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Cel-Sci's H1N1 Program is "Moving So Fast" PDF  | Print |  E-mail
Written by M.E.Garza   
Tuesday, 20 October 2009 00:00

BioMedReportsIn the mid 80's, Dr. Daniel Zimmerman, inventor of the L.E.A.P.S.™ technology, and a long-time member of the team at CEL-SCI (AMEX:CVM) was working with a diagnostics company but he really felt it was time to make a change in direction. Luckily, he did.






Special Report: 60 Minutes on H1N1

He began searching to find a way to shift career gears and move into the area of therapy. An immunologist by trade and experience, he felt a drive to start looking more closely at other immune functions and systems.

"The one area that intrigued me, because of it's importance in a number of diseases, was the area of cellular immunology," explains Dr. Zimmerman.

That area concerns the interactions among cells and molecules of the immune system, and how such interactions contribute to the recognition and elimination of pathogens.

In the most simple terms, humans possess a range of nonspecific mechanical and biochemical defenses against routinely encountered bacteria, parasites, viruses, and fungi. The skin, for example, is an effective physical barrier to infection. Basic chemical defenses are also present in blood, saliva, and tears, and on mucous membranes. True protection stems from the host's ability to mount responses targeted to specific organisms, and to retain a form of “memory” that results in a rapid, efficient response to a given organism upon a repeat encounter. This more formal sense of immunity, termed adaptive immunity, depends upon the coordinated activities of cells and molecules of the immune system.

"We made a lot of progress over the years," says Zimmerman. "Even back then, we knew that the induction of an immune response was not a simple phenomenon involving a one-on-one type of relationship. We knew that it required multiple targets interacting simultaneously- or close to simultaneously- so as to initiate an immune response. Otherwise you would not induce an immune response, you might actually end up inhibiting it."

It was this idea of taking several different interactions and training the immune response to be more specific to a medical need that led him down the path towards developing L.E.A.P.S.™ - CEL-SCI's patented technology that is used to directly mimic cell/cell interactions on the T-cell surface with synthetic peptides.

Until recently, there hasn't been much attention paid to the development of this platform, but the scientific data and studies which have been making their way into various journals and presentations are starting to paint a picture full of hope for those suffering from any number of diseases for which antigenic epitope sequences have been identified. Those include infectious diseases, cancer, autoimmune diseases, allergic asthma and allergies. Select diseases of any component of the brain or the spinal cord, such as Alzheimer’s are also potential candidates for this technology platform as well.

"We started putting these things together with outside collaborators like Dr. Ken Rosenthal (Professor, Microbiology, Immunology and Biochemistry, Northeastern Ohio Universities Colleges of Medicine and Pharmacology) and directing our research in the area of different immune conditions because there are areas of tremendous need for this- a market and medical need," explains Zimmerman. "We found that we could induce the disease and we found that we could also treat them with these L.E.A.P.S™ vaccines.

"Because we're a small company we really had to focus on areas where some of the major needs are in Autoimmune diseases [the list is quite long]. Obviously Rheumatoid Arthritis (RA) is one of them, there are several others, such as Multiple sclerosis (MS), Insulin-dependent diabetes (IDDM), but we've really had to concentrate our focus and that's what we've been doing for the last two years now and we're starting to see the results [as presented this past weekend at the American College of Rheumatology's annual meeting in Philadelphia].

"I should also mention that our collaborators at Northeastern Ohio, have actually taken the technology and have been working on some of the mechanisms of action and they'll be presenting some of that later at some upcoming conferences and meetings so that's also quite encouraging."

L.E.A.P.S™ has also captured a great deal of attention in the area of H1N1, but details about the company's dealings with the U.S. Food and Drug Administration (FDA) and its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment for hospitalized H1N1 patients are still hard to pry from the doctor, who becomes more pensive as he carefully navigates the disclosure minefield.

"Actually, I'm not really at liberty to talk about that," Zimmerman acknowledges. "We are in the process of collecting data, assimilating it and will surely present it at the appropriate time and place, but we've taken the basic concepts that we've identified with these other systems and applied them to our knowledge base for H1N1.

"There's a large amount information available now on H1N1. For example, we know that there are a number of epitopes that are what we call 'highly conserved' and are found in regions of the virus that are essential for life function so they can't readily mutate. We've focused our technology on those regions because one of the problems with H1N1 and other influenza viruses is the large amount of genetic mutations that occur so we wanted to minimize the impact of those as part of any vaccine program that we might develop. We've looked at the varioous genetic sequences of the strains, combined them with our knowledge of the L.E.A.P.S™ technology from previous work in other models, we've had the conjugates prepared and I'm really... Um... I can't go into any more detail...  But," says a suddenly smiling and confident Zimmerman, "It's quite exciting! I can say that much about it."

"It's consuming a lot of our time. We've had to put a large amount of resources on it and it's really quite an opportunity for us. Our work in Rheumatoid Arthritis will go on because we feel this is a better therapy with better benefits, but the H1N1 crisis is such an emergency that we really could not ignore it. I think we would be remiss if we had tried to ignore it, so we're taking all we've learned from these other systems and we're applying it here.

"This is the way science is done. In little steps. It's one thing to do a research study where you don't have to worry about all this documentation, but when you're doing it like we are, you have to have very good documentation of what you've done and you can reproduce it. Then you can present it to an agency like the FDA and show that you know what you're doing. It's well documented. it's founded in science and it's safe- which is one of the primary concerns of any regulatory agency- and that its efficacious and will do what you claim it will do.

"The H1N1 program is moving so fast that the normal considerations are a bit different here, but we still have to be aware of all of that. The FDA is quite concerned that any vaccine or therapy be safe and effective and no one can fault the agency for wanting that."




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Comments (13)add comment

Bill Hahn said:

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Way to go Dr Z!!!! LEAPS is the most exciting and promising system for using the immune system in disease treatment ever, you must be very pleased to see your baby bearing fruit! And none too soon!
 
October 20, 2009
Votes: +0

LS Chaturvedi said:

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I have a full faith in Cell-Sci Technology (AMEX:CVM) which is going to develop the 21st Centuary Medicine for devastating human diseases for betterment for our Society. Their techology not only "KILL" the infected area but also inhances the protection by activating our Immune System to cure the DISEASE for ever.
Wish a good luck for their time and effort for developing such Technolgy.

 
October 20, 2009
Votes: +0

Jason said:

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This is good news and I'm long on CVM but now I'm confused about it's current funding for Mulikine. On previous press reports and news articles it was stated that with current interest and private investments of almost 20 million CVM is fully funded to commence and get through phase III trials. Today an article was released by Investor Soup stating "Additionally, the Company obtained new financing of $5,845,241 in June of 2009, net of financing costs of $339,329. The Company is currently working toward a transaction that will finance its phase III clinical trial of Multikine".

Does CVM have the funds to finance the Phase III trials or are they currently seeking funding? I'm sure I can't be the only investor that caught on to this statement and are now questioning the validity of previous statements. Any insight that you can provide will be appreciated.

 
October 20, 2009
Votes: +1

nick77 said:

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Very good report. We have much to be hopeful for while being careful not to make false claims. The gathering of data, the analysis of the data all serve to make better treatments in the future. Good science takes a long time. Every once in awhile, when we are working toward a goal, something that is really useful for society takes place. There must be continued research into the basic sciences. Research takes money. That's the job of the investor, to help fund the science that is needed. The scientist today needs to report advances in terms that investors understand, and that is what Dr. Zimmerman did for me today.
 
October 20, 2009
Votes: +1

Jo Sauza said:

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My question is, why is Cel-Sci today stating that it won't begin the Phase III Trial of Multikine until they raise more
money when only a few weeks ago they stated that they had raised the money necessary for the trial, $20 million, by selling almost 15 million shares of CVM stock? That is a worrisome contradiction....are they going to apply the $20 million to the trial or not; OR did they not receive that $20 million after all......? Another point is that they have been
saying for many months now that the validation of their manufacturing facility was "soon" to be finalized??? I am a
share holder and would really appreciate some clarification.
 
October 20, 2009
Votes: +0

josh said:

...
I like what you guys are doing, and think this is a huge step towards many cures, the research that you and your company have done will save/better many lives, its just a matter of time till everyone knows about your break through,
keep up the good work.
 
October 20, 2009
Votes: +1

silvestre marcelo said:

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Hello guys,
Keep up the good works and keep us posting I like cvm and dr.Zimmerman specially the LEAPS technology.
CVM go!go!go!CVM go!I am going to stay investing on CVM!such a great company and they are the future of the world in term of medication.

Silvestre Marcelo
 
October 20, 2009
Votes: +1

truu said:

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Jason and Jo Sauza asked questions about funding for the Multikine Phase III trial: "Does CVM have the funds to finance the Phase III trials or are they currently seeking funding?"

Let me share with you the answer provided BY THE COMPANY in YESTERDAY'S SEC Filing (October 19, 2009): " Since CEL-SCI recently obtained substantial financing, CEL-SCI is moving forward rapidly to launch its global Phase III clinical trial." This is THE MOST RECENT information provided by the company, and represents a very distinct change in wording from previous SEC filings. This comes from Page 5 of this link (http://www.sec.gov/Archives/ed...000233.txt) and appears in the 4th paragraph on Page 5. Scroll down until you find it.

In my opinion, there could be some VERY big things in store for CVM investors very soon. Thank you Mr. Garza for your continued research and for helping people learn about the amazing things this company is doing.
 
October 20, 2009
Votes: +1

Roy said:

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Investor Soup's report was incomplete. See SEC filings.
 
October 20, 2009
Votes: +0

Duaine Swarthout said:

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Truu, did you continue to read the sec filings, on page 8 or 9, I had stock in this company until I read the sec filings, I sold all my stock, I was skeptical before the sec filings. I wanted to believe, so I did. I was skeptical before and it confirmed I had made a mistake. I my opinion.
 
October 20, 2009
Votes: +0

markbuti said:

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Very exciting developments for Cel-Sci.... I believe they're working on some very beneficial immunotherapies.... Because they've been working on their technology for quite a few years.... investors are seeking for tangible near-term successes (i.e. major partnerships, commencement of PIII for Multikine, successful results in H1N1 clinical trial, etc.). It's not good enough to be working on potentially blockbuster treatments.... we need to see results... with a steady progression towards commercialization. I'm long CVM because I beleive in what they're doing.... but repeating that oft-repeated line from Jerry Mcguire.... "Show me the Money!"
 
October 20, 2009
Votes: +1

Navroz said:

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Guess what! A dilution is coming before CVMs H1N1 resluts.
Garza we saw this in HEB and CTIC!

We really do not like to get crushed again. I have a faith in your report BUT suspicious about these pharamas.
 
October 20, 2009
Votes: +1

Mike L said:

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Mr. Garza,

I was wondering if you had gathered any updated information regarding Cel-Sci's results/work with LEAPs on malaria with the US Navy studies. Did Dr. Zimmerman mention anything about this area of study?
 
October 30, 2009
Votes: +0

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Last Updated on Wednesday, 21 October 2009 05:17
 

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