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The data from the solid tumor trial demonstrate that SF1126 iswell-tolerated in a twice-weekly I.V. infusion at exposure levels that havebeen shown to be active in preclinical studies. In the current trial, patientsare dosed twice-weekly for four weeks, as part of a 28-day SF1126, treatmentcycle. Investigators are assessing the safety, activity and pharmacokineticsof SF1126 as measured by standard response evaluation criteria in solid tumors(RECIST).
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To date, 17 patients with a wide range of solid tumors have been enrolledin this multicenter, dose-cohort escalating trial, which is being conducted atT-Gen Clinical Research Services in Scottsdale, Ariz.; the Arizona CancerCenter in Tucson, Ariz.; and the IU Simon Cancer Center in Indianapolis.Stable disease has been observed in three of 12 patients who have completed atleast one cycle of treatment, including a prostate, endometrial and ovariancancer patient. Adverse events noted so far were limited to nausea, vomiting,diarrhea and rash. All adverse events have been non-cumulative andreversible. With these encouraging results, patient enrollment hasaccelerated, and full enrolment of the trial is anticipated by the end of thethird quarter.
"As a leader in the clinical development of PI3 kinase inhibitors, we arepleased to announce this positive safety data and early signals of activityseen with SF1126," said Dennis McKeever, Semafore Pharmaceuticals' CEO. "Webelieve that SF1126's dual action of antitumor and antiangiogenic activityrepresents a step forward in delivering new therapies to cancer patients."
About SF1126
SF1126 is a small-molecule conjugate containing a pan-PI3K inhibitor thatselectively inhibits all PI3K class I isoforms. In addition to inhibiting PI3kinase, SF1126 inhibits mTOR, DNA-PK, Polo-like 1 kinases, PIM1 and CK2 - allbelieved to play significant roles in the control of cellsurvival/proliferation signals and in cancer. SF1126 is the only PI3Kinhibitor demonstrated in preclinical studies to cause an oxidative stressmechanism in cancer cells, resulting in decreased proliferation and apoptosis.A major factor in tumor resistance to approved chemotherapy agents is thoughtto be the activation of the PI3K/PTEN pathway. As a result, it is believedthat inhibiting this pathway with SF1126 could resensitize the cancer cells toapproved anticancer agents and lead to possible synergistic anticanceractivity. Clinical combination studies with SF1126 are being planned.
About Semafore Pharmaceuticals
Semafore Pharmaceuticals is a clinical-stage drug discovery anddevelopment company focused on small-molecule modulators of the PI3 kinase andPTEN cell signaling pathway, a promising target pathway for multipledisorders, including the company's focus - cancer. Semafore is one of thefirst biopharmaceutical companies to focus on both PI3K and PTEN and hassuccessfully discovered and is developing a portfolio of drug candidatesaddressing these targets.
Semafore is actively seeking partnerships or other strategic alliances tohelp fulfill the promise of SF1126. For more information visit the company'sWeb site at www.SemaforePharma.com .Contacts: Semafore Pharmaceuticals Inc. Sandi Yurichuk (650) 576-5769 [email protected] Russo Partners LLC David Schull (212) 845-4271 [email protected]
SOURCE Semafore Pharmaceuticals Inc.
