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Semafore Pharmaceuticals Reports Positive Interim Results from a Phase I Study of SF1126, a Targeted Pan-PI3K Inhibitor, in Patients with Advanced Solid Tumors

INDIANAPOLIS, June 4 /PRNewswire/ -- Semafore Pharmaceuticals Inc. today 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 .


Semafore Pharmaceuticals Inc.

Sandi Yurichuk

(650) 576-5769

Russo Partners LLC

David Schull

(212) 845-4271

SOURCE Semafore Pharmaceuticals Inc.
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