Semafore Pharmaceuticals Inc. reported interim data from a Phase I study of its lead product
candidate, SF1126, a targeted pan-PI3 kinase (PI3K) inhibitor, in patients
with advanced solid tumors. SF1126 is the first PI3 kinase inhibitor to be
evaluated clinically in both solid tumor and multiple myeloma trials.
The data from the solid tumor trial demonstrate that SF1126 is
well-tolerated in a twice-weekly I.V. infusion at exposure levels that have
been shown to be active in preclinical studies. In the current trial,
patients are dosed twice-weekly for four weeks, as part of a 28-day SF1126,
treatment cycle. Investigators are assessing the safety, activity and
pharmacokinetics of SF1126 as measured by standard response evaluation
criteria in solid tumors (RECIST).
To date, 17 patients with a wide range of solid tumors have been
enrolled in this multicenter, dose-cohort escalating trial, which is being
conducted at T-Gen Clinical Research Services in Scottsdale, Ariz.; the
Arizona Cancer Center in Tucson, Ariz.; and the IU Simon Cancer Center in
Indianapolis. Stable disease has been observed in three of 12 patients who
have completed at least one cycle of treatment, including a prostate,
endometrial and ovarian cancer patient. Adverse events noted so far were
limited to nausea, vomiting, diarrhea and rash. All adverse events have
been non-cumulative and reversible. With these encouraging results, patient
enrollment has accelerated, and full enrolment of the trial is anticipated
by the end of the third quarter.
"As a leader in the clinical development of PI3 kinase inhibitors, we
are pleased to announce this positive safety data and early signals of
activity seen with SF1126," said Dennis McKeever, Semafore Pharmaceuticals'
CEO. "We believe that SF1126's dual action of antitumor and antiangiogenic
activity represents a step forward in delivering new therapies to cancer
patients."
About SF1126
SF1126 is a small-molecule conjugate containing a pan-PI3K inhibitor
that selectively inhibits all PI3K class I isoforms. In addition to
inhibiting PI3 kinase, SF1126 inhibits mTOR, DNA-PK, Polo-like 1 kinases,
PIM1 and CK2 - all believed to play significant roles in the control of
cell survival/proliferation signals and in cancer. SF1126 is the only PI3K
inhibitor demonstrated in preclinical studies to cause an oxidative stress
mechanism in cancer cells, resulting in decreased proliferation and
apoptosis. 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 believed that inhibiting this pathway with SF1126 could
resensitize the cancer cells to approved anticancer agents and lead to
possible synergistic anticancer activity. Clinical combination studies with
SF1126 are being planned.
About Semafore Pharmaceuticals
Semafore Pharmaceuticals 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.
Semafore is actively seeking partnerships or other strategic alliances
to help fulfill the promise of SF1126. For more information visit the
company's Web site at SemaforePharma.
Semafore Pharmaceuticals Inc.
SemaforePharma