RICHMOND, British Columbia, June 27, 2011 (GLOBE NEWSWIRE) -- BioCurex Inc. (OTCBB:BOCX), a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics, today announced that CEO, Dr. Ricardo Moro, released a letter to shareholders. The letter serves to update Shareholders on the current events at BioCurex and the Company's plans for the future.
In the past few months, we have converted our canine RECAF tests to work with a synthetic peptide and we can say conclusively that it performs better than the previous antibody-based test. We have also been working on ways to preserve canine serum samples at room temperature for 10 to 14 days without affecting their RECAF test value. This is of paramount commercial relevance because veterinarians anywhere in North America could then send us the samples to test by regular mail at a fraction of the cost of shipping them frozen (in some locations, the cost of shipping frozen samples is higher than the cost of the test). It goes without saying that this innovation is very relevant to distributors in the USA and Canada because it lowers the cost of the test for the veterinarian by about 50 percent without lowering margins for them or the Company. By the same token, this will also help our future distributors in Europe and Asia. We have made significant progress in developing this technology, but research in an emerging field is unpredictable and thus time consuming. Yet, as the Company works through the experimental options that will provide the most stable results, the value of the data and the knowledge acquired by BioCurex, the more valuable the underlying technology and future products should be to the marketplace. There are many examples like this one and it is difficult to keep our shareholders up to date on the weekly advances we make in all these fronts. Thus, rather than discussing them one by one we'll focus on the value of the company and its technology, because shareholders who see their value deteriorate tend to lose focus on the company's inherent value.
Although this is our near term focus, BioCurex is not just a cancer diagnostic company. While we have concentrated our efforts on blood tests for cancer detection, our technology is broadly based on the existence of a molecule we named RECAF that is present in cancer cells but practically absent from healthy cells. Thus, we can use RECAF for diagnostic purposes and we can also use RECAF to image tumors and selectively target them for destruction. Tumors can be imaged using radioactive isotopes or targeted for killing with toxins or poisons that hone on RECAF and destroy RECAF bearing cancer cells without damaging normal cells that lack RECAF. This should ameliorate the unwanted side effects of chemotherapy. In the past, we have shown that cancer imaging and targeting are possible (see http://biocurex.com/media/Review_BioCurex.pdf) and there are several basic scientific papers published on the use of RECAF for cancer imaging. While cancer imaging and targeting is possible with the older technology shown in that review, it can be done much better with the peptides described in the PCT patent we recently filed. While that patent protects diagnostic applications, most of its claims are for cancer targeting and imaging with good reasons. Biological agents, such as antibodies, cannot be easily modified, whereas the synthesis of peptides can be programmed to make any desired structural configuration. Thus, synthetic peptides can be tailored to any specific need and used in ways biological compounds cannot be used.
There are many applications covered by the PCT patent, which, upon approval, will also extend protection over our proprietary technology for 20 additional years. For example, the RECAF binding peptide is small enough to be incorporated into the genome of viruses that do not normally infect human cells. This results in the expression of the peptide on the surface of the virus which allows the virus to bind to RECAF bearing cells, gain entry, replicate and eventually destroy the cancer cells selectively. The hundreds of copies of the virus that are produced during replication are released and go on to infect and kill other cancer cells. That is essentially what happens over the first few days of a common cold infection, only that in this case, the virus would only infect and kill cancer cells and due to the virus replication - from which the term 'going viral' comes from – the killing efficiency multiplies significantly.
A similar effect can be achieved with passive vesicles of fat-like material called liposomes containing a cell poison or a chemotherapy agent. These liposomes can be coated with the RECAF seeking peptide and therefore target only cancer cells.
Another claim in the peptide patent describes its use to purge bone marrow from leukemic cells so that patients requiring a bone marrow transplant can use their own marrow rather than using another person's bone marrow, thus eliminating histocompatibility problems. While we do not know yet if cancer therapy is possible using viruses or liposomes described above, we do have some very preliminary evidence showing that we could use the RECAF system to purge malignant cells from the bone marrow of leukemia patients.
These are just some examples of the possibilities the technology has to offer; there are many more, many of which will be developed in collaborations with scientists or companies specializing in the specific areas of application.
In the meantime, we remain focused on the blood tests for cancer detection in humans and in canines. The latter offers a sizable market with the advantage of not requiring regulatory approvals. Early on, our strategy was to obtain proof of concept for an application, demonstrate it to large companies and then license the technology to them, who would then develop it further into a commercial product and market it. Once an application was licensed, the idea was to move to the next application covered by our patents, obtain proof of concept and repeat the process. This strategy aimed at maximizing the return on our patent claims and it resulted in licenses to two major corporations. Before licensing and paying an upfront fee, these companies carried out extensive due diligence on our technology and used blood samples of their own in blind tests to evaluate the potential of our tests. One of our licensees even presented results slightly better than ours at an international cancer marker congress. Yet, the journey to commercialization has proven more difficult than expected. Thus, we changed our strategy and decided to present current and future licensees with a turnkey test, now based on the RECAF binding peptide mentioned above. As part of this process we decided to file a 510K application later this year for marketing approval with the FDA, which should facilitate our current licensees and generate more value for future licensees. Moreover, it will allow us to market the test in the USA.
While the FDA takes approximately three months to review an application, there is a great deal of work that needs to be done before filing. We could file an earlier FDA application using the antibody-based test knowing that we will render it obsolete as soon as we finish our work on the peptide. We believe that would be an irresponsible way of using our resources. We have always tried to be efficient in the use of cash and filing a 510(k) knowing that the product will be obsolete even before it is approved is neither frugal nor efficient. This is another example in which waiting conserves the company's cash and improves the final result. We plan to file a 510(k) application with the FDA later this year.
BioCurex China is established in Shanghai, within a facility dedicated to manufacturing rapid tests for the Chinese market (examples of rapid tests are the pregnancy test or glucose tests available at drug stores). This provides us with access to the technology and the know-how required to develop and manufacture rapid tests for both human and canines. We achieve the best results when the intensity of the reaction is assessed with a small (hand-held) instrument similar to the ones used by diabetic patients to measure their blood glucose rather than visually. Our associates in Shanghai have developed an inexpensive reader for rapid tests and they are adapting our rapid test to work with that hand-held reader. The market impact of having an inexpensive reader with a rapid test that can be performed at the vet's clinic in real time cannot be stressed enough.
Two weeks ago we announced the publication of a significant paper in an international peer reviewed scientific journal, Springer Science + Business Media. The paper revealed, for the first time in history, that a combination of RECAF with another commonly used cancer marker (CA125) can be used for screening for ovarian cancer, detecting 75 percent of early stage cancer (I and II), where curability approaches 90 percent. The study received accolades from the peer reviewers who evaluated it for publication. http://www.springerlink.com/content/y662152100073x41/
Last week, we were congratulated by the Editor-in-Chief of that scientific journal, our article has become the most downloaded paper for the previous 30 days; an indication of the attention it has generated within the scientific community.
This scientific paper is significant because it represents the opinions of the specialists in the field who reviewed it and agree that the results should be published. Moreover, their approval also supports the concept that RECAF has a place in cancer screening. We are talking about testing, once a year, the female population at large, not just the 22,000 women who are diagnosed with ovarian cancer each year. This potential, together with the potential of the other applications discussed above represent the true value of our company. Those who have followed this company for an extended period of time know that we have delivered on the objectives we have set forth to accomplish, from developing a unique product for both human and veterinary use, to licensing our technology to industry giants, to securing $6 million in capital in January 2010. It is by the same token and with the support emerging from scientific evidence, the validation of our results by our peers and the improvements in our technology emerging from our latest patent filing, that we are confident we'll succeed in getting our licensees back online and/or secure new licensees who will take advantage of this opportunity.
In summary, BioCurex has a large list of potential RECAF based applications, each one of which represents a very large market. These applications are covered by our patents and in some cases there is proof of concept. In the past few months, we have made important progress in all the technical areas related to the blood tests and other applications mentioned above. The development of our new RECAF binding peptide is a significant step forward both technically and commercially because its patent extends the protection of our technology for almost two more decades. While some of the abovementioned applications will be developed in collaboration with other institutions, we continue focused, 100 percent on getting the RECAF blood tests for canines and for humans to market as soon as possible, including the filing of an FDA 510K application for the human test.
On behalf of the entire team at BioCurex, we look forward to executing on our business plan. In addition, we will provide as much detail on our progress in a timely fashion and would like to thank all of our shareholders for their patience and support.
Sincerely, Ricardo Moro, MD.
CEO BioCurex Inc.
About BioCurex, Inc.
BioCurex, Inc. is a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics. The technology identifies a universal cancer marker known as RECAF.
RECAF is a molecule that is present on cancer cells but not detected in significant levels on healthy cells or benign tumor cells. It is the receptor for alpha-fetoprotein and is classified as an oncofetal antigen due to its presence on both fetal and malignant tissues. This characteristic makes RECAF a more accurate indicator of cancer than most current tumor markers.
BioCurex is commercializing its technology through licensing arrangements with companies that develop and market diagnostic tests for the large automated clinical laboratory setting, through development and marketing of non-automated clinical laboratory tests, through development of rapid, point-of-care test formats, and through marketing of its OncoPet RECAF test for cancer in companion animals.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories (NYSE:ABT) and with Alere (NYSE:ALR), formerly Inverness Medical Innovations (NYSE:IMA).
For further information on these agreements visit:
http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt.
For more information about the Company, please visit www.BioCurex.com.
For more information about OncoPet Diagnostics Inc., please visit:
www.OncoPetDiagnostics.com.
Forward-Looking Statements
The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are "forward-looking statements'' within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.