, Inc.
Investor Relations Manager Phone: 212-696-4455
Aastrom Biosciences, Inc. Glenn Silver, ext. 271 (media)
Phone: 734-930-5777 David Walsey, ext. 230 (investors)
Holger Beckmann
Managing Director
Zellera AG
Berlin, Germany
Phone: 49-30-2065-9165
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SOURCE Aastrom Biosciences, Inc.
CO: Aastrom Biosciences, Inc.
ST: Michigan
IN: BIO MTC
SU:
02/14/2002 08:04 EST prnewswire.com |
