ANTIGENICS (AGEN) ANOUNCES GOOD NEWS

Time might have come for cancer vaccines to be considered by oncologists, especially for those late-stage cancers, or cancers that do not respond to current therapies. We had good news from Provenge, developed by Dendreon (DNDN) and now we are getting good news from Antigenics’ vaccine Oncorphage. The good news hcame up in the results of a Phase 1/2 investigator-sponsored trial of Oncophage® (vitespen) in recurrent, high-grade glioma. They demonstrated that the drug had significant tumor-specific immune response in all 12 treated patients, of which four continue to receive Oncophage and eight have completed treatment. Seven of these eight evaluable patients have exceeded the historical median benchmark of 6.5 months survival from time of recurrence. It is, indeed, encouraging news.

Promising is that a correlation between the immune response elicited by Oncophage vaccination and the potential clinical benefit was observed. More comforting is that prolonged improvement in overall survival compared with historical controls has been observed and occurred in patients who are inflicted with a terrible malignancy.

Commenting on the paper presented at AANS, Henry Brem, MD, director of neurosurgery at Johns Hopkins, noted, “This is an encouraging study of a therapeutic cancer vaccine that targets multiple tumor antigens, supported by rigorous immunomonitoring. A larger Phase 2 trial is certainly warranted to evaluate efficacy.” Dr. Brem is a developer of Gliadel® Wafer (polifeprosan 20 with carmustine implant, MGI Pharma), the first approved local therapy for glioma.

Oncophage contains the ‘antigenic fingerprint’ of the individual patient’s particular cancer. The vaccine is designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. Oncophage does not cause the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy.

The vaccine has been granted fast track and orphan drug designations from the FDA in both metastatic melanoma and renal cell carcinoma.

The investigator-sponsored Phase 1/2 study is designed to evaluate the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma. The trial involves two cohorts of six patients, both receiving a minimum of four Oncophage injections: the first cohort receives biweekly vaccinations; the second cohort receives weekly vaccinations. Patients are monitored for immune response before and after Oncophage treatment using three different techniques.

The investigators will continue to follow patients for overall survival. Researchers plan to present further results from the Phase 1/2 trial of Oncophage in late 2007 and submit the findings for peer-review publication. Based on these results, the Phase 2 portion of this study is expected to move forward in mid-2007.

Changing the management of recurrent glioma from a life threatening disease, in which survival rates are typically 25 to 26 weeks, into a chronic disease with extended survival and improved quality of life for patients is the company’s goal. The firm believes that, Although survival data are encouraging, a larger Phase 2 study will be required to determine the benefit of Oncophage for patients with recurrent glioma. The consistent, tumor-specific immune response seen in these patients suggests that in the right patient population, Oncophage could have a significant impact.

Glioma is a cancer affecting the central nervous system that begins in glial cells (connective tissue cells that surround and support nerve cells). Malignant glioma is currently a fatal disease. The American Cancer Society estimates that 20,500 malignant tumors of the brain or spinal cord will be diagnosed during 2007 in the United States, and that about 12,740 people will die from these tumors. Brain and spinal cord tumors account for about 1 percent of all cancers and 2 percent of all cancer-related deaths.
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