History

CEL-SCI's story is one of vision, persistence, and survival in the face of overwhelming odds. Despite downturns in the biotech sector, lack of funding, and a lengthy clinical trial process associated with the development of its cancer therapy, CEL-SCI is finally at the end game! Our lead cancer product, Multikine®, has performed well in Phase II trials, and is now approved for a global Phase III trial.

The story began at the Max Plank Institute in Germany in the late 1970s, with groundbreaking science and research supporting the theory that the immune system could fight cancer. Maximilian de Clara, the Company's founder, believed strongly that the immune system played an important role in fighting this disease, but he lacked the technology to turn his idea into a product. A visionary and successful entrepreneur, Maximilian was not easily discouraged. He funded the early Multikine® research at the Max Plank Institute in 1978, founded CEL-SCI around the idea of Multikine® in 1983, took the Company public soon thereafter and located it at the office of the Company's patent attorney in the Washington, D.C area.

Dr. Dudley Dumonde, the renowned scientist who coined the term "cytokine" (Multikine® contains a mixture of cytokines), conducted the first clinical trials for CEL-SCI between 1985 and 1988 in England. Until 1992, CEL-SCI was cash poor and struggling to survive. The technology necessary to manufacture Multikine® as a biological drug product on a sufficient scale suitable for conducting widespread studies in humans and ultimately commercialization only became available in 1993. It was then that CEL-SCI committed to the full commercial development of Multikine®. Professional management and scientific personnel were hired, a research laboratory was built and a small pilot plant manufacturing facility was constructed.

We firmly believed that for an immunotherapeutic agent to be successful, it had to be administered first-line, before the immune system could be damaged by traditional therapies such as chemotherapy, surgery and radiation. This caused us to aggressively pursue a first-line indication for advanced primary head and neck cancer. The strategy was controversial because physicians had to be convinced to assess first-line use of Multikine®; which meant using Multikine® before using any other therapies. Then multiple and lengthy clinical trials had to be conducted, which prolonged the product development cycle. CEL-SCI persisted with its belief, despite the delays and additional complexities. The company's persistence proved worthwhile.

From 1994 to 2000, CEL-SCI completed a successful series of Phase I and Phase II trials with Multikine®. In 2001, a lengthy and costly manufacturing process validation was completed, which provided a high level of scientific assurance that CEL-SCI could reliably and reproducibly manufacture an acceptable product. Completion of the manufacturing process validation for Multikine® was a very important achievement for CEL-SCI for two reasons; not only was it a necessary step prior to commercial distribution of the product, but also because it helped minimize our business risk and enhanced our ability to compete successfully in the marketplace.

Unfortunately, the following year saw the collapse of the biotech sector, sending CEL-SCI back into survival mode as funding dried up sector-wide. CEL-SCI soldiered on and spent the next few years publishing a significant body of data for Multikine® in peer reviewed scientific journals. Some of the published data included:

Things began to improve again in August of 2005, when Canada became the first country to give clearance for Multikine® to enter Phase III trials. The US followed with the same clearance in January 2007. In addition to this good news, the FDA designated Multikine® as an orphan drug in 2007. This was a great achievement because the status qualified CEL-SCI for a number of very significant incentives, including:

In August 2006 CEL-SCI raised $8.3 million and followed that up with another $15 million in equity capital in April 2007.  In August 2007 CEL-SCI announced a deal with a real estate investment group to build a 73,000 square foot manufacturing facility for Multikine®. In October 2008, CEL-SCI took possession of the new facility. 

The financial crisis of 2008 and 2009 hit CEL-SCI very hard and led to significant delays in finishing the validation of the manufacturing facility and the start-up of the Phase III clinical trial. However, management pulled together, went without salaries and funded CEL-SCI with its own money through these difficult times. The second half of 2009 brought significant improvement and allowed CEL-SCI to raise close to $50 million. This marked the first time ever that CEL-SCI was properly financed to do its work. With these funds in hand CEL-SCI is now preparing its global Phase III clinical trial for Multikine®.

Biotech research and drug development is a long and arduous road. CEL-SCI has endured the biotech boom and bust cycles, and our committed team has persisted because of the strength of our belief in the promise of Multikine®. We have never taken any shortcuts in our research or product development, nor have we given up major marketing rights or control of Multikine® to licensees because we strongly believe in preserving the greatest value for our shareholders. We are extremely excited about the final phase of the development of Multikine® and we hope to build a great company that will serve patients and shareholders alike.