Investors of Cel-Sci Corp (AMEX: CVM) and victims of head and neck cancer have all been anxiously anticipating news regarding the validation of Cel Sci’s new, state-of-the-art manufacturing facility near Baltimore, MD where the potentially ground breaking cancer immunotherapy treatment, Multikine, will be manufactured to support its upcoming Phase III clinical trial.

For those new to Cel-Sci, Multikine is the company's flagship immunotherapeutic head and neck cancer treatment and is the first immunotherapeutic agent being developed as a first-line standard of care cancer treatment.

The clinical development of Multikine, already deemed safe and effective in a Phase II trial and then subsequently cleared for Phase III by the FDA, has been on hold as Cel-Sci dedicated the majority of their time and resources to build the Baltimore production facility. However, during the construction period when news releases regarding Multikine were few and far between, many speculated that there must be something amiss with Cel Sci, some even went so far as to question the legitimacy of the company and the very existence of the facility itself; even as Cel-Sci's L.E.A.P.S. technology jumped into the spotlight after the FDA became aware of its potential as a treatment for victims of the swine flu.

To put uncertainties to rest, late last week I was presented with an inside look at the company's new facility. Hosting my media credentialed tour were Dr. Eyal Talor, Cel Sci’s Senior Vice President of Research and Manufacturing and Mr. W. Brooke Jones, Cel-Sci’s Vice President of Quality Assurance. Both Dr. Talor and Mr. Jones undoubtedly had more pressing duties to attend to that day than walking me around the facility, however, both were also quite proud to show off the results of their vision-turned-reality.

After spending just over an hour inside the facility, I will say that at the conclusion of the tour, it was clear to me that I had not only witnessed an inside view of a best-in-class facility, but that the much talked about facility was also in its final validation stages.

In fact, according to Mr. Jones, the facility's validation process will most likely be completed within the "fourth quarter 2009" time frame that has previously been released in statements by the company.

As investors and followers of the Cel-Sci story well know, the validation is extremely important because once the facility is validated, then the Multikine Phase III trial can commence. Of note, and this was clarified for me by Mr. Jones and Dr. Talor, the facility in itself has already been cleared by design by the FDA and the validation that is currently ongoing is internal to Cel-Sci. The internal validation will ensure that the facility meets, and then can maintain, the standards of an FDA inspection which could occur at any time. The inspections, according to Dr. Talor, have become more frequent since Multikine will now be tested in a fairly large patient population during the Phase III trial; up to 800 patients, according to the trial design described on the Cel-Sci website.

As the tour got underway, Dr. Talor and Mr. Jones led me through the hallways, where I observed many Cel-Sci employees hard at work putting the finishing touches on what I could only imagine was a very long and consuming process of validation. Their work was not quite done yet, as the validation process is on-going, but I couldn't help but get the feeling that within the confines of the facility, the eager anticipation of all involved filled the spaces; an anticipation that would soon give way to the production of a potentially ground-breaking cancer immunotherapy treatment; a treatment that, if it works as advertised, could potentially save or extend the lives of millions of patients, over time.

I couldn't, of course, see everything during my tour. Many areas were deemed either too 'classified' or too 'clean' for the purpose of my visit, but the inner core of the facility was most certainly an impressive maze of rooms dominated by strict standards of cleanliness and air purity. Additionally, the vigorous and measured movement-of-personnel protocol within the 'clean' areas was an indication to me that the facility is just about ready for action.

Quite possibly the most impressive area of the facility was an area that I couldn't see - the 'Aseptic Filling Room'. In this space, Cel-Sci scientists will be able to conduct a 'cold aseptic fill' at a temperature of only 4°C. When pressed for details, Dr. Talor explained to me the benefits of utilizing the 4°C fill over using other available options out there, and the following statement taken from a March press release best summarizes his explanation:

"The use of a cold 4°C fill, as opposed to the normal room temperature fill, significantly increases the probability of maintaining drug activity, potency and thus potentially extending the shelf life of new biological and stem cell produced products."

Additionally, once the facility is validated, Cel-Sci will become the only entity offering the 4°C cold fill on a contract basis, meaning the potential to bring in significant revenue now exists.

Cel-Sci's CEO Geert Kersten perfectly summarizes the decision making process behind constructing the 'cold fill room' into the facility:

"We developed this unique cold fill technology over the course of many years and built this new facility for our cancer drug Multikine at a cost of about $22 million because we had not been able to find a company that could do a true 4°C cold fill for us. The best they could do was turn the temperature down to 60° Fahrenheit, without the needed humidity control. We have now created something very unique and something that addresses a true need in the market place. Through our new service we will help advance new treatment therapies while also creating substantial shareholder value through the income from the facility."

In my opinion, the cold fill capability and technology will eventually pay for itself, in terms of product saved and inbound contract revenue.

Also worth noting from the tour is the amount of free space available for expansion. The company has made no secret of the extra expansion space, some of which is now being used a warehouse, but all of the extra space will without a doubt be needed if Multikine proves successful in the upcoming Phase III trial.

Mr. Jones and Dr. Talor have successfully turned their vision into reality; and a fully validated production plant is within reach. According to the men who have spent most of their energy planning and building it, that validation can't come soon enough. As Mr. Jones, at one point during the tour mentioned, CEO Geert Kersten is constantly checking on the status of the validation process because "he wants to get his product moving."

For Cel-Sci, a small biotech that has at times struggled for survival, the future has never brighter. A potential treatment for victims of the swine flu has cast the company onto the national stage, but long term investors can also be confident in the fact that the long-awaited and much-anticipated start of the Multikine Phase III trial is now imminent.

The fourth quarter should be an exciting one for Cel Sci, its investors, and most importantly, for patients suffering from head and neck cancer who may now be given a new source of hope.

Disclosure: Long CVM.
Vinny Cassano also authors the popular stock investing web site VFC's Stock House.

BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section

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