Curis Receives Approval to Start Phase 1 Clinical Trial of Cur-61414 for Treatment of Sporadic Basal Cell Carcinoma.

Business/Science Editors

CAMBRIDGE, Mass.--(BW HealthWire)--Sept. 5, 2001

-New Therapeutic Approach Offers Patients an Alternative to Surgery-

Curis, Inc. (NASDAQ: CRIS) today announced a Phase 1 Open-Label, Sequential Dose-Escalation Study of Intralesional Injection (inside the tumor itself) of Cur-61414 in Patients with Sporadic Basal Cell Carcinoma, the most common form of skin cancer.

Cancer of the skin (including melanoma and non-melanoma) accounts for nearly half of all cancers in the United States. Approximately 1.3 million patients are diagnosed with non-melanoma skin cancer annually, with Basal Cell Carcinoma (BCC) accounting for 75 percent of cases. BCC is a slow-growing tumor that rarely metastasizes, and the relative 5-year survival rate is greater than 99%. BCC occurs primarily in Caucasians, frequently in individuals 40 years or older, with slightly higher frequency in males.

According to Doros Platika, MD, Curis, Inc. President and CEO, "Although surgical treatment is essentially curative, significant scarring and even disfigurement may occur with the removal of large lesions, multiple lesions and lesions in cosmetically sensitive areas such as the face. Therefore, a therapy with a similar cure rate that provides a tissue-sparing alternative to surgery is highly desirable."

Dr. Platika added, "Recent molecular and genetic studies have demonstrated that virtually all human BCC tumors carry mutations in genes involved in the Hedgehog pathway, resulting in the aberrant activation of this pathway and abnormal cell growth. Cur-61414 is a small molecule that inhibits the Hedgehog pathway, which is being developed as a locally-administered therapy and tissue-sparing alternative to surgery for BCC."

About Curis, Inc.

Curis, Inc. is developing products that sustain health through regenerative medicine. The Company utilizes technologies and insights gained through the study of developmental biology to facilitate the discovery and development of new approaches to repair and regeneration of tissues and organs damaged by disease and/or trauma. Through these discoveries, the Company has developed a pipeline of promising new therapies for the treatment of major diseases, including neurological disorders, diabetes, oncology, cardiovascular and renal disease.

The Curis technology platform and product development pipeline is based on developmental biology signaling pathways, adult stem cells, and cell-based therapies. Curis Research is conducted both internally and through alliances, partnerships and joint ventures with companies and organizations including Aegera Therapeutics and McGill University, Montreal, Canada; Micromet AG, Munich, Germany; and Elan Corporation, Dublin, Ireland.

For more information, please visit the Curis web site at www.curis.com.

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, and other risks and uncertainties associated with the biotechnology industry. For additional factors that could cause actual results to differ materially, please refer to the risk factors section of the Curis Annual Report on Form 10-k for the year ended December 31,2000 with the Securities and Exchange Commission on March 30, 2001. The forward-looking statements contained herein represent the judgment of Curis, as of the date of this release, and Curis disclaims any intent or obligation to update such forward-looking statements to reflect any change in Curis' expectations with regard thereto or any change in events, conditions, circumstances on which such statements are based.