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Nov 16 2009, 8:30 AM EST

Semafore Pharmaceuticals Announces Phase I Data Presentation Highlighting Novel PI3K Pathway Inhibitor at 51st ASH Annual Meeting

News source: Business Wire

Researchers are scheduled to present Phase I data relating to Semafore Pharmaceuticals’ lead product candidate, SF1126, as a treatment for patients with relapsed and refractory myeloma during the 51st American Society of Hematology (ASH) Annual Meeting, December 5 - 8, 2009, at the Ernst N. Morial Convention Center in New Orleans, LA.

Poster details are as follows:

Presentation 3879: Preliminary Results of a Phase I Study of the Pan-PI3 Kinase Inhibitor SF1126 in Patients with Relapsed and Refractory Myeloma

Monday, Dec. 7, 2009, 6:00 PM-8:00 PM

Hall E (Ernest N. Morial Convention Center)

Poster Board III-815

Conclusions: The PI3K inhibitor SF1126 resulted in similar pharmacokinetics (PK) to that seen in solid tumor patients and in vivo studies demonstrated that PI3K activity in the plasma cell compartment of the bone marrow had suppression of this key pathway following SF1126. Completion of the study at the current dose (1110mg/m2) and planning for a future trial combining SF1126 with other active agents in myeloma is currently ongoing. Additional PK/pharmacodynamic and clinical data from this trial will be available.

A copy of the abstract is now available on ASH's website at http://www.hematology.org or Semafore’s website at http://www.semaforepharma.com/publications.html.

About SF1126

Semafore Pharmaceuticals’ lead product candidate, SF1126, inhibits both the phosphoinositide-3-kinase (PI3K) and mammalian target of rapamycin (mTOR), two key members of the PI3K signaling pathway that is vital to several essential biological processes, such as cell proliferation and survival. PI3K is commonly altered in human cancers, making inhibition of the target attractive for cancer therapy.

In view of the fact that mTOR can be activated in a PI3K-independent manner, dual PI3K-mTOR inhibitors, such as SF1126, are expected to offer a therapeutic advantage. As a prodrug that is administered in an inactive form, SF1126 is also unique among clinical stage, dual PI3K-mTOR inhibitors. Once administered, SF1126 targets specific transmembrane cell adhesion proteins known as integrins that are expressed in new tumor vasculature and within the tumor compartment. Because of the targeted design of SF1126, there is a markedly lower chance of inhibiting PI3K and mTOR in healthy, non-cancerous cells which reduces the potential for side-effects.

Data from an ongoing Phase I clinical trial of SF1126 in patients with solid tumors recently presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated selective inhibition of the PI3K pathway in tumor tissue but not in normal skin tissue. Notably, there were no clinically significant changes in glucose or insulin levels reported at biologically active doses. Upon completion of single agent Phase I trials, Semafore Pharmaceuticals expects to initiate combination trials in the near future.

About Semafore Pharmaceuticals, Inc.

Founded in 2000, Semafore Pharmaceuticals is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule signal transduction inhibitors targeting the phosphoinositide-3-kinase (PI3K) pathway for the treatment of cancer and other serious diseases. The PI3K signaling pathway is vital to several biological processes, such as cell proliferation and survival, and is commonly altered in human cancers, making inhibition of the target attractive for cancer therapy. For more information see the company’s web site at www.semaforepharma.com

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