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(R) (bortezomib) for Injection; a Phase I study of
NPI-0052, a proteasome inhibitor; and a Phase I study of perifosine,
REVLIMID(R) (lenalidomide), and dexamethasone.
For more information, please visit themmrc.
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
SemaforePharma.
Semafore Pharmaceuticals Inc.
SemaforePharma