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eric 03-27-2007 04:06 AM

PI3K Inhibitor SF1126
 
http://www.therapeuticsdaily.com/new...e&channelID=29INDIANAPOLIS, March 26 /PRNewswire/ -- Semafore Pharmaceuticals, Inc. today announced the recent initiation of a Phase I clinical trial of its lead PI3 kinase (PI3K) inhibitor, SF1126, in patients with solid tumor cancers. The trial is being conducted under the supervision of Daniel Von Hoff, M.D. at TGen Clinical Research Services at Scottsdale Healthcare's Virginia G Piper Cancer Center. Indiana University Cancer Center is also a site for this study. The open label, ascending dose trial is assessing safety, pharmacokinetic and pharmacodynamic parameters in patients with relapsed solid cancers that are thought to be driven by PI3 kinase activation or loss of the associated PTEN function. These include a wide range of cancer types, including endometrial, renal cell, breast, hormone refractory prostate and ovarian cancers.

"Initiating our first clinical trial of SF1126 is an important milestone for Semafore, and we are eager to evaluate its safety and activity in patients," said John Sima, interim CEO of Semafore. "SF1126 is the first known broad-spectrum PI3K inhibitor to enter human trials and it has demonstrated good tolerability and promising anti-cancer activity in a wide range of preclinical cancer studies. We are grateful for the assistance of our many distinguished expert advisers in helping us to reach this milestone and to the Cancer Treatment Research Foundation, which has provided funding to support this study."

In preclinical studies, SF1126 has been shown to be a key inhibitor of many of the biological processes involved in tumor growth and dissemination. SF1126 is a small molecule conjugate containing a pan-PI3K inhibitor that selectively inhibits all PI3K class IA isoforms and other key members of the PI3K superfamily, including DNA-PK and mTOR. Recent advances in knowledge about cell signaling pathways indicate that these targets play a critical role in the progression of cancer. Preclinically, SF1126 has been shown to inhibit angiogenesis and cellular proliferation, induce apoptosis, block pro-survival signals and produce synergistic anti-tumor effects in combination with chemotherapy. SF1126 has demonstrated promising in vivo activity in a variety of preclinical mouse cancer models, including prostate, breast, ovarian, lung, multiple myeloma, brain and other cancers.

About Semafore

Semafore is a clinical stage drug discovery and development company focused on small molecule modulators of the PI3 kinase and PTEN cell signaling pathway, a promising target pathway 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 addressing these targets. 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 & Regulatory Affairs GendeLLindheim BioCom Partners

(317) 876-3075 (212) 918-4650

Semafore Pharmaceuticals, Inc.

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

Web site: http://www.semaforepharma.com/


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