Bullish $10 Million Bet Placed By New CRO After CEL-SCI Acts To Accelerate Phase III Enrollment Print E-mail
By Ray Dirks of Ray Dirks Research   
Wednesday, 24 April 2013 00:00
icon_newsnotesIn newly published news, CEL-SCI Corporation (NYSE MKT: CVM) has provided investors a much needed update on the Phase III Clinical Trial of its investigational drug Multikine.

We perceive this as a bullish advancement for several reasons.

Some may recall that in early April, when shares were starting to bounce off 52-week lows, we told investors that CEL-SCI shares appeared to be trading at undervalued levels and that several insiders at the company, led by Chief Executive Officer, Geert Kersten, purchased nearly 400,000 shares at discounted prices. Within a couple of sessions, shares bounced back (over 27.62% from those lows) but could head higher now that the company hired two clinical research organizations (CRO’s) who are international leaders in managing oncology trials-- Aptiv Solutions and Ergomed—to not only manage, but also expand the firm’s global Phase III study for the treatment of head and neck cancer.

According to the company, both CRO’s will help the Company grow the trial by 60-80 clinical sites globally and that will likely mean more positive news flow in the days and months ahead.

The two CRO’s are have replaced the current CRO managing the study and that may be a good thing, since having watched the trading on the stock, it appeared to us that some investors may have been fearful that little or no enrollment had occurred in the pivotal Phase III trials. Obviously, we now have guidance that the opposite is actually true.

The company states that to date, the study has enrolled 117 patients and has been conducted at 39 sites in 8 countries, including three centers in Israel where CEL-SCI’s partner Teva Pharmaceuticals has the marketing rights, and nine centers in Taiwan where the Company’s partner Orient Europhama has the marketing rights.

In addition, under a co-development agreement, privately-held firm Ergomed will contribute up to $10 million towards the study where it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount. Ergomed will be responsible for the majority of the new patient enrollment since it has a novel model for clinical site management to accelerate patient recruitment and retention.

At Ray Dirks Research we believe that Ergomed’s contribution hints that something big may be coming. It remains to be seen whether investors will agree and that this news will continue to have a positive effect on the share price—particularly as we expect to hear more news about new clinical sites and patients being added more regularly.

After speaking to management about these positive developments, we continue to feel that current prices remain underappreciated, especially given how far along in the FDA approval process the company now finds themselves. We also take note that Ergomed has almost 25 physicians who can directly call on clinical sites to aid recruitment and retention. 

CEL-SCI obviously believes that interaction on a physician to physician level is what is needed to help physicians increase enrollment in the Multikine study.

“They key to our study is the speed of enrollment,” said CEO Kersten. “The CRO we selected is putting $10 million of their own money at stake. This, combined with our own observations in other studies makes us comfortable with their projections for enrollment figures.”

Very active CEL-SCI shares broke a down trend recently and are currently trading -54.48% below their 52-week high of $.58, so we see some technical room to the upside at these levels. The market has also seen a -1.85% decrease in the number of shares currently short the stock with approximately five days left to cover.


Disclosure: None

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