Barry delivered a 30 minute speech which left little room for questions. This was a prerequisite for the conference and was not his fault. I watched three presentations and all three were rushed. As a result, ENZO appeared in many ways to be the same old ENZO, for those not listening. For those listening, there were some huge releases of information. Most notably, the HEP-B Trials data was released. No kidding. And the HIV Trials were discussed in considerably more detail than I feel people were aware of. They do not know the story and cannot track in a machine gun atmosphere. Barry could not pause for effect. So the crowd was mostly lost from moment 1. One woman did ask Barry about the Patient who was supposedly “cured” in the HIV trials. I had to smile at that question. Barry explained that this was the first patient, not necessarily the best response, but all tracked in similar fashion.

I watched Millenium and HGSI before ENZO. Millenium and HGSI employ thousands of people, and depict all kinds of wonderful things, but as to TRUE exploitation of the human genome, they do not have even one trial between them involving true Gene Therapy or true Stem Cell/Gene Therapy combinations. They did not show even ONE preclinical model with promise. NOT ONE. Instead, they rely upon proteomics or antibody exploitation. I agree there are some exciting things available through their research, as they discovered these novelties through the use of the human genome, but none comparable to ENZO. Not even close. Nor will they cure bacon with their approach. Sorry to say. Maybe in the future, but not now. It is interesting to note something Dr. Hazeltine (Chairman, Founder of HGSI) said about HGSI. He said the genes of interest were already known, as to the diseases which matter most, economically speaking. Millenium also stated their fast search systems had identified numerous ta!
rgets and have filled their pipelines. HGSI and Millenium say they can make human trials more efficient and less costly. They look and smell to me, like BIG PHARMAS poised to get into the very same trouble. NOT DELIVERING. They are not curing anything. They indicated no direct awareness or intent to conduct actual gene therapy, stem cell therapy, development of platforms for evasion of immune system issues, delivery concerns, expression concerns, replication concerns, transcription and translation issues, placement issues, gene or antisense gene expression models. Nothing. Only the use of proteins and antibodies, discovered from pathways emerging from the human genome. They cannot deliver proteins where needed, when needed, and at sustainable levels. In comparison, ENZO can demonstrate a means through which the cell can be converted to produce the proteins desired or to NOT produce certain proteins. HGSI and Millenium had nothing of the sort to demonstrate. Instead, they have !
the “systems” and the “people” to create thousands of Patents, but not with the meat that is currently lacking on the plate of the huge Pharmeceuticals. I see the Biotech giants falling prey to their own lack of true knowledge. ENZO has the meat, IMO. But ENZO needs to step out of their shell. I got 10 times more information at the breakout, by asking. “Ask and you shall receive, I suppose?”.

Here is more to the ENZO release, read carefully…

Afterwards, there was a 30 minute breakout session, during which a few analysts grilled Barry on growth information, which to me matters very little. ENZO’s growth is based upon blockbuster development, although there is something else coming, clinicals and diagnostics related, apparently soon. The automated platform for rapid analysis is something a bit different than I first understood. Those familiar with PCR analysis will be happy to note, ENZO has something non-isothermal, cheaper, better, faster, and WORKING RIGHT NOW including the necessary equipment. No Abbott, no BDX, all by themselves. Barry said (and yes this has been said before), there were in discussions with a couple major players. He compared the opportunity to the current AFFX contract (even though PCR analysis is wholly different and does not conflict) and characterized the opportunity (and the players) as much, much bigger. Perhaps this is the GLAXO thing we heard about a few months ago? Because the system i!
s working now, with equipment, Barry made it clear (in the breakout) the system was ready for commercialization!

Barry insisted again, ALL NON-RADIOACTIVE PROBING TECHNIQUES ARE OWNED BY ENZO AND ITS PATENTS HOLD, AS BEFORE. Given all the litigation in the industry, I think the absence of anyone attacking ENZO right now, helps to emphasize ENZO’s enviable position.

The HEP-B Trial data really shocked me to see, right there, vividly displayed. Here is what I saw, 85% of the Patients were tracked for 20 weeks. The data was averaged across the group. The remaining 15% have not failed. Dr. Engelhardt explained that the remaining 3 Patients were still undergoing tests. There is no play on words, regarding any missing data. All the data is complied according to FDA approved techniques. A “before” and “after” biopsy was performed. Some Patients were naïve (a few never have used any drug for HEP-B) the rest varied, no one was HIV+ in those trials (for now). In order to make it clear, so everyone could understand, in both trials, Dr. Engelhardt stated that “no patient has failed so much as a single test”. The time spent is necessary to do it the FDA way. Now, here’s the beef on EHT-899. Brace yourself. Viral loads were depicted on a graph. It was an average for all 12 Patients, unlike HIV which was (and has been) depicted as a single individual. !
The viral load was VEREMIC, CHROIC for all patients. This was a prerequisite. ALT Enzymes averaged slightly over 200 for the group of 12. Inflammation was high and the effect observed prior to therapy being applied, is a high inflammation, high ALT and high viral load, readily classified as chronic HEP-B Infection. As I suspected, the EHT-899 was reduced in potency per pill, to allow the effect to slowly build. But even ENZO was not prepared for what was about to happen, right before their eyes. Remember, they have the prosimian model, but comparatively, the prosimians were tolerized much more rapidly (tiny little tree shrew, big fat pill). Here goes my observation. Week 1, nothing. 2, nothing. 3, 4, 5, nothing. 6,7,8, slight INCREASE in viral load. In fact, the viral load suddenly turns up in a tiny spike in week 8 and then, plummets almost to “0”. WOW! At the very same moment Alt enzymes start to fall at what looks like a geometric rate. Smooth even slant. ALT reduces from 2!
00 to slightly above “0”. I suppose on average, about a 5. Viral load increases at that point from near zero to a steady flat line. In the end, viral load is slightly less than half its average level, prior to tolerization using EHT-899. Post tolerization, the viral load is characterized as “carrier” level.

Inflammation is an interesting story. No one in the group ever saw the inflammation increase from the moment of application of EHT-899. Fibrosis and all other indicia stayed at the same level and then reduced, more for some, less for others. Inflammation reduction varies more per person, however, in the best case individual, inflammation was reduced all the way down to slightly above normal! In others it was higher, but in all cases, significantly reduced. Some of this was on the chart and some was gathered by asking Dr. Engelhardt. Dr. Engelhardt stated that this is, taken as a whole, the greatest response from any regimen known to mankind. Lamividine and Interkeukin II offer a 50% response rate and DIFFERENT overall effect, at high cost and with side effects. This IS a replacement for Lamividine and Interleukin II, although it would also be compatible with these two antivirals. ENZO was negotiating for more research centers in other countries for HEP-B efforts. He expects an!
 expanded Phase II encompassing about 200 people. He also said, there will be no Phase III. Let me clarify. ENZO intends to make application in Israel (I believe he said Israel) for full release. As such, Dr. Engelhardt felt the pathway to the world’s needy as a function of time, would be reduced by many years. Chronic HEP-B is mostly found in other underdeveloped countries, due to lack of nutrition and many other factors. Barry confirmed something I desperately wanted to hear. Yes, ENZO would open trials in the U.S. Yes, they would continue on the FDA route. But he also emphasized the FDA would take the Government of Israel’s approval and subsequent release into consideration. The next phase (expanded II) is a dose escalation study. This is an interesting part of ENZO’s work because in actuality, the study will be a de-escalation study. This is so very unusual, that there is no name for it. So it is termed “dose escalation” but in fact, ENZO wants to get it down to 5 pills +-!
, taken over a 1 week period as promised. Dr. Engelhardt said that they could get EHT-899 therapy down to just a few pills, taken only for a short period of time. Cost?
 $ 100. AND VERY PROFITABLE. This answers why. Why skip the FDA? Cheap and easy to manufacture, quick to market. No time for the FDA. GREAT! Sounds like a potential for a product release by mid-next year. It was crystal clear to me. Phase II expanded would take only a few weeks to administer and a few months to gather data. Remember, the de-escalation? 5 pills, maybe a week to administer? See what I mean? Phase II expanded will be quick. Again, ENZO reiterated they were in discussions in several countries to commence ASAP. Dr. Engelhardt also indicated the results on the chart were sustained. EHT-899 has delivered what appears to be, to date, sustained remission of the veremic condition, a consistent reduction of ALT enzymes to “0” and substantial, sustained and substantial reduction of inflammation in all patients. EVEN WHEN EHT-899 is removed! This is as it should be. Tolerization was meant to work in this manner. THE EFFECT IS APPARENTLY, PERMANENT, AND WITH NO MEASURABLE S!
IDE EFFECT WHATSOEVER. I reiterate, I think they have a shot at being in the market by next summer. Remember this, HEP-B is a virus which eventually clears on its own. Only the chronic condition stops a person from clearing the virus, naturally. The liver becomes a source of HEP-B virus, and a spiral effect is seen in the chronic patient. More inflammation, more viral production, a veremic state. ENZO reversed the veremic state and delivered sustained remission, at a level which represents the carrier level. In time, the virus will clear. Experts in this field, would agree that removal of the chronic indicia will lead to the natural clearing of the virus. Nothing precludes the use of EHT-899 in combination with the current therapeutics. EHT-899 is simple, cheap, elegant and effective. The platform works.

HIV. ENZO said its HIV results were astonishing. In 9801-230, ENZO laid out the things they would do. All of the things ENZO hoped for, have been proven to the FDA, according to that protocol. Successful engraftment was more a Phase II issue and was not mentioned in the protocol, but nonetheless, engraftment has been seen now in all patients. Not only had the first patient exhibited engraftment data, they all have exhibited engraftment data. The data collection process is just now completing. ENZO showed its proprietary genetic probing in action on screen, proving the presence of HGTV-43 in peripheral blood cells. A gene chip result, of sorts, was displayed for all to see, which indicated the presence of the three antisense genes in peripheral blood. Dr. Engelhardt reiterated, ALL CELL TYPES have been observed in ALL PATIENTS, bearing the antisense genes. He was very clear on these points. HIV Phase II starts very soon, Barry stated “well before the end of the year”. When aske!
d about fasttrack, Dr. Engelhardt indicated that Fasttrack would not apply until they were in Phase II. Then, with Phase II data submitted and Phase III impending, maybe a fasttrack was possible. HOWEVER, when working with Frank AIDs patients, the net effect of HGTV-43 in a patient with no immune system may cause ENZO to move more quickly back to the FDA, provided the cause/effect seen in a Frank AIDs patient warrants such action. I got a question in which was been troubling me. No longer, though. “Is a Frank AIDs patient still endowed with precursor cells which are not infected by HIV? Answer “yes”. Within the bone marrow, 95% +- of the precursor cells are NOT INFECTED by HIV, even after Frank AIDs has set in. Precursors are slightly different from mature Immune System Components. They have a lower metabolism and do not exhibit as many receptors as a mature CD4+. I then asked Dr. Engelhardt to explain Leukophoresis to the people in the breakout. He explained that white blood !
cells, precursor and non-precursor (babies and mature ones) are found in tissues, most of the time. So a leukophoresis machine would capture hardly any, if not for two different drug based means to coax white cells into the peripheral blood. The system is a fully approved means to SUCCESSFULLY TREAT other immune system disorders. I could not get into it with Dr. Engelhardt, as he needed to get to the TV studio, but I want people to understand, the Leukophoresis system has been used to restore immune systems for SCID and other maladies. I found a study, which concluded by demonstrating that a very small starter colony, applied to a SCID patient, completely restored the immune system. Not just one patient, but several. A Dr. Cohn reported that “we now know that a small starter colony is all that is needed to repopulate the entire immune system”. This was from 6-7 years ago, using the Leukophoresis machine. I think Dr. Englhardt was trying to express that the HIV+ Patients will n!
ot ever become AIDs. Only through expanded study and formation of statistical relevance, will the FDA agree. As to Frank AIDs, the protocols will be more complex, per se, but not all that much. It is clear, even if conducted under one protocol, there are actually going to be several offshoots. One for HIV+, one for initial Frank AIDs. I suspect different complexities for more advanced patients.

Will cancer respond the same? Other virus’? Bacterial infections? The answer is yes. Every day, the human body deals with these threats, quite effectively. The only reason the body fails, falls to minute differences in immune system function. ENZO is prepared to deliver the tiny advantage, which tips the scales, in favor of the Patient. And the net effect will be stunning and remarkable, but no different really from a healthy person’s advantage, against an aggressor pathogen or condition. Is it so hard to believe?

Leveraging the genome was a common theme at the conference. As far as I could see, HGSI and Millenium have learned from the genome, but they have not leveraged the human genome. Not at all. ENZO, on the other hand, has prepared to become the premiere provider of genetic delivery platforms. ENZO leverages the human genome because they demonstrate, that it can be permanently changed, that their genes express reliably, that the net effect is an impervious cell, collecting and destroying HIV. I have to say, the ability to expose and present this information seems lacking. I admit, that the format of the conference demands overheads and fancy projections. Analysts want high expenditures in R & D and fancy high speed developmental platforms. But ENZO’s R & D is done and they cannot see it. ENZO could run with their current developments for a few decades, understanding that follow on Patent efforts will still be necessary and a 5 million per year R & D budget is actually overkill. It!
 is overkill, WHEN YOU ALREADY HAVE WHAT YOU NEED. ENZO cured chronic HEP-B right in front of everyone, and I do not think most noticed. But I have to believe UBS’ Mr. Harris will notice. ENZO is ready to deliver a working product in EHT-899. A product that represents a platform for the treatment of many autoimmune abnormalities. HGTV-43 has paved the way for an IN VIVO vector. No matter how the genetic chips fall, ENZO has the key Patents. PCR is about to be rendered obsolete. ENZO even mentioned development of some new tools, to monitor gene therapy from within the cell. They intend to commercialize those tools, for any who would follow in their footsteps. I am looking behind ENZO. Who else does these things? I am looking in front of ENZO and see nothing but opportunity. They need help. They need to step out with their enviable lead. No one else appearing at the Warburg conference has a grasp on the opportunity like ENZO. Not even if you combine them all.

How can we, collectively, help ENZO? They need to accelerate all programs and cannot see it. What can we do?

Here is the biggest news yet. I asked Dr. Engelhardt about whole body transductions. Is the FDA ready? What is the current state of the art? Dr. Engelhardt explained something, which I was not aware of. The human cell is hard to transfect in such a way as to make permanent change. HGTV does it, but only outside the body. By permanent change, Dr. Engelhardt means the addition or genes or antisense genes, in such a manner as to assure replication, if any treated cell was to replicate. He stated “no one has ever transduced a whole individual, successfully. Some attempts have been made. Their failures included low transduction rates and impermanent results. AAV type vectors were used.” He also mentioned Lenti and Retroviral vectors for this purpose. Here is the mega-blaster >>>”ENZO BIOCHEM is positioned, for IN VIVO demonstration of a whole body transducer”<<< ENZO has a platform for the delivery of genes or antisense genes which makes permanent change to a high percentage of tar!
get cells, IN VIVO. This change will replicate with the cell. I then asked Dr. Engelhardt, “what stops ENZO from inserting the –43 antisense genes, into an HIV+ Patient, “whole body” and literally blast HIV out”? His answer>>>”From your mouth to g-d’s ear”. He intimated that the FDA was not a limiting factor in attempting such a feat. I hope, reading this, people understand how to put all the thoughts into one thought. Here is a progression, to help you see the light:

1) Create a means to treat one cell, make it impervious to HIV and prove it, as was done at Cornell

2) Test it on humans. Prove that the immune system is reconstructed and will not collapse

3) Improve the vector, so the protocol is rendered less invasive, more effective. (Dump leukophoresis, switch to a new vector that is direct injectible, but causes the same effect as HGTV-43 without machines, without invasion, without bone marrow work.)

4) Continue to prove the final system on HIV+, Frank AIDs, advanced AIDs

5) For advanced AIDs, combine Bone Marrow Transplant and other therapeutic platforms with HGTV-43 to attain maximum life saving effect and restoration.

I think it is possible, we will see a new vector. ENZO already has the vector developed. Dr. Engelhardt was clear on this. The FDA is apparently not limiting ENZO’s options, or other’s in the area of transducing a whole patient, in order to get all cells doing the same thing at the came time. In this case, HIV would be blasted out of the system in about 30 days, +-. Can you just imagine? THIS LITERALLY IS THE SCIENCE WE SEE DEPICTED IN STAR TREK, COME TO LIFE!

Sincerely,

Larry Glaser