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New Data On Semafore PI3K/PTEN Programs Confirm Potential in Multiple Cancer Indications

Posted on: 08/30/2004

New Data On Semafore PI3K/PTEN Programs Confirm Potential in Multiple Cancer Indications

Press Release Source: Semafore Pharmaceuticals, Inc.

Thursday August 26, 7:01 am ET
- PTEN Inhibitor First to Demonstrate Pharmaceutical Proof-of-Concept -
- Targeted PI3K Inhibitor Safety and Efficacy Demonstrated in Third Cancer Model -

INDIANAPOLIS, Aug. 26 /PRNewswire/ -- Semafore Pharmaceuticals, Inc., an emerging leader in developing small molecule cancer therapies addressing critical cell signaling pathways, today announced that data from its PI3 kinase (PI3K) and PTEN inhibitor programs will be presented at the Third International Congress on Targeted Therapies in Cancer on August 27th in Washington D.C. Dr. Donald Durden* of Emory University, inventor of Semafore's key intellectual property and now Senior Scientific Advisor to the company, will present evidence demonstrating the first proof-of-concept for a known PTEN inhibitor, and Semafore President and CSO Dr. Joseph Garlich will present a poster demonstrating the safety and efficacy of Semafore's lead targeted PI3K inhibitor in a preclinical glioma model, expanding on prior positive data in models of small cell lung cancer and prostate cancer.

"These new data are significant because they add to our growing understanding of how the PI3K/PTEN pathway, the 'yin and yang' of cell survival and cell death, can be harnessed for clinical benefit to patients," said Dr. Durden. "This pathway is a critical intercept point in cell signaling that controls angiogenesis, apoptosis, migration, invasion and metastasis. As such, it has potential as a powerful new target for therapies for cancer and other serious diseases. These data confirm that Semafore's PI3K inhibitor program has potential in multiple cancers, and they also provide the first report describing Semafore's internally-generated, proprietary small molecule PTEN inhibitor, SF1720."

In his presentation, Dr. Durden demonstrates how PI3K and PTEN inhibitors can be employed to modulate key processes involved in the growth and spread of cancer. Unlike other cell signaling pathways, the PI3K pathway is non- redundant, activating multiple downstream cellular signals critical to cell survival. A growing body of data support the significant anti-tumor effects of inhibiting this central target, and Dr. Durden presents in vivo data showing the anti-tumor and anti-angiogenic efficacy of Semafore's targeted PI3K inhibitor, SF1126, in a mouse model of glioma, as well as biochemical evidence from an analysis of downstream markers demonstrating that SF1126 is acting on its intended target, the PI3K receptor.

Dr. Durden's presentation also discusses PTEN, the only cell signaling pathway known to be capable of modulating PI3K. PTEN inhibitors are expected to have potential application in diseases where safeguarding cell survival is crucial, including protection of the bone marrow during chemotherapy and in cardiovascular indications to protect the heart from ischemia and reperfusion injury. But until now, researchers have not had success in identifying useful PTEN inhibitors. Dr. Durden presents data demonstrating for the first time good drug-like activity with Semafore's PTEN inhibitor SF1720.

The poster discussed by Dr. Garlich further reports on studies demonstrating that SF1126, a prodrug with modifications designed to specifically target tumor neovascularization, can be administered in a clinically relevant formulation and displays good efficacy in a xenograft model of brain cancer (U87MG), in a dose-response and dose-frequency dependant manner. Administered as a single agent, SF1126 reduced glioma tumor volume by as much as 90 percent and was well tolerated. These new data confirm similar findings in previous studies of SF1126 in mouse models of non-small cell lung cancer and prostate cancer. The data also confirm earlier studies showing that SF1126 achieves significantly greater efficacy with less toxicity than an untargeted version of the drug.

"This study demonstrates in a third type of cancer the broad anti-tumor potential of Semafore's lead targeted PI3K inhibitor," said Dr. Garlich. "We believe that modulating the PI3K/PTEN pathway offers great promise as a novel and powerful new anti-cancer tool, and we look forward to reporting on our progress in advancing our PI3K and PTEN modulators towards the clinic in the coming months."

Animal testing of SF1126 is continuing, and Semafore expects to file an IND and initiate clinical trials with the compound in the second half of next year.

Dr. Durden's presentation, "Inhibitors of PI3 Kinase and PTEN Pathways for Cancer Therapy" is scheduled at 4:00 pm EDT on August 27th.

The poster "In Vivo Efficacy in Brain Cancer Xenograft Models Using a Novel Vascular Targeted PI3-Kinase Inhibitor," by Joseph Garlich, Jing Dong Su, Mary Patterson, Bob Suhr, Chris Menkhous, Frank Lloyd, and Donald Durden will be presented on August 27th by Dr. Garlich.

Professor of Pediatric Oncology and Hematology at Emory University School of Medicine, and Scientific Director of Basic and Translational Research at the AFLAC Cancer Center & Blood Disorders Service of the Children's Healthcare of Atlanta and Emory University. About Semafore

Semafore is an Indianapolis-based company discovering and developing small molecule cancer drugs to modulate critical cell signaling pathways. The company's programs leverage a breakthrough -- the discovery of the PI3K /PTEN pathway's role as the primary non-redundant controlling mechanism for angiogenesis, cell survival, programmed cell death (apoptosis), cell migration and cell proliferation. Semafore is establishing a leadership position in this important new area and has already produced a portfolio of high potential drug candidates. Its lead programs, PI3 Kinase inhibitors (Interceptors(TM)) for cancer therapy and PTEN inhibitors (MarrowShield(TM)) for protection by a single agent against radiation and chemotherapy-induced anemia, neutropenia, and thrombocytopenia, are in pre-clinical development and are scheduled to enter clinical trials in 2005. Semafore's lead products are expected to have significant efficacy advantages compared to existing and developmental cancer therapies. The company's core technology and intellectual property are exclusively licensed from Indiana University. For more information, see the company's Web site .

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

Source: Semafore Pharmaceuticals, Inc.

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