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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 425
FILED BY CURIS, INC.
PURSUANT TO RULE 425 UNDER THE SECURITIES ACT OF 1933
SUBJECT COMPANY: CURIS, INC.
Date of Report: June 7, 2000
The statements in this press release that are not historical facts are forward-
looking statements that involve risks and uncertainties including, without
limitation, risks associated with the inherent uncertainty of pharmaceutical
research, product development, regulatory approval and commercialization, the
impact of competitive products, patents, patent litigation, product liability,
third party reimbursement, required stockholder approvals and other risks and
uncertainties associated with the biotechnology industry and merger transactions
generally.
Investors and security holders are advised to read the joint proxy
statement/prospectus regarding the business combination transaction referenced
in the foregoing information, when it becomes available, because it will contain
important information. Such joint proxy statement/prospectus has been filed with
the Securities and Exchange Commission by Curis, Inc. Investors and security
holders may obtain a free copy of the joint proxy statement/prospectus and other
documents filed by Curis, Inc. at the Commission's web site at www.sec.gov. The
joint proxy statement/prospectus and such other documents may also be obtained
directly from Curis, Inc., Creative BioMolecules, Inc., Ontogeny, Inc. and
Reprogenesis, Inc.
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Contacts:
Daniel Omstead, Eng. ScD Robert Gottlieb or
President and CEO Michael Mitchell
Reprogenesis, Inc. Feinstein Kean Healthcare
(617) 499-2928 (617) 577-8110
FOR IMMEDIATE RELEASE:
----------------------
Reprogenesis Reports Preclinical Studies in PNAS on Tissue Engineered
Product to Prevent (Re)stenosis
- Vascugel product, nearing clinical trials, will be part of Curis development
portfolio, new regenerative medicine company being formed through merger of
Creative BioMolecules (NASDAQ: CBMI), Reprogenesis and Ontogeny -
Cambridge, MA, June 6, 2000 - Scientists at Reprogenesis, Inc., the
Massachusetts Institute of Technology and Boston University today reported
research supporting the potential use of Vascugel, a perivascular tissue
engineered implant to prevent (re)stenosis (the (re)occlusion of a treated blood
vessel due to smooth muscle cell proliferation) and thrombosis (vessel occlusion
due to the formation of blood clots), thereby enhancing the efficacy of
cardiovascular procedures such as coronary artery bypass surgery and
angioplasty. The study demonstrates that within blood vessels, multiple
biochemical compounds are involved in regulating the processes that lead to
(re)stenosis and thrombosis, and ultimately the need for further vascular
treatment. Results are published in the June 6 issue of the Proceedings of the
National Academy of Sciences (PNAS).
Products based on this tissue engineering approach will become part of the
regenerative medicine pipeline of Curis, Inc., which will be a new public
company formed through an announced merger (pending shareholder approval) of
Reprogenesis, Inc. Creative BioMolecules, Inc. (NASDAQ: CBMI) and Ontogeny, Inc.
Curis plans to begin clinical trials with an initial product, Vascugel, later
this year to prevent stenosis following coronary bypass surgery. Vascugel
consists of endothelial (blood vessel wall) cells in a gelatin-based polymer
matrix designed to be placed around the outside of a blood vessel, where for a
period of weeks it provides a continuous supply of factors to inhibit unwanted
smooth muscle cell proliferation (intimal hyperplasia).
"Normally, endothelial cells regulate blood vessel repair by maintaining a
balance between cell growth promotion and inhibition. However, when
- more -
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Reprogenesis, Inc. PNAS
June 6, 2000
Page 2
patients undergo interventional procedures to repair, remove or bypass blockages
in blood vessels, this balance is disrupted and the blockages can return
rapidly," said Elazer R. Edelman, M.D., Ph.D., Director, Harvard-MIT Biomedical
Engineering Center. "Our studies demonstrate that these regulatory activities
involve a complex interplay of several distinct signals. It is hard to imagine
that a single drug could mimic this level of control and for this reason
cellular implants are a logical means of replicating the normal multiple
signaling environment that can prevent the return of existing or generation of
new blockages."
"The results of this study, along with other published preclinical results, are
a strong validation of the Vascugel approach to managing (re)stenosis," said
Daniel R. Omstead, Eng Sc.D., President and CEO of Reprogenesis. "We expect to
commence Vascugel's Phase I clinical trials in coronary bypass graft patients
later this year. Vascugel is part of a pipeline of several products developed
by Reprogenesis, including a pediatric reflux product, Chondrogel, which is
currently in late-stage clinical development."
Coronary artery disease affects 12.2 million people and is the leading cause of
death in the U.S. Currently there are 1.3 million coronary bypass grafts and
transcatheter procedures in the U.S. each year and approximately 20-40 percent
fail due to (re)stenosis, resulting in annual costs of over $1 billion.
"The use of tissue engineered cells to prevent (re)stenosis could represent an
exceptional opportunity for advancing the value of regenerative medicine," said
Doros Platika, M.D., President and CEO of Ontogeny who will serve as President
and CEO of Curis. "Vascugel will bolster Curis' pipeline of products that
repair and restore function and improve quality of life."
Specifically, the researchers compared the effect of normal endothelial cells in
a matrix to endothelial cells genetically manipulated to produce low levels of a
compound, called perlecan, believed to play a key role in blood vessel repair.
When placed around porcine arteries following an angioplasty procedure, the
normal cells significantly inhibited intimal hyperplasia. The perlecan
deficient cells' ability to prevent intimal hyperplasia was reduced but not
eliminated. In contrast to the normal cells' ability to inhibit injury related
clotting (thrombosis), the perlecan deficient cells were completely ineffective
in preventing occlusive thrombosis.
"Our data reflect that the cooperative action of endothelial cell factors is
necessary to observe inhibition [of intimal hyperplasia]," the authors said.
"These observations could be clinically relevant and may explain why single
endothelial-derived products, aimed at one of the cellular events thought to
- more -
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Reprogenesis, Inc. PNAS
June 6, 2000
Page 3
be involved in either thrombosis or smooth muscle cell proliferation, do not
lead to full control of restenosis."
In addition to Dr. Edelman, authors on the paper included Matthew A. Nugent,
Ph.D. of the Boston University School of Medicine, and Helen M. Nugent, Ph.D.,
Reprogenesis, Senior Scientist. The research is currently supported by the
National Heart, Lung, and Blood Institute and by Reprogenesis through a $2
million Advanced Technology Program (ATP) grant, which was awarded by the
National Institute of Standards and Technology (NIST) to Reprogenesis in 1999.
Curis, Inc. will be a leader in the emerging field of regenerative medicine.
Formed by the merger of three Boston area biotechnology companies, Creative
BioMolecules Inc., (NASDAQ: CBMI), Ontogeny, Inc. and Reprogenesis, Inc., Curis
will combine insight gained through the study of developmental biology with
high-throughput screening capabilities, proteins, cells and biocompatible
materials to enable the development of new regenerative medicine therapies.
Curis' pipeline will include: 1) a product which is currently under regulatory
review in the United States, Europe and Australia; 2) multiple products in late-
stage clinical development; 3) numerous early clinical and advanced preclinical
products; and 4) a discovery engine that combines functional genomics and
developmental biology across multiple medical indications. These products have
the potential to change the way degenerative disease, cancer and other disorders
associated with loss of function are treated. Curis will be a publicly held
company located in Cambridge, Massachusetts. For more information, please visit
the Curis web site at http://www.Curis.com.
Reprogenesis, Inc. develops products for minimally invasive in vivo tissue
augmentation and repair using the Company's proprietary technology, which
presents therapeutic opportunities in a broad range of markets. The Company's
pipeline is represented by products that create structural tissue to augment or
correct anatomical defects, restore physiological function, and repair or
restore anatomical organs. The technology is initially being applied in the
areas of urology, cardiovascular biology, and plastic and reconstructive
surgery.
The statements in this news release that are not historical facts are forward-
looking statements that involve risks and uncertainties including, without
limitation, risks associated with the inherent uncertainty of pharmaceutical
research, product development, regulatory approval and commercialization, the
impact of competitive products, patents, patent litigation, product liability,
third party reimbursement, required stockholder approvals and other risks and
uncertainties associated with the biotechnology industry and
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Reprogenesis, Inc. PNAS
June 6, 2000
Page 4
merger transactions generally. For additional factors that could cause actual
results to differ materially, please refer to the risk factors section of
Creative BioMolecules, Inc.'s Form 10K for the year ended 1999.
Investors and security holders are advised to read the joint proxy
statement/prospectus regarding the business combination transaction referenced
in the foregoing information, because it will contain important information.
Such joint proxy statement/prospectus was filed with the Securities and Exchange
Commission by Curis, Inc. on March 14, 2000, as amended. Investors and security
holders may obtain a free copy of the joint proxy statement/prospectus and other
documents filed by Curis, Inc. at the Commission's web site at www.sec.gov. The
joint proxy statement/prospectus and such other documents may also be obtained
directly from Creative BioMolecules, Inc., Ontogeny, Inc. and Reprogenesis, Inc.
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