AIM ImmunoTech Inc (AIM) 2010 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Hemispherx BioPharma third quarter results of operations conference call. At this time all participants have been placed on a listen-only mode after which we will open the floor for a question-and-answer session following the presentation. Before we begin the conference call, I need to brief all of you on forward-looking statements.

Information contained in this conference call other than historical information should be considered forward-looking and the subject of various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve the risk of completion of clinical trials, of competition, changing market conditions, changes in laws and regulations affecting the industry, and numerous other factors discussed in press releases issued by the Company and its filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company, including Ampligen and Alferon LDO are not designated safe and effective by regulatory authorities for general use and are legally available only through clinical trials for the referenced disorders. Forward-looking statements in this call represent the Company's judgment as of today's date. And the Company disclaims any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon and injection do not imply that the product will ever be specifically approved commercially for other treatment indications.

It is now my pleasure to turn the floor over to your host Dr. William Carter, Chairman and CEO of Hemispherx BioPharma. Sir, the floor is yours.

Thank you very much and good morning everyone. Thank you for listening, especially those in Europe, and good afternoon to you. We are planning with this conference call to reinitiate our regular corporate updates after the quarterly earnings, which we discontinued during what we call the previous litigation period. I'll have a few introductory remarks and turn the program over to Dr. David Strayer, our medical director who will update you on our various clinical trial programs, and Dr. Strayer will be followed by Mr. Wayne Pambianchi of the Sage Group who will update us on a variety of strategic partnering initiatives, and following Wayne, Thomas Equels our new Executive Vice Chairmen, who will provide an update on several legal issues. Then we'll return for questions and answers.

The strategic focus for the Company, of course, continues to be primarily on our platform technologies Ampligen and Alferon N injection. We'll have some new information today concerning our focus on Ampligen for the potential treatment of Chronic Fatigue Syndrome. There is very exciting new developments in that area, which Dr. Strayer will bring you up on, and also on the influenza vaccine enhancement program where we're looking at Ampligen as a potential addition for both therapeutic and preventative vaccine developments. As you know Alferon N is an FDA-approved product for the indication of refractory or recurring gentle warts, HPB. And it's also now being aggressively investigated for the potential treatment of hospitalized influenza patients. We have a new formulation of this product called Alferon LDO, which means low-dose oral, this is an experimental antiviral formulation, which we'll also bring you up to date on.

I'm going to begin today with an update on our New Brunswick facility. As many of you know, we own and operate a 43,000-square-foot FDA approved facility in New Brunswick, New Jersey, which was originally primarily designed to produce Alferon N. And you may -- some of you may recall that in September of 2009, the Board of Directors approved up to $4.4 million enhancement of that facility, which included capital improvements, engineering modifications, system upgrades, and the introduction of building management systems to enhance the production of three products, Alferon N injection, Alferon LDO and Ampligen. Of course, the latter two are experimental therapeutics.

While we outsource certain components of our research and development, which includes particularly marketing and distribution, we maintain a systems managers strong control over the entire process through our quality assurance group and our clinical monitoring group, much like, for example, the assembly of an aircraft by Boeing. So I'm very pleased, especially pleased today, to tell you that the facility upgrade, which has been spear-headed by Mr. Springgate and some outstanding researchers at that facility moving exceptionally well. I'm going to give you a few examples of what's happening there, and the implications of what is happening in that facility.

We have very good news on two fronts. Number one, we have been able to realize great cost savings in the acquisition of biofermenters and new equipment which we believe can increase the efficiency of production of both Alferon N and Ampligen, especially Alferon N. Much of this equipment actually comes -- new equipment still in boxes, with some 90% savings on list price, this is primarily due to the fact that there is a massive migration of many pharmaceutical firms, largely to the Far East, leaving behind a lot of excellent equipment which is still in its uncrated condition. So we're going to be able to realize a savings of millions of dollars, I think, at the end of the day, through the acquisition of new equipment, which was originally planned for use by other pharmaceutical companies, but which companies have apparently migrated to non-US-based manufacturing facilities.

The other good news on this front is that tremendous availability of experienced people; highly motivated and under very favorable employment conditions have joined us to assist in this initiative. To just give you a few examples of the quality of the staff of what's going on, as you know, our facility, like any manufacturing facility, is regularly inspected by the FDA. We were inspected on June 21 and June 22, 2010, that's fiscal year 2010, under what's called the SEDAR high-risk work site drug plan. And this inspection was to provide examination of current good manufacturing practice and focussed primarily on the Alferon N product. The inspection was conducted in accordance with agency procedures for therapeutic biological products, and the current most recent inspection covered quality and facilities and equipment systems, and during this inspection a complete tour was made of the whole facility and documents were reviewed that related to our what's called out of specification investigation and process and component deviation reports.

Keep in mind that because of the historic large number of pharmaceutical companies in the New Jersey northeast corridor, there is a large number of very experienced FDA inspectors and often considered among the best in the country, because of the productivity of the pharmaceutical companies in the northeast. These meetings included discussions with the inspector for our plans to produce Alferon N and Alferon LDO and Ampligen as experimental therapeutics at this facility and particularly pleased to say there were no deficiencies found during this inspection, and there is no FDA 483 forms which are commonly issued during an inspection of a large facility. So this is really an outstanding record of our staff, and I think it bodes well potentially for the compliance of our products going forward, and certainly it is an outstanding record when you consider that of other companies which operate on what we call sometimes a Route One pharmaceutical corridor.

Now the tests which are still ongoing in our new bioreactors, indicate an ability to increase the production of Alferon N by factor of at least five to ten-fold. Surely we're going to be submitting protocols to the FDA to allow us to evaluate the product identity between the amended and enhanced methods that we're using today versus the methods that we used in the original submission of a biologic license. And as you'll hear from Dr. Strayer, we will have -- we will have active trials with the Alferon N in various hospitals. Right now principally in India. Now the plan is to expand our marketing activity. We have a number of negotiations under way with partners in that area. We expect, we anticipate -- this is of course subject to ongoing work -- we anticipate that we will be prepared to commence sales sometime in the first quarter with a smaller amount of newly manufactured Alferon N, and then as we go towards the end of the second quarter, and the third quarter we would anticipate much larger amounts of Alferon N being potentially available for commercial sale.

So the significance of these findings is that we have the potential to widen the indication dramatically, especially to include the hospitalized influenza patient, and the potential ability to enter much larger markets than we've previously been able to do, and of course the inherent possibility that we will have significant flexibility in pricing models, which we didn't have when we had the older more laborious laboratory methods of production. You may remember that historically the best year in the what I call the catalog-base sales of Alferon N was about $2 million to $3 million and obviously the program that is under way is designed to make that a historical fact which is no longer relevant to Alferon N as we go forward to a -- to what we think will be a very robust program going forward. I am going to turn it over now to Dr. Strayer.

Thank you, Dr. Carter. Good morning. I am Dr. David Strayer, Medical Director for Hemispherx. Hemispherx presented an abstract at the first international workshop on XMRV which was sponsored by the National Institutes of Health in September of this year. There was tremendous interest in XMRV and closely related polytropic virus workshops.

To give you a little bit of history, this virus, retrovirus, XMRV was originally detected in men with prostate cancer. Subsequently, a peer reviewed paper was published in the October 8th, 2009 issue of Science Express by a consortium of investigators from the Whittemore Peterson institute, The National Cancer Institute and the Cleveland Clinic. This paper records the discovery of XMRV in the blood 67% of patients with Chronic Fatigue Syndrome, compared to the 3.7% of healthy normal controls. Evidence also suggested that approximately 50% of the affected Chronic Fatigue Syndrome subjects mounted a specific anti-body response against XMRV. The infected virus was also greater than 99% identical to the virus that was previously detected in prostate cancer. Earlier this year, we formed a collaboration with the Whittemore Peterson Institute to evaluate the potential role of Ampligen, an experimental therapeutic in the treatment of chronic fatigue patients who are XMRV positive versus negative. Patients with Chronic Fatigue Syndrome were known to display various immune system abnormalities and are also -- and they also experienced both higher cancer rates and neurological pathology, all of which has been associated with other known retroviruses such as HIV and HTLV-1.

Ampligen was in fact originally developed as a broad spectrum antiviral, an immune modulator, and has previously demonstrated activity against retroviruses in model systems. The first step undertaken in our analysis of XMRV was to evaluate the presence of antibodies directed against XMRV in blood samples of Chronic Fatigue Syndrome subjects. The objective of this study was to compare demographic parameters and health and performance status of XMRV anti-body positive versus negative CFS subjects that were enrolled in a Phase III clinical trial evaluating the safety and efficacy of Ampligen, a toll-like receptor 3 agonist. The response to Ampligen was regarded as the primary end point; treadmill exercise duration was also evaluated. The results suggest that XMRV antibody negative subjects have lower activity level and reduced ability to complete normal daily activity. In addition, the XMRV antibody positive cohort had a greater relative percentage of patients showing a greater than or equal to 25% increase in exercise treadmill duration with Ampligen treatment compared to placebo than the XMRV antibody-negative cohort. This response advantage of the XMRV positive versus negative subjects of Ampligen, compared to placebo may translate into leaving a smaller sample size for future clinical research using a placebo controlled parallel study design. Additional studies to further evaluate XMRV and Chronic Fatigue Syndrome are currently under way.

I would now like to provide you with an update on the clinical study underway in India with Alferon injection. The purpose of this study is to test the effectiveness of Alferon N injection to reduce the time to clinical stability and time to discharge of patients hospitalized with influenza. In April of this year we now see new partnerships with Max Neeman International, one of the leading and largest clinical research organizations in India. This collaborative clinical research effort is intended to utilize Ampligen and Alferon injection for treatment of seriously ill patients hospitalized with either seasonal or pandemic influenza. We obtained approval to begin the study from the Indian Drug Controllers General on July 13, 2010. Enrollment began during the monsoon season and will continue into the winter flu season. Currently we have four active clinical sites with the potential to open up six additional sites as deemed necessary. To summarize the data we're seeing on the XMRV virus in Chronic Fatigue Syndrome patients can potentially play an important role in the next Phase III study in Chronic Fatigue Syndrome. Plus this virus was newly discovered in patients with Chronic Fatigue Syndrome when the additional study was originally requested, and certainly warrants the time currently being spent up front trying to enter into an additional study to test the potential role that it's playing in the trial design. We also remain enthusiastic about the interest in Ampligen as the toll-like receptor 3 agonist and its potential role as a vaccine adjuvant, not only for seasonal, avian and swine flu but also for its potential role as an adjuvant in cancer vaccine. I will now turn this call over to Wayne Pambianchi, Managing Partner of Sage Group.

Thank you, Dr. Strayer. I'm Wayne Pambianchi with the Sage Group and for those of you who do not know Sage, we're finishing our 16th year of advising technology based healthcare firms on their strategies and working with them to close transactions that help build value. We have nine senior members, five in the US, one on the ground in each of the EU, Japan, Israel and Australia, and all of us have decades of operational strategic and transactional experience. Over our careers, which span back decades, we have completed numbers of transactions both on the buy side, sell side, partnering and licensing et cetera, but I can honestly say that we have not really, as far as I can recall, encountered program with so many programs rich with potential as Hemispherx. And it is our job to continue to work closely with Hemispherx management to help make this potential become a reality. And I'll share with you now some of the programs that we continue to work on.

As Dr. Strayer and Dr. Carter outlined Hemispherx has two major product programs. One Ampligen and one Alferon, with respect to Ampligen, we are working on partnering efforts for Ampligen to treat CFS and believe that the emergence of the XMRV work as an associated marker with CFS, as Dr. Strayer just described, will have a significant impact on many aspects of this indication, not the least of which is partner interest, based on the prospect of being able to identify those patients most likely to respond to Ampligen -- those CFS patients most likely to respond to Ampligen. And as you heard from Dr. Strayer just now these data are very encouraging. While we work on full fledged development and commercial partnerships, we've also been working to gain commercial relations with appropriate organizations in other parts of the world including Latin America, Asia, in the EU, all for the sale Ampligen for Chronic Fatigue Syndrome under what can be called compassionate use provisions.

Hemispherx announced its relationship with GP Pharma in the summer of this year, and we're working together with them to close on another one very soon in another part of the world. The second major application of Ampligen as Dr. Strayer referred to is as a powerful immune response enhancer for use with vaccines against infectious agents as well as diseases like cancer. We have a healthy and productive dialog with Dr. Hasegawa on his pioneering work in Japan, with a nasal H5N1 vaccine used in conjunction with Ampligen. And following technical exchanges which have occurred over the last couple of months, we have planned a senior level scientific and business meeting in Japan in the next couple of months hopefully before year end depending upon calendars. We also continue to work on what we've referred to in the past as the broad vaccine initiative. That has yielded good results.

We have three potential business transactions in serious discussions right now , as well as a significant human clinical study in cancer with a leading researcher in the field. The second major Hemispherx product is Alferon, and here in the US we are exploring both direct and partnership alternatives to gear up to meet the increased production capacity that you heard about from Dr. Carter and Dr. Strayer earlier. On the outside of the US or ex-US we're in the final stages of discussions with our Ampligen partner in Latin America, GP Pharma, to expand that relationship and include Alferon as well. We've also commenced efforts in other parts of the world to expand the commercialization of Alferon N, this in China, Japan and the Middle East. This with the development of sales in Alferon N for all of its possible indications. We're also in active discussions with CRO's to conduct a study now underway in India that Dr. Strayer just described into another part of the world. I will turn the floor over to Thomas Equels, Executive Vice Chairman and Corporate Council for Hemispherx.

Hello everyone, I'm Tom Equels; my report to you today has to do with some significant litigation results, a little less than a year ago there were some securities class actions and derivative actions that were filed. I'm happy to announce that on August 24, 2010, as a result of court mediation proceedings, we entered into a written agreement, in principal, with the court-appointed lead plaintiffs to settle all of the currently pending security class actions consolidated in the US District Court for the Eastern District of Pennsylvania.

As we reported in our most recent 10-Q, the parties entered into a stipulation and agreement of settlement on September 24, 2010, and on October 20, 2010 the court entered an order preliminarily approving the settlement directing the issuance of notice and scheduling a settlement fairness hearing for January 20, 2011. Now, if this settlement receives final court approval it will be paid from our insurance coverage and will not result in the payment of any funds by us. Furthermore, the settlement expressly is not an admission of any culpability by Hemispherx or its officers. In addition to the securities class actions, on November 10, 2010, we were happy to advise the court that we and the plaintiffs in the related shareholder derivative litigation had also reached an agreement in principal. The terms of which are still being finalized. This settlement agreement is also one that will require court approval.

However, if the settlement receives final approval by the court it, too, will be paid from insurance proceeds and not result in the payment of any funds by Hemispherx. Furthermore, the settlement will expressly provide that it is not an admission of culpability by Hemispherx or its officers. Now accordingly, once the parties have finalized and executed these agreements, we will submit it to the court for approval of the derivative action, and the timing of that one hopes will be similar, if not parallel, to the securities class action that are also being settled, and we hope to have both of these important pieces of litigation fully resolved by the end of January, 2011. That having been said, I'm turning the podium back over to Dr. Carter. Thank you, Dr. Carter.

Thanks very much, Tom. I will say that we feel very fortunate to have you not only because of the outstanding resolution of these litigations that he has just mentioned , but also Tom has a very wide knowledge of international marketing, which he is successfully helping us apply to the Ampligen and the Alferon and the Alferon LDO initiatives. So we're very pleased to have a very vital new member of our management team.

I want to now turn actually to the FDA. And you may be aware that coverage of the Company's recently been initiated by the Maxim healthcare team and while they're very encouraged about the potential sales of our products, they point out that we need some clarity with respect to our FDA directions. So what I'm going to do right now is comment on some upcoming events, which we think will provide clarity with respect to the FDA configuration. As many of you know, on November 25, 2009, we did receive a complete response letter. We'll call that CRL, from the FDA, which dealt with our Ampligen new drug application. The most important comment was the FDA reviewers felt they couldn't approve the application in its present form.

They had a series of specific issues. I think the most important issue was that the FDA reviewers felt that the two primary clinical studies submitted did not provide sufficient credible evidence on the efficacy of Ampligen, and they recommended at least one additional clinical study, which would show convincing effect and confirm that safety in the target population. Now, we have been actively analyzing that data from the FDA letter, and actually one of the -- one of the ancillary comments was that the agency felt that we also needed, among other things, additional data on what's call the QT interval.

For those of you who follow chronic disease and medications given in chronic diseases, you know that the agency has a high level of concern that the drug do no unexpected harm to cardiac function. And one of the measurements that they use historically is what's called a well-controlled QT interval study, which is -- which is, for those of you who are nascent electro-cardiagraphers, this is the time between when you get the start of the Q wave and the end of the T wave and the heart's electrical cycle. And the reason the agency is so interested in it, is that when that gets prolonged, you put a patient at cardiac risk. And, in fact, we know that patients with Chronic Fatigue Syndrome, especially women in their relatively early years and in their early 40's, can be prone to cardiac abnormalities, including massive heart attacks, which is one of the three major reasons for death in this relatively young and female population.

So we are very -- I am very excited to tell you that it looks like in several days from now a major peer reviewed publication will appear on Ampligen, and its effect on the QT interval in Chronic Fatigue Syndrome. And one of the outstanding features of this peer-reviewed article, which by the way comes directly from the 516 study, which was our major pivotal study, is that Ampligen improves the QT interval. And we think that part of the reason for this is that patients on Ampligen reduce their so-called concomitant medications. Some of these medications for pain and the severe symptomatology of Chronic Fatigue Syndrome do have a blackbox warning which tells the user that you might get into cardiac problems. So when you discontinue these medications based on the salutary effects of Ampligen in this placebo-controlled study, you do see a dramatic statistical improvement in the QT interval which implies that there is going to be an improvement in cardiac rhythm. So this is a major advance and we expect this publication to appear sometime within the next week or so.

Now, coming back to an important point that Dr. Strayer made, concerning Chronic Fatigue Syndrome and Ampligen. You may remember that in October 8, 2009, in a journal called Science Express, which was just prior to us receiving a complete response letter, a group of researchers at Whittemore Peterson Institute in Nevada, and the National Cancer Institute and the Cleveland Clinic, reported the presence of this novel virus, XMRV virus. We immediately began a series of collaborations which are ongoing with this group and Dr. Strayer summarized some of the early findings of that study. Namely number one that we did confirm the very high incidence of this virus, this virus in this disorder, and, number two, it appeared that the patients who had antibody responses to XMRV would have a superior therapeutic response to Ampligen. This is based on a study now that is ongoing, and the final, as you'll hear in a moment, of course, the final results are not in. But certainly the direction of these studies is extremely -- extremely promising, and for those of you who follow these types of potential biomarkers in chronic diseases, you know that the existence of a marker is an invaluable tool for gaining confidence in the clinical data, especially if the marker proves to be a surrogate for the therapeutic response, which based on the early data appears -- may appear to be the case with Ampligen.

So based on the new QT data, the improvement in electro-cardiographic behavior, in patients who take Ampligen versus placebo in the 516 study, and most especially based on the XMRV new data, which of course the initial data just came out, just before we received that complete response letter, and of course none of that data could have been included as part of the initial completed response. We're in the process of preparing a request to the agency to keep our new drug application open while we assemble new data on these fronts. And Dr. Strayer and his statistical team and the people who are doing the laboratory work, have actually filed -- haven't filed it yet with the agency -- but they have actually prepared several months ago and they recently amended it, what is called a formal prospective study plan or protocol, which will be submitted in the next few days to the agency. And this will actually constitute a formal laboratory study within the 516 study.

So the study within a study with a formal statistical plan that we'll be able to treat this data in a very rigorous way and then integrate it with the exercise tolerance table, which of course the agency has never objected to the use of the ETT and they appear to have a comfort level with the exercise tolerance level -- exercise tolerance test as a so-called primary end point. Now which we hope we can reinforce this with a continuation of the results which Dr. Strayer mentioned to you, and in which he presented several week ago, at an NIH meeting. We're very encouraged about this, and this formal request will be submitted very, very shortly to the agency. This may, obviously, alter numerous factors that evolve around the confirmatory study, both the size of the study, the duration of the study, even whether the study would itself be required, this would be all based on the prospective protocol analysis which is being done. And of course all of these samples being transferred to researchers, obviously, this is all done on a very blinded basis, so the opportunity for prejudice in the results is very low.

Now the -- Wayne has mentioned to you that we are very encouraged about the Japanese relationship and there has been a series of peer-reviewed papers there, I think now about four papers out of the Japanese National Institutes of Health and Dr. Hasegawa; we're very encouraged about that. And at the same time we're evaluating other potential influenza alliances, which would give us an opportunity to explore the potential benefit of Ampligen as an adjuvant. We continue to believe that the TLR3 is the preferred way to rejuvenate these vaccines, and primarily because the nature of the immunological signal appears to be very favorable for small side effects and no long-term sequelae, and by long-term sequelae, I mean for example, elaboration of lympho kinds that might trigger cancer or auto immune diseases. This was a major part of our Ampligen 516 study. And while it is certainly true we haven't monetized that study yet, we have gotten extraordinarily valuable data which will help us not own only in the chronic fatigue scenarios, but also other scenarios where manufacturers are trying to figure out the best way to enhance the potency and potentially even the cross-protection of the vaccine.

I'll end up here with a comment about another FDA issue, which is the Alferon N LDO program, which I think you know from our Qs and our K, that program was put on a hold sometime back by the FDA. Initially for three reasons. Number one, they thought there needed to be a better clinical design. This is a -- this is a program now to both prevent and treat influenza, and it involves large numbers of patients in an outpatient setting. So it is basically the hand maiden if you will to the Alferon N hospitalized patient study. We've put it on hold for three reasons. Number one, inadequacy of clinic design. We've remediated that and the FDA acknowledged our clinical design was adequate.

Number two, as we pointed out in the Q and the K, since we got the initial license, there was some new methodology that's been applied for biologic therapy to look at the proteins that you're using and these are enhanced -- we call them enhanced analytical methods. They didn't exist when we got our initial FDA approval for Alferon N, and the agency wanted us to use these tests with respect to LDO, which is a new experimental formulation. Our staff in New Brunswick over a series of several months implemented these tests. We presented the results to the FDA, and they found these results satisfactory. So the one remaining FDA request, was to produce three months stability data on the LDO preparatory to doing these preventative trials. That data was submitted to the FDA yesterday.

So our feeling is that we have -- we have met the various conditions that place that study on a clinical hold and right now we're aggressively looking at different geographic areas to implement that study. It's possible that study might even be done in Eastern Europe. It's also possible it might be done in India. And, of course, it is possible that it might be done in the United States. Not only do you want to look at costing issue, but you want to look at rate of accrual. So rate of accrual of course depends upon which parts of the world have the heaviest incidence of influenza at the time you do the study. Anyway, we're encouraged about this LDO program. Of course, if it were positive, this would be a breakthrough to have an oral version of interferon which would do the magnificent activities of interferon but not require a needle. Interferon of course continues to be the center piece of many, many treatments not the least of which is Hepatitis C, Multiple Sclerosis, et cetera. So I think I've covered those items and I'm going to open it up now for some questions operator.

(Operator Instructions) Our first question today is coming from Bart Goemaere. Please note your affiliation, then pose your question.

Hi, this is Bart Goemaere with BeursTIPS from Belgium. I have a few questions. First of all, about Chronic Fatigue Syndrome. Can you enlighten us a little bit more about the timing for the meeting with the FDA and, let's see, the construction of your SPA protocol?

This is Bill Carter. I'll turn it over to Dave in just a moment, but I would say we're in a very rapid development mode for acquiring new data, Bart. I would say we got probably 10% or 15% of the data that we -- that we want to have a really meaningful meeting with the agency. Now, as you know, there's a whole spectrum of new tests out there, and there was some controversy about the reliability of the tests as recently as six or eight weeks ago when a consortium of researchers, and this is important, the Food and Drug Administration researchers, NIH researchers, and Harvard University published a definitive paper which in their view, and we tend to agree with them, but in their view published in the proceedings of the National Academy of Sciences, they explained why there were ambiguous results in certain other labs and they set forward a method for reliable measurement of the virus.

We think this is a potential ground-breaking paper. They actually looked back at patients who were -- had chronic fatigue 16 years ago, and had samples that were available for testing. They actually looked at mitochondrial material, as well, which was a sanctuary where you wouldn't likely have any contamination. Now, one of our major collaborators -- one of our major collaborators is the group at the Whittemore Peterson Clinic. They have just moved their laboratories within what David, the last few weeks?

Yes.

In the last few weeks they've had a major move in their laboratories which has set them back two or three more weeks. Suffice it to say , that we're doing everything possible. We want to study hundreds of patients with XMRV using the very best methodology available.

I don't think we've mentioned it today, but we are expanding our open label study in 511 of which the patient will have his or her XMRV level tested at baseline and also during the course of treatment. So we will be robustly getting new data and obviously open to collaborations not only with NIH, FDA, but other parties who have qualified methodology. I would like to think that within a period of another eight or 12 weeks, we would be in a position to make a recommendation for a definitive meeting with the agency. And whether or not that evolves to what's called a special protocol assessment, or simply going forward on the basis of the data we have in the completed response letter, that's to be determined. I can just tell you that we -- we have -- we are doing everything possible to not only evaluate the 516 study, which already has hit some interesting pay dirt, but we're enlarging the patient population under existing protocols, which are already approved and authorized by the agency.

We have made certain amendments in those protocols, and Dr. Strayer has done this, to capture new data which will -- which gives interrelationship between XMRV and Chronic Fatigue Syndrome and potential treatment intervention with Ampligen. I would hope that within one quarter we would be -- we would have moved what I've arbitrarily said is 10% to 15% of the data, we would move it up to something more like 65% to 80% of the data. When we're in that position, then we're going to -- then we're going to engage the agency in a meaningful meeting. Meanwhile, Dr. Strayer is actually submitting protocols for data analysis to the agency this week, which of these prospective protocols which the agency historically lacks a prospective predeclared study plan rather than what is often called data dredging, which is looking for data any way you can.

He's presenting two protocols this week to the deputy commissioner. So we've got that ball rolling. I think -- clearly I think we're doing the right thing. You get a virus -- what is it 86.5% incidence in some of the studies of the chronic fatigue patients, a virus that is known in lower animals to cause many of the symptoms that we see in chronic fatigue patients, we would be derelict not to collect all of that data as quickly as we can before engaging the FDA. And of course to the extent that we can, collaborating with the FDA and other federal agencies in the actual analysis of the data in the actual interpretation and the actual operation of the data, not doing this data internally but doing it through independent laboratories and ultimately of course producing peer-reviewed literature. Did you have other questions?

(Operator Instructions) Our next question is coming from [Douglas Longstat]. Your line is live.

Do you have a question?

His line has disconnected. (Operator Instructions)

This is Dr. Carter. One thing I would also like to mention is that Mr. Pambianchi is presenting the Hemispherx portfolio at the Maxim Healthcare Conference. What time is that on Thursday?

3.00.

That's at 3.00, and that will be a live -- live internet presentation and there will be a lot more granularity about the XMRV data, and the implications of that data, and significant more granularity about the exciting QT data, that will be also presented in detail and we encourage you, who are interested in this, to participate in Wayne's -- Wayne's presentation at 3.00 on Thursday.

Thank you. Our next question today is a follow-up from Bart Goemaere, your line is live.

Okay. Sorry, but there was a technical difficulty, I have an extra question about the Alferon study in India. Can you shed any light on the enrollment rate so far, and when do you think you're going to reach full enrollment in that study?

Yes, as I mentioned, we obtained approval from the Indian government in July, and initiated the site selection particulars process during the summer. As we started enrolling patients in the summer at a low rate, basically to make sure we fine-tune the protocols and got the sites trained. There is a low level of influenza that occurs during the monsoon season, so we did pick up about seven patients so far during that time period. But the real influenza is going to be during the winter season. So the idea here is that we're really geared up here now to -- to complete enrollment during this winter season.

Okay. When you think that's going to end then?

Pardon?

When do you think that winter season ends in India?

It is similar to the season here. Where it will peak -- it is in the northern hemisphere, so it is very similar to our season here, which typically peaks in January. But it varies from season to season so, the planned use is now the increasing number of sites as needed to make sure we get everything enrolled during this season.

Okay. What is the amount of patients in that study?

50 patients, which is initially planned.

Okay. And then another question about the therapeutic cancer vaccine initiative, can you shed a little bit more light on that, when is the study going to start, how many patients do you think you will enroll in that study, and when is the study going to end?

We can't be specific on that today. We're actually in the final stages of protocol assessment and contract signatories. And but I would -- I would expect that before -- well, lets say in the next several weeks we would be able to make some definitive announcements in that area. We just -- we're just not able to do it today. As I think some of you may be aware, we have a very distinguished clinical oncologist, Dr. Christopher Nicodemus has joined us as a consultant over a year ago, and he was very instrumental in the Phase III trials of Obirax which was a promising therapy for ovarian cancer, which unfortunately didn't succeed in that study, but Dr. Nicodemus has other ideas and other relationships in working with him and Dr. [Beaugard] who also has a rich history in the oncologic area. We do have a number of studies. One in particular -- one major study that we would expect to announce before year-end , we simply need a little bit more time to finalize the contracts and the protocol. And we're very, very excited in this area. This is with the highest level of -- of oncologic research in the United States, the most distinguished cancer centers. We simply need a little bit more time. And we may indeed convene another conference call because of the importance of this subject. Again, I would expect that it would be done well before year-end 2010. Sorry we can't give you more granularity today.

Okay. I'm looking forward to that conference call, then. Okay. That's it, thank you a lot and I hope we can see the next quarter another conference call.

Okay. Thanks for your participation, Bart. I think that we've ran about 50 minutes here. So for those of you who have any additional questions, feel free to run them through Diane Will and again I encourage you to look at the slide presentation, and the detail that will be available on Thursday at around 3.00 on the Maxim Healthcare internet broadcast, which I think you'll be able to get the coordinates for that from our own website or just put Maxim Healthcare in your enter button, you should be able to get it. This particular call that you participated in today, should be available for the next several weeks. Thanks very much for your interest.

Thank you, ladies and gentlemen, this does conclude today's conference call. You may disconnect your phone lines and have a wonderful day. Thanks for your participation