CEL-SCI Corp (CVM)

The fundamentals:

   The focus of Cel Sci on the enhancement and modification of cell-mediated immunity represents a fundamentally interesting approach in medicine. The “flagship” product is Multikine for the treatment of head and neck cancer. Regulatory progress is now reached the point of having obtained FDA approval for phase 3 study. If positive the planned phase 3 trial would likely be a pivotal trial. The endpoints and subject numbers involved provide seem reasonable and obtainable. The lack of serious adverse events suggests a favorable weighting of risk in evaluating the risk benefit calculus for the drug. If proven effective in the target indication of head and neck cancer, Multikine might be investigated for clinical effects in other types of cancer, and if these studies proved positive, this would represent a further expansion in the potential market.

   Very recently the company has received attention regarding its effort to develop an approach to the acute care of HN1. The FDA has been receptive and there is reportedly and evidently a positive, collaborative relationship of the FDA and the company. I believe that this may bode well for the future phase 3 trial work with Multikine. The company has been able to raise reasonable expectable level of funding for the Multikine phase 3 clinical trial.

Technical aspects: Of interest with regard to the chart are:

   1.) Very heavy, and largely unprecedented volume in the last two weeks with as much as 60 million shares, the equivalent of over 40% of the entire market cap of all shares trading in a single day. There appear to be consistent levels of support/resistance overthe stock’s existence since it began in 1991. There is recent, impressive upward movement through resistance levels, including gapping with confirmation and consolidation, and putatively bullish formations such as head and shoulders.


Disclaimer: I own shares. My interest in the stock is mainly based on my evaluation of the scientific and clinical significance of the enhancement and modification of cell-mediated immunity. which I accumulated from 25 cents to six dollars starting in 1996. It is my biggest position.