Cleveland, OH, February 27, 2007 - Athersys, Inc. has announced that it has successfully produced a clinical grade master cell bank and initial product doses intended to support its clinical trial activity in 2007 and 2008. The master cell bank and dose production runs were completed under Good Manufacturing Practices (GMP) by Lonza, a leading contract manufacturer of biopharmaceuticals headquartered in Basel, Switzerland.
MultiStem(R) is a multipotent adult progenitor cell (MAPC)-based product manufactured under Athersys' specifications and release criteria. MultiStem(R) are stem cells isolated from the bone marrow and other non-embryonic tissue sources that have the potential to develop into a range of cell types and can be expanded extensively ex vivo while retaining their potency. Dr. Catherine Verfaillie and her colleagues initially discovered and characterized these stem cells, as described in a series of publications in leading scientific journals. Since then, a growing number of labs around the world have isolated and characterized non-embryonic stem cells that display the fundamental properties described by Dr. Verfaillie and her colleagues.
"We view GMP production as an important milestone for Athersys, and for the advancement of MAPC-based products in the clinic," said BJ Lehmann, President and Chief Operating Officer at Athersys. "This achievement further demonstrates that we can readily transfer the cell isolation and production processes to third parties. Additionally, we believe that our master cell bank gives us the potential to manufacture hundreds of thousands or more MultiStem(R) doses from a single donor, enabling us to advance multiple programs into clinical development, and treat patients with a variety of conditions."
Athersys engaged Lonza to assist it in the scale-up and manufacturing of its clinical grade product, using Athersys's production processes. "We are excited about this relationship and our role in supporting Athersys's entry into the clinic with its MultiStem(R) product," said David Smith, Vice President, Cell Therapy Bioservices at Lonza. "Athersys's production process has proven to be robust and scalable, providing a strong foundation for conducting clinical development."
Athersys has completed multiple animal studies demonstrating that MultiStem(R) can be safely infused and provides significant benefit in a number of disease models. "Based on the pre-clinical results, we are very enthusiastic about the use of MultiStem(R) to treat patients suffering heart attacks or other ischemic injuries, such as stroke, and to support recovery following bone marrow transplantation," said Robert Deans, Ph.D., Senior Vice President of Regenerative Medicine at Athersys. "Pending the completion of final safety studies, our intention is to file INDs for the initiation of phase I clinical trials testing MultiStem(R) in several indications."
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. Through the application of its proprietary technologies, it has established a pipeline of therapeutic product development programs in multiple disease areas. Athersys' lead product candidate, ATHX-105, a highly selective agonist of the serotonin receptor 5HT2c, a validated molecular target located in the region of the brain that regulates appetite and food intake. Compounds acting on this target have been shown to reduce appetite and result in weight loss in animal models and humans. In addition to its lead product candidate, the company is developing novel pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary capabilities and technologies including Random Activation of Gene Expression (RAGE).
Athersys is developing MultiStem(R) to treat patients for certain cardiovascular disorders, stroke, bone marrow transplantation and oncology support, as well as other disease indications. MultiStem(R) is a patented stem cell product that is based on a special class of adult-derived stem cells known as Multipotent Adult Progenitor Cells (MAPC). Unlike most other adult stem cell types, these cells have a demonstrated ability to form a broad range of cell types, contributing to a range of tissues. In addition, the cells may be isolated from the bone marrow and other non-embryonic tissue sources, can be routinely expanded to create large product inventories, and are being developed for off-the-shelf treatment of patients. Athersys is a founding member of the Center for Stem Cell and Regenerative Medicine based in Cleveland, Ohio, with the Cleveland Clinic, University Hospitals and Case Western Reserve University.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of pharmaceutical active ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also a leading provider of value added chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SWX Swiss Exchange. In 2006 Lonza had sales of CHF 2.91 billion. Further information can be found at www.lonza.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the possibility of delays in, adverse results of, and excessive costs of the development process; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 361-9495
Tel: (201) 316-9413
Fax: (201) 696-3533
Mobile: (845) 270-0548