ISIS 3521, a new anti-cancer compound, has shown to produce significant improvement in survival time for patients with non-small cell lung cancer in early phase clinical trials. These results have prompted the Federal Drug Administration (FDA) to grant ISIS 3521 “

fast track” status – the quickest route available for drugs to reach FDA approval.

Approximately 75% of persons who have lung cancer have a type of cancer referred to as non-small cell lung cancer (NSCLC). There are actually many different types of lung cancer that are considered to be NSCLC, which are named according to the type of cell within the lung that the cancer originated. These include epidermoid or squamous carcinoma, adenocarcinoma, large cell carcinoma, adenosquamous carcinoma and undifferentiated carcinoma. Standard treatment options depend on the stage of cancer and may consist of surgery, chemotherapy, radiation and/or biologic therapy (treatment utilizing the patient’s immune system to fight cancer). Late stage or advanced NSCLC refers to cancer that has spread from the lung to distant sites in the body. The average time of survival following current standard treatments is approximately 8 months for patients with advanced NSCLC. This poor survival time clearly indicates a need for novel treatment strategies in order to provide improved outcomes for these patients.

A novel treatment approach utilizing a compound called ISIS 3521 is currently being evaluated in late-phase clinical trials for the treatment of advanced NSCLC. ISIS 3521 works by inhibiting the production of a protein called

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protein kinase C alpha (PKC-a). PKC-a facilitates cellular function and growth through modulating certain chemical information flow into and out of cells and regulating specific cellular responses to stimuli. In some types of cancer, PKC-a is produced in an uncontrolled manner, stimulating excessive replication and growth of cancer cells. ISIS 3521 inhibits the production of PKC-a, ultimately blocking this pathway of growth for cancer cells. ISIS 3521 produces its effects by binding to specific molecules at a genetic level that are responsible for the initial development of PKC-a. Since this binding takes place at a genetic level, specificity can be obtained for the exclusive inhibition of PKC-a, while allowing other cellular functions in the body to continue as normal. This fact is important as it keeps side effects from treatment to a minimum.

In a recent clinical trial, patients with advanced NSCLC received ISIS 3521 in addition to standard chemotherapy agents carboplatin and paclitaxel. The average survival time for these patients following treatment was 1 ½ years – over double the time compared to standard treatments. In addition, this treatment regimen was very well tolerated. These results are extremely encouraging as they show promise in significantly extending survival for patients with this disease.

The last phase of clinical trials prior to FDA approval are currently underway in the evaluation of ISIS 3521 for advanced NSCLC. Results from these trials should be concluded within the next couple of years. Patients with advanced NSCLC may wish to speak with their physician about the risks and benefits of participating in a clinical trial evaluating ISIS 3521. Two sources of information about ongoing clinical trials that can be discussed with a doctor include comprehensive, easy-to-use listing services provided by the National Cancer Institute (cancer.gov) and eCancerTrials.com. eCancerTrials.com also provides personalized clinical trial searches on behalf of patients.

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