Aastrom Biosciences and Neoprobe Corporation Enter Into Cell Therapy Development Agreement; Companies to Co-Develop Proprietary Lymphocyte Therapy for Cancer.Business Editors, Health/Medical Writers DUBLIN, OHIO--(BW HealthWire)--June 5, 2001 Aastrom Biosciences, Inc. (Nasdaq:ASTM ASTM abbr. American Society for Testing and Materials ) and Neoprobe Corporation (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :NEOP NEOP Neoprobe Corporation (stock symbol) NEOP Near Earth Object Program NEOP New England Order of Protection NEOP Nuclear Explosive Operating Procedure ) announced today the initiation of a development collaboration between the two companies for a new immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. cell therapy product to treat cancer. The collaboration will integrate Neoprobe's proprietary lymph node lymph node Small, rounded mass of lymphoid tissue contained in connective tissue. They occur all along lymphatic vessels, with clusters in certain areas (e.g., neck, groin, armpits). lymphocyte (LNL LNL Laboratori Nazionali di Legnaro (Italy) LNL Light and Love LNL Linear Nonlinear Learning ) cell technology with Aastrom's patented AastromReplicell(TM) System and lymphocyte production technologies, with the goal of producing a clinically usable cell therapy product. "We intend to assess whether the AastromReplicell(TM) System can provide a consistent and reliable means to clinically evaluate and commercialize Neoprobe's proprietary activated LNL cell technology as an oncology therapy," stated David Bupp, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Neoprobe. "Upon a successful completion of our assessment, we anticipate incorporating the AastromReplicell(TM) System into Neoprobe's Phase II study for colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . We also intend to evaluate the AastromReplicell(TM) System in conjunction with Neoprobe's cellular therapy programs for breast cancer and to enhance the effectiveness of chemotherapy agents in a variety of cancers. In connection with Neoprobe's development alliance with Cira Ltd., the AastromReplicell(TM) System will also be evaluated in applications to treat viral diseases and immune dysfunction." "Cell-based immunotherapies for cancer treatment are beginning to show promising clinical results," stated R. Douglas Armstrong, Ph.D., President and CEO of Aastrom. "The field is being accelerated by discoveries of specific cell populations, such as Neoprobe's LNL cell technology, that are therapeutically active. What has been missing, is an effective way to produce these cells in a clinical environment, and in a way that retains a high level of biological activity. It is our plan to automate the LNL process on the AastromReplicell(TM) System toward the objective of enabling a more practical delivery of this therapeutic approach into large-scale clinical development and towards standard medical practices." Neoprobe has been developing activated LNL cell therapies to treat breast and colorectal cancer. The proprietary LNL process was evaluated in Phase I/II clinical studies in metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal patients, most of whom had extensive hepatic disease. Despite the advanced nature of their disease, the treated patients had an extended median survival compared to that which normally would have been expected based upon the advanced nature of the patient's disease. In addition, an improved response to standard chemotherapy agents was observed in the treated patients. Aastrom is developing proprietary products and processes intended to meet the critical objectives of providing a high-quality, biologically-active cell product through processes that are compliant with regulatory requirements and made accessible at the point of patient care. The AastromReplicell(TM) System platform is being used by Aastrom to develop several cell therapeutic products that are in various clinical trials and studies, including the SC-I stem cell therapy stem cell therapy Cell therapy Molecular medicine A technology in which a person's own cells–eg, neuronal stem cells are triggered to revert to their primitive embryonic form, then redifferentiate into mature cells of various organs product, the CB-I cord blood cord blood n. Blood present in the umbilical vessels at the time of delivery. cell product, the OC-I bone cell product, and the DC-I dendritic cell dendritic cell n. 1. A cell that has branching processes. 2. Any of the cells in the neural crest of the embryonic ectoderm having extensive processes and developing early as producers of melanin. vaccine product. About Neoprobe Corporation In addition to investigating LNL cell technology as a part of Neoprobe's Activated Cellular Therapy Initiative, Neoprobe manufactures a line of gamma detection systems currently being used for intra-operative lymphatic lymphatic /lym·phat·ic/ (lim-fat´ik) 1. pertaining to lymph or to a lymphatic vessel. 2. a lymphatic vessel. lym·phat·ic adj. mapping (ILM), an emerging standard of care technology for breast cancer and melanoma. ILM begins with a patient being injected at the site of a tumor with a commercially available radioactive tracing agent. The agent is intended to follow the same lymphatic flow as the cancer would if it had metastasized or spread to lymph nodes Lymph nodes Small, bean-shaped masses of tissue scattered along the lymphatic system that act as filters and immune monitors, removing fluids, bacteria, or cancer cells that travel through the lymph system. . The surgeon, using the gamma radiation detection probe, may then identify key (sentinel) lymph nodes to be tested for cancer. Neoprobe has begun the clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of a proprietary agent to be used in ILM procedures. Neoprobe also pioneered the development of a technology called radioimmunoguided surgery (RIGS(R)) to assist in the surgical treatment of colorectal cancer. The RIGS(R) colorectal technology has been optioned to a development entity, NuRigs, Ltd., which was formed to pursue clinical evaluation of the product and receive regulatory clearances to begin marketing the product. About Aastrom Biosciences, Inc. Aastrom is a leader in the development of proprietary cell therapeutics and cell products based on its dual-technology platforms: patented "single-pass perfusion" providing cells with enhanced 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 the DC-I dendritic cell and Dendricell(TM) products for use in the rapidly emerging cancer vaccine market and the OC-I bone progenitor cell product for the treatment of degenerative bone diseases such as osteoporosis. The AastromReplicell(TM) System, the SC-I bone marrow stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. product and the CB-I cord blood cell product have 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. Please visit our websites at www.aastrom.com and www.neoprobe.com This document contains forward-looking statements, including without limitation, statements concerning intended areas of research, product development objectives, anticipated clinical trial results, commercialization plans, potential product applications, and potential advantages of the AastromReplicell(TM) System and various Neoprobe products including LNL cell therapy, which involve risks and uncertainties. The forward-looking statements are also identified through use of the words "intend," "may," "expected," "plan," 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 from expectations are the results obtained from clinical trial and product development activities, regulatory approval requirements, competitive developments, the availability of resources and the allocation of resources allocation of resources Apportionment of productive assets among different uses. The issue of resource allocation arises as societies seek to balance limited resources (capital, labour, land) against the various and often unlimited wants of their members. among different potential uses. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, limited revenues, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distributor(s), uncertainty of market acceptance, competition, limited marketing and manufacturing experience, and other risks detailed in Aastrom's and Neoprobe's Annual Reports on Form-10K and other filings with the Securities and Exchange Commission. Neither company undertakes any obligation to publicly update or revise any forward-looking statements. |
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