By: lovingitall0
08 Oct 2004, 02:15 PM EDT
Msg. 169661 of 170523
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AVR118 and RA: "The potential of a non-toxic immunomodulator such as AVR118 in the
therapy of Rheumatoid Arthritis could be significant, as AVR118 appears to
lack the often toxic effects of currently used mainstay therapies such as
corticosteroids, COX inhibitors, gold compounds and methotrexate," stated
Irach Taraporewala, Ph.D., ADVR's head of structural chemistry."
-------------------------------

YONKERS, N.Y., Dec. 3 /PRNewswire-FirstCall/ -- Advanced Viral Research
Corp. (OTC Bulletin Board: ADVR) today announced that its novel
immunomodulator AVR118 (formerly known as Product R) has exhibited therapeutic
effects in both an animal model of inflammatory arthritis and in a clinical
trial of patients with rheumatoid arthritis. In experiments with an animal
model of inflammatory arthritis, performed at The Weizmann Institute of
Research in Rehovot, Israel, the administration of AVR118 significantly
suppressed the development of inflammation in the animals' joints compared to
non-treated control animals. The results in the animal model were validated by
an open-label clinical trial conducted in Argentina in 27 patients. All
patients in the trial had improvement in quality of life including resolution
or significant decrease in intensity of pain, the ability to exercise, to
perform housework, and to engage in social activities. In addition, all
patients showed objective signs of decreased inflammation, and increased
mobility, of affected joints.

"These positive results highlight the anti-inflammatory properties of
AVR118 and underline the potential of AVR118 as an anti-inflammatory
therapeutic agent," said Eli Wilner, Chairman of the Board of ADVR.

Animal Model

In the Weizmann Institute animal model, inflammatory arthritis was induced
by injecting complete Freund's adjuvant containing inactivated Mycobacterium
tuberculosis into rats. AVR118 was administered for 14 days out of the
twenty-four days that the animals were observed for the full development of
inflammation. The anti-inflammatory effects of AVR118 were evident even for
the ten days following the discontinuation of the drug. This adjuvant
arthritis model in animals serves as an experimental model for human
rheumatoid arthritis.

Clinical Study

In the clinical trial, 27 female patients, ranging in age from 29 to
50 years, with mild to moderately severe rheumatoid arthritis, were treated
with AVR118 for a period of 90 days. These patients had previously been
treated with other anti-inflammatory drugs such as aspirin. By day 90, all
patients had either complete regression or significant decrease of joint
swelling. Measurements of joint mobility showed improvement in all patients.
All patients showed decreases in the level of the erythrocyte sedimentation
rate (ESR) by day 90 of therapy and most patients showed decreases in the
latex fixation test. There were no significant side effects of AVR118 observed
in this study.

"Inflammation and cachexia are inextricably linked by metabolic pathways
that have common origins and targets; areas where modulation can occur for
maximum impact on the process," said James T. D'Olimpio M.D., a clinical
consultant to ADVR and expert in the treatment of cachexia. "In addition, the
pathways involved with inflammation are not just confined to separate and
distinct disease entities, but are a common thread that impacts on quality of
life in many unrelated diseases such as AIDS, Cancer, Rheumatoid Arthritis and
other conditions in which weight loss, weakness, poor outcomes and non-
compliance to treatment are major clinical concerns. These results appear to
confirm the potent anti-inflammatory properties of AVR118."

Cytokines and chemokines play important roles in the progression of
rheumatoid arthritis. The development of clinical rheumatoid joint
inflammation is associated with increase of the chemokine interleukin-8 (IL-8)
in joint tissue. Pro-inflammatory cytokines such as interleukin-1 (IL-1),
tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) are present
at high levels in arthritic joints and their blood concentrations increase
with the severity of the disease. Monocytes migrate into the joints from the
blood and are activated to differentiate into macrophages in the joint tissue
by inflammatory cytokines and chemokines such as IL-1, IL-6, IL-8, and
TNF-alpha. Activated macrophages play an important role in joint inflammation
and destruction. The joint tissue attracts the monocytes into the joints
through the production of the chemokines monocyte chemoattractant protein-1
(MCP-1) and IL-8. In laboratory experiments ADVR scientists have shown that
AVR118 modulates the synthesis of cytokines and chemokines including MCP-1,
IL-8, IL-1 beta, and IL-6. Although AVR118 stimulates the synthesis of the
pro-inflammatory chemokines MCP-1 and IL-8 by native monocytes in cell
culture, highly activated macrophages are turned off with decreased synthesis
of MCP-1 and IL-8.
"Rheumatoid arthritis is a systemic disease that serves as a model for
other auto-immune diseases. The anti-inflammatory activity of AVR118 in the
animal model, and in the rheumatoid arthritis patients in the clinical trial,
including the amelioration of the systemic manifestations of the disease,
suggests the possibility of treating not only Rheumatoid Arthritis with AVR118
but also a broad range of inflammatory processes associated with human
diseases," explained Shalom Z. Hirschman, M.D., Chief Scientist at ADVR. "In
the laboratory, AVR118 modulates the synthesis of pro-inflammatory cytokines
and chemokines implicated in the inflammatory process in patients with
Rheumatoid Arthritis. If these clinical results are validated by future
clinical trials, then AVR118 would represent an important advance in the
treatment of this systemic disease marked by crippling arthritis."

"The potential of a non-toxic immunomodulator such as AVR118 in the
therapy of Rheumatoid Arthritis could be significant, as AVR118 appears to
lack the often toxic effects of currently used mainstay therapies such as
corticosteroids, COX inhibitors, gold compounds and methotrexate," stated
Irach Taraporewala, Ph.D., ADVR's head of structural chemistry. Dr.
Taraporewala is an experienced research scientist in the design of
anti-inflammatory small molecules for the treatment of rheumatoid arthritis.

Rheumatoid Arthritis Market

Rheumatoid arthritis usually begins between the ages of 25 to 55 years.
More than 85% of patients with rheumatoid arthritis are over the age of 50.
Among patients with rheumatoid arthritis, women outnumber men by three to one.
In the United States, approximately 1% of the population, or 2.5 million
people, have rheumatoid arthritis. It occurs in of all ethnic groups and in
all parts of the world. As the population in the developing world ages, and
with a rising incidence of the disease, the world market for safe and
effective rheumatoid arthritis treatment is projected to reach $6.6 billion
annually by the year 2009.

ADVR's AVR118 represents a biopolymer chemistry that possesses novel
immunomodulator activity. This peptide-nucleic acid, which to date has shown
no indication of human toxicity, appears to stimulate the proinflammatory
responses required to combat viral infections such as AIDS and human papilloma
virus and to dampen aberrant autoimmune-type inflammatory responses, such as
occur in patients with rheumatoid arthritis. Therefore, AVR118 has been
termed a "switch-type" immunomodulator. AVR118 is in clinical trials in
Israel for the treatment of cachexia (body wasting) in patients with AIDS.

For further information regarding Advanced Viral Research Corp., please
visit our website at http://www.adviral.com.



 
By: lovingitall0
11 Oct 2004, 09:30 AM EDT
Msg. 169950 of 170523
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Clarification On Declaration of Helsinki, World Medical Association

11 Oct 2004

The World Medical Association has clarified one of its ethical guidelines to physicians on biomedical research to ensure that those people taking part in research would continue to have access to proven beneficial treatment following the research study.

The Declaration of Helsinki, regarded as the world's most widely recognised source of ethical guidance on biomedical research on humans, was revised four years ago and one of its aims was to try to preclude double standards in research in industrialised and developing countries.

Its provision in paragraph 30 of the Declaration that 'At the conclusion of the study every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study' met with various interpretations.

The aim of the paragraph was to ensure that research subjects would have access to treatment that had been proven to be beneficial. But it was claimed that this standard of care was unrealistic and could not be implemented. To maintain this requirement, it was argued, would deter sponsors from initiating needed research. Others, especially from developing countries, considered that the requirement could and should be met.

At its annual General Assembly in Tokyo last week, more than 400 WMA delegates from 40 countries decided to issue a note of clarification to paragraph 30 of the Declaration.

This states 'The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.

'Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review'.

Dr Yoram Blachar, chairman of the WMA, said: 'The WMA's primary considerations have always been that the best interests of patients be served and that no good ethical research should be restricted. The WMA is adamant not to compromise the ethical principles that the medical profession stands for.

'We hope that this clarification will best achieve that aim'.

# # #

The World Medical Association (WMA) is an independent confederation of national medical associations from almost 80 countries and represents more than eight million physicians. Acting on behalf of patients and physicians, the WMA endeavours to achieve the highest possible standards of medical care, ethics, education and health-related human rights for all people.

 
By: lovingitall0
11 Oct 2004, 09:59 AM EDT
Msg. 169952 of 170523
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FDA had found problems in flu vaccine plant in 2003 but did nothing

11 Oct 2004

In 2003 the FDA had found problems at the Chiron, Liverpool, UK flu vaccine plant - however, they did not order a full inspection or suggest the plant be closed down. The FDA inspection only took place last weekend after the British authorities suspended the company's licence in that plant.

50% of the USA's flu vaccine supply was to have come from the Liverpool plant.

The FDA says they carry inspections every two years. They say they did not know about more serious problems until August 25th this year when Chiron told them 6 to 8 vaccines were contaminated.

An FDA spokesperson, Karen Midhun stated that in 2003 the FDA had discovered some contaminated batches of flu vaccine which had been reprocessed. The licence does not allow reprocessing. She said Chiron told them it was sorting the problem out. In August 2004 Chiron told the FDA another batch was contaminated, Midhun said.

Congress asked on Friday how was it that the FDA was caught out like this and did not carry out any contingency plan in August.

Henry Waxman (California) said "The British government immediately announced that it had already purchased a backup supply of vaccine (when they heard the August batch was also contaminated)….public health officials (in the USA) appear to have been taken completely by surprise."

The FDA spokesperson said Chiron assured them that the problem was not very big - basically, the FDA did nothing and took the company's word that all was being sorted out. They thought Chiron would deliver the 48 million doses in October.

In October 5th the UK authorities (MHRA) suspended Chiron Liverpool's licence and did not allow the batches to be moved.

 
By: lovingitall0
14 Oct 2004, 08:56 AM EDT
Msg. 170301 of 170523
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Clues found in how cancer spreads to liver

Tuesday, October 12, 2004

NEW ORLEANS, Oct 12, 2004 (United Press International via COMTEX) -- California researchers have identified what appears to be one mechanism used when cancer spreads to the liver from other organs.

Surgeons from the John Wayne Cancer Institute in Santa Monica focused on receptor CXCR4 genes, which are normally idle in normal cells, but showed up in the livers of patients with colorectal cancer and melanoma.

When cancer cells bearing the CXCR4 receptor were stimulated by a protein that binds to them, there was a significant increase in cell migrational activity, said Dr. Joseph Kim, a fellow in surgical oncology at the institute.

He said further research could lead to the development of drugs that target the CXCR4 receptor to treat cancers that metastasize to the liver.

"Industry is currently producing methods to specifically target cancer cells by targeting the CXCR4," Kim said.


The study was presented in New Orleans at the 2004 annual Clinical Congress of the American College of Surgeons.


 
By: DIAMONDring
14 Oct 2004, 09:21 AM EDT
Msg. 170302 of 170523
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1952 report was hope for advr in 85-86 when it came to market and one of the reasons i bought! but its 2004!!! in 86 it was .08 and now were at .105!!! were a horse at the starting gate and stumbling to get out of the gate some 20 years later!!!!! im depressed!

 
By: shaggydogs
14 Oct 2004, 11:37 AM EDT
Msg. 170305 of 170523
(This msg. is a reply to 170302 by DIAMONDring.)
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DIAMONDring, first, if you were around and able to purchase ADVR during 85-86 you should have be able to do so over a considerable period of time [6-months to 1-year] for around $0.03.

Second, if you have been around since 1985 and have been just slightly active, you should have been able to participate to some degree in a couple of ‘stake’ races where the PPS reach around $2.00 and also in a number of ‘claim’ races where the PPS oscillated a number of times over different price swings between $0.30-$0.70.

Sorry, I don’t agree that ADVR is like a horse at the starting gate stumbling to get out of the gate. I rather think that ADVR is like a horse put out to pasture at a stud farm waiting for somebody to pay the price for its golden spermatozoa. LOL

 
By: lovingitall0
14 Oct 2004, 12:56 PM EDT
Msg. 170308 of 170523
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Cancer patients recovery rates rising

The Jerusalem Post, Oct. 14, 2004
By JUDY SIEGEL-ITZKOVICH

The global fight against cancer during the past three decades has borne fruit, with a three-fold increase of recovery rates here and abroad.

Fully 63 percent of all cancer patients recover, and there are 120,000 Israelis among the 20 million around the world who have beaten cancer, the Israel Cancer Association reported Wednesday.

This upbeat message was presented ahead of next Monday's Knock on the Door campaign to raise funds for cancer research, treatment, rehabilitation, and public education.

Retiring ICA chairman Prof. Eliezer Robinson said at a press conference that early diagnosis and improved treatment has allowed the majority of patients to put the disease behind them. When there is not a full cure, in many cases cancer has become a manageable chronic disease, he said.

The US has a national plan to save 100,000 of its population from dying of cancer during the next 15 years and to reduce the numbers of those who get cancer by 60,000. The Israel National Council on Oncology is working on a similar target here.

Five-year Western world survival rates for colon cancer have reached 61.7%, 55.4% after 10 years, and 52.3% after 20 years. The corresponding survival rates for lung and respiratory cancer is 15%, 10.6%, and 6.5%; for melanoma 89%, 86.7%, and 82.8%; for breast cancer 86.4%, 78.3%, and 65%; for ovarian cancer 55%, 49.9%, and 49.3%; for prostate cancer 98.8%, 95.2%, and 81.1%; for testicular cancer 94.7%, 94%, and 88.2%; for bladder cancer 82.1%, 76.2%, and 67.9%; for thyroid cancer 96%, 95.8%, and 94%; and for Hodgkin's lymphoma 85.1%, 79.8%, and 67.1%.

An ICA publicity campaign this week will lead up to the Knock on the Door campaign, when school children, youth movement members, and other volunteers solicit funds to raise NIS 12 million for the organization. The campaign chairman this year is Mossy Wertheim, chairman of Coca-Cola Israel and chairman of the Second Channel's Keshet TV franchisee. He called on the business community to contribute to the effort along with individuals.

The ICA has urged Finance Minister Binyamin Netanyahu to allocate tens of millions of shekels immediately for upgrading and expanding radiotherapy facilities in major centers around the country and adding vital anti-cancer drugs to the basket of health services. The lack of such facilities and technologies present a real danger to cancer patients, Robinson said.

Prof. Rene Olivier Mirimanoff, president of the radiotherapy group in the European Organization for Cancer Research and Treatment, said at the press conference that more than 40% of all cancer patients have been cured thanks to radiotherapy using linear accelerators. Nearly one in three people will get cancer, and one in six people in the world will benefit from radiation therapy, he said. Even though the public believe radiotherapy is expensive, it constitutes only 5% to 10% of the costs of cancer treatment and thus is very cost efficient, Mirimanoff said. Today it is also much more exact, effective, and safer than before, he said.

One accelerator is needed for a population of 150,000 to 170,000, the actual rate in a country like Switzerland, he said. But Israel has one accelerator for every 350,000 people, which shows that the lack of radiotherapy equipment is very serious and demands immediate rectification, the ICA said.

The European Community will fund a major new study during the coming year in 13 countries to find whether there is a connection between the use of cellular phones and cancer. The Israeli part of the study will be financed partly by the ICA. Dr. Sigal Sadetzky of the Gertner Institute for Epidemiological Research and Health Policy at Sheba Medical Center will coordinate the Israeli study, which will include over 1,500 cellular phone users who have been diagnosed with malignant tumors of the brain, auditory nerve, and salivary glands during the past three years and compare them with a control group.

The Israel Cancer Registry announced what it called the world's first population-based survey of carriers of genetic mutations for breast cancer compared with women who are not carriers. Registry director Prof. Gad Rennert said that it included all Israeli women diagnosed with breast cancer in 1987 and 1988 and included a decade of follow-up.




 
By: DIAMONDring
14 Oct 2004, 01:13 PM EDT
Msg. 170309 of 170523
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shaggs my first buy was 4/86 @ .08 and yes made $$ on advr from then to now. the only reason it ran to those levels was a very BULLIST market (i remember qcom up 100.00 in a day) those were the good ol days. so my point is its going on 20 years and were saying the same things now (04) then we said or hoped then (86) i agree we have something that could be HUGE $$$$ but man its sure taking its time!
ps .. you would think in 20 years a drug company could take apart riticulose and figure out what it is/does and by now come out with there version its been that long! heck there probably on phase 20 by now.
good luck shaggs your posts are always class!
- - - - -
View Replies »
 
By: lovingitall0
14 Oct 2004, 04:21 PM EDT
Msg. 170319 of 170523
(This msg. is a reply to 170315 by shaggydogs.)
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"Isn’t it wonderful to know that ADVR has reported on the need to not only down-regulate the CCR5 receptor but to down-regulate co-receptors, like the CXCR4 receptor from being available for viruses to enter and infect a human cell. Dr. Kim suggests the need to develop drugs to target (only) the CXCR4 receptor to treat cancers that metastasize to the liver.

ADVR has in hand a non-toxic immunomodulator drug which down-regulates, to a measurable degree, all co-receptors from being available for viruses to enter and infect a human cell. Could it be that ADVR’s AVR118 is a drug that can target the CXCR4 receptor along with all co-receptors to treat cancers that metastasize to the liver or to other areas or organs of the body?"
-------------------------------------
THANKS, shaggydogs! for being as intuitive and knowledgeable as you are

It figures that you would see this also.

Ahhhhhhhhh!

LuvAmore!




 
By: lovingitall0
15 Oct 2004, 11:44 AM EDT
Msg. 170344 of 170523
Jump to msg. #  
Study IDs Target For Preventing Sexual Transmission Of HIV

10/14/04 -- Researchers have shown that it may be possible to block male to female HIV transmission in heterosexual intercourse and have identified the target for blocking that transmission, according to an article from the Oct. 14 issue of Science, presented today at the American Medical Association 23rd Annual Science Reporters Conference in Washington, D.C.

"Effective methods for blocking the transmission of HIV are urgently needed," said Michael Lederman, M.D., Scott R. Inkley Professor of Medicine and director of the Case Western Reserve University/University Hospitals of Cleveland Center for AIDS Research, in Cleveland, Ohio, and lead author on the paper. "Our study focuses on a strategy for preventing transmission of HIV through the vagina. We have identified a potential target, a mechanism critical for the transmission at vaginal sites of infection, that may offer a simple strategy for preventing HIV transmission."

"The vast majority of HIV infections in the world are sexually transmitted, most commonly through heterosexual sex," Dr. Lederman said. "But there has been substantial debate as to how the virus actually gets into cells at these sites of transmission, called mucosal sites. HIV can use certain cell surface molecules such as CCR5 to gain entry into immune system cells called CD4. We knew that people with a mutation whose CD4 cells' surface lack CCR5 are almost completely protected from acquiring HIV infection."

"But HIV can also use other target molecules to get into other cells. Thus, there was some uncertainty as to how HIV was transmitted at mucosal sites and therefore which pathways needed to be blocked in order to prevent HIV transmission there. We decided to test the hypothesis that blocking CCR5 alone would be sufficient to protect rhesus macaques from vaginal challenge with a virus like HIV. A natural immune messenger (chemokine) called RANTES can bind to CCR5 and by binding, forces the cell to internalize the CCR5 receptor so HIV cannot bind to it. We developed an altered RANTES molecule, called PSC-RANTES, that is thousands of times more effective than RANTES at targeting CCR5 making it unavailable to the virus."

In their experiment, Dr. Lederman and his colleagues applied a highly concentrated solution containing the altered chemokine to the vaginal membranes of rhesus macaque monkeys and challenged them with high doses of a virus that combined the outer surface of HIV and the inner workings of SIV - so called SHIV. The solution was successful in protecting the macaques without any detectable side effects.

"There is still a lot of work to be done before we have an affordable, easy to use method of blocking transmission of HIV through the vaginal membranes," Dr. Lederman said. "But we have taken an important step. Now that we have shown that it is possible to block SHIV transmission through the vagina in macaques and have identified the target molecule for blocking that transmission, the door is open to the development of a topical agent that could prevent infection with HIV in humans."

Source: American Medical Association


 
By: shaggydogs
15 Oct 2004, 11:45 AM EDT
Msg. 170345 of 170523
(This msg. is a reply to 170336 by mind31.)
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Barry, your claim that AVR118 is not a peptide nucleic acid [PNA] when the ADVR web site, which you promised lovingitall you would read [that is, http://www.adviral.com/pharmaceuticals/ ], specifically states that 118 is a PNA, puzzles me to no end. If you have the audacity to claim that 118 is not a PNA in contrast to what is stated at the ADVR web site, can you please explain to this board how you have arrived at such an confounding conclusion?
 
By: lovingitall0
15 Oct 2004, 11:53 AM EDT
Msg. 170346 of 170523
(This msg. is a reply to 170336 by mind31.)
Jump to msg. #  
PNA and ADVR CORPORATE PROFILE

Advanced Viral Research Corp. (OTCBB:ADVR) is a biopharmaceutical company committed to researching, developing and bringing to market new therapies for viral and other diseases. Founded in 1984, the Company has headquarters in Yonkers, New York. The approximately 17,650 square-foot complex includes executive offices, research laboratory space and a production facility designed to manufacture pharmaceuticals to cGMP standards.

Advanced Viral’s principal pharmaceutical product, AVR118, represents a new type of biopolymer chemistry that also possesses novel immunomodulator activity. This non-toxic peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses.

AVR118 is being studied for the promise shown in its ability to mitigate the toxic side effects of other drugs (including those used to treat HIV infection and chemotherapeutic drugs employed in the treatment of cancers); for its ability to stimulate the immune system to attack tumor cells (especially those cancer cells that have been damaged by chemotherapeutic agents): and for its ability to treat cachexia (wasting) in patients with AIDS or cancer.

In 1996, Dr. Shalom Z. Hirschman joined the Company as President and CEO and has led the research team investigating the drug’s complex chemistry. Dr. Hirschman was director of the Division of Infectious Diseases at The Mount Sinai School of Medicine for nearly three decades and was an internationally recognized researcher in the fields of infectious diseases. Research activities over the past several years have been focused primarily on research, testing and analysis of AVR118 in the laboratory (In Vitro), on animals, and on preparing for and performing tests and analysis of AVR118 on human patients participating in clinical trials.

Under Dr. Hirschman's scientific leadership, ADVR is committed to obtaining FDA approval of AVR118 and to market the drug in the U.S. and select worldwide markets. In order to expedite the successful submission and approval of the Company's Investigational New Drug Applications, the Company retained the regulatory consulting firm GloboMax, LLC to guide the applications through the FDA approval process.

In August of 2003 Dr. Shalom Z. Hirschman resigned as President and CEO and assumed the position as Chief Scientist. Eli Wilner, Chairman of the Board, served as the Company's interim CEO. In February 2004, Elma Hawkins became CEO of Advanced Viral Research.

http://www.adviral.com/ADVR/thisis/profile.htm



 
By: Ourobouros
15 Oct 2004, 03:19 PM EDT
Msg. 170372 of 170523
(This msg. is a reply to 170359 by DIAMONDring.)
Jump to msg. #  
"if there was no DICKIE $$$$ where would advr be? "

I would also like to add

"if there was no DICKIE where would Viagra be? "
 
By: lovingitall0
16 Oct 2004, 08:32 AM EDT
Msg. 170459 of 170523
(This msg. is a reply to 170336 by mind31.)
Jump to msg. #  
June 6, 2004: ADVR Presented Results of its AVR118 Phase 1/2 Clinical Program at ASCO

All Patients with Anorexia at Entry Regained Appetite

YONKERS, N.Y., June 6 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp.

(BULLETIN BOARD: ADVR) announced today that the company presented interim results of its Phase 1/2 clinical program with its flagship product, AVR118, at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans, LA.

The presentation "Anti-Cachectic Effects of a Novel Peptide Nucleic Acid Complex: Preliminary Results of a Phase1/2 Clinical Trial," given by James T. D'Olimpio M.D, showed the results of Phase 1/2 clinical trials conducted in Israel.

A total of 25 cachectic patients (patients with cancer cachexia or AIDS wasting) were enrolled in the trials. Ten patients with advanced AIDS and two patients with advanced pancreatic cancer received AVR118 subcutaneously at a dose of 0.4 ml/day for 28 days (6 days/week). Eight AIDS patients received a dose of 2.0 ml/day and five patients received 4.0 ml/day at the same schedule.

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 were measured for all AIDS patients. Spontaneous patient comments regarding quality of life (QOL) parameters, including improvement in mood, appetite, alertness, activities of daily living (ADLs), malaise, myalgia and power/energy were recorded. Adverse events were monitored.

All dose groups showed an increase in weight, strength and fat percentage, with more significant improvements in the two higher dose levels. All patients with anorexia at entry became anorexia-free after three weeks of therapy. Spontaneous patient comments reflect widespread, dose-related improvements in Quality of Life (QOL). AVR118 continues to show a favorable safety profile.

"This trial was designed as a dose-escalation study and we are pleasantly surprised to see such strong data given the relatively short treatment period," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "We are very encouraged by the results, most importantly with the resolution of anorexia in all study participants."

Results Reported - AIDS:0.4 ml dose* All patients were anorexia-free after three weeks of treatment. (Onepatient did not have anorexia at baseline).* Half of the patients reported increased daily activity.2 ml dose* All patients were anorexia-free after three weeks of treatment.* At the end of four weeks of treatment the average weight of patientsincreased by over a pound.* All patients had an increase of fat percentage after treatment and thiswas sustained in the majority of patients.* Approximately half of the patients reported an improvement in theirmood and increased daily activities.4 ml dose* All patients were anorexia free after three weeks of treatment. It isimportant to note that 50 percent of patients had Grade Two anorexia atbaseline.* Patients in this cohort increased their average weight by 2.2 poundsover four weeks of treatment. This effect continued through thefollowing four weeks at which point the average weight had increased by2.6 pounds over baseline.* All patients showed an increase in fat percentage which was sustainedafter treatment discontinuation in all patients.* 100 percent of patients reported an increase in daily activity.* 80 percent of patients reported decreased fatigue.Results Reported - Pancreatic Cancer:* Both patients had improved weight (4% increase)* Improved fat percentage (20% increase)* Improved strength (5 % increase)

ADVR's AVR118 represents a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which to date has demonstrated a very favorable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.



 
By: lovingitall0
16 Oct 2004, 08:45 AM EDT
Msg. 170460 of 170523
(This msg. is a reply to 170336 by mind31.)
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AVR118: Product R (Reticulose™) is a peptide–nucleic acid immunomodulator

IL-8 AND MCP-1 SECRETION IS ENHANCED BY THE PEPTIDE-NUCLEIC ACID IMMUNOMODULATOR, PRODUCT R, IN U937 CELLS AND PRIMARY HUMAN MONOCYTES

Cytokine May 2001, vol. 14, no. 4, pp. 234-239(6)

Lazzarino D.A.; de Diego M.; Hirschman S.Z.; Zhang K.Y.; Shaikh S.; Musi E.; Liaw L.; Alexander R.J.

Advanced Viral Research Institute, Advanced Viral Research Corp., 200 Corporate Boulevard South, Yonkers, New York, 10701, USA

Abstract:

Product R (Reticulose™) is a peptide–nucleic acid immunomodulator recently shown to enhance the expression of mRNAs encoding pro-inflammatory cytokines.

Interleukin 8 (IL-8) and macrophage chemoattractant protein-1 (MCP-1) are pro-inflammatory chemokines involved in immune cell mobilization and stimulation. To determine whether Product R acts by upregulating these chemokines, we assayed its effects on the expression of IL-8 and MCP-1 mRNAs and proteins by human monocytic U937 cells and by adherent peripheral blood mononuclear cells (PBMCs). U937 cells were cultured for 0–21 days in media containing 0–20% Product R or phosphate-buffered saline (PBS). Compared to control cultures, cells cultured in Product R expressed increased amounts of IL-8 and MCP-1 mRNAs, as measured by reverse transcriptase-polymerase chain reaction (RT-PCR). Product R also increased secretion of IL-8 and MCP-1, as measured by enzyme-linked immunosorbent assay (ELISA), and boosted secretion induced by bacterial lipopolysaccharide (LPS), in a time- and dose-dependent manner. In adherent PBMCs, Product R increased IL-8 and MCP-1 secretion, but reduced LPS-induced MCP-1 secretion. While mRNAs encoding the IL-8 receptor, CXCR2, and the MCP-1 receptor, CCR2, were increased in U937 cells cultured in 5–10% Product R, we observed no change in binding of receptor-specific antibodies. These findings suggest that Product R upregulates the expression of IL-8 and MCP-1, which may boost immune system activity in virally-infected patients.


 
By: Chrisdez
16 Oct 2004, 10:42 AM EDT
Msg. 170472 of 170523
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Here's a brief synopsis of drugs in development (entry inhibitors)
http://www.hivandhepatitis.com/2004icr/11croi/docs/0213/021304_c.html#four