Semafore Pharmaceuticals, Inc. Presents New Data Supporting Advancement Of Its Targeted PI3K Inhibitor SF1126 Into Phase 1 Trials

PHILADELPHIA and INDIANAPOLIS, Nov. 17 /PRNewswire/ -- Semafore Pharmaceuticals, Inc., an emerging leader in small molecule cancer therapies addressing critical cell signaling pathways, today presented new data that add to the growing body of preclinical data demonstrating the clinical potential of Semafore’s proprietary targeted prodrug technology. The data also support the safety and potential efficacy of its lead targeted PI3K kinase inhibitor SF1126 as a new approach to treating cancer, as well as the company’s plans to advance SF1126 into clinical trials in 2006. The data were presented today at the 17th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia, Pennsylvania.

Semafore’s focus on Pl3K inhibition reflects the centrality of the PI3K pathway, a high profile anti-cancer target that is a critical intercept point controlling multiple cell functions associated with cancer progression. The centrality of Pl3K minimizes the possibility that the anti-cancer effects of inhibitors can be bypassed by other signaling mechanisms, but it also carries the risk of toxicity to healthy tissues. Semafore’s prodrug technology offers a way to enhance delivery of PI3K inhibitors selectively to the tissues of therapeutic interest while lessening the systemic exposure seen with non-prodrug approaches.

“These data add to the growing body of preclinical evidence supporting advancement of SF1126 into clinical trials in 2006,” said Joseph Garlich, Ph.D., president of Semafore. “Despite the great promise of the Pl3K pathway as a cancer target, until now no one has been able to design inhibitors that have demonstrated as much potential as our lead compound. The more that we and our research partners study SF1126, the more confident we become that our targeted prodrug technology has produced a drug candidate with significant anti-cancer potential.”

In its poster, Preclinical Efficacy, Safety, PK and PD of the PI3 Kinase Inhibitor, Semafore researchers confirmed key factors needed to progress SF1126 into clinical trials. New pharmacokinetic and pharmacodynamic data indicate that SF1126 causes prolonged knockdown in vivo of PI3K in tumors for more than four hours, and they also confirm earlier studies proving that SF1126 does in fact exert its effects through the mechanism of Pl3K inhibition. The data demonstrate that Semafore’s specific targeting approach results in significantly greater efficacy in a xenograft tumor model than a similar method. Semafore researchers will also discuss preclinical data reinforcing the excellent safety profile of the drug.

Semafore’s poster “Preclinical Efficacy, Safety, PK and PD of the PI 3 Kinase Inhibitor SF1126,” by Joseph R. Garlich, Jing Dong Su, Toni Miller, Mary Patterson, Tim Smith, Christopher Menkhaus, Bob Suhr, Xiaodong Peng of Semafore Pharmaceuticals, Inc., Indianapolis, IN, and Donald L. Durden* will be presented at 12:30pm and again at 5:30pm on November 17th.

*AFLAC Center for Cancer Research, Winship Cancer Center, Emory University School of Medicine, Atlanta, GA

Additional contributions to the data presented include work performed by Dr. Gordon B. Mills and his research group at MD Anderson Cancer Center.

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 PI3K and PTEN and has successfully discovered and is developing a portfolio of drug candidates. These programs have the potential to be the first of a new class of targeted cancer agents. The company’s lead clinical candidate, SF1126, is a pan-PI3K inhibitor and the company expects to file an IND for SF1126 in 2006 focusing on cancers known to be dependant on the PI3K pathway such as brain cancer, Herceptin-resistant breast cancer, hormone refractory prostate cancer and ovarian cancers. Semafore has also discovered the first drug-like small molecule PTEN inhibitors for cell protection, therapeutic angiogenesis and cancer sensitization. These compounds have exciting potential to completely change the way cancer and other disorders are treated. For more information, see the company’s website www.semaforepharma.com

Contacts: Semafore Pharmaceuticals, Inc. Media: Derek A. Small Barbara Lindheim Director of Corporate Development GendeLLindheim BioCom Partners (317) 876-3075 (212) 918-4650

Semafore Pharmaceuticals, Inc.

CONTACT: Derek A. Small, Director of Corporate Development for SemaforePharmaceuticals, Inc., +1-317-876-3075, media, Barbara Lindheim ofGendeLLindheim BioCom Partners, +1-212-918-4650

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