Semafore Pharmaceuticals, Inc. Announces Foundation Grant To Support Upcoming Phase I Clinical Trial

INDIANAPOLIS, Dec. 1 /PRNewswire/ -- Semafore Pharmaceuticals, Inc. today announced receipt of a grant from Cancer Treatment Research Foundation (CTRF) that will support all patient-associated costs of Semafore's upcoming Phase I clinical trial for lead PI3K inhibitor, SF1126.

"The Foundation's intent is to accelerate cures for cancer by funding clinical trials based on sound science and the potential to make a positive impact on cancer patients in a short period of time," said Melissa Pontikes, President of CTRF. "We believe that Semafore's first-in-human clinical trial of SF1126 has this potential."

CTRF, founded in 1991, funds peer-reviewed grants to cancer researchers for early stage patient-centered clinical trials. To date, CTRF has awarded over 60 grants totaling more than $15 million to oncology investigators at institutions including MD Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, Dana Farber Cancer Institute and the Mayo Clinic. The one-year $535,000 grant to Semafore is for patient-associated costs. Semafore will fund all other costs associated with the study.

The SF1126 Phase l trial will assess safety and pharmacokinetic and pharmacodynamic parameters in patients with relapsed solid cancers where PI3K and associated PTEN pathways play a potential role. The company also intends to conduct molecular marker and imaging studies to help determine the optimal dosage and biological activity of SF1126. The Principal Investigator for the Phase I trial is Daniel D. Von Hoff, M.D.

"We appreciate that CTRF is taking a leadership role in supporting the SF1126 Phase l solid cancer program," says Dr. Joseph Garlich, President and Chief Scientist of Semafore. "These resources are enabling us to advance SF1126 in clinical development more rapidly than would otherwise have been possible. In addition, we are delighted that noted cancer expert Dr. Von Hoff has signed on as principal investigator of our Phase l program."

Phase I trial Principal Investigator Dr. Daniel Von Hoff is currently Physician-in-Chief and Director of the Clinical Translational Research Division of the Translational Genomics Research Institute (TGen), Clinical Professor of Medicine at the University of Arizona and Chief Science Officer at the Scottsdale Healthcare Research Center. Dr. Von Hoff is a former President of the American Association for Cancer Research, a member of the FDA's Oncology Drugs Advisory Committee and a member of the Board of Scientific Advisors of the National Cancer Institute. Dr. Von Hoff has helped direct more than 250 cancer Phase I clinical trials and has contributed to the successful development and approval of more than 15 marketed cancer drugs.

About SF1126

SF1126 is a small molecule that selectively inhibits PI3K Class IA isoforms and other key members of the PI3K pathway such as DNA-PK and mTOR. Recent advances indicate that these targets play a critical role in the progression of cancer and many groups are searching for effective safe inhibitors of these targets. In preclinical studies, SF1126 has been shown to be a key regulator of many of the processes involved in tumor growth and dissemination. Preclinically, SF1126 inhibits angiogenesis, induces apoptosis, controls upstream and downstream signaling and produces synergistic anti-tumor effects in combination with chemotherapy and radiation. SF1126 has demonstrated promising activity in a variety of preclinical cancer models, including prostate, breast, ovarian, lung, leukemia, multiple myeloma, brain and other cancers.

About Semafore

Semafore is an Indianapolis-based drug discovery and development company focused on small molecule modulators of the PI3 Kinase (PI3K) and PTEN cell signaling pathway, one of the most promising target pathways for multiple disorders, including the company's focus, cancer. Semafore is one of the first biopharmaceutical companies to focus on both PI3K and PTEN and has successfully discovered and is developing a portfolio of drug candidates. The company expects to file an IND for its lead clinical candidate, PI3K inhibitor SF1126, in December of 2006. Semafore has also discovered the first drug-like small molecule PTEN modulators for cancer therapy, cell protection and therapeutic angiogenesis. For more information see the company's website at http://www.semaforepharma.com.

Contacts: Semafore Pharmaceuticals, Inc. Media: Derek A. Small Barbara Lindheim Business Development GendeLLindheim BioCom Partners & Regulatory Affairs (212) 918-4650 (317) 876-3075

Semafore Pharmaceuticals, Inc.

CONTACT: Derek A. Small, Business Development & Regulatory Affairs ofSemafore Pharmaceuticals, Inc., +1-317-876-3075; or Media: Barbara Lindheimof GendeLLindheim BioCom Partners, +1-212-918-4650

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