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CytImmune Presents Positive CYT-6019 Data During the American,Society of Clinical Oncology Annual Meeting in Chicago

oiding uptake by the liver and spleen and (2) target delivery of TNF directly to tumor sites.

At 27 nanometers in size, these nanoparticles are small enough to circulate safely through the body but too large to exit the blood stream except through the newly formed and leaky vasculature at solid tumors. TNF molecules on the surface of these gold nanoparticles act as tumor-targeting agents, binding to receptors at the site of disease and pulling nearly all TNF out of the circulation. By selectively accumulating TNF in and around solid tumors, Aurimune limits the biodistribution of TNF and prevents its uptake by healthy organs and tissues.

Preliminary data from the Phase 1 study indicates that CYT-6091 is seen in tumors, but not in healthy tissue, and that the mechanism of targeting solid tumors is independent of tumor type. To date the drug has had no effect on renal, liver or immune function and no unexpected serious adverse events have been reported. CYT-6091 induces a predictable and controllable febrile response, and has yet to induce hypotension, the dose limiting toxic effect of TNF.

"The next step is to safely and systemically administer doses of TNF at levels similar to the clinical experience with isolated limb perfusion where efficacy (i.e. tumor regression) has been observed in 85% of patients treated," said Tamarkin. "If successful, such an achievement represents a significant step forward in advancing cancer therapy."

In preclinical studies, CytImmune achieved safe and targeted delivery of TNF at levels necessary for biologic response - in some cases far exceeding established lethal doses for TNF alone.

The Phase 1 clinical trial for CYT-6091 (Aurimune) began in May 2006 at the NCI Center for Cancer Research, Bethesda, MD. To date, 15 patients have participated in the study. Patients included in the study thus far have been late-stage pancreatic, breast, colon, melanoma, sarcoma and lung cancer sufferers. Twelve addition
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