Filing wih the SEC Makes Cel-Sci's Plans Look Even More Enticing to Investors Print E-mail
By M.E.Garza   
Tuesday, 25 August 2009 05:27

Shares of CEL-SCI continue to tick upward as signs point to a resurection of sorts for this biotech play that many had on the ropes and ready for a knock-out punch.

This was a company struggling to keep their doors open before a recent influx of millions in bullish investment capital and recent debt pay-offs.

One can see trading volume increasing as speculators have begun to move in now that the most recent filings with the SEC have confirmed that CEL-SCI has also been quietly positioning itself as a player in the H1N1 space with solutions that will get the attention of parties at the CDC, FDA and beyond (if they haven't already).  This possibility now ringing more true than ever given the warning bells sounded by the Obama administration's advisory group on Science and Technology, who said in a report released yesterday afternoon that the H1N1 flu virus could cause as many as 30,000 and 90,000 deaths in the United States and that it "poses a serious health threat" to young people and children- unlike past strains of the virus.

The widely published report predicts that at least 1.8 million people will be hospitalized during the epidemic, with up to 300,000 patients requiring intensive care units. These patients could occupy 50-100 percent of all ICU beds in affected regions at the peak of the epidemic and would place "enormous stress" on ICU units.

Keep in mind that these are U.S. numbers alone and that this is one of the few countries with the financial resources to begin "hording" vaccine suuplies.  Imagine what the impact might be in coutries with far, far fewer resources.

From a trading standpoint, one need only look at the recent run ups by "small" companies like Novavax, Inc. (NasdaqGM:NVAX), BioCryst Pharmaceuticals Inc. (Nasdaq:BCRX), and Generex Biotechnology (Nasdaq:GNBT) to realize that speculative buyers have not only been turning the increasingly bad news into a Swine Flu Bonanza. Look at what those stocks were trading at back in March and realize that it only gets more interesting from here.

And so, day after day, we see press releases from companies attempting to position themselves as players in this space. Still, few have offered solutions that prove substantive after a close look under the microscope, both figuratively and literally.

By contrast, CEL-SCI has become tantalizingly alluring because they have kept their head down, busily preparing both in the lab and via back channels in Washington- at least according to some sources at our nations capital, interestingly, not far from where CEL-SCI is headquartered.

When I first approached them for comments after stumbling across them while doing research for my investigative article about H1N1 they said only enough as was required. Now, more details have emerged about the rumored flu vaccine and treatment I first told our subscribers about over the weekend. Although the details were very sketchy when we interviewed the company CEO, Geert Kersten on Friday, we have now pieced together more information about their innovative, dare I say revolutionary, approach to dealing with the growing flu problem.

The latest filing with the SEC confirms, that CEL-SCI has created one (and perhaps even several) potential peptide vaccine/treatments against H1N1 swine flu using their L.E.A.P.S.™ technology- a patented, T-cell modulation, peptide epitope delivery technology. The platform has enabled CEL-SCI to begin pre-clinical formulation, evaluation and testing of a new application of its H1N1 vaccine, which will allow the targeting of "mutated" versions of H1N1 swine and other influenza viruses. World health officials believe that the influenza virus may mutate and evolve between now and the winter flu season.

According to the filing:

"In conjunction with the testing, CEL-SCI has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non changing epitopes of the different strains of Type A Influenza viruses (H1N1,H5N1, H3N1, etc.), including "swine", "avian or bird", and "Spanish Influenza", in order to minimize the change of viral "escape by mutations" from immune recognition. CEL-SCI's L.E.A.P.S. flu vaccine contains epitopes known to be associated with immune protection against  influenza in animal models."

This is a developing story. As we mentioned earlier we have scheduled an interview with the company CEO, who was not available for immediate comment.

It is known, however that administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated, peptide antigens and may provide a new method to treat and prevent certain diseases (the company has disclosed that they are also working on a potential rheumatoid arthritis vaccine).

"The ability to generate a specific immune response is important because many diseases are often not combated effectively due to the body's selection of the 'inappropriate' immune response. The capability to specifically reprogram an immune response may offer a more effective approach than existing vaccines and
drugs in attacking an underlying disease."

Also according to the filing, CEL-SCI also discovered a second peptide named CEL-2000.

"The data from animal studies of rheumatoid arthritis using the CEL-2000 treatment vaccine demonstrated that CEL-2000 is an effective treatment against arthritis with fewer administrations than those required by other anti-rheumatoid arthritis treatments, including Enbrel(R). CEL-2000 is also potentially a more disease type specific therapy, is calculated to be significantly less expensive and may be useful in patients unable to tolerate or who may not be responsive to existing anti-arthritis therapies."

New details have begun to emerge about Cel-Sci Corporation's (Amex:CVM) new new, state-of-the-art "Cold-Fill" manufacturing facility which will not only be used to manufacture Multikine® the world's first immunotherapeutic agent (which is being developed as a first-line standard of care treatment for cancer) for both the Phase III trials and commercial sales, but CEL-SCI plans to offer the use of the facility as a service to pharmaceutical companies and others, particularly those that need to "fill and finish" their drugs in a cold environment (4 degrees Celsius, or approximately 39 degrees Fahrenheit).

This is a key process of filling injectable drugs in a sterile manner and is an important part of the manufacturing process for many medicines.

This lab, which many now consider a cornerstone to the future financial success of the company is located near Baltimore, MD. According to newly released documents filed with the SEC, it was designed over several years, and was built out to CEL-SCI's specifications during the past 18 months.

One insider calls it "absolutely state-of-the art" and "extremely impressive down to the smallest screw."

An interview between CEL-SCI's CEO, Geert Kersten, has been scheduled and more details will follow in this space as soon as I can provide them, but CEL-SCI believes it will be able to charge approximately $150,000 for an eight hour fill and finish "run" at this extremely unique facility whose aseptic filling suites are maintained at FDA and EU ISO classifications of 5/6. CEL-SCI also has the capability to formulate,
inspect, label and package biologic products at cold temperatures. Furthermore, the company discloses that they do not know of any other facility in the United States which is able to provide cold 4 degrees Celsius finish and fill services on a contract basis.

What this will mean for the financial security and future of the company is significant, particularly given the fact that the  fastest  area of growth in the  biopharmaceutical  and  pharmaceutical markets is biologics,  and most recently stem cell products. These compounds and
therapies are derived from or mimic human cells or proteins and other  molecules.  Nearly  all of the major  drugs  developed  for unmet medical  needs  (e.g.,   Avastin(R),   Erbitux(R),   Rituxan(R),   Herceptin(R), Copaxon(R), etc.) are biologics.  Biologics are usually very sensitive to such things as heat and humidty and are known to  quickly  lose their  biological  activity  if  exposed to room or elevated  temperatures (which may also affect the shelf-life of a biologic- with the  result being  that the  product  cannot be  stored  for as long as desired). 

These products do not generally lose activity when kept at 4 degrees Celsius.

This story continues to develop and we will keep you posted.

Disclosure: No Positions




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