Advaxis, Inc. (OTCBB: ADXS)

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August 28, 2009 Issue

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Advaxis Is Using The Listeria Bacteria To Activate The Immune System To Attack And Fight Various Kinds Of Cancers And Infectious Diseases

Company Profile:

Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board. Advaxis is developing attenuated live Lm vaccines that deliver engineered tumor antigens fused to an adjuvant protein, which stimulate multiple simultaneous immunological mechanisms to fight cancer and infectious disease.

Thomas A. Moore

Chairman of the Board of Directors and Chief Executive Officer

Effective December 15, 2006, Thomas Moore was named Chairman of the Board of Directors and Chief Executive Officer of Advaxis, Inc. (OTCBB: ADXS). He also serves as Chairman of the Board of Directors of Mayan Pigments, Inc., a proprietary colorant company developing patented Mayan pigment technology; Medmeme LLC, global medical knowledge and competitive intelligence database company serving the professional healthcare community worldwide; MD Offices, an electronic medical records provider; and Opt-e-scrip, Inc., a drug response assessment company that markets a clinical system to compare multiple drugs in the same patient. From June 2002 to June 2004 Mr. Moore was Chief Executive Officer and President of Biopure Corporation (Nasdaq: BPUR), a developer of oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues. Prior to that, from 1996 to November 2000 he was Chief Executive Officer and President of Nelson Communications. Mr. Moore had a 23-year career with the Procter & Gamble Company (NYSE: PG) in multiple managerial positions, including President of Health Care Products where he was responsible for prescription and over-the-counter medications worldwide, and Group Vice President of the Procter & Gamble Company.


Advaxis, Inc.
The Technology Centre
of New Jersey
675 US Route One South
North Brunswick, NJ 08902
Phone: 732-545-1590


Interview conducted by: Lynn Fosse, Senior Editor,, Published – August 28, 2009

Mr. Moore, how has Advaxis changed under your leadership?

Mr. Moore: “Advaxis has taken new directions in three different areas. First from the standpoint of the financial structure, I led a raise a year and a half ago, which both gave the company enough funds to operate, and allowed us to buy out a previous toxic debt provision. So it helped significantly clean up the balance sheet. The raise we conducted was straight stock and warrants, so we have been able to back out of toxic financing structures into something that investors can clearly understand and I think buy into. Two, we have worked with FDA to develop a clinical program that is more commercially oriented than the one the company had before. The company was developing its first construct, originally for cervical cancer and now we have broadened it to work both for cervical cancer, which is terrible problem worldwide, but relatively rare in the United States, and complemented that with a program in something called CIN, or cervical dysplasia, which is the predecessor condition to cervical cancer, which is very common in the US. That is what PAP smears are designed to detect. By creating a more diversified clinical program, we have a better commercial platform for the company. The company has developed more aggressive public interface thanks to the people on our team. We are presenting more science to conferences and the more investor outreach activity, which has been helpful to the company and its shareholders.”


CEOCFO: Would you explain what your concept and technology is all about?

Mr. Moore: “We use the body’s own immune system to fight various kinds of cancers and infectious diseases. We employ a very novel technique for that by using a bacterium the body encounters very frequently and for which the body has a very strong immune reaction. Then we further modify the bacteria, so the immune reaction is directed against whatever we choose, with our first constructs against specific kinds of cancer. We inject the patient with this modified Listeria that stimulates the immune system and directs it to attack the tumor. In animal trials we have shown extraordinary results where every animal benefits from it and amongst normal animals, 75% of tumors that were preexisting before we injected, were actually cleared. With human research on our first construct, targets cervical cancer, we showed some very encouraging results. While on a very small base, it suggested at least for that group of patients we were able to double their survival time, compared to what would be expected and increase the percent of women who survived up to a year from an expected 5% to 53%.”


CEOCFO: Those are large numbers and a significant difference!

Mr. Moore: “We think this is a very significant technology, which has great potential, but it is up to the company to develop it so that everyone agrees. Scientifically our work is creating a considerable degree of excitement. It is up to us to take it to Phase II trials that we are getting ready to launch, which demonstrate amongst a larger group of women, that what we have seen in animals and what we saw in a first small clinical trial; is in fact real. We are pretty optimistic that it is.”


CEOCFO: Has Listeria been used in the past?

Mr. Moore: “The idea actually stems back to the 19th century. In the 1800’s, a cancer physician in New York, found that if his patients came down with certain types of infectious diseases like small pox or yellow fever, [found that] their tumors stopped growing and started to shrink. That was [at] a time when nobody knew about the immune system. But he observed this effect; so, he developed something called Coley’s Toxin, as his name is Dr. Coley. It would be deliberately administered to cancer victims, and while they suffered from this infection, the cancer often temporarily went into reverse. A hundred and twenty years later Dr. Yvonne Paterson, who is a professor and associate dean at the University of Pennsylvania, developed the idea of utilizing Listeria to create somewhat the same effects but in a much more specific and targeted way. Other bacteria had been experimented with for this type of application but they have all proven to be either much less effective or much more dangerous than the choice of Listeria. So with Dr. Paterson’s initial research and continuing research, in a close relationship with Advaxis, we have been able to create a terrific body of intellectual property around the use of Listeria and certain improvements we have put in the system that make the bacteria safe. In addition, we have found ways to further heighten immune reaction and address some problems that previous cancer immuno-therapies had that we think we have now licked.”


CEOCFO: Where is the source of Listeria?

Mr. Moore:Listeria is all around us. Finding Listeria is as simple as checking your salad. Listeria is a common bacterium as it appears in the soil, leafy vegetables and dairy products. Periodically, you will see news reports about people coming down with a Listeria-caused illness generally because they have an impaired immune system or through some bad planning at a family picnic. Listeria is easy to find. What we do to it though, is hard to do. We genetically alter it to make it both safer and further enhance the immune reaction. We put into the Listeria what is called an antigen, which is like a small sample of the tumor we want to attack; it does not have to come specifically from the patient but through the generic sample of that tumor. We fuse that to an additional protein that significantly enhances the immune effect.. So, you have this Listeria that has been altered and, when injected into the body takes up residence and continually secretes its payload that redirects the immune response to Listeria, against the tumor. That is how you get your immune attack. Human beings probably contract cancer several times in their lives, but the immune system normally detects it and sweeps it away so you never even know. But, occasionally the immune system doesn’t do that and the tumor is allowed to develop and the tumor actually gets protection from the immune system, which will foil an immune attack. We are break this tolerance of cancer as a foreign tissue and get the immune system to attack it, in an especially powerful way. We have also shown we reduce the cells that counter an immune attack by 80%. So we can both reducing the size or eliminate the tumor and with what are pretty minimal side-effects for the patient.”


CEOCFO: Does the general availability make it an inexpensive treatment?
Mr. Moore: “It is expensive because the technology is very involved and creative; but manufacturing it is relatively inexpensive.”


CEOCFO: Where are you today in the process?
Mr. Moore: “We have successfully completed our Phase I trial and we have FDA approval to a Phase II clinical program to go after this precursor condition called CIN which is what women detect with PAP smears. That market in the US is huge. The number of women who are contracting CIN is probably around 450,000 and 250,000 women a year; actually undergo surgery to treat the condition. In that area, we are conducting a Phase II trial, which we hope will demonstrate that we can reduce the need for surgery dramatically for those women and allow them to avoid the pain are risk associated with surgery. On the cervical cancer side, we are going to do a large study in India where cervical cancer is a huge problem, because they do not use PAP smears as commonly as we do in the United States. Our objective will be to demonstrate a significant increase in survival time and quality of life; in line with what we demonstrated already in our Phase I study among a similar population.”


CEOCFO: Is there a time when you will be looking at partnering?

Mr. Moore: “There are partnering discussions going on, but nothing that I can say is confirmed at this point. Generally, our strategy, as with all biotechs, is to try to get a partner at a time when our shareholders can get a good value and when it makes it possible to accelerate the development of the technology.”


CEOCFO: Are there many competing technology in this area?

Mr. Moore: “There is a lot of Listeria research going on at universities, but at this point in time we are the only commercial company developing commercial applications for the technology.”


CEOCFO: So you are ahead of the game!
Mr. Moore: “We are very much ahead of the game. That is very good for us, and with our patents, we think we can stay ahead of the game.”


CEOCFO: In closing, for potential investors, why does Advaxis stand out?

Mr. Moore: “Advaxis stands out for three key reasons. Number one is the history of this technology, which so far is really pretty sterling. Our animal results are certainly superior to any company we know of and our human trials, while a very small base, are extremely encouraging. We have a clinical program going forward that is sound and commercially oriented, which could lead to licensing opportunities some time between now and the next 24-28 months. Second, our team has years of experience in actually developing pharmaceuticals and making them commercially successful. We think we bring a high degree of experience and a good track record to the party. Lastly, the science of immunotherapy in general now is getting a lot of recognition and increasing acceptance as likely the next wave of how we will treat cancer as well as other infectious diseases. Our approach is unique, but makes great scientific sense. We think we can deliver the goods.”


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“In animal trials we have shown extraordinary results where every animal benefits from it and amongst normal animals, 75% of tumors that were preexisting before we injected, were actually cleared. With human research on our first construct, targets cervical cancer, we showed some very encouraging results. While on a very small base, it suggested at least for that group of patients we were able to double their survival time, compared to what would be expected and increase the percent of women who survived up to a year from an expected 5% to 53%.” - Thomas A. Moore does not purchase or make
recommendation on stocks based on the interviews published.