ANN ARBOR, Mich., May 21 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (NasdaqSC: ASTM) today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) Grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health (NIH). The $101,000 grant, entitled Clinical Human Cell Production System for Broad Use, supports the initial development phase for a new system that is intended to enable the production of a variety of primary human cell types. The new system will incorporate components of Aastrom''s existing proprietary technologies in cell production processes and devices, and is intended to meet cell production needs for early clinical stage cell therapies at sites where the full production capabilities of the AastromReplicell(TM) System are not yet needed. It is expected that researchers and investigators may choose to use the new broad-use system as the transition from manual "flask-culturing" of cells, and then move to the AastromReplicell(TM) System for fully-automated cell culturing.
The need for this capability was underscored by NIH reviewers of the project who stated, " ... the product to be developed is a technically innovative tool that is urgently needed to facilitate development of many different cellular therapies ... this is an innovative approach to a problem that has existed for a long time and has remained unsolved ... availability of this type of tool should drive a variety of potential cellular therapies from the research laboratory into the marketplace."
The exploration and use of human cells produced outside of the body in cell culture for the treatment of a variety of medical problems is increasing in both the number and diversity of approaches. Research in this field has progressed from learning how to grow desired human cells, such as stem cells or cells of the immune system, to the present need of producing these cells on a high-quality, clinical scale.
Aastrom is a leader in this field, having previously developed the AastromReplicell(TM) System, an automated cell production platform designed for commercial production of designated cell products. The AastromReplicell(TM) System is used by the Company for the production of its proprietary therapeutic cell products, and is also being marketed and sold to researchers and companies for the production of their cells for clinical trials in Europe and the United States.
"This grant enables Aastrom to increase our ability to incorporate our technology, including our patented single-pass perfusion (SPP), into a wider number of cell therapy applications, and more readily move new therapeutic cells into clinical evaluation," said Brian Hampson, Vice President Product Development of Aastrom, and Principal Investigator of the study. "Once proven useful in a clinical indication, we can transfer the process to the AastromReplicell(TM) System for global medical use. By leveraging patented technologies already proven in the AastromReplicell(TM) System, we believe we are providing a strong foundation for a successful outcome to the study."
Aastrom''s SPP technology has been proven as an effective culture process for primary human cell production and will be incorporated into the new system, along with key elements of the closed-system automation technology developed for the AastromReplicell(TM) System. The new system is intended for the production of almost any cell type, offering investigators wide flexibility in the development of their cell therapies for clinical use. By providing a flexible development capability, the new system should facilitate a broader range of collaborations and development activities for new Aastrom cell products.
The success of Phase I of this new broad-use cell production system may enable Aastrom to offer the system to researchers and investigators, as well as its own scientific partners, for use in further clinical trials. If this should happen, Aastrom would be able to pursue Phase II and III grant awards. In addition, the validation of this new system would extend Aastrom''s Cell Production Products (CPP) business line.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a late-stage development company focused on human cell-based therapies. The AastromReplicell(TM) System - a patented, integrated system of instrumentation and single-use consumable kits for the production of patient-specific cells - is the Company''s core technology for its Prescription Cell Products (PCP) business and its Cell Production Products (CPP) business. The principal focus of the PCP business is the repair or regeneration of tissue intended for large markets such as bone grafting and severe osteoporosis. The CPP business markets the AastromReplicell(TM) System to researchers and companies for their production of cells for clinical trials. These two businesses are intended to enable Aastrom to generate multiple paths to revenue. The initial commercial phase of the CPP business for dendritic cell production products is underway in Europe and the United States. For more information, visit Aastrom''s website at www.aastrom.com/.
This document contains forward-looking statements, including without limitation, statements concerning product development objectives, potential product applications, future collaborative activities, and potential advantages of Aastrom''s technology, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "expected," "intended," "potential," "may," "should," "can," "believe," "would," 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 product development difficulties, 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 or Becky Anderson Investor Relations Department Aastrom Biosciences, Inc. Phone: (734) 930-5777
Aastrom Biosciences, Inc.
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The need for this capability was underscored by NIH reviewers of the project who stated, " ... the product to be developed is a technically innovative tool that is urgently needed to facilitate development of many different cellular therapies ... this is an innovative approach to a problem that has existed for a long time and has remained unsolved ... availability of this type of tool should drive a variety of potential cellular therapies from the research laboratory into the marketplace."
The exploration and use of human cells produced outside of the body in cell culture for the treatment of a variety of medical problems is increasing in both the number and diversity of approaches. Research in this field has progressed from learning how to grow desired human cells, such as stem cells or cells of the immune system, to the present need of producing these cells on a high-quality, clinical scale.
Aastrom is a leader in this field, having previously developed the AastromReplicell(TM) System, an automated cell production platform designed for commercial production of designated cell products. The AastromReplicell(TM) System is used by the Company for the production of its proprietary therapeutic cell products, and is also being marketed and sold to researchers and companies for the production of their cells for clinical trials in Europe and the United States.
"This grant enables Aastrom to increase our ability to incorporate our technology, including our patented single-pass perfusion (SPP), into a wider number of cell therapy applications, and more readily move new therapeutic cells into clinical evaluation," said Brian Hampson, Vice President Product Development of Aastrom, and Principal Investigator of the study. "Once proven useful in a clinical indication, we can transfer the process to the AastromReplicell(TM) System for global medical use. By leveraging patented technologies already proven in the AastromReplicell(TM) System, we believe we are providing a strong foundation for a successful outcome to the study."
Aastrom''s SPP technology has been proven as an effective culture process for primary human cell production and will be incorporated into the new system, along with key elements of the closed-system automation technology developed for the AastromReplicell(TM) System. The new system is intended for the production of almost any cell type, offering investigators wide flexibility in the development of their cell therapies for clinical use. By providing a flexible development capability, the new system should facilitate a broader range of collaborations and development activities for new Aastrom cell products.
The success of Phase I of this new broad-use cell production system may enable Aastrom to offer the system to researchers and investigators, as well as its own scientific partners, for use in further clinical trials. If this should happen, Aastrom would be able to pursue Phase II and III grant awards. In addition, the validation of this new system would extend Aastrom''s Cell Production Products (CPP) business line.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a late-stage development company focused on human cell-based therapies. The AastromReplicell(TM) System - a patented, integrated system of instrumentation and single-use consumable kits for the production of patient-specific cells - is the Company''s core technology for its Prescription Cell Products (PCP) business and its Cell Production Products (CPP) business. The principal focus of the PCP business is the repair or regeneration of tissue intended for large markets such as bone grafting and severe osteoporosis. The CPP business markets the AastromReplicell(TM) System to researchers and companies for their production of cells for clinical trials. These two businesses are intended to enable Aastrom to generate multiple paths to revenue. The initial commercial phase of the CPP business for dendritic cell production products is underway in Europe and the United States. For more information, visit Aastrom''s website at www.aastrom.com/.
This document contains forward-looking statements, including without limitation, statements concerning product development objectives, potential product applications, future collaborative activities, and potential advantages of Aastrom''s technology, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "expected," "intended," "potential," "may," "should," "can," "believe," "would," 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 product development difficulties, 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 or Becky Anderson Investor Relations Department Aastrom Biosciences, Inc. Phone: (734) 930-5777
Aastrom Biosciences, Inc.
© PR Newswire
