Osiris Therapeutics, Inc. Reports U.S. Patent Allowance for the Allogeneic Adult Mesenchymal Stem Cells

Business Editors & Health/Medical Writers

BIOWIRE2K

BALTIMORE, Md.--(BUSINESS WIRE)--Nov. 29, 2001

Osiris Therapeutics, Inc., announced today the allowance of its U.S. patent application covering the use of allogeneic human mesenchymal stem cells (MSCs).

The application protects the use of MSCs for the growth or repair of all connective tissues, including bone, cartilage, muscle, stroma, fat and other tissues. The MSCs may be administered systemically, locally or in a carrier. The cells may further be gene modified to express genetic material of interest.

This allowance follows recent scientific reports demonstrating the MSCs' ability to evade recognition by cells of the immune system, to stably engraft and to differentiate into functional tissues, all without the need for immunosuppressive therapy.

Osiris uses fully mismatched MSCs in its preclinical models to demonstrate the lack of immunogenicity in bone repair in canines and baboons, cardiac repair in swine and rats and meniscal regeneration in goats. Osiris has also shown that allogeneic MSCs may be delivered in multiple doses, from the same or different donors, without immune recognition.

The Osiris business model is based on the donor-derived, "off-the-shelf" adult stem cell product. The traditional patient-derived (autologous) cell therapies are limited in their application due to high production costs, an absolute inability to address acute care indications, restrictions on the donor source based on health or age and numerous logistical complexities.

Osiris believes it has overcome these problems by combining the allogeneic discovery with both the Company's proprietary scalable closed system MSC manufacturing process and cryopreservation for simple product storage for greater than one year, allowing immediate availability at the physician's site.

The same base MSC product is formulated for different indications and delivered by infusion, injection or by implantation on structural matrices to the site of the damaged tissue. This permits substantial development, manufacturing and regulatory efficiencies.

Clinical trials are ongoing in the U.S. and in Europe with MSCs for bone marrow and peripheral blood stem cell transplantation support and in the US for bone regeneration. Phase I clinical trials are anticipated to begin in early 2002 for cardiac regeneration post myocardial infarction and for meniscal repair.

These and other clinical trials will investigate the safety and utility of "off-the-shelf" MSCs.

This patent will extend Osiris' existing comprehensive patent estate, which comprises 27 issued U.S. patents and a substantial number of allowed and pending applications.

Osiris' issued patents cover the field, including the human MSC itself from any starting material, gene-modified MSCs, therapeutic methods, ex vivo differentiation compositions and methods, production and assay reagents.

Osiris Therapeutics, Inc. is a private development stage biotechnology company that develops adult mesenchymal stem cells ("MSCs") for the regeneration of bone marrow stroma, bone, cartilage and heart muscle tissues that have been damaged by injury, aging or degenerative disease. Osiris is also developing adult MSCs as a delivery platform for gene therapy.

The use of the donor-derived "off-the-shelf" product for all clinical indications could make MSC-based cellular therapies a feasible and cost-effective treatment for the acute injury setting as well as for chronic disease states.

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