ASTM was your call Joe and I like it!:
*********************************************************************
New Bioreactor Grows Blood Cells
A bioreactor that provides the right environment for bone marrow cells to produce human blood cells has been developed by Aastrom Biosciences Inc., Ann Arbor, Mich., as part of a completed two-year project co-funded by the NIST Advanced Technology Program.
The new technology may provide improved therapies for patients with cancer, AIDS, and genetic blood diseases currently treated with invasive and expensive bone marrow transplants and other newer forms of cell therapy. In the long term, the company's process also may provide a way to supplement the blood donor system.
When the company received its ATP award in 1992 it had about 15 employees and a laboratory process developed at the University of Michigan for growing human stem cells outside the body. (Stem cells are the body's blood cell factories, the producers of white and red blood cells and platelets.) Today, the company has 45 employees, a prototype clinical process capable of growing 100 times as many stem cells, and a $20 million investment commitment from COBE Laboratories to develop the bioreactor into a commercial product.
Aastrom has received patents for its bioreactor system, the first for replicating stem cells. The bioreactor provides an environment that mimics that in the body. About 10 milliliters (half a tablespoon) of a patient's bone marrow cells are placed in the reactor, an automated chamber that circulates nutrients and fluids needed for the stem cells to reproduce. After 12 days, the reactor has produced several billion stem, white, and other blood cells, enough for one transplant. These cells then can be injected into the patient to rapidly boost the body's disease-fighting ability.
Contact: Walter Ogier, (313) 930-5555.
**********************************************************************
Aastrom Biosciences Announces Operational Changes to focus Support on European Product Launch and U.S. Trials
Ann Arbor, Michigan, November 5, 1998 - Aastrom Biosciences, Inc. (Nasdaq: ASTM) announced today operational changes designed to focus the Company's resources on the pending European launch of the AastromReplicellTM Cell Production System (System) and on initiation of U.S. pivotal clinical trials. Aastrom recently obtained approval to affix the CE Mark to the AastromReplicellTM System instrumentation platform, and plans are underway to launch the product in major European markets following production manufacturing.
"To date, Aastrom has been a development-stage company, working to bring our technology to commercialization. We are now at that exciting point in time of initial product launch and the Company must adjust to this new operational challenge. Product launch will require new fiscal and operational support. With recognition of the current restrictive status of the capital market for small-cap healthcare companies, we feel it is important to concentrate all of our current resources on two main objectives: launch of the AastromReplicellTM System and its evaluation in our U.S. pivotal trials," stated R. Douglas Armstrong, Ph.D., President and CEO of Aastrom.
As part of the operational change, certain research and development and associated support areas are being reduced by approximately 19 staff positions, in addition to certain other contract positions, reducing overall operating expenses by approximately 15%. Staff and operations that are required for product manufacturing and support, along with staff to support the Company's current clinical trials will remain, including all current department heads and management team members. Management noted that in addition to a decrease in expenses related to the reorganization, development expenses for the AastromReplicellTM System are expected to decrease as the product approaches market launch. Prior to the reduction, Aastrom employed 87 individuals.
Dr. Armstrong added, "This is a point in our Company's history that is concurrently both one of the saddest and proudest. We are bringing to market a unique and pioneering therapeutic product, yet in order to advance this product into the marketplace, we have to reduce our staffing, for the first time ever, in other areas. We are very appreciative of the contributions that the individuals who are leaving have made to help advance the AastromReplicellTM System toward product launch. This project has required the integration of many different fields of expertise, and we would not have had this level of success without the efforts of each of these individuals."
The AastromReplicellTM System is a clinical system designed to enable care providers to produce cells used for therapeutic procedures. The product is comprised of an instrumentation platform that can operate a family of single-use therapy kits. Clinical trials are underway to test the SC-I Therapy Kit for production of human bone marrow, and the CB-I Therapy Kit for production of human cord blood cells, both for use in stem cell therapy applications. These two kits, along with the AastromReplicellTM System instrumentation platform, are being prepared for launch in Europe and for initiation of U.S. pivotal trials required for submission of a Pre-Market Approval application (PMA) to the FDA.
In addition to the CE Mark approval announcement, the Company has also recently announced the positive progress of two key clinical trials. Results from a multi-center trial, evaluating bone marrow stem cells produced in the SC-I Therapy Kit, demonstrated that cells enabled desired engraftment recovery rates when used with a low, and otherwise sub-therapeutic, dose of peripheral blood stem cells (PBSC). The process enabled as much as a 10-fold reduction in the PBSC dose required, which subsequently would reduce the 5 to 25 hour invasive procedure time otherwise required. A separate trial, evaluating the CB-1 Therapy Kit used with the AastromReplicellTM System to produce supplemental cord blood cells for donor sourced ("allogeneic") stem cell transplants, is also underway. This pediatric trial was recently expanded following positive results in the pilot phase, which showed safety and favorable 100-day survival rates of the patients receiving AastromReplicellTM System-produced cells.
Aastrom Biosciences, Inc. is pioneering the development of proprietary clinical systems including the AastromReplicellTM System, a first of its kind product, to enable physicians and patients greater accessibility to cells used for therapy. The AastromReplicellTM 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 AastromReplicellTM System is an experimental device under development, and is not available for sale at this time.
This document contains forward-looking statements, including without limitation, statements concerning product development objectives, clinical trial results, commercial introduction, and potential advantages of the AastromReplicellTM 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.
# # #
Contact:
Todd E. Simpson
VP Finance and Administration, CFO
Aastrom Biosciences, Inc.
phone: 734-930-5777
Investor & Media Contacts:
Francesca T. DeVellis
Feinstein Kean Partners Inc.
phone: 617-577-8110
Please visit our website at www.aastrom.com |
