If Dr. Moro did give two presentations, then when can we expect to see the abstract for "RECAF as a Cancer Marker for Gastrointestinal Diseases?"

In the next edition of Tumor Biology?

BioCurex Inc., Vancouver, Canada (www.biocurex.com)

Aim: To characterize the performance of a serum test based on the RECAF cancer marker for detection of cancers of the gastrointestinal tract.

Method: Competitive RIA, ELISA and chemiluminescence assays were developed to measure the concentration of the RECAF cancer marker in the serum of cancer patients and healthy individuals. The assay was performed on 96 well plates coated with an anti-RECAF monoclonal antibody. A suitable dilution of the serum was mixed with labeled pure RECAF using 125I, horseradish peroxidase or acridinium respectively. After incubating for 2 hours and thorough washing, the remaining labeled RECAF was measured with either a gamma counter, an ELISA reader with a 450 nm filter (after the addition of TMB to develop the reaction) or a flash plate luminometer. ROC Statistical analysis was used to determine the tests ability to discriminate cancer samples from normal samples.

Results: All formats performed in a similar manner (r>0.85). The table below shows the results:

Cancer type
Nr of Cancers
Nr of Normals
Cutoff (Units)
Sensitivity
Specificity

Liver *
15
128
4,900
100%
94%

Pancreatic #
10
50
4,600
100%
95%

Stomach 1st study *
48
40
4,600
90%
98%

Stomach 2nd study *
15
128
4,550
100%
94%

Colorectal &
51
85
4,800
100%
93%

*=Chemiluminescence, #=RIA, &=ELISA.

RECAF differentiated colorectal cancers from normal samples better than CEA and CA19.9.

Conclusion: The RECAF blood tests discriminate cancer samples from samples from healthy individuals with high sensitivity and specificity and therefore it could be used as one of the clinical laboratory tests to identify these diseases.

Would you consider calling St Jude's Hospital? They are constantly searching for ways to help children with cancer. Personally, I can't think of a better way for your discovery to help those innocent children that would benefit greatly from Recaf.

We receive calls from patients on a regular basis. The problem we have is that we cannot produce results for clinical purposes; just for research purposes, until we have FDA approval or a clinical lab setting up a home brew test that they can then use to report the results to clinicians. All that said, I would embrace any possibility of moving this marker forward, if you can provide a phone number and the name of the person you know (please email to me directly at [email protected]).

Why were the cutoff levels different for each of the tests? For example Liver@ 4900 units but stomach @ 4600 units?

Because of the way the Receiver Operation Characteristics (ROC) algorithm works. This is the statistical analysis used to determine sensitivity and specificity and it works like this: Sort the RECAF Units of all the tests in ascending order. Then take the first RECAF Units value and use it as a cutoff. See how many normals fall below that value (this are true negatives and represent the specificity for that cutoff value). See how many cancers fall above that value (this represents the sensitivity). Then choose the next patients RECAF Units value as the next cutoff and repeat the process. At the end, we have a table with a column representing all the serum values (which were used as cutoffs) another column with the sensitivities for each RECAF value and a 3rd column with the specificities. Each row contains a patients RECAF value, the sensitivity at that cutoff and the specificity for that cutoff. Since the set of values from one study to another change, because the patients are different, the cutoffs are necessarily different. Also, the calculations might not produce exactly 95% specificity and therefore, sometimes, we need to choose the closest values. As the number of cases increases, the spread between two consecutive RECAF values in the table becomes smaller (but seldom exactly the same). While the difference is small and therefore inconsequential, from a formal point of view, this is precisely one of the drawbacks of using ROC analysis. However, its advantages supersede this drawback and therefore it is the most widely used way of assessing the performance of an assay.

Dr. Moro, I am very interested in the imaging capabilities of Recaf.

We have seen a few of the images from mice and humans with the use of Recaf. I hope that I am not oversimplifying this but could't trials for imaging be set up in animals / humans relatively easy. This technology would be a no brainer if a company could package a highly specific and sensitive wide spectrum marker with imaging. Have we approached a large company such as GE or Siemens to license the imaging to?

"Our technology can locate the tumor in the body using present hospital equipment. Preliminary results have been attained in humans." After clicking the link, go to slide #16
http://www.biocurex.com/pages/PowerP...

Recaf is not just a wide spectrum cancer marker. It also attaches itself to the cancer in the body and can be identified / imaged.

My understanding is that Goshen has been working on imaging but one would think that Recaf with the imaging capability would trump all others. Even if we didn't take the next step to send a cancer killer with the Recaf, atleast cancer could be diagnosed and verified with regard to its location. This would be a large step for mankind.

1.Test for cancer regardless of type or location with a great sensitivity / specificity.
2. Locate the cancer via imaging with standard present hospital equipment.

Why would anyone want to use any other specific marker at this point? The specific markers would fall to the way side.

Your comments are right on the nail! And the answer is yes, as far as we can tell, one could find a patient that is RECAF positive and find the location of the tumor after the injection of labeled AFP or an antibody. That is in fact the embodiment of the continuation-in-part patents we have ongoing in several countries and approved in others.

Moreover, it is reasonable to speculate that we can increase the dose of radioactivity and irradiate the tumor. One of the collaborations discussed in ISOBM 2008 is with a group interested in doing exactly that.

When we explored the possibility of using RECAF for imaging, we found that the cost of the clinical trial which is very different from testing blood, because now we would have to inject patients with radioactive substances is very high and out of our possibilities for the time being. The antibody along for injecting just 25 patients costs about $1M to produce under FDA requirements.

To approach large imaging companies (GE, Philips, Siemens, etc), we need more basic results and that requires an animal facility set up for handling radioactivity, which is also very expensive. This collaboration is an attempt to circumvent these difficulties while having the backup of a University environment validating our claims.

Dr Moro this is a loaded question, so I am sorry if it appears unintentionally as criticism, but since a loan of 3 million was borrowed and is the only reason for the angst among shareholders, are you and Dr Wittenberg willing to pay off the loan with shares or borrowed money (or stock) from yourselves to remove the only remaining dead weight on this company's share price. You can always pay yourself back with more shares. It is unequivocally the only reason this stock is not at the 2-3 dollar range or are you confident that we will receive money from other sources? By the way, I have witnessed an incredible journey from your very beginnings to where the technology has progressed. I am confident that this technology possesses a valuable key in the fight against cancer. Your shareholders would appreciate any transcripts from the ISOBM that could enlighten us further on the sentiments of your peers. You DO DELIVER and that is the only reason I never waiver and have consistently taken advantage of the share price at these levels. Thanks for your comments. It does steady the ship, and takes away from the unjustified, relentless bashing.

Your question is neither loaded nor is it taken as a criticism. It is quite legitimate and it merits an answer in 3 parts:

1) Neither Dr. Wittenberg nor myself have cash in hand to pay the remaining of the debt. If I did, I probably would, but I have not sold any significant number of shares for almost 3 years and I work on this fulltime.

2) I am not sure of the legal implications of selling our shares to finance the company. The regulations specify that S-8 stock cannot be used for financing or promotion, but it might be different if it is used to provide the company with a loan to be re-paid when we get more cash. If the loan is re-paid with shares, they would have to be 144 stock, which is not a problem because we\ dont sell them anyway.

3) Some time ago, we engaged JP Turner to obtain financing. They brought up Centrecourt. After months of going back and forth, we rejected the deal. JP Turner revived it by offering to raise another $3M, with restricted stock at 25% discount over market, which could be used for many things, included payment of the loan. At the time, we were heading for a DOW at 14,000 points, a joint presentation with Abbott at ISOBM 2007, and we were advanced in our negotiations to license the technology to Biosite/Inversness. Thus, we took the loan, engaged JP Turner to raise us money as a private placement and started working on the documentation to do the private placement. The paperwork was ready by the time Inverness was announced and as a result the fund raising was postponed. The events known by all caught us (and Mr. Greenspan) by surprise and the wild swings on the share price prevented any efforts to set a price until recently. We are currently working very hard with over a dozen brokers to finance the company and while our convertible loan is currently around $1.6M, we do not need to raise all the money at once; we need approximately $200K/month, something that is relatively small compared to the efforts in place. DISCLAIMER: All that said, we do not want to mislead our shareholders promising results that might not be attainable in a market where conditions are not only extremely difficult and highly unpredictable.

Saliva test and others

Does Dr. Moro have plans to make a Rapid point-of-care test using saliva in addition to a blood test?

Yes, and we know that the sensitivity of the point-of-care strips is enough to detect the amount or RECAF in saliva. We need to put some work on this, because the saliva tests showed slightly lower results than the blood tests and the point-of-care results are slightly lower than the ones obtained with chemiluminescence, ELISA or RIA formats. We do not know yet how good or bad is the result of combining both handicaps. It will likely need some hard work to trim it and some investment in a small instrument similar to blood sugar detectors for home use to make it more precise. Currently, and given the economy and market conditions, we are using all of our resources on getting product to market (via licensees, direct sales of RECAF results and manual tests).

Are we at the end of the road as far as developing new diagnostic tests?

No, see above and below.

Can you envision anything beyond the saliva and rapid tests like a urine test?

We are working at present on a urine test, but we do not have any results to share yet.

Inverness contract

Are there product milestones in the Inverness contract and if so, when are they due? Is there progress on restructuring the debt to Camofi Master into common stock and when can we expect resolution of the debt?

There are no further milestones with Inverness. However, there are minimal royalties to start sometime in the future, as disclosed in the agreement posted at the SEC site.

For obvious reasons, I cannot comment on the debt situation until we have something material.

Commercialization

Dr. Moro

I will not be shy about stating our technology is earth shattering to state it lightly. The results with regard to the Area Under the Curve (AUC) are off the charts in comparison to other markers. http://www.biocurex.com/pages/tokyo_...

I would purchase the test in my next office visit if it were available and would also want my wife and other loved ones above 30 years of age to purchase the test as well. This in its self should be a guage as to how well Recaf will do in the market.

While I am guilty of using the word soon on a daily basis, can you give us a better time frame of anticipated trials and or commercialization of Recaf?

(IMO) The response to this can be a double edged sword with regard to share price. A time frame of 1 to 6 months would make me want to purchase even more shares. 1 year to ? would probably produce the same volume we have recently seen.

As it stands currently from a shareholders point of view Just like our famous government bailout, we can see its potential but know only bits and pieces of the plan. The unknown time frame makes it difficult to purchase shares in excess of an already healthy portfolio of Biocurex shares.

Thank You.

Thank you for your comments and your support.

This is a difficult question to answer because of the market mess we are all in. Money needs to be used sparsely and therefore progress is now slower. On the other hand, ALL we are doing now is focused on commercializing the tests. Revenue from our licensees will be much larger than our manual tests, as explained in a recent press release, but we are not at liberty to discuss time-to-market in reference to licensees. The manual tests should start generating revenue in the first half of 2009. How long the snowball will take to get big enough to generate profits it almost impossible to predict.

DISCLAIMER: We might never be able to generate enough profits to cover our expenses.

I am sure our dedicated basher will use these disclaimers against us in at least 30 posts, but they needs to be stated for legal reasons.

All I can say is that we are pushing as hard as we can on putting this technology in the marketplace.

Moving forward

Does Biocurex require more patent protection for its diagnostic division before pursuing commercialization?

No, we do not. There will be more patents because we learn things and we can use them to further protect the technology and extend the life of our current patents, but they are not necessary to commercialize the technology.

If this is the case, how many more patent filings are expected before commercialization can proceed?

Correction: Questions for Dr. Moro regarding RECAF sales in China

One of my previously submitted questions (#1) referenced the "Bejing" market, when I meant to reference the "Shanghai" market. The updated questions are shown below. Please delete my earlier post.

I'm happy to hear that Biocurex is moving closer to revenue (and a third licensee). Congratulations to Dr. Moro and staff!

I was wondering if Dr. Moro might be able to answer a couple of questions:

1. Have any of the hospitals/physicians in the Shanghai area already expressed an interest in purchasing/using the RECAF tests, or will the Biocurex China sales staff be "cold calling" to get initial sales?

We have already collected samples from hospitals in Shanghai waiting to be tested as soon as the kits arrive. The first round will be for demonstration purposes then well start doing it for money. The fact that we have received the samples is an indication of the interest on behalf of the physicians supplying them.

2. In your opinion, will the RECAF sales and test results from the Chinese market be a significant determining factor as to whether or not your other licensees move forward with automated RECAF tests and/or the rapid test (i.e., do you expect that they will wait and see how things go in China first?)

Our licensees will not wait until they see how things go in China, they are thousands of times larger than us, they have a large marketing force and they set up their own agendas. I imagine that if they see us succeed, that has to have a positive impact in them.

An interesting addition to sales in China is the collection of data that might be used for FDA applications in the USA and the equivalent agencies in other countries.

Thank you!

1) When and how much revenue do you expect from China? (Obviously, this is a test market, but there must be some idea).

See above.

2) Approximate cost to Biocurex and profit per test?

I do not think we want to share this with our customers. In general, the major cost of these kits is their initial development investment. I once calculated the cost of an ELISA for a different substance and it came up to approximately US$25 for 96 determinations (which can be from 40 to 80 tests depending on whether the tests are done in duplicates or singletons). The reimbursement amount for other cancer markers in the USA is $25-$30 per test. That is a rather large markup. A free-PSA (fPSA) test which increases PSA specificity by about 20% sells for approximately US$100 (each test). RECAF works significantly better than fPSA. In essence, the profit should be significant.

3) Is China a test market and will their government subsidize the cost for the test?

Yes and no. Shanghai is not sought as a test market, but it will teach us a lot, at least about how to move the tests to other territories within China.

4) Can we get an update on interest from universities and research centers?

Yes, as soon as we structure the collaborations I will write a summary of all of them.

Congratulations! I am trying to be patient. Your willingness to address shareholders is greatly appreciated, and will be the difference in retaining longterm shareholders that share in your vision as well as garnering new investors.

Thank you for your support and your patience. It has been a great journey for all of us and we feel that we are close to turn a basic idea into something that will help patients and make money. How often does one start with an idea that ends up exceeding ones own expectations? I personally thought that we could detect cancer measuring RECAF in blood, but I did not expect the sensitivity, specificity and the numbers we got with early stages of breast and prostate cancer, two of the most prevalent forms of this hideous disease. Neither did I expect the technical difficulties we encountered when we tried to move from the radioactive assay to the non-radioactive formats, which delayed the project. It is a good thing that they are now solved. It is indeed a pity that the market conditions are what they are Ford and GM are doing worse and that is no consolation, but it is indicative of the general crisis in which we are all immersed.

Are there plans for subsidiaries in any other parts of the world?

Dr. Moro: This is so exciting for the company. When others are pulling back we're expanding. Thanks for sharing the good news and especially thanks for the material you sent via snail mail.

We are expanding geographically, but keep in mind that we are actually concentrating all of our efforts in commercializing product as soon as possible. The China initiative, which will be followed by others, is a way to fast track revenues..

What is to prevent Biocurex from selling home brewed tests in health food stores? I've wondered this for a long while. There are all kinds of non approved remedies in health food stores.

I had a phone conversation with a shareholder a while ago. He asked me where we planned on selling the point-of-care tests. I said At the doctors office. He said: Why not at the drug stores? I would get one done every month. That way, I increase my chances of surviving if I get cancer. I am a medical doctor and I think that a doctor should handle this delicate issue, since not all positive patients will have cancer (as happens with mammography, echography, MRI and essentially any diagnostic tool used by itself). The point-of-care test is meant as an aid for the physician in his/her diagnostic process. On the other hand, if one removes the obvious emotional component, the logic of my interlocutor is right. He would have the best chances to survive