At a clinical symposium on viral diseases held in Miami Beach, Fla., on September 1, 1960, a retired colonel in the U.S. Medical Corps. spoke to the gathering of his early experiences with an anti-viral drug called Reticulose. Recalling that he was introduced to the drug during the early days of World War II by its inventor, Dr. Vincent LaPenta, as LaPenta administered the drug to several laboratory technicians who had become ill with influenza, Dr. Ralph Thompson said: "I shall never forget the miraculous course that followed the treatment with this drug and well remember those others of my command who became ill and stricken with influenza, who did not receive Reticulose therapy. They were actually ill; ill and incapacitated from 7 to 10 days. These observations made a lasting and indelible imprint on me....
"It was only after my retirement from the medical military service and upon entering the realm of private practice in my chosen specialty of pathology that I had the opportunity of suggesting the use of Reticulose on several practically moribund children with virulent encephalitis. Again, I witnessed phenomenal and rapid cures. ... I know we will lower the morbidity rate, lessen the suffering due to various viral infections by treating them with Reticulose. In my opinion, the future of Reticulose holds great promise."
Twenty six years have passed since those comments at the symposium were made and these many years later the great promise that Dr. Thompson foresaw for Reticulose has yet to be realized. Two years after Dr. Thompson spoke at the symposium, Reticulose, which had been 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, mumps orchitis, chicken pox and measles, was re-classified by the Food and Drug Administration as a "new drug," as part of a sweeping change in the approval process of pharmaceuticals. This development prompted the drug's distributor at the time to conclude that the cost of providing the government agency with the necessary documentation and studies for re-approval of the drug could not be managed for at least three years, and that decision set in a motion a series of situations in which the rights to the drug would change hands in anticipation of securing FDA approval to market the drug here in the United States.
Now, 53 years after Dr. LaPenta formulated it, a small Miami-based company called Advanced Viral Research (Pink Sheets - $.16uB - $.20uA), buoyed by the $400,000 raised through a public offering in 1986 and the possible exercise of A, B, and C warrants attached to the original $.01 per unit offering, is attempting to revive the high hopes of men like Dr. Thompson. Advanced Viral Research believes it may have found in Reticulose a successful treatment for a disease that was not even known throughout the time that the drug was successfully marketed -- acquired immune deficiency syndrome (AIDS). To that end, the company has filed an Investigational New Drug Application with the FDA to conduct human clinical trials on the drug's effect on the AIDS virus. In addition to acquiring the rights to the drug, the company has entered into an agreement with a Bahamian contractor who will produce the product exclusively for the company in the same manufacturing facility -- recently remodeled -- which produced Reticulose from 1968 to 1972. Because Reticulose is an organic compound it is not easily duplicated, but management is fairly certain from its own analyses that its initial production run of the drug has in fact yielded the drug Reticulose. After receiving confirmation from an independent laboratory, which is expected by April, Advanced Viral Research will notify the FDA that it is ready fortne plantto be inspected, and will await the government agency's approvalof its protocol submitted for study. Company officials believe the FDA's decision on whether to grant the company permission to per- form clinical trials on AIDS patients could come in the next 60 days. Reticulose reportedly stimulates the body's immune system to increase production of interferon in the presence of certain viral infections.
While the drug holds out the promise of a possible AIDS treatment down the road here in the U.S., should it eventually be approved for sale by the FDA, investors who climb aboard the stock now can benefit from the company's more immediate prospects of sales to foreign countries where, in the past, good sales have been enjoyed.
In April, Bernard Friedland, president of Advanced Viral Research, will be traveling to Southeast Asia to seek sales contracts in Hong Kong, Tai- wan, Korea and Singapore, where Reticulose is known and has been sold before in the 1970s. The company intends to contact all of the major and medium-sized companies in those countries, but to select only the best companies in each country as the exclusive importer and distributor for its anti-viral agent. When those relationships are formed, Advanced Viral Research will train their representatives in marketing techniques. Friedland already has in his pocket a three-year contract to market the drug in Mexico -- the contract with the Don Byme organization represents $450,000 in sales for Advanced Viral Research.
Friedland's familiarity with Reticulose goes back long before he and his partner, William Bregman, now secretary-treasurer of Advanced Viral Research, purchased the rights to the drug in 1984...
The tale of Reticulose's origins, its early use, bright prospects and unrequited hopes has all the twists and turns of a good detective story. Our story begins in 1934 when the concept of an anti-viral agent composed of peptones, peptides, lipoproteins and nucleic acid occurred to Dr. Vin- cent LaPenta, a native of Indianapolis. For his original compound, Dr. LaPenta chose horse serum proteins, but due to occasional adverse reactions encountered, he and his son, B. E. LaPenta, decided to use bovine serum albumin in combination with peptones, and ribonucleic acid to pro- duce a non-toxic anti-viral agent now known as Reticulose.
In the early 1940s, the LaPenta's formed a corporation, Chemico Laboratories Inc., headed by B. E. LaPenta, which produced Reticulose and distributed it locally for the treatment of various viral diseases. From 1951 through 1960, considerable scientific research was conducted on animals concerning the effectiveness, scope and use of the pharmaceutical.
From 1960 to 1962, Chemico Laboratories had an exclusive distribution contract for Reticulose with the pharmaceutical division of Phillips Roxane Company, a major drug company. In that two-year period more than one million ampules of Reticulose were sold. After the FDA re-classified the drug in 1962, the Phillips Roxane Company concluded that it would not have the funds to perform the demanding studies needed to carry the drug through the re-approval process for at least three years and released Chemico from their exclusive distribution contract. And Chemico, in no financial position to conduct the studies itself, began searching for a company that could develop the product for foreign markets where no FDA approval would be needed. In 1965, its search resulted in its merger with and absorption by Key Pharmaceuticals Inc. Key began constructing a manufacturing facility in Freeport, Bahamas -- the same facility now under contract to produce Reticulose for Advanced Viral Research -- and in 1967 filed a New Drug Application for Reticulose with the FDA. By 1969, the manufacturing facility in Freeport was completed and producing Reticulose, operating as a separate subsidiary named Key Pharmaceuticals Ltd. Key opened registrations and marketing for the product in the Phillipines, Singapore, Malaysia, Taiwan, Thai- land, Hong Kong and Japan, and made preliminary contacts with various health ministries in Europe, but decided that the expense of securing FDA approval for the drug in the United States was too great, and to withdrawal its FDA application for the time being.
Manufacturing and marketing continued on a limited scale directly to agents in Southeast Asia, and registration was further pursued in Japan, where laboratory and human studies were begun. It was at this time that LaPenta decided to train an employee of Key Pharmaceuticals in the proprietary methods for the formulation of Reticulose. That employee, who was to serve as LaPenta's back- up, was Bernard Friedland.
In 1972, Key Pharmaceuticals Inc. itself became the subject of a merger with Transmedix. As a result of the merger, Key's entire management team was replaced except for Friedland. One of the first changes new management made was to sell Reticulose, its trademark, manufacturing facility and contract with LaPenta to Cepher Chen Yan Sun of Grace Limited Partnership of Singapore, and Cepher Co. of Hong Kong. Chen planned to sell Reticulose to the government of mainland China, but financial difficulties totally unrelated to the pharmaceutical business made his plan unworkable. Chen broke the contract with LaPenta, defaulted on the mortgage on the manufacturing plant and was subsequently barred from doing pharmaceutical business with the governments of Singapore and Hong Kong. Chen was forced into bankruptcy, and all the Reticulose rights and assets were placed into the hands of a Hong Kong Court receiver. An American purchased the manufacturing plant as a speculation, and LaPenta died in 1975.
In 1984, Friedland, who had been working for Key Pharmaceuticals for nearly 30 years in capacities ranging from quality control and research to regulatory affairs, and his partner, William Bregman, learned of the availability of the rights to Reticulose and of the availability of the original Freeport company, its port authority license and manufacturing facility. The partners purchased all the rights to Reticulose, the shares and structure of the Bahamas company, and arranged a lease-purchase agreement for the manufacturing facility with the American owner. In 1985, they formed Advanced Viral Research Corp. to market Reticulose on a worldwide basis and arranged the public offering which took place in 1986. As a result of that offering there are 153,846,154 shares of Advanced Viral Research outstanding with 40 million in the public float.
One can not help but wonder what Dr. Thompson would think -- if indeed he is alive today -- of the latest attempts to make Reticulose a house- hold word. Given the long history of the drug, its apparent safety, its past acceptance in foreign markets and the tenacity in which a variety of individuals have pursued its dream, we think Reticulose and Advanced Viral Research are worthy of investors' attentions. And with the added kicker that Reticulose just may turn out to be an effective treatment for AIDS, what more could a penny market speculator ask for?
Advanced Viral Research, 827 Lincoln Rd., Miami Beach, FL 33139, (305) 674-0842.
Broker Contacts: Caren Cussen and Andy Grossman of Mostel & Taylor, (800) 338-9922 or (212) 308-3700.
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A piece of info from 2000 continue on down.
|To: Rick Varone who wrote (183)||10/27/2000 11:16:40 AM|
|From: DAN LITTLE||Read Replies (1) of 253|
|Hi Rick, I thought I would try and give three points of
view on when we might see the IND filed. Just for the fun of it.
Globomax is an excellent company with an excellent track record and is guiding ADVR through the FDA process. ADVR will soon be having a pre-IND meeting with the FDA. The maximum amount of time it takes for the FDA to schedule a meeting after receiving the meeting request is 74 days. optimistically speaking, it should take about half that time (37 days). ADVR is undoubtedly within 14 days of requesting the pre-IND meeting. After the meeting there will be very little that needs to be done, given Globalmax's guidance. The IND will need some finishing touches and we do have the holidays coming up (BTW happy holidays in advance). This should put the filing date no later then the 1st of January. The first IND will be for the topical application of product R. Also, love what you've done with your hair.
Globomax is certainly a good company with a good track record. ADVR will request a pre-IND meeting as soon as the agenda is finalized. The FDA should be able to schedule a pre-IND meeting within 45 days of receiving the request. ADVR is probably within 30 days of requesting the pre-IND meeting. There will be a few minor changes that the FDA will want, but should take no longer then three weeks for ADVR to comply. ADVR should file for the IND no later then the 10th of February. The first IND will be for the topical application of Product R according to Mr Gallentar.
Globomax is entitled to a mistake or two just like everyone else. They are bound to overlook something. When ADVR gets around to requesting a pre-IND meeting the FDA won't get it scheduled for at least 60 days. Whatever Globomax has overlooked will take 3 months or longer to correct. There are still inspections to do and a lawsuit to deal with. ADVR will be lucky to submit an IND application by June 1st. We don't know what the first IND will be for, despite what Allen has said. Your haircut sucks.
I am going with number 2 with a little bit of number 1 thrown in (nice haircut).
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peptide nucleic acids,,Reticulose, antiviral, peptide-nucleic acid, treatment of autoimmune diseases, rheumatoid arthritis, Barrs, Bronchitis, fever, MS, epstien barr, flu, depression, ADVR, avr118, product R, peptide nucleic acids. Reticulose(tm) is an antiviral peptide-nucleic acid complex preparation which is currently being produced. Other products in development are for the treatment of autoimmune diseases such as rheumatoid arthritis, mylocation.net,
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