CEL-SCI Corporation is a small cap biotech company focused on developing drugs that utilize the immune system to improve cancer treatment and infectious disease. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently in a pivotal Phase III clinical trial. CEL-SCI is also developing its LEAPS technology platform as an immunotherapy for possible treatment for H1N1 hospitalized patients (LEAPS-H1N1-DC) and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing). The immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu. Most of the company’s resources are dedicated to the development of Multikine. This is the area of the company that we believe investors should focus. CEL-SCI has operations in Vienna, Virginia, and in and near Baltimore, Maryland. The company was formed as a Colorado corporation in 1983.
Multikine is currently being developed as a potential therapeutic agent for the treatment of head and neck cancer. It uses the immune system to produce an anti-tumor immune response. Multikine is a defined mixture of 14 cytokines. Immunotherapy is one of the more recent approaches to cancer therapy. It is based on the generally-accepted hypothesis that the immune system is the best tool humans have for fighting disease. Data from Phase I and Phase II clinical trials suggest that Multikine simulates the activities of a healthy person’s immune system, enabling it to use the body’s own anti-tumor immune response. In Phase I and Phase II clinical trials, and in the ongoing Phase III clinical trial, Multikine is administered prior to any other cancer therapy because CEL-SCI believes that this is the period when there is a greater potential of activating an anti-tumor immune response. Once the patient has had surgery or has received radiation with or without chemotherapy, the immune system may be weakened and may be less able to mount an anti-tumor immune response. Multikine is injected around the tumor and in the vicinity of the draining local lymph nodes because these are the areas in which metastases are believed to be most likely develop and where the cancer may recur in most cancer patients with this disease.
The Multikine Phase III trial is expected to be the largest head and neck cancer clinical study ever conducted with planned enrollment of 880 patients (in order to have approximately 784 evaluable subjects). The Phase III study is an open-label, randomized, controlled, multi-center study. Worldwide there are an estimated 600,000 new cases of head and neck cancer diagnosed each year, which represents about 5% – 6% of all newly diagnosed cancers. There are about 40,000 new cases in the U.S. and 100,000 new cases in Europe diagnosed annually. If the drug can penetrate 25% of the market in the U.S. and Europe at its peak that would be 35,000 treatments per year. We have assumed a price of $50,000 per course of therapy. This would imply peak sales potential of $1.75 billion. If approved, we expect Multikine could reach the market in the 2018 – 2020 timeframe.