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Advanced Viral Research Corp (OTCBB: ADVR) - AVR 118 Already has Initial Evidence of Efficacy Based on the Completed Israel Phase I and II Clinical Trial
Advanced Viral Research Corporation (OTCBB: ADVR)
ADVR is a small biotechnology firm developing a product named AVR 118, as a late stage “Quality of Life” drug for cancer patients.
Wasting syndromes in Cancer and AIDS have similar patho-physiologic mechanisms and treatment remains problematic, especially in advanced disease. A novel Peptide Nucleic Acid (AVR 118), has been shown to improve weight gain and quality of life in multiple anecdotal reports. It was approved for clinical trial by the Israeli Health Ministry in June 2002.
The clinical trial in Israel was very encouraging for Advanced Viral.
The results were positive with higher doses showing larger improvements. That is a very important characteristic because it further provides evidence that the drug is demonstrating true activity vs. random chance. Dose escalations studies with higher doses showing increased efficacy is a strong signal of positive drug activity.
Twenty-nine of the 30 patients had anorexia before beginning treatment with AVR118. Anorexia resolved in a dose-related fashion, with all patients at the highest dose becoming anorexia-free after three weeks of treatment. Benefit appeared to continue beyond the end of dosing, with all patients being free from anorexia four weeks after receiving the last dose of AVR118.
ADVR continues with Phase II clinical trials in the US with AVR 118.
The potential for an effective late stage “Quality of Life” drug for cancer patients remains huge.
ADVR is a small biotechnology firm that holds the patents to AVR 118 and has been developing the product as a “Quality of Life” drug in late state cancer patients.
AVR118 is being studied for its ability to treat cachexia (wasting) in patients with AIDS or cancer.
The Phase I/II clinical trial of AVR118 in AIDS patients, which was conducted in Israel, concluded that AVR118 continues to demonstrate evidence of unique patient benefits, a favorable safety profile, and no apparent drug-related adverse events. Unique patient benefits included weight gain, mood improvement, decrease in fatigue, and increase in ability to perform everyday tasks.
Unacceptable safety profiles are the main reason drugs fail during the FDA clinical trail process. With AVR118, there is ample evidence to indicate that safety will not be an issue with this drug.
Reticulose, the first generation drug of AVR118 has already been used over one million times in humans and is still being actively used today.
This is extremely unusual that a drug, actively in the FDA clinical trial process, has this amount of human anecdotal data. Considering this data is in-vivo (human) adds a lot of confidence that the drug will not demonstrate any unacceptable safety concerns.
AVR 118 is a product that already has undergone extensive development.
ADVR is definitely a company to consider.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #1 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): Patents
Advanced Viral Research Corporation (OTCBB: ADVR)
Patent protection and trade secret protection is extremely important for biotechnology companies. For a small developmental company, Advanced Viral Research has done a very impressive job with patent protection.
To date, the company has been issued or granted 13 U.S. patents, two Australian patents, one Mexican patent, one Israeli patent and two patents in China for AVR118. In addition, the company has nine patent applications pending with the U.S. Patent and Trademark Office (“PTO”) and 30 pending foreign patent applications.
The Company's undervalued patent portfolio (issued and pending) include treatment of basal cell carcinoma, anemia, suppressed immune systems (i.e. during chemotherapy), adenovirus, lupus, parvovirus, skin diseases (genital herpes, shingles, HPV, etc.) and HIV (as an adjunct therapy with currently FDA approved therapies). Company holds patent for older drug ("Reticulose") and improved drug ("Product R" in patent portfolio--since renamed AVR118).
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #2 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): "Bird Flu"
Advanced Viral Research Corporation (OTCBB: ADVR)
Avian Flu (H5N1) “BIRD FLU”
It is obvious that the bird flu is getting a lot of media attention these days because the potential threat of another flu pandemic is real. This potential threat is indeed scary for most people. With this increase media attention many biotech companies are now promoting that there drugs may provide benefits against the bird flu.
The company has reported that they are performing pre-clinical research on the bird flu virus and initial results were positive. Further research might now progress to in-vivo (Human) testing.
However, with Advanced Viral Research one should not forget what the history of this drug was. Dr. Vincent LaPenta in 1934 developed this drug with its primary use as an anti-viral. Since then, Reticulose, was on the market for three decades and in that time had a blemish free record as a safe treatment for Herpetic diseases, encephalitis, generalized vaccine, virus infectious hepatitis, Asian influenza, mononucleosis, viral pneumonia, chicken pox and measles, before the FDA in the early 1960’s had the drug re-classified as a "new drug," as part of a sweeping change in the approval process of pharmaceuticals.
In addition, the company in 1989 had Reticulose tested by the National Institute of Allergy and Infectious Diseases (NIH). The testing by the NIH demonstrated positive results for Influenza A, which included Flu A/Taiwan/1/8L (H1N1), Lenigrad/360/86 (H3N2) and WSN (H1N1).
It would appear that with this type of history and significant anecdotal efficacy with influenza would suggest that AVR118 can be a strong potential candidate for the “Bird Flu”. Remember AVR118 is not a vaccine for the flu; it helps lessen the severity of the flu once it is contracted. An important component in preparing for the next Pandemic is not only creating a vaccine, but also stockpiling of antiviral medications. This is as per CDC guidelines, dated January 17, 2006 (www.cdc.gov/flu/pandemic). AVR118 would be a perfect drug for antiviral stockpiling because of its past history and also the drug is very stable, has a long shelf life and does not require refrigeration.
The federal government is taking a very pro-active position with Bird Flu, allocating millions of dollars for preparation. If indeed the company is successful in getting the government to test AVR118 against the “Bird Flu” this stock would, understandably, generate significant interest.
The US Government's BioShield program could purchase & stockpile AVR118 prior to FDA approval. Under the Bioshield legislation, drugs that demonstrate efficacy & safety can be purchased and stockpiled before official FDA approval if the Centers for Disease Control and Prevention declare a health emergency.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Beacon Equity Research Announces Investment Opinion:
Advanced Viral Research Corp. Rated 'Speculative Buy,'
Target $.36 by Beacon Equity Research
Advanced Viral Research Corporation (OTCBB: ADVR)
Beacon Equity Research Announces Investment Opinion: Advanced Viral Research Corp. Rated 'Speculative Buy,' Target $.36 by Beacon Equity Research
Thursday , May 11, 2006 08:09 ET
DALLAS, May 11, 2006 (BUSINESS WIRE) -- Advanced Viral Research Corp. (OTCBB: ADVR) has been rated "Speculative Buy," with a price target of $.36 by Beacon Equity Research. The report is authored by Senior Research Analyst, Kris Goldcross, CFA.
In the report, Mr. Goldcross writes, "Advanced Viral Research currently holds a diverse and sizable patent portfolio consisting of thirteen U.S. patents, two Australian patents, one Mexican patent, one Israeli patent, and two patents in China. These patents are related to the usages of AVR118, including its use in the topical treatment of skin diseases and eye afflictions. Specifically, AVR118 may be used for the treatment of genital herpes and shingles; the treatment of basal cell carcinoma; the treatment of anemia associated with chronic renal failure; chemotherapy and HIV therapy; combination therapy for HIV; the treatment of lupus; and the treatment of rheumatoid arthritis."
"Judging from valuations of previous biotech firms at this stage of development and with a similar pipeline of products it is not unreasonable to argue that Advanced Viral Research Corporation could command a market capitalization of around $250 million. This figure could even be much higher if the firm is able to secure FDA approval of any drug and move forward to commercialization. At that point we feel the value of the equity could be as high as $500 million to $1 billion, depending on how the market reacts to its products."
Beacon Equity Research Disclosure
The analysts contributing to this report do not hold any shares of Advanced Viral Research Corp. (ADVR). Additionally, the analysts contributing to this report certify that the views expressed herein accurately reflect the analysts' personal views as to the subject securities and issuers. The analyst(s) writing this report recognize and aspire to all of the CFA Institute Guidelines for Independent Research. Beacon Equity Research ("Beacon") certifies that no part of the analysts' compensation was, is, or will be, directly or indirectly, related to the specific recommendation or views expressed by the analysts in the report. Beacon has been compensated 158,000 free trading shares from a non-controlling third party for enrollment in this research program. To remove any conflicts of interest, all shares have been sold as of the issuance of this report. This report is based on data obtained from sources we believe to be reliable, but is not guaranteed as to accuracy and does not purport to be complete. As such, the report should not be construed as advice designed to meet the particular investment needs of any investor. Any opinions expressed herein are subject to change.
Anyone interested in receiving alerts regarding Advanced Viral Research Corp. research should email members*beaconequityresearch.com with "ADVR" in the subject line.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #3 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): Value Comparisons
Advanced Viral Research Corporation (OTCBB: ADVR)
Biotech Market Capitalization Comparisons
Why buy a biotech stock? Because the rewards are enormous. If you invest early at the right price, with an early-stage biotech company, the returns are not measured in percentages, but in multiples of the previous price.
Stocks trade at perceived values of the company’s worth, not at what the company is actually worth. The art of investing is finding companies where the perceived value is inaccurate. Then taking advantage of those inaccuracies before everyone else realizes they exist.
As an example of the investment potential of investing in Biotech companies early in the clinical trial process is the investment returns seen by Immunex (IMNX) and Imclone (IMCL) investors. Immunex has one major drug currently approved for Rheumatoid arthritis (Enbrel), but by investing two years BEFORE that drug's market approval an investor would have seen phenomenal returns (IMNX actually went to $75 in 2000). And IMCL investors who invested in 1995, when the investment was definitely considered "Speculative", have been rewarded with a substantial return on their investment. IMCL's drug for colorectal cancer patients, Erbitux, attracted the attention of Bristol Myers (BMY) which resulted in BMY investing $2.2 Billion into IMCL. And Erbitux addresses a very small niche market of patients that are not responding to other colorectal cancer therapies---an efficacy rate of only 23%.
Below are some comparisons:
Immunex (IMNX) bought out by Amgen (AMGN) at $28/share in AMGN stock Price on July 30, 1996 (split adjusted) 96 cents Market Capitalization at Buyout Price --$14.74 Billion
Imclone (IMCL) Price in May 2002) $16.25 Price on February 28, 1995 19 cents Market Capitalization then $1.18 Billion
Advanced Viral Research (Price now at $0.07)
Current Market Capitalization $ 52.25 Million
Again, Immunex had one major drug "Enbrel", approved in 1998, for the treatment of rheumatoid arthritis (with some reported negative side effects). Imclone has one major drug, Erbitux, approved for colorectal cancer.
ADVR, in comparison, is in Phase II clinical trials for cancer and Type 2 Diabetes with a drug with a long safety profile history and efficacy with a number of viral infections and autoimmune conditions. The market capitalization disparity spells opportunity for aggressive investors.
It would appear that Advanced Viral Research Corporation (OTCBB: ADVR) has an unrealistically low perceived value. An investor buying at these prices is clearly getting a stock where the potential rewards justify the risk.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #4 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): Acquisition Target
Advanced Viral Research Corporation (OTCBB: ADVR)
Potential Acquisition or Partnership
Historically, large pharmaceutical companies would rarely look at companies with early stage drugs, but now acquisitions and partnerships with drugs in Phase I & II are becoming common.
Almost all large pharmaceutical companies have large multi-billion dollar holes in there drug pipelines, mainly caused by expiring drug patents. These same companies also have billions of dollars in cash overseas. They recently fought hard and won a significant victory that will allow them to repatriate the funds back to the US with very favorable tax rules. The amount of cash coming back is estimated to be $80-90 Billion dollars (That is Billion not Million). Almost all large-pharma executives have placed acquisitions of companies and products at the top of their list for things to do. The majority of these acquisitions are predicted to take place in late 2006 and early 2007.
Is Advanced Viral Research Corporation a likely candidate? If the Phase II cancer trial reports positive results this company would be a potential candidate for acquisition or partnership.
The current cancer trial is testing AVR118 with late stage cancer patients to improve quality of life. This is a very important and overlooked area for cancer patients. There are few drugs available that adequately address this problem and the demand is great and growing, as the population ages. A drug that shows efficacy in this area would be of great interest to any large pharma that markets cancer drugs. It would be a natural addition to its product line. The potential for a good quality of life drug is huge.
For instance, if Advanced Viral Research got acquired even for 300 Million that would equal a 5X return for investors at current low prices. Remember most large pharma acquisitions have price tags in the billions. A 300 Million purchase would almost be considered petty cash to a large pharmaceutical company.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #6 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): Safety
Advanced Viral Research Corporation (OTCBB: ADVR)
AVR118 (Safety Profile)
Unacceptable safety profiles are the main reason drugs fail during the FDA clinical trail process. With AVR118, there is ample evidence to indicate that safety will not be an issue with this drug.
Traditional developmental biotech companies start the drug development process in the laboratory. It normally requires research on thousands of compounds before a compound that shows promise advances to pre-clinical testing. Pre-clinical testing can take several more years. Pre-Clinical testing only happens in the lab and on animals.
If the drug continues to demonstrate potential a company will file an IND (Investigational New Drug) application. If the IND is accepted by the FDA, only then can the drug advance to FDA clinical trials where the drug starts the testing process on humans.
Reticulose, the first generation drug of AVR118 has already been used over one million times in humans and is still being actively used today. This is extremely unusual that a drug, actively in the FDA clinical trial process, has this amount of human anecdotal data. Considering this data is in-vivo (human) adds a lot of confidence that drug will not demonstrate any unacceptable safety concerns.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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hey juice i got a little of this at .09 just to hold for a while.... see what happens down the road.
Posts: 2794 | From: nyc | Registered: Aug 2005
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-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Advanced Viral Research Corp. Announces Completion of Accrual in First Part of Diabetes Study
YONKERS, N.Y.--(BUSINESS WIRE)--May 12, 2006--Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) announced today that it has completed enrollment of subjects in the first part of the Phase I study in Type 2 diabetic patients. In this study, 30 subjects with type 2 diabetes, being treated with sulfonylureas and/or metformin, were expected to be enrolled. The primary objective was to explore the effect of daily doses 4.0 ml of AVR118 given subcutaneously on blood glucose, as compared to subjects not receiving AVR118. All 30 subjects have been enrolled.
Earlier this year, the Company amended the protocol for this study to include an additional 12 subjects at a dose of 1.0 ml of AVR118 given subcutaneously daily for 15 days, followed by one week of dosing every other day. Accrual of the additional 12 patients is currently ongoing.
Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases. For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com.
Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 (Product R) is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Source: Advanced Viral Research Corp.
Contact:
Equity Relations, Inc. Richard Brown, 617-314-7379
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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Reason #7 to Consider Advanced Viral Research Corporation (OTCBB: ADVR): Israel Trial
Advanced Viral Research Corporation (OTCBB: ADVR)
Completed Israel Clinical Trial
AVR118 already has initial evidence of efficacy based on the completed Israel Phase I/II clinical trial.
The results were positive with higher doses showing larger improvements. That is a very important characteristic because it further provides evidence that the drug is demonstrating true activity vs. random chance. Dose escalations studies with higher doses showing increased efficacy is a strong signal of positive drug activity.
Details of the trial results are as follows:
A total of 30 cachectic patients with AIDS wasting were enrolled in the trial. Three groups of 10 patients each received AVR118 subcutaneously at a dose of 0.4, 2.0 or 4.0 ml/day for 28 days (six days/week).
All patients were followed for 28 days after treatment was completed. Total weight, body mass index (BMI), fat percentage, strength, calf and arm circumference, and skin fold thickness were measured for all patients. Spontaneous patient comments regarding quality of life parameters, including improvement in mood, appetite, alertness, and activities of daily living, malaise, myalgia and power/energy were recorded. Adverse events were monitored. All dose groups showed an improvement in weight, strength, BMI, and calf circumference, with more significant improvements in the two higher dose levels. The patients at the highest dose appeared to have the most benefit.
Twenty-nine of the 30 patients had anorexia before beginning treatment with AVR118. Anorexia resolved in a dose-related fashion, with all patients at the highest dose becoming anorexia-free after three weeks of treatment. Benefit appeared to continue beyond the end of dosing, with all patients being free from anorexia four weeks after receiving the last dose of AVR118. Spontaneous patient comments were recorded and reflect widespread, dose-related improvements in quality of life.
-------------------- The difference between genius and stupidity is that genius has its limits Posts: 10204 | From: NYC | Registered: Mar 2006
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