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Semafore and Multiple Myeloma Research Consortium (MMRC) dose first patient in phase i study of targeted pi3 kinase (PI3K) inhibitor


INDIANAPOLIS, and NORWALK,Conn. — January 7, 2008
Clinical Trial is Semafore's Second to Evaluate Safety, Tolerability of Lead Candidate SF1126, Ninth Clinical Trial to Launch in the MMRCM

Semafore Pharmaceuticals Inc. and the Multiple Myeloma Research Consortium (MMRC) today announced the dosing of the first patient in a Phase I study of Semafore's lead product candidate, SF1126, a targeted PI3 kinase (PI3K) inhibitor. The MMRC is the only research model of its kind that brings together 13 leading academic institutions to accelerate the development of novel and combination treatments for multiple myeloma.

The single-agent, dose-escalating, multiple-dose trial, which will enroll up to 30 multiple myeloma patients at three MMRC member institutions in the United States and Canada, is designed to evaluate the safety and tolerability of SF1126 in patients who have failed at least two prior treatments. The Winship Cancer Institute of Emory University in Atlanta is the lead site for the study.

"The start of our second Phase I trial is a significant milestone for Semafore," said Edward L. Jacobs, president and chief executive officer of the company. "We intend to explore several development opportunities for SF1126 based on our extensive preclinical research and the anticipated findings of our early stage clinical studies. A highly targeted therapeutic that inhibits the powerful PI3K pathway, SF1126 has tremendous potential as both a single-agent and combination product."

Semafore is one of the first recipients of the LEAD grant from the MMRC's sister organization, the Multiple Myeloma Research Foundation (MMRF), which provides funding to biotechnology companies to accelerate the development of innovative and effective multiple myeloma treatments through the early stages of the drug development process. In 2006, the MMRF awarded funding to Semafore to support the development of SF1126 for multiple myeloma. In early 2007, Semafore selected the MMRC to facilitate the development of SF1126.

Kathy Giusti, founder and chief executive officer of the MMRC, as well as a myeloma patient, said: "PI3 kinase is one of the premier targets for oncology overall, as well as for myeloma specifically. We are proud to have partnered with Semafore to rapidly move SF1126 into a clinical trial for multiple myeloma."

Semafore is currently evaluating SF1126 as a single agent in a multi-center Phase I trial involving patients with refractory or advanced solid tumors. The company expects to report data from this trial this year.

About SF1126

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. A major factor in tumor resistance to approved chemotherapy agents is thought to be the activation of the PI3K/PTEN pathway. As a result, it is thought that inhibiting this pathway, via SF1126, could cause the resetting of sensitivity to approved agents and exhibit synergistic anticancer effects.

About the Multiple Myeloma Research Consortium (MMRC)

The Multiple Myeloma Research Consortium (MMRC) is a 509a3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is comprised of the MMRC and 13 member institutions: City of Hope Cancer Center, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Mayo Clinic, Ohio State University, Roswell Park Cancer Institute, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, and Washington University of St. Louis.

The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community, as an optimal research model to rapidly address critical challenges in accelerating drug development and explore opportunities in the most promising areas of myeloma research–genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. The MMRC is facilitating several other clinical trials, including two Phase II trials of carfilzomib, a proteasome inhibitor; a Phase II trial of LBH589, a histone deacetylase inhibitor, as well as a Phase Ib trial of LBH589 in combination with VELCADE® (bortezomib) for Injection; a Phase I study of NPI-0052, a proteasome inhibitor; and a Phase I study of perifosine, REVLIMID® (lenalidomide), and dexamethasone.

For more information, please visit www.themmrc.org.

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 www.SemaforePharma.com.

CONTACTS:

Semafore Pharmaceuticals Inc.
Bob Marshall or Ed Jacobs
(480) 278-8200

Multiple Myeloma Research Consortium
Anne Quinn Young, MPH
(203) 652-0212