Sarcomas are rare neoplasms that arise from the mesenchymal tissues of the body. In the United States, there are approximately 13,230 cases diagnosed each year, representing less than 1% of all new cancers. Of these cases, roughly 80% originate from soft tissue, with the remainder originating from bone. Prognosis remains poor, with more than 5,290 patients in the US dying of the disease each year. Recurrence rates range from 30% to 50%.

Despite undergoing potentially curative surgical resection or combination therapy, the majority of patients with recurrent sarcoma die as a result of further recurrences. The overwhelming majority of pediatric patients ultimately succumb to their disease following the development of recurrent, chemoresistant disease, and their prognosis remains unacceptably poor despite aggressive multimodality treatment. The addition of chemotherapy to surgical resection has not been shown to improve outcome in adult sarcomas. Thus, in the majority of cases, the current standard of care following treatment of metastatic disease and the achievement of disease-free status is watchful waiting.

MabVax is currently enrolling Stage IV sarcoma patients in a proof of concept Phase II clinical trial at 14 sites in the United States. The clinical trial will test the ability of the vaccine to elicit protective antibodies that can kill the circulating tumor cells and micrometastases that remain and can cause tumor recurrence after all standard therapy is administered to the patient.

Please click on the Clinical Trials heading for additional information and follow the link to the ClinicalTrials.gov website.

In the United States, small cell lung cancer (SCLC) accounts for about 15% of all lung cancer cases or 30,000 new cases per year. The current prognosis for patients with SCLC is extremely poor with nearly 30,000 patients dying from this disease annually resulting in a 5-year survival rate of less than 10%. Unfortunately, the prognosis for these patients remains unsatisfactory even though considerable improvements in diagnosis and therapy have been made over the past 10 to 15 years. The etiology of SCLC is this cancer is primarily caused by cigarette smoke. The prevalence of patients in the United States with SCLC is less than 100,000.

Small cell lung cancer is a cancer with a high unmet medical need and one of the largest patient populations that are the initial focus of the company. Without treatment, small cell carcinoma of the lung has the most aggressive clinical course of any type of pulmonary tumor, with median survival from diagnosis of only 2 to 4 months. Compared with other cell types of lung cancer, small cell carcinoma has a greater tendency to be widely disseminated by the time of diagnosis but is responsive to chemotherapy and irradiation in the initial treatment period. Because patients with small cell lung cancer tend to develop distant metastases, localized forms of treatment, such as surgical resection or radiation therapy, rarely produce long-term survival.

Estimated new cases and deaths from lung cancer (small cell and non-small cell combined) in the United States in 2006:

Type of Lung Cancer	New Cases	Deaths	5 Year Survival
Small Cell	30,000	29,000	5% to 10%
Non Small Cell	140,000	130,000	15%

Current programs yield overall objective response rates of 65% to 90% and complete response rates of 45% to 75%. Because of the frequent presence of occult metastatic disease, chemotherapy is the cornerstone of treatment for patients with limited-stage small cell lung cancer. No clear evidence is available from reported data that maintenance chemotherapy will improve survival duration.

A Phase I clinical trial utilizing a pentavalent vaccine will begin in the second quarter of 2011 at MSKCC. This is a pilot trial evaluating the safety and immunogenicity of the vaccine for patients with SCLC. Patients with SCLC who have completed all planned initial therapy and have maintained a partial or complete response will be enrolled. A Phase II trial is planned for the first half of 2012 pending the outcome of the Phase I trial.

Ovarian cancer is a cancer that forms in tissues of the ovary. Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells). There are 21,880 new cases of ovarian cancer per year with 13,850 deaths. It is estimated that there are 174,000 surviving patients.

The current standard treatment for patients with advanced ovarian cancer consists of aggressive surgical cytoreduction followed by taxane and platinum-based chemotherapy. While the median overall survival for optimally debulked patients has increased to 65.6 months, less than 30% of patients will remain free of disease. Many patients will have chemotherapy-sensitive disease initially at recurrence, and can reenter successive remissions with additional treatment. Subsequent remissions are of progressively shorter duration until chemotherapy resistance uniformly develops.

The National Cancer institute, the Gynecological Oncology Group and MSKCC have combined to sponsor a Phase II proof of concept clinical trial that is now currently recruiting patients at 14 sites in the United States. The company believes that immune directed therapy is ideally suited for evaluation in patients who are in clinical remission when the disease burden is lowest, and evaluating treatments designed to prolong the duration of such remissions remain a high priority.

Please click on the Clinical Trials heading for additional information and follow the link to the ClinicalTrials.gov website.