AIM ImmunoTech Inc (AIM) 2010 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Hemispherx Biopharma 2010 year-end 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 is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, change in market conditions, change in laws and regulations affecting these industries, and numerous other factors discussed in this conference call and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company, including Ampligen and Alferon LDO, are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders.

The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of preclinical or clinical trials do not imply that any study product will ever be approved commercially for the studied or 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.

Good morning everyone. There will be six participants in the call today, four Hemispherx staff members and two key collaborators. I'd like to introduce the people, because a couple of these people have not participated in prior conference calls. Hemispherx staff will include Mr. Thomas Equels, Vice-Chairman and Counsel to the Company; Mr. Chip Bernhardt, Chief Financial Officer; Dr. Strayer, our Medical Director, and Dr. Chris Nicodemus, who is Chairman and Chief Scientific Officer of Advanced Immune Therapeutics. He has, by way of background, he has written several seminal papers on a potential use of Ampligen in the cancer vaccines space, and I consider Chris to be really a visionary in the area of cancer immunotherapeutics. We've had ongoing collaborations now for a couple of years. So (inaudible) that he can be here today as well.

Also, we will have Dr. Howard Urnovitz, who is also a key collaborator and recently a participant in a potentially very important patent of Hemispherx has filed in the chronic fatigue space. Howard is the founder of Chronix Biomedical and is a pioneer in the area of introducing new diagnostic approaches in diseases. For example, one of his earlier discoveries was the first validated urinary test for the diagnosis of HIV disease, so he brings a strong background of success at the FDA and in diagnostic science to the collaboration with Hemispherx. I think you will all find his comments today of great interest. Certainly, they created great interest at our Ninth Annual Clinical Investigators Meeting which was held about a month ago. For those of you who look at the blog sites, you see there's a lot of interest about the cutting-edge work of Howard.

So the sequence of presentations today will be a brief introduction by me, which will include a comment on the delay in the annual meeting. It will be followed by Dr. Strayer, who will speak about chronic fatigue syndrome perspectives, and that will include our expanded clinical trials and our new diagnostic programs which are very exciting (technical difficulty) of researchers around the world, including Dr. Urnovitz. He will then introduce Howard, who will drill down on the diagnostic programs that we have in place in chronic fatigue syndrome. After his presentation, Dr. Strayer will make a brief update on the Alferon Phase II clinical studies and the progress in India. Then we'll turn the program offer to Dr. Nicodemus for specific perspectives about Ampligen in the cancer vaccine space. He comes (technical difficulty) some of you saw the very interesting paper that was presented at the American Association of Cancer Research on Sunday from the University of Washington. Dr. Nicodemus will speak about this and expand the conversation. Then we will turn the program over to Mr. Equels for an update on some of the litigation issues, which I am happy to say he has resolved very favorably for Hemispherx; he will go into some details there. Finally, I'll talk about the commercial progress, especially the commercial progress for the dramatic expansion of our Alferon capability, which of course is our commercial product in the New Brunswick facility, and then we'll turn it over for Q&A.

As I think many of you know, the annual meeting was delayed actually for a number of months. It's rather interesting. I think we owe a lot of credit to Mr. Bernhardt for being able to resolve the question. For those of you who have looked into the 10-K, you'll notice that the principal SEC question which held up the Annual Meeting was how we will were valuing certain warrants which were issued a couple several years ago, a couple of years ago, with respect to a series of tranches that overall raised about $6 million. In some of the warrants which were attached to these transactions, there were certain clauses which allowed the parties to be able to create cash for their warrants. Basically the clause had to do with what happens if Hemispherx goes private, what would happen to warrants. That was (technical difficulty) at what's call an SEC parlance, a fundamental transaction. If Hemispherx were to go farther, which of course is a remote event at this point, it would create some liability for the Company. So Mr. Bernhardt undertook a very torturous and detailed program which involved bringing in external experts, using a relatively new model for valuing these warrants which is called Monte Carlo model. He is happy to talk about it in the Q&A in more detail if you'd like. But it turns out that these warrants will need to be reevaluated each quarter.

Now, for those of you who are interested in warrants, because we are all interested in them, these particular warrants have strike prices which I'm going to give you, one as follows. Some of them have a strike price of $1.65, others at $1.38. Then there are two other warrants that have strike prices of $1.31 and $1.34. So right now, they are obviously outside the money, but despite this, it requires a substantial amount of time in order to properly value them in the event of a so-called fundamental transaction, which the principal one would be the going private of Hemispherx. In any case, the issue was resolved, the Annual Meeting did occur and we of course -- sorry for the delay in conducting the Annual Meeting, but it was a very unusual situation of analysis of a group of warrants.

I'll now turn the program over to Dr. Strayer.

Thank you Dr. Carter.

Last December, the FDA granted us a one-year extension to file a response to a complete response letter. In our request to the Agency for the extension, we submitted a protocol to prospectively analyze samples from our Phase III study in AMP-516 for markers of a new retrovirus called XMRV. XMRV was originally detected in men with prostate cancer. In October of 2009, a peer-reviewed paper was published by a consortium of investigators from the Whittemore Peterson Institute, The National Cancer Institute and The Cleveland Clinic. This paper reported the detection of XMRV in the blood of 67% of patients with chronic fatigue syndrome, While only 3.7% of healthy normal controls were positive for XMRV. Also, approximately 50% of the affected chronic fatigue syndrome subjects (inaudible) a specific antibody response against XMRV.

Before the collaboration with the Whittemore Peterson Institute to evaluate the potential role of Ampligen in experimental therapeutics than the treatment of chronic fatigue syndrome patients were XMRV positive (technical difficulty) negative. To help expedite this collaboration, we are in the process of adding additional clinical sites to our AMP-511 chronic fatigue syndrome treatment protocol in which, after completion of the first 24 weeks, approximately properly 80% of the patients elect to continue receiving AMP-511 from the study. This expansion of AMP-511 will facilitate our ability to investigate through our collaboration with the Whittemore Peterson Institute, a relationship between the magnitude (technical difficulty) to Ampligen and any XMRV antiviral activity.

Ampligen was originally developed as a broad spectrum antiviral, and it's benefited activity against retrovirus in model systems. Our initial collaboration with the Whittemore Peterson Institute was to evaluate for the presence of antibodies directed against XMRV and blood samples from chronic fatigue syndrome patients. The results suggest that XMRV antibody positive cohorts added greater relative percent of patients showing a greater than or equal to (technical difficulty) 25% increase than exercised (inaudible) duration with Ampligen treatment compared to placebo in the XMRV antibody negative cohort.

More recently, through our continued collaboration with the Whittemore Peterson Institute and a new collaboration with Chronix Biomedical which you'll hear about shortly, we have extended these results by (technical difficulty) of additional subjects who are positive for XMRV by culturing XMRV from blood at the Whittemore Peterson Institute, whereby detection of XMRV (technical difficulty) in blood using advanced DNA sequencing platforms at Chronix Biomedical. This technology is extremely powerful and has the potential not only to detect XMRV but to also form the basis of a new diagnostic test for chronic fatigue syndrome.

I will now turn the call over to Dr. Urnovitz to discuss this in greater detail.

Thank you Dr. Strayer. This is Dr. Howard Urnovitz. I'm the Chief Executive Officer and Chief Science Officer and Founder of Chronix Biomedical. It's a private company. Chronix Biomedical is a discovery company focused -- focusing on the diagnosis, monitoring, and management of a broad range of cancers and other chronic conditions.

Chronix has demonstrated the utility of its diagnostic and prognostic approach in chronic neurologic diseases, in breast and prostate cancer and in multiple myeloma. It's currently conducting studies in other cancers and chronic fatigue syndrome. Chronix is headquartered in San Jose, California and has its research facilities in Germany.

Chronix generates its intellectual property through its experimental approach of analyzing fragments of DNA, often released into the bloodstream during the process of apoptosis, or programmed cell death. Chronix is using its proprietary technology, advanced DNA sequencing platforms, and the most advanced DNA sequencers to measure alterations in specific regions of the human chromosome, which can be detected as distinctive signatures in cell-free blood or in DNA. By focusing on these signatures, Chronix technology can detect the presence of disease damaged cells in a simple blood sample without needing to biopsy diseased cells or tissues. Our technology taps into the dynamic (technical difficulty) information provided by the genomic alterations unique to each diseased cell. We capture what is happening to the DNA very early and throughout the disease process in real-time and patient by patient. That's how our approach differs from the tests that focus on static genomic data, or protein biomarkers.

The patient-unique signatures captured by Chronix technology may prove useful as a companion diagnostic, a test that is used to help guide treatment decisions and to provide information about the disease process to help pharmaceutical companies select the most efficacious drug candidates. Chronix looks forward to evaluating its diagnostic technology in chronic fatigue syndrome in a study being planned by Chronix and Hemispherx Biopharma. Chronix and Hemispherx will be conducting studies aimed at validating the utility of the Chronix technology to identify how different individuals can respond to Hemispherx experimental drug Ampligen.

With that, I now turn the floor back to Dr. Strayer for an update on Hemispherx influenza programs.

This is Dr. Carter. Thanks very much Howard. I think the participants on the call would be interested to know that already there has been a major transfer of the samples from the Hemispherx repository, which of course includes specimens on many hundreds of patients as well as normals. This has already been transferred to Dr. Urnovitz as well as to various other collaborators who are pursuing parallel diagnostic tracks.

Some of you may know that there will be an update meeting at the National Institutes of Health tomorrow. While Dr. Urnovitz and Dr. Strayer will not be speaking at the meeting, there will be a meeting of our internal research group at the Bethesda location.

Basically, we are optimistic that, going forward sometime towards the second quarter, we will have organized a body of data which will expand upon the initial presentations which were made at the [NIIM] investigators conference in March, and the participants of which were identified in a news release that the Company made shortly after the conclusion of that meeting. So we anticipate that, from our present perspective, that there should be a series of scientific papers coming out in the second and third quarter based on this consortium of research, which is led by Dr. Urnovitz, and taking advantage of this very well studied repository of specimens which Dr. Strayer and his colleagues have created over the years. Undoubtedly, this is the largest repository of chronic fatigue specimens that exists, and of course we not only have the specimens that we are buying but we also have so much ancillary data which is very helpful for understanding. We have therapeutic intervention data; we have cytokine data; we have a variety of safety parameters. All this exists of course in an electronic form from our presently pending drug applications, but we can take this data and put it into the diagnostic matrix that Dr. Urnovitz and the other collaborators are creating now. So we are very excited about how this is going to roll out in the coming weeks and months.

Now I'll turn it over to Dr. Strayer.

Thank you Dr. Carter. I'm going to switch gears and talk about our Alferon studies. Our double-blind placebo-controlled clinical trial of Alferon N Injection (technical difficulty) is for the treatment of seriously ill patients hospitalized with either seasonal or pandemic influenza. As of April 2011, we have five active clinical sites and are currently adding additional sites because enrollment has progressed at a slower rate than originally projected. The major difficulty encountered has been a (technical difficulty) screening process and with a high screen failure rate, primarily because of negative results with regard to confirmation of an influenza diagnosis. In attempt to expedite the screening process, we've recently added a second point-of-care screening test which we believe will broaden out the range of [infections] (technical difficulty) influenza viruses.

With regard to Alferon LDO, in late December of 2010, the FDA informed us that the Agency had completed its (technical difficulty) complete response to the clinical hold, and had lifted the clinical hold, thereby allowing our Phase (technical difficulty) randomized double-blinded placebo-controlled study of Alferon LDO for the prophylaxis and treatment of seasonal and pandemic influenza to proceed. We are currently looking at different geographical areas to implement this study.

Finally, I want to update you on the use of intranasal (technical difficulty) as an adjuvant for influenza vaccination. In 2010 Dr. Hasegawa, Chief of the Laboratory of Infectious Disease and Pathology at Japan's National Institutes of Infectious Diseases, and his coworkers published a paper extending their previous studies (technical difficulty) the vaccine adjuvant in our mouse model system. They extended it now to a primate model. In this recent peer-reviewed publication, they showed that by addition of Ampligen to an H5N1 (technical difficulty) influenza intranasal vaccine, the monkeys were protected completely from a viral challenge with the homologous highly pathogenic H5N1 influenza virus. Moreover, evidence of cross-reactivity was also seen against mutated variants of highly pathogenic H5N1. Based on the work of Dr. Hasegawa and his coworkers [of] additional animal safety data using the Ampligen intranasally in mice, we have had discussions with the Agency concerning a new clinical protocol using Ampligen as an intranasal influenza vaccine adjuvant in humans. The Agency has agreed in principle to a Phase I/II clinical study design submitted for their (technical difficulty) pre-IND meeting (inaudible). They also made a number of recommendations for improvements in this [kind of a] study, which we are currently incorporating into a revised clinical protocol. We plan to submit the revised protocol to the Agency in the near term as part of a new IND.

I will now turn the floor over to Dr. Nicodemus to discuss our Company's cancer initiatives.

Thank you Dr. Strayer. I'm Dr. Chris Nicodemus. I'm a clinical immunologist with a special interest in the immunotherapeutic treatment of cancer. I'm the Founder and Chief Scientific Officer of Advanced Immune Therapeutics, a private immunology research company based in Austin, and I am a consultant to Hemispherx. I also was the co-author on a paper which Dr. Carter referred to that we presented this past weekend at the American Association of Cancer Research in Orlando.

I have been focusing on ways to enhance the immune response that one is able to achieve with a variety of vaccines or other therapeutic approaches for inducing immunity to allow the immune system to fight cancer. One of those agents that I've been working with has been Ampligen. I've been asked to participate in the meeting to talk about Ampligen a little bit more in this context. This is obviously a different application of the product than what has been talked about in the other portions of the call.

But Ampligen is in fact a very potent toll-like receptor agonist, which means it stimulates one of the TLR3 pathways. TLR3 is one of several toll-like receptors, and ones that you may also be familiar with are such compounds as CpG, which stimulates a different toll-like receptor, and the lipid A molecules which also stimulate in this case TLR4. So there are a variety of toll-like receptors that have all been characterized just in the last decade. In fact a lot of this work is really very recent.

Ampligen was originally designed as an interferon inducer because of its safety profile relative to other interferon inducers. This was before the time that the toll-like receptor pathways were identified. In fact, there has obviously been a large clinical experience using Ampligen, which from the perspective of our cancer immunotherapist is very important because they are looking for ways to stimulate immunity, and (technical difficulty) to use compounds that have clinical experience as opposed to perhaps combining agents that haven't been used in people before. So with this, we have found and we published on this last year that Ampligen stimulates the specific immune response (inaudible) dendritic cells. And dendritic cells are a form of antigen processing cells, so it's how the immune system takes anything that it wants to develop a response to and presents it (technical difficulty) effector cells with the immune system (inaudible) the T cells or the lymphocytes. This biology has been well characterized in the last several years, and independent investigation at a number of leading institutions have assembled a very substantial body of literature now that really does characterize this biology and gives us insights into how we might use this therapeutic advantage. So the role of Ampligen is a potential immunotherapeutic enhancer [or] adjuvant for cancer immunotherapy I think is now well established.

I think it's also noteworthy that there is recent successes for the immunotherapy of cancer, notably recent approval of ipilimumab and also last year the approval of Provenge are two examples of immunotherapeutic products that are using the immune system to fight cancer so that the promise of these treatments moving forward is substantial.

Our presentation at the AACR (inaudible) the potential for Ampligen when combined with (inaudible) viruses is a breast cancer model, and Ampligen was able to improve the efficacy of the vaccine in this model. It's important because it generates data that will now be translated into human clinical trials.

So at this stage, we are very excited because Ampligen (technical difficulty) positioning itself to now be introduced in yet another area which is in combination with a variety of immunotherapeutic strategies. We anticipate that clinical studies in several different specific applications will be rolling out at different institutions around the country in the coming months.

With that, I believe Dr. Carter would make a comment and then --

Thanks very much Chris. Chris has really been the prime mover over the last 24-plus months in creating collaborations which, as he implied, are and will lead to clinical trials really very momentarily. As he suggested, breast cancer and ovarian cancer are primary targets. I encourage you, those of you who may have seen it mentioned before, to -- if you have a moment, to go back and look at his recent few articles in cancer immunology which I think are -- lead to the direction that we are pursuing very, very aggressively. So that is going to become a very significant topic area for us in the coming quarter and indeed throughout the three remaining quarters of this year.

I'll turn the program over now to the Executive Vice Chairman and General Counsel, Tom Equels.

Good morning everyone. Thank you, Dr. Carter. I'm Tom Equels, Hemispherx Executive Vice Chairman and General Counsel.

I'm pleased to announce that the federal court in Pennsylvania has approved the final settlements of both the securities class actions and the shareholders derivatives actions which we had discussed in some previous meetings a little more than a year ago. Pursuant to the terms of the settlement, no Company funds were expended as the settlements were fully funded by the Company's insurance, and there was no admission of wrongdoing on the part of Hemispherx.

Further, I'm pleased to announce the successful resolution of the approximately $5 million claim brought against the Company by MidSouth Capital related to a claim for commission as to certain fundraising that was done for the Company. The federal court in Atlanta, Georgia recently dismissed its claims entirely, and that resolves the pending potential appeal of that case.

Finally, with regard to the approximately $188 million judgment, which is final, there was no appeal, which the Company obtained in federal court in Florida against Johannesburg Consolidated Investments, also known as JCI, a public company in South Africa, we're in the final stages of preparing an action to domesticate that judgment in South Africa.

That concludes the major and material matters that I've handled as General Counsel.

Okay. Congratulations on the whole spectrum of your progress and accomplishments, Tom.

Thank you.

Before turning it over to Q&A, I'd just like to make a couple of commercially-oriented observations.

Looking at the work of and the projected work which Dr. Nicodemus mentioned, which included the two recently approved cancer vaccines, on March 31, Medicare approved a $93,000 payment for the use of the prosthetic cancer vaccine [Aprendion]. At about the same time Eli Lilly -- sorry, not Eli Lilly, Bristol-Myers Squibb of course announced that they expected that their new melanoma drug ipilimumab would be priced at roughly $120,000 a patient. So there's very interesting economic evidence out there that once paydirt is reached in the cancer vaccine area, especially in these (inaudible) life-threatening cancers, that the reimbursement perspective may emerge quite favorable.

I would like to close my comments before questions by just a couple of moments on the facility in New Brunswick. I don't know many of you have seen that facility, but it is a large one, relatively large. It's 43,000 square feet and two large buildings, of course our FDA manufacturing facilities, FDA approved and has an establishment license for Alferon N.

One of the great challenges with Alferon N of course has been that is the only natural interferon, meaning that it had to come from human blood which was secured from the American Red Cross. It was a very labor-intensive process. I understand that in the earlier days when they went full manufacturing runs that not only did they have the buildings filled but they actually put trailers in a large parking lot and basically might have as many as 200, 225 people who were processing very small (inaudible) in which was contained the Alferon N.

However, due to the outstanding work of our team in New Brunswick led by Wayne Springate and Dr. Russ Lander and Dr. Chris Cavalli and their very outstanding staff which probably has an average age of about 24, they are working six, seven days a week typically, they have managed now to position themselves where, in the next steps of our production, we will be going through 600-liter tanks, which basically instead of having 200 to 225 people mixing small vessels, we will have 1 to 2 operators looking at (technical difficulty) and managing these large tanks. While the process is not yet complete and the amendments to our approval have of course not been submitted or approved by the FDA, we are very optimistic that the product coming out of those 600-liter tanks will be identical to the product which was made in the smaller containers. This will really be a major breakthrough in the production of Alferon N, which is as you know has many unique features which grow from the fact that it is the only FDA approved interferon in the United States which is made from human cells. It has no recombinant features. Therefore, it has -- it is a perfect mirror image of the body's own interferon.

Recently, you may have seen one of our releases. We were very fortunate to higher Ron Ritz, who had been in charge of the [BUD] unit at Johnson & Johnson -- I guess there's 100 to 200 people there -- before he became a senior manager manufacturing executive at Enzon. He is going to the team with a huge experience and I think that this team will be able to produce unprecedented amounts of this product, which will dwarf what we were ever able to make in the past. Of course, in anticipation of that led by Mr. Equels and others [who] is presently exploring new marketing arrangements which we hope to be able to announce sometime in the next quarter, pending of course the completion of those negotiations.

So with that, I think we will turn it over for questions and answers. Would the operator bring on the questions now?

Certainly. (Operator Instructions). Bart Goemaere.

This is Bart Goemaere from BeursTipd in Belgium. I have five questions. I'll go over them one by one. The first question is for Dr. Strayer regarding the clinical trial in India. What is the exact amount of patients that have to be in the trial and what's present number of patients that is in the trial right now?

We have an enrollment plan of 60 subjects total. We have 14 that are enrolled presently. I might say that all 14 have completed the full 30-day course and had no evidence of any toxicities, (inaudible) toxicities.

There is a plan to accelerate the enrollment. When is it expected that you are fully enrolled?

Over the next two months, we're going to be increasing the number of sites, as I mentioned. We also added the second RAPID antigen test which will hopefully improve the screening. We screened a large number of patients, but 70% of those patients were not confirmed to have influenza. So, we are hoping that, by addition of the second RAPID antigen test, that will dramatically change. So if that in fact happens, we would plan to -- we would complete the enrollment through the next flu season.

Okay. The second question is also for Dr. Strayer and for Howard Urnovitz. Regarding the chronic fatigue syndrome test in cooperation with Chronix Biomedical, how long do you think it will take to let's say set up such a test? When do think such a test can be approved? Because if I understand it correctly, the let's say approval of the test is a prerequisite to start the Phase III clinical trial in chronic fatigue syndrome.

Dr. Strayer, do you want me to explain the first phase and then you can explain the second? Okay. So this is Dr. Urnovitz of Chronix Biomedical. So the first study for us to do is a blinded proof-of-principle study where we are sequencing number of statistically veiled samples that in our control means that we will have that done by the end of May and hope to send -- submit a manuscript end of June and then more immediately start planning a larger clinical trial, and we're determining the size of that. There certainly should be more than let's say 300 samples, and do that larger validation and then publish that data.

Dr. Strayer, do you want to describe what happens after that?

Yes. Once we have some confidence that this diagnostic test is predictive, at least in our test samples and test groups of patients that are being studied, we will need to go out and obtain additional samples, really independent samples, from a number of sources that are all (inaudible) blinded against the normal controls. The good thing about it is Dr. Urnovitz's tests can be done quite rapidly, so it shouldn't take that long to do these samples. We'll be, over the next month or so, we will be [lining] up these samples so that we [should] be able to move directly into that phase. So we would expect that by the end of summer or in the fall that we should have this completed.

Okay. Then afterwards then, you're planning a meeting with the FDA on the protocol for the new Phase III clinical trial. Is that correct?

After we have this data, we obviously have to see what the data shows. Then based on what we see, then we would have a meeting with the FDA to discuss how to go forward, what's the best way to go forward.

This is Dr. Carter. If you read the recent approval of Human Genome Sciences lupus erythematosus drug, you will see that drug was obviously approved on the basis of a retrospective study of a subset of patients in a Phase III study that was initially deemed to be insufficient. But upon subset analysis retrospectively, the Agency determined that it was -- it met the criteria for safety and efficacy.

We can't predict -- we cannot of course at this point predict the robustness of the data that will be derived. Everything that has been seen so far in a relatively small number of samples is very encouraging. But it will -- whether or not there is a requirement for an additional Phase III study or indeed could perhaps be a Phase IV postmarketing study, this will all turn on the robustness of the data, and as you suggest the necessity to validate the laboratory components to be sure that they meet a regulatory standard. But it's certainly not inevitable.

History teaches that in chronic severe diseases for which there is severe debilitation and especially in this instance where Dr. Strayer, working with our senior statisticians, we actually submitted to the Agency a prospective protocol which showed exactly what we would do with the samples as we obtain them. So there is no way this will be interpreted as data dredging, which is a popular way to try to find a positive (inaudible) prospective protocol on file showing exactly the methods and the statistical programs that will be used and how that data will be then connected to the efficacy data that we already have. So in one scenario, we simply amend the existing and [encourage] the existing tables by putting in the virus component data -- or I should say it may be something more complex than virus. Let's call it (inaudible) or some variation therein. We have been given that invitation and authority by the Agency to execute this work on or before -- what is it David, the end of November or something?

Yes, November.

At such time as we have data was we believe is robust enough, we will of course commence earlier meetings. There's no need to necessarily wait, but beyond the point that we as a group of physicians and scientists have concluded that the data is sufficiently robust, then of course we would have a meeting. It might be sooner than Dr. Strayer, much sooner; it might be somewhat later.

Okay. Then another question for Dr. Strayer regarding your Alferon clinical trial in the United States. Because the line was not so good, is it correct that you're applying for a new protocol, or how do I have to understand that?

Yes, there will be a new protocol under a new IND for the use of Ampligen as a vaccine adjuvant.

Okay. Then two questions about partnering. First of all, your deal you have with Biken in Japan, why there is no -- why is there no agreement yet? Because the agreement has expired I think it was in September. The second question on partnering is regarding partnering on Ampligen. If I'm not mistaken, in the last clinical trial, there were talks about discussions with the prospective partners. What's the status of this right now?

This is Will Carter. Bart, one point I don't think David perhaps made sufficiently clear due to the telephone issues. We already have authorization in principle from the FDA to conduct an intranasal trial. We have not submitted the final protocol, but we have submitted the [luminus] data to the Agency, telephone meetings have been held, and as Dr. Strayer said, the Agency is agreeable in principle to the study that we plan to do, which would be an intranasal application of Ampligen with an influenza vaccine. So it's really a matter right now of us simply submitting the final protocol, which I'm looking at here to the left of the phone. So we are preparing to launch that protocol in the second quarter. Absent any unusual surprises, that is a likely outcome.

One of the reasons that we've done it in this way is, as you imply, the Biken relationship has been unusually protracted, and we made the decision to proceed with the clinical trial, with or without a formal contract or understanding with the Biken organization. We consider that the trial is of sufficient importance that it should be done regardless of the status of the Biken relationship.

What's positive about that relationship is that the proof of principle in the augmentation of Ampligen, both for seasonal vaccines and the ability (inaudible) across species and protect against pandemic flu using seasonal vaccines, that has been demonstrated in a series of peer-reviewed articles published by Dr. Hasegawa and in some cases Dr. Strayer has been coinvestigator -- a series of peer-reviewed articles over the last couple of years. So the scientific foundation has been laid. At this point, we certainly can give no assurances that there will be a Biken relationship. However, we can give assurances that we do believe that we will conduct the anticipated clinical trial very shortly. We've actually already identified the candidate, location for the trial, etc.

Is that in the United States or is that in Japan?

It is in the United States (inaudible) which is why we have had the ongoing dialogue with the FDA. We plan to conduct the trial in the United States. Based upon the data that we have now, we believe that trial should commence sometime in the second quarter.

I want to emphasize that we have not yet filed the final protocol. However, I'm looking at it to the left of the podium, and we can certainly file it within a few days. That starts a 30 -- what is it David? A 30-day trial? During a 30-day period, they can ask questions or they can decline to ask questions, in which case, after 30 days, we would be allowed to start the protocol. But we have identified the location. We will get exactly the conclusions that we anticipated from the Biken relationship, and in fact arguably we'll get much more because we never had an understanding that the Biken product would be brought to the United States. We would've had to study in Japan, whereas the products that we're working with now we think have greater application on a worldwide basis, which of course is where we would like to be.

Anything else on partnering in Ampligen?

Not at the moment. It's an area -- it's a very, very active effort, especially under the leadership of (inaudible) and Mr. [Pan Lianki]. I think one of the big focuses at the moment has been to -- an undertaking to complete the negotiation with our marketing partner so that when the yields of Alferon N come out of our facility, that we will be poised to be able to distribute and market that product. So there's been a lot of effort in that area, very regular meetings. There was, I think, a meeting this week. But of course we are looking at the other issues as well.

Okay, thank you very much, and good luck.

Thanks so much for your questions. Are there any further questions, operator, or Diane?

Yes. [Rodrigo Joya].

Michael [Caine].

In the past conference calls on the cancer vaccine side of things, in November, Dr. Carter said within weeks (technical difficulty) dotting the "I's", crossing the "T's" with a cancer contract or partnership, and then today you're saying momentarily. Back in 2009, it was delicate negotiations with a top [bio] vaccine maker. I'd like to know where we stand on this, really. I don't understand. It's always something in the future.

Let me say this. We have two SBA authorizations in hand to commence cancer vaccine trials. We've chosen not to mention these institutions which are obviously renowned institutions, as Dr. Nicodemus suggested, until we actually enroll the first patient, because as Dr. Strayer pointed out, we were disappointed in the rate of enrollment in India. We think we've found ways to overcome it. As you pointed out, we were crossing "I's" and dotting "T's" several months ago. We haven't made any announcements about those trials. Those investigators were at our annual -- ninth annual meeting a month ago. We do have FDA authorization to start the trials. Patients are being screened for these trials. I would expect that very, very soon, when the first patient goes on, we will make the announcement. These areas will be breast cancer and ovarian cancer. But a corporate policy has been made that, until we put the patient on, let's hold back on announcing the trial.

But I can assure you that, in this case, literally the "I's" are dotted and the "T's" are crossed, and the contracts are signed, and all of the necessary regulatory approvals are in place. Indeed, in one case, the drug has already been shipped to the cancer center. So you're right, I'm not going to say that delays don't happen. There's a lot of regulatory issues here. Sometimes when you're dealing with these large mega-universities, you run into challenges with the intellectual transfer [office]. But all of that is behind us, and I think we will be announcing this very shortly.

Do you have any other questions, or was that it for the moment?

We will take one or two more questions if there are. We've been here about an hour, so will try to wrap it up shortly. But are there any more questions at the moment?

We have no further questions in queue at this time.

Thank you so much. If you do have further questions, please direct them to Diane, and we will try to get back to you as soon as possible. Thanks for your interest. Bye.

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