disturbing! If Bill Bregman is posting here. If Mark's undeniable
connection to him is reality. If you look at 3 years of posts. Born on
dates. Friedland liquidation. Content of posts. I see smoke. I smell
fire. I smell arson. I see fire marshall. I see penalty! Never play with
matches near dry pines. The needles go quick!
better hope he is not part of the inner circle! Wilner is liable if so!
Bregman should not be obtaining any sensitive information. Wilner and
Van Sant better review their legal liability. Bob Woodward.
Cancer Risk Factor: Human Papillomavirus Infects All Ages of Women in
Women's Health Weekly, 04.22.04
Focusing on an inner-city area of Ibadan, Nigeria, J.O. Thomas and colleagues examined the prevalence of and risk factors for cervical infection with human papillomavirus (HPV). Nine hundred thirty-two sexually active women age 15 or older were interviewed and cervical cell samples were obtained. "A total of 32 different HPV types were identified with an HPV prevalence of 26.3 percent overall and 24.8 percent among women without cervical lesions; or age-standardized to the world standard population of 28.3 and 27.3 percent, respectively," the investigators reported.
High-risk HPV types, including HPV 16,31,35 and 58, predominated, and 33.5 percent of all infections involved more than one HPV type. According to the authors, "Unlike most populations studied so far, HPV prevalence was high not only among young women, but also in middle and old age."
Increased HPV positivity was found among single women and illiterate women. Associations were also found with anti- herpes simplex-2 antibodies and with the husband's extramarital relationships. The investigators suggested that "high prevalence of HPV in all age groups may be a distinctive feature of populations where HPV transmission continues into middle age and cervical cancer incidence is very high."
The study, "Prevalence of Papillomavirus Infection in Women in Ibadan, Nigeria: a Population-Based Study," was published in the British Journal of Cancer (2004;90(3):638-645).
was a time when I thought it was "cute" that he was up here
unannounced, posting a little tidibt every now and again - but he has
crossed the line, he knows it (I think) and I feel for sure his lawyers
have told him the same at some point.
That he chooses to be involved at this level smacks of deceit and comes darn close to being unethical - and legally reportable!
crazy thought just popped into my mind.....curious as to WHY "mbengineer"
is so concerned about MY attending the Florida meeting. I don't know if
he is Bill Bregman, or not....but, if I WERE TO ATTEND THE FLORIDA
MEETING, would "mbengineer" still show up. I had met Bregman a
few years ago, and would be able to identify him on sight! Hmmmmmm!!!!
P.S. Is anyone else attending the Florida meeting? Barry Allen???
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.
hmmmmmmmmmm! So far they missed the part about sales. Even though, as I recall, one muckity-muck told us to expect a product a few years back.
I just wonder who was in charge of making sure 30 patients could be found for a study of such a short duration. They told us to expect results 12 months after they started. Nov. 14th 2002?
Just venting, every once in a while I think about what management has been said and their seeming lack of direction and it pizzws me off.
(Voluntary Disclosure: Position- Long)
course:]...The Tribulations of Clinical Trials
Efforts are afoot to improve the output of the drug research pipeline | By Susan Warner
A plain tablet in a no-name blister-pack. It could save a life.
Or maybe not.
Since 1994, the Food and Drug Administration has approved year-to-year increases in the number of new candidate drugs for human testing in the United States, rising from 3,350 in 1996 to 3,900 in 2002. But the number of drugs that successfully negotiate the trial process and ultimately receive FDA approval is frustratingly low. Despite pharmaceutical companies' and the National Institutes of Health's research budgets doubling since 1993, the number of approvals for new drugs with a novel chemical structure fell from 53 in 1996 to 21 in 2003.
"Currently, a striking feature of this path [to market] is the difficulty, at any point, of predicting ultimate success with a novel candidate," states a recent FDA report.
And herein lies a large part of the problem: While new technologies have lead to significant breakthroughs at the front-end of the drug development process, the same hasn't happened at the drug-trial stage. "Not enough applied scientific work has been done in creating new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in a faster time frame, with more certainty, and at lower costs. As a result, the vast majority of investigational products that enter clinical trials fail," the FDA states in its report.
Other issues that contribute to the paucity of new drug approvals include: poor trial design (see Feature | From P Valves to Bayesian Statistics, It's All in the Numbers), the shortage of adequately trained clinicians, problems with surrogate endpoints, the industry's reluctance to move toward a more streamlined approach to data collection, and attracting enough patients to fill the trials.
BEYOND OBSERVATION The foundation of the modern clinical trial process was laid in 1938 with the Federal Food, Drug, and Cosmetic Act. In the early 1960s, the current system of clinical trials evolved, in which new drugs pass through three distinct phases of controlled testing for safety and efficacy, says Paul Herrling, head of global research at Novartis. Historically, physicians with an interest in research worked with drugs in small patient groups to develop treatment strategies based largely on experience and anecdotal evidence. Edward Jenner, in 1796, determined that the cow-pox virus could thwart small pox and about a century later, Bayer chemist Felix Hoffmann learned about the pain-relief aspects of aspirin: He gave it to his father, who had arthritis.
The three phases progressively involve more people who are tested over longer periods of time. Phase I assesses how the compound affects the body: how it is absorbed, distributed, metabolized, and excreted. A typical study involves between 20 and 100 healthy volunteers; about 70% of new drugs pass this stage. Phase II studies assess the effectiveness of the novel drug in treating patients. Several hundred subjects are generally involved in these proof-of-concept studies, and 33% of the drugs pass muster. Subsequent Phase II studies assess the most appropriate dose.
In Phase III, hundreds, maybe thousands, of patients take the drug or a placebo to confirm both efficacy and safety. Phase III studies frequently are longer in duration in order to provide additional reassurance regarding safety. Between 25% and 30% of the drugs clear this hurdle. Thus, only about 8% of drug submissions make it to market. Herrling says that today's more scientific process is necessary and appropriate, but it shifts much of drug development away from the clinic until the final stages. This remoteness from patients, he says, invites a higher attrition rate.
Mark B. McClellan, former head of the FDA and now administrator of the Centers for Medicare and Medicaid Services, agrees. In the 1980s and 1990s, researchers followed a simple path to a receptor target and then synthesized the molecule to fit it, he said in an interview with The Scientist last year. Now, the process is more complex. "Most product developers are testing compounds on glass slides doing microarray work, seeing if there is an impact on gene expression," McClellan said. "The problem is, [we're] not developing a whole lot of knowledge on what it means for patients." To help, the FDA outlines in its March report a goal of developing new, publicly available scientific tools such as assays, standards, computer-modeling techniques, biomarkers, and new clinical-trial endpoints that are designed to make the drug development and testing processes more effective.
A further confounding factor regarding the paucity of new drugs is what biotechnology analyst Brian Rye calls a poverty of riches: So many molecules to investigate, and so many of them miss their targets. "[Researchers are] having a hard time deciphering which of those targets will be validated," says Rye, of Janney Montgomery Scott in Philadelphia.
Consequently, it is not the drugs that are failing per se, says Eric Rowinsky, an oncology researcher who directs the Institute for Drug Development, University of Texas Health Science Center, San Antonio. "We have to select the disease and develop the methodologies to identify the tumors in which the target is really being turned on," he says. The molecular dissection of disease, to determine the importance of the target that is driving the cancer, is desperately needed; it goes hand in hand with the development of targeted therapies. "We should be conducting clinical trials in those tumors in which the target is functionally important, or in those tumors in which the target is driving the malignancy."
TIME, MONEY, AND TRIALS The stakes in drug development are high. It takes nearly eight years to develop a drug, almost twice as long as it took 20 years ago. The cost of failure can be mighty. Last fall, Merck & Co. shocked financial markets when it announced it would discontinue work on a promising new antidepressant, aprepitant, which had already received marketing approval as an antinausea drug, after it failed in Phase III trials. Shares in the company's stock tumbled 6.5% in a single day. Even the costs of success are staggeringly large: more than $1 billion per drug, from concept to market, according to a report by the Tufts Center for the Study of Drug Development, cited by the FDA. Rye says the number seems high, but adds that Pharma could be including the costs of failed molecules.
Despite this, the FDA identifies two key issues that will inevitably cost more in terms of money and time. The first is the testing of a wider range of doses of candidate drugs; the other is the detection of rare adverse effects.
FDA staff and some academics suspect that one issue contributing to Phase III failures may be that companies do not conduct adequate dose-response studies in Phase II. Typically, dosing is a trade-off. Companies want to use a high enough dose to guarantee effectiveness, but not so much that it triggers safety issues.
Robert Temple, who directs the Office of Medical Policy in the FDA's Center for Drug Evaluation and Research, says companies are sometimes reluctant to spend additional time and money testing dosage. "Sometimes if you just plunge forward and study a single dose in Phase III and you get it right, you can save yourself a couple years and be out there ahead of somebody else," he says.
Susan Ellenberg, director of the Office of Biostatistics and Epidemiology in the FDA's Center for Biologics Evaluation and Research, recalls an early AZT study that showed its effectiveness in treating HIV. The results were so good that the study was canceled. "Later on we found out the dose was twice as high as needed to be," she says. "Everyone was glad we got it on the market quicker, but it proved so toxic a lot of people wouldn't take it."
The issue of safety can be dealt with better if the drug trials were larger, the FDA says. "Clinical trials ... in most cases are neither large enough nor long enough to provide all information on a drug's safety. At the time of approval for marketing, the safety database of a new drug will often include 3,000 to 4,000 exposed individuals, an insufficient number to detect rare adverse events. For example, in order to have a 95% chance of detecting an adverse event with an incidence of 1 per 10,000 patients, an exposed population of 30,000 patients would be required."
Considering the struggle that clinical researchers have now in trying to attract subjects, the FDA's position may be unrealistic. Rare side effects, and those that develop with chronic use or that have a long latency period are difficult or impossible to detect. Furthermore, drug trials rarely include special populations, such as children and the elderly, who are often taking several types of medications. And, trials do not always represent the population that may be exposed to the drug after approval.
Put yourself in the shoes of a small-to-midsize biotech, Rye says. On the one hand is a promising drug; a large trial would be ideal. But the patent has a finite shelf life, and the costs of signing everyone up, including patients, doctors, and centers, are significant. "You have got to balance," says Rye.
A further potential hurdle: Congress recently ordered the FDA to give new guidance on safety procedures. The agency is considering mandatory so-called risk-management plans, which would require additional safety information, including larger safety studies to screen earlier for potential adverse reactions that may affect only a few people. Formal rulings on risk- management programs are expected this year.
Until now, these risk-management programs were negotiated as part of the approval process. Ira Loss, executive vice president at Washington Analysis, an equity research firm, points to Accutane, which has had additional safety requirements and warning labels attached to it because of its danger to pregnant women. Lotronex, the drug for irritable bowel syndrome that the FDA withdrew, was allowed back on the market only after its manufacturer, GlaxoSmithKline (GSK), complied with a risk-management program.
"Industry doesn't like it because it is more red tape and a burden, but I think we have come to a point where every product will have a risk-management program of some sort," says Loss.
TRIAL MANAGEMENT WOES A noted measure of the relative inefficiency of the drug industry is that it did not move toward electronic data management until recently. The pharmaceutical sector lags behind other industries in developing computer-data capabilities, mainly because it has been successful under the old paper-based system, says Glenn Gormley, vice president of US clinical development at the British pharmaceutical firm, AstraZeneca. "We've been doing clinical trials more or less the same way for 20 years. The technology is there; it's just a matter of adopting it."
Last year researchers wrote in The Journal of the American Medical Association that "although cost-benefit models of hypothetical computer-based patient record systems have shown a significant cost advantage, the entire healthcare industry continues to invest significantly less in information technology (IT) than any other information-intensive industry."
But there is movement. Novartis, for example, designed its data-management system and has been using it since December 2001. The company reported saving $65 million (US) in 2003.
Another problem is actual trial implementation. There are too few researchers to conduct them, and currently, only 8% of principal investigators conducting industry-sponsored clinical trials are younger than 40 years of age.
For the past 30 years, many top physicians have turned away from going into medical research, says David Korn, senior vice president for biomedical and health sciences research at the Association of American Medical Colleges. "Bright MDs and PhDs chose to go after the experimental models. Doing research on people is difficult and, one could say, heavily burdened by regulations."
And then there's the issue of trying to attract, and keep, trial participants in the first place; roughly 5 million or so people are enrolled currently. The American Cancer Society says that only 5% of adult patients with cancer participate in drug trials.
MOVING FORWARD Many anticipate that a mixture of new technologies and improved regulations will increase the efficiency of the clinical trials. Some companies are trying to improve the chances of success by further studying drugs before they reach the trial stage. "The companies who will be able to do this efficiently and fast will have a huge advantage over those who can't," says Gormley. AstraZeneca and other pharmaceutical companies are changing their drug-design strategies to include what's called front-loading risk: to evaluate risk early on and find ways to test for fatal flaws in a compound.
Ron Krall, GSK's senior vice president of global development, says the company is putting a new emphasis on improving the quality of lead drugs. Using new high-throughput screening equipment, GSK is sifting through more compounds to find those that generate a stronger response to disease targets. "One of the things that makes it difficult to do clinical trials is when the molecule is messy: It's not very selective or it has different mechanisms of action or produces a lot of effects," says Krall. "As we get more potency ... and more specificity in our molecules, that allows us to really narrow the focus of our clinical trials and improve their quality."
Like other companies, GSK is applying pharmacogenetics, the study of genetic variation underlying differential response to drugs, particularly genes involved in drug metabolism. "We don't know for sure that this is going to be successful in improving the efficacy and safety of our medicines, but we're confident it will pay off in identifying sets of patients who have improved efficacy and safety profiles," says Krall. He adds that the company is using large patient databases to narrow down the investigators with whom it wants to work. "A lot of the noise in clinical trials comes from the differences in patients that exist among the centers."
A controversial issue involves the use of surrogate endpoints and markers as proxies for the ultimate endpoint--disease eradication, or longer survival--which could take years to prove. Some patient activists say that these endpoints may ultimately hurt patients by creating useless new drug therapies. For example, postmenopausal hormones can reduce cholesterol, an endpoint that researchers hoped would prove the benefit of using hormone replacement therapy (HRT) to prevent heart disease. However, when large-scale trials were run through the Women's Health Initiative, it was shown that HRT lead to increased cardiovascular problems.
Adopting a new biomarker or surrogate endpoint for effectiveness standards can speed up clinical development. For example, the adoption of CD4 cell counts and, subsequently, measures of viral load as surrogate markers for anti-HIV drug approvals, allowed the rapid clinical workup and approval of life-extending antiviral drugs, with time from first human use to market as short as 3.5 years.
Barbara Brenner, executive director of Breast Cancer Action in San Francisco, says that using surrogate endpoints to reach approval could be tantamount to guesswork. "The problem we're now seeing is a move to yet earlier stages in the biology of cancer and the use of surrogates for the endpoints we're looking for," she says. "It is mind-boggling that this is the direction of cancer-drug approval."
The FDA's Temple acknowledges that there are disagreements. "We approve some drugs based on endpoints that some people don't think are as good as we should have," he says. "But there are [others] who would argue that what we should be doing is [shooting for] survival ... We've not accepted that position." Endpoints other than survival were the basis for 73% of all cancer drug approvals (including accelerated approvals) between 1990 and 2002, and for 67% of all regular (nonaccelerated) cancer drug approvals during the same time period.3
Another goal is to improve interactions between companies and the FDA. Companies complain about delays and multiple reviews, although most acknowledge the process sped up when the Prescription Drug User Fee Act of 1992 was passed. The law, which was reauthorized in 2002, requires companies to fund FDA staffing in return for guaranteed review times. Even with the new funds, the agency can be overwhelmed, pharmaceutical executives say. "What we would like to do is interact regularly with the agency, but they have many companies asking to do the same thing," says Gormley.
Former FDA director McClellan says that early contact can help in reducing cost and time. In trying to avoid multiple cycle reviews, one of the FDA's new initiatives is a test project in which the agency is meeting earlier with the drug companies and giving them earlier feedback on applications, even on ideas still in development.
Discovering viable, agreeable solutions to make the drugs flow more freely and quicker through the pipelines will involve a host of remedies, including tolerance. "I think we are going to have to be more patient," says Rowinsky. "We live in a short-term society. Investors are screaming for results right away, bean counters are screaming for big numbers right away; we're often slaves to investors. ... Patience is a virtue."
- - - - -
-I really doubt they will have all 30 patients completed and the results
tabulated before the ASCO meeting. The SEC filing of the annual report
dated 3/20/2004 stated that 23 patients had been enrolled, of which 22
were completed. Since it takes at least two months for the study from
start to finish once the patient is enrolled, plus time after that to
compile the data it appears unlikely that the study will be completed in
time for the ASCO meeting. Unless by some miracle, the remaining 7
patients were enrolled all together within a week or so of the annual
report date. If the ASCO meeting abstract does indeed deal with the AIDS
trial in Israel, it may reflect the data on the first 23 patients - that
is my view. Since they have already submitted the research abstract with
the results to ASCO, it stands to reason that the report should have
only included data on the completed patients.
Somebody meeting Elma in Florida this weekend could directly ask her of the current status of the trial and its anticipated completion date.
Pharmaceuticals Awarded NIH/SBIR Grant for HIV/AIDS Program
BLUE BELL, Pa.--(BUSINESS WIRE)--04/29/2004--
Funding to Support Identification of Novel, Orally Active Drug Leads Targeting Viral Entry Inhibition Mediated by gp41
Locus Pharmaceuticals today announced that is was awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health for "The Design and Development of Potent gp41 Inhibitors." This fully funded award of $180,000 will be used to support the development of novel, drug-like small molecules that disrupt the gp41 mediated viral fusion process. Inhibition of this critical step in the HIV viral life cycle is expected to lead to more effective treatments preventing HIV-1 viral infection.
"Recognition by the National Institutes of Health of Locus's efforts in this highly competitive and important disease area represents a validation of our unique, computationally-directed drug discovery technology, in particular when applied to challenging drug targets like HIV. This award will enhance our extensive work in the area of identifying orally active fusion inhibitors targeting the virus-host cell fusion process. To date, we have made significant progress in the identification of two lead small molecule series and are working toward the selection of an optimal drug candidate to advance into human clinical trials in 2005," said Dr. Bruce Dorsey, Principal Investigator and Director of Chemistry of Locus Pharmaceuticals.
Locus's Novel Approach to HIV
Locus uses three highly integrated technologies to deploy its innovative approach in developing novel, small molecule drug candidates. This powerful approach deploys proprietary computationally-driven algorithms to identify viable binding sites on a target protein and automatically builds the most effective and synthesizable compounds de novo from Locus's 40,000 fragment data set. While such a process may traditionally take years to realize, Locus's in-house 2.3 teraflop super computer allows for a more rapid and efficient process that can often be completed in 4-6 months. By also deploying its in-house crystallography capabilities, Locus is able to affirm the appropriate binding of lead compounds and assure the final selection of clinical compounds. Locus has applied its core technologies to the published gp41 crystal structure identified by Dr. Peter Kim, Dr. Min Lu and other leading HIV research experts as a basis for selecting an IND candidate by early 2005.
"HIV has become increasingly resistant to existing antiviral therapies and there is a pressing need for new drug targets. Viruses that are resistant to existing drugs are sensitive to entry inhibitors. Small molecule inhibitors that block gp41 would be highly desirable since they could be taken by mouth, would be effective against viruses that are resistant to existing therapies, and target a region of the virus that is highly conserved," said Dr. Robert Doms, M.D., Chairman, Dept. of Microbiology, University of Pennsylvania.
HIV: Significant Medical Need
Human immunodeficiency virus (HIV), the etiologic agent of acquired immune deficiency syndrome (AIDS) has infected over 40 million people worldwide. In the U.S., nearly one million Americans are infected with HIV with 40,000 additional cases diagnosed annually according to CDC data. Despite recent improvements in antiretroviral therapy, there remains an urgent need for novel and improved methods of treatment for individuals who are suffering from AIDS. Although highly active antiretroviral therapy (HAART) has dramatically improved patient outcomes, the limitations of treatment options include the emergence of resistant viruses, poor pharmacokinetics, and reduced patient compliance as a result of adverse side effects and treatment regimens. Therefore, the need for additional therapeutic modalities that are safe and convenient remains high.
About Locus Pharmaceuticals
Locus Pharmaceuticals is a privately held pharmaceutical company focused on developing novel, small molecule therapeutics to address major unmet medical needs. Locus combines powerful and proprietary, fragment-based, computational technology with one of the world's fastest Linux-based supercomputer clusters to simultaneously identify relevant binding sites on protein disease targets and rapidly generate novel, drug-like small molecules that bind specifically to those protein sites. Locus further enhances this process through its in-house crystallography effort to assure the most competitive outcome. In contrast to other computational or drug discovery approaches, the Locus technology requires only a high-resolution, 3-dimensional structure of the target protein to implement its drug discovery process. Presently, Locus Pharmaceuticals is synthesizing and developing novel, computationally predicted, drug candidates for the treatment of debilitating and life-threatening human diseases including HIV/AIDS, cancer and inflammation.
CONTACT:Locus Pharmaceuticals, Inc. H. Joseph Reiser, Ph.D., 215-358-2001 or Wise Communications, LLC Kori B. Beer, 610-216-0634
SOURCE: Locus Pharmaceuticals, Inc.
04/29/2004 10:53 EASTERN
Shakeout at .12-.125 range coming up....barring any bad news ADVR should
rebound while closing the huge hole there../200 day retest...MOO
bought 2 Mil shares .155 , I will not Sell 1 share for less than a
(Voluntary Disclosure: Position- Long)
have invested over 300k , and I know what i an talking about..thanks
(Voluntary Disclosure: Position- Long)
Trouble,Well yes there is other BB's....here they are....Aven1
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)
- - - - -
were taking a long memorial weekend to save vacation days ill let you no
what happens. also sue yes .60 sounds great personally i have a sell for
75% of my long shares for 1.23 if it doesnt happen in 04 it will never
and i love advr but this is it #### or get of the pot for advr.
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)
liarfox, you go out of your way to lie. GLTY means "good luck to
you" and you know that.
As for bashing straights, what is that?- I am straight- I just do not condone the gay bashing that you and your son have engaged in here.
PS To answer your question to Bob, yes, it is OK to bash straights. It is also OK to bash Republicans IMO.
Patients Et Long-Term Boost With Short, Intermittent Drug Regimen
Source: National Institutes of Health
National Institutes of Health (NIH) scientists report that brief, widely-spaced courses of the experimental immune- boosting drug interleukin-2 (IL-2) allow people with HIV to maintain near normal levels of a key immune system cell for long periods. The researchers, from NIH's National Institute of Allergy and Infectious Diseases (NIAID) and the Warren G. Magnuson Clinical Center, describe their findings in the May 1 issue of the journal "Blood".
"These data provide strong evidence that IL-2 therapy, which can be self-administered by patients, could be an important adjunct to highly active antiretroviral therapy (HAART)," says NIAID Deputy Director John R. La Montagne, Ph.D.
The new report summarizes the experience of 77 HIV-positive individuals who enrolled in extension phases of three long- running AIDS clinical trials. Participants were taught to inject themselves subcutaneously with IL-2 twice daily in 5-day-long cycles. Cycles were initiated as often as necessary to maintain levels of immune cells called CD4+ T cells at predetermined, individually tailored amounts. HIV infection causes progressive loss of CD4+ T cells. Without enough of these "helper" immune cells, people with HIV disease have a hard time fending off infections. IL-2 can boost CD4+ T cell levels, with the goal of improving overall immune health.
Because HIV infection causes progressive immune destruction, it stands to reason that immune-stimulation therapy, such as IL-2, might play a substantial role in treating patients with this condition, notes Richard Davey, Jr., M.D., an NIAID AIDS clinician who headed the studies reported in "Blood". Indeed, during the early 1980s NIH physicians pioneered the use of long courses of IL-2 to treat individuals whose immune systems had mysteriously failed. Scientists now know those people were suffering from AIDS, but at the time the virus causing AIDS had yet to be identified.
Although NIH physicians have accumulated over 20 years of experience with IL-2 therapy, the most impressive results began to appear in the early 1990s when the doctors started treating patients with short, intermittent cycles of the drug, Dr. Davey says. Today, HIV patients receiving IL-2 therapy typically begin with 5-day-long cycles every other month while taking drugs, such as HAART, on a sustained basis. According to Dr. Davey, this regimen often raises an HIV patient's CD4+ T cell levels well into the normal range after only a few cycles. The new research suggests IL-2 therapy can then be administered much less frequently without loss of benefit.
Most studies to date have looked at IL-2 therapy only over relatively short periods, says Dr. Davey. In contrast, the average length of patient follow-up described in the current paper is about six years. Patients in these trials have received an average of 10 IL-2 cycles during the course of their involvement, with most of the cycles occurring in the initial years of participation. Of the original 77 volunteers, 61 achieved and maintained normal or nearly normal levels of CD4+ T cells for periods ranging from two to 91 months between IL-2 cycles. During the most recent period of study, the average time between cycles was more than 3 years. (Of the 16 people no longer participating, one died, one developed non-Hodgkin's lymphoma, eight elected to follow other treatment plans and six experienced CD4 cell count declines that did not respond to IL-2 therapy.)
"Patients described in this study are still being followed," says Dr. Davey. "There are also trials planned or underway to learn if IL-2 therapy could delay or obviate the need for continuous HAART, thereby sparing persons with HIV disease from the serious side-effects that HAART can cause. The early experience from some small preliminary studies in this area suggests that this may indeed be a possibility, although larger trials are clearly needed to explore this fully."
For information about AIDS treatment or to enroll in a clinical study, please contact or call: 1-800-HIV-0440 (1- 800-448-0440).
lovingitall, I have asked a few to look at this board and they feel
there is a deliberate attempt to keep the price down and investors away.
I have also been told that a certain few have no conscious at all about
how their posts appear to others and that in fact it may underscore
their negative balance on the company in their own personal
portfolio and actually be a mask for their hatetred on
Advanced Viral. Some claim to have averages over .50 and
might realize that a phase 1 result may not in fact let them
out. One biotech "guru" [just a novice really] said that
the company not even approach a dollar for several years
when a large Phase 3 is finished.
- - - - -