Day: 12/05/2011

Drugs That Control Genes May Treat Lung Cancer

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Researchers Report Some Success Against Advanced Lung Cancer With Epigenetic Drugs.

A new approach to treating cancer appears to help certain patients with advanced lung cancer, and researchers say they think they may have a way of spotting those who will benefit.

The small study is generating big excitement in the world of cancer treatment because it demonstrates that so-called epigenetic drugs may work when traditional chemotherapy has failed.

Epigenetic drugs work by controlling gene expression — the way information from genes is used to create products such as proteins.

The study is published in Cancer Discovery.

“This is a … groundbreaking study, showing that by modifying the epigenetics of a cancer cell we can get real responses in lung cancer,” said Jeffrey A. Engleman, MD, PhD, director of thoracic oncology at Massachusetts General Hospital, in Boston, in a news briefing. “And getting real responses in lung cancer is actually quite difficult, so we take special notice of therapies that can do this.” He was not involved in the research.

New Approach to Treating Cancer

All 45 patients recruited for the study had non-small-cell lung cancer, the leading cancer killer in the U.S.

All had tumors that had spread beyond their lungs despite treatment with an average of three other therapies.

“These are patients with very advanced disease” who have little chance of survival, says study researcher Charles Rudin, MD, PhD. He is professor of oncology and associate director for clinical research at Johns Hopkins University Kimmel Cancer Center in Baltimore.

Rudin says that he has consulted for Syndax Pharmaceuticals, the company that makes one of the drugs tested in the study.

Most patients with cancer this advanced are only expected to survive for about four months, the researchers note.

After treatment with a combination of the medications Vidaza, which is FDA approved to treat certain rare blood disorders, and the experimental pill entinostat, however, the average survival for the entire group was 6.4 months.

Doctors who wrote an editorial on the study note that this result was just shy of the same average survival (6.7 months) seen in patients treated with Tarceva, the only medication that’s approved to treat patients with non-small-cell lung cancer that has spread to other organs.

The figure from the new study, however, included 11 patients who dropped out of the study before finishing a single cycle of treatment.

Among patients who finished at least one full treatment cycle, the average survival was even higher, about 8.6 months.

What’s more, four of 19 patients who got chemotherapy after the experimental drug combo had dramatic responses to those treatments, “raising the hypothesis that maybe the epigenetic therapy is in some way priming the tumor for response to chemotherapy,” Rudin says.

In total, seven patients who took part in the trial are still alive; two have survived for more than four years.

Two patients in the study had remarkable results.

In one patient, the cancer completely disappeared for 14 months, though she later developed a different kind of lung cancer that proved fatal.

A second patient saw tumors that had spread to his liver vanish and the primary tumor in his lung shrink.

Researchers described the drugs as well tolerated with few side effects for patients. The most commonly reported side effect was fatigue.

Despite their promising results, researchers say there’s still a lot more to be learned before the epigenetic therapy becomes a mainstream treatment.

“This trial is small,” Rudin says, “and these results certainly need to be confirmed in a larger study population.”

Researchers say larger studies testing the drug combo are already underway.

“This is not yet a study that would in any way impact standard of care for this disease. But I think it opens up a new avenue that may be of real benefit to these patients,” Rudin says.

Understanding Epigenetics

The drugs are believed to work by blocking a process that stops the activity of genes that naturally block tumor growth. In some cancers, these genes are switched off, taking out one of the body’s natural defenses.

In contrast to drugs that target a specific gene or a mutation in a gene when it shows up in cancers, epigenetic therapies aim to control gene expression.

To help explain how it works, researcher Stephen A. Baylin, MD, professor and deputy director of the Kimmel Cancer Center at Johns Hopkins University, likens genes to the hard drive on a computer.

“But the hard drive needs a software package to tell it how to function and epigenetics is essentially that software package,” Baylin says. Baylin says he has no financial interest in the drugs tested in the study, but that he has helped develop a blood test used in the research.

“In every patient’s cancer, of every type, hundreds of genes can also be affected by abnormalities in the software package, or epigenetic abnormalities, and that’s what we are theoretically trying to target,” he says.

Who Will Benefit?

One key question is why some people in the study had dramatic responses to the medications when others did not.

To answer that, researchers gave 26 patients in the study blood tests to check the function of four genes that were shown in an earlier study to affect how aggressively lung cancers might spread.

If at least two of the four genes were switched off, lung cancers are more likely to recur and spread.

And indeed, in 10 patients who had at least two silenced genes, using the epigenetic drug therapy to turn those genes back on increased survival significantly compared to 16 patients whose genes weren’t switched off in the first place.

“The investigators have done a great job in trying to identify specific biomarkers,” Engleman says. “We need to know which patients will respond to these therapies.”

Source:nature genetics

 

FDA Rejects Avastin for Breast Cancer

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FDA Finds Big Risks, Little Benefit in Avastin for Late-Stage Breast Cancer

The FDA has revoked its approval of Avastin for the treatment of breast cancer.

The ruling followed the unanimous advice of a June 2011 advisory panel, which found that the cancer drug carries major risks but few benefits for women with late-stage breast cancer.

Genentech, which makes Avastin, appealed an earlier FDA ruling, permitting continued use of Avastin in breast cancer while the FDA considered the appeal. The FDA today rejected that appeal.

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments,” FDA Commissioner Margaret Hamburg, MD, said in a news release. “But … it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit.”

The Research

No study has shown that Avastin helps breast cancer patients live longer or improve their quality of life. However, one early study suggested that it might improve survival by about half a year. Later studies did not fully confirm this possible benefit, according to the FDA’s analysis.

Genentech had been planning a new study of Avastin in breast cancer patients. But that would not be completed before 2016. The company said today it fully intends to complete the study as well as other ongoing studies of avastin and breast cancer.

“I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug,” Hamburg said at a news conference.

In addition to Avastin’s common side effects of nosebleed and severe high blood pressure, serious side effects include: massive bleeding; perforation of the nose, stomach, and intestines; blood clots; heart attack; kidney damage; wounds that do not heal; and a condition called RPLS  that is characterized by headache, confusion, seizures, and vision loss.

Despite these risks, many women facing metastatic breast cancer have petitioned the FDA to retain their access to Avastin. Without FDA approval, Avastin might not be reimbursed by insurance companies — or by Medicare/Medicaid. The wholesale price of Avastin is $7,500 a month, which does not include infusion costs. The FDA is not allowed to consider cost in its approval decisions.

“We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States,”  Hal Barron, MD, Genentech chief medical officer, says in a news release.

Avastin will remain on the market as an approved treatment for certain types of colon, lung, kidney, and brain cancer (glioblastoma multiforme).

Source:FDA

 

 

 

Coffee May Cut Endometrial Cancer Risk

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Women Who Drink 4 or More Cups Daily Had 30% Lower Risk, but Lifestyle Matters, Too
coffee and beans

Long-time coffee fans who drink four or more cups a day of caffeinated coffee may be reducing their endometrial cancer risk by 30%, a new study shows.

And if you prefer decaf, drinking two or more cups showed a trend toward reducing risk by about 22%. “Consistent with other reports, this study suggests that women who drink coffee, regular or decaf, are at reduced risk of endometrial cancer,” says study researcher Edward Giovannucci, MD, ScD, professor of nutrition and epidemiology at Harvard School of Public Health.

Even so, Giovannucci says, “It’s premature to recommend that women take up coffee to reduce the risk of endometrial cancer.” He found a link, not cause and effect.

About 46,470 new cases of endometrial cancer and 8,120 deaths are expected in 2011, according to the American Cancer Society. The cancer occurs in the womb, or inner lining of the uterus.

Tracking Coffee Habits and Cancer Risk

Giovannucci evaluated more than 67,000 women enrolled in the long-running Nurses’ Health Study to examine the link between coffee and endometrial cancer risk.

During the 26-year follow-up, there were 672 cases of endometrial cancer.

The researchers found a stronger protective effect among obese women, which has also been found in other research. Obesity is a risk factor for endometrial cancer.

The link between four or more cups of coffee and reduced risk of endometrial cancer was also stronger for:

  • past or current smokers
  • women past menopause
  • women not on menopausal hormone therapy

“Coffee seems to improve insulin resistance, which lowers insulin levels,” Giovannucci says, and coffee and caffeine have also been shown to decrease estrogen levels.

“Both high estrogen and high insulin have been associated with higher risk of endometrial cancer,” he says.

As for the stronger effect in smokers, he says, “We don’t know why at this point.”

It’s not clear if the results would apply to those who drink coffee with sweeteners or cream, the researchers say. No information was given on how the women drank their coffee. Adding sugar or cream could offset any potential benefits.

It might be more than the caffeine providing the protection, Giovannucci says. “Coffee contains numerous compounds (outside of caffeine) that may improve insulin action in the body.”

Coffee and Endometrial Cancer Risk: Second Opinion

The results are “intriguing,” says Marji McCullough, ScD, RD, strategic director of nutritional epidemiology for the American Cancer Society. She reviewed the study but was not involved in it.

The finding about a weaker link in people who have never smoked needs more study, she says.

But McCullough agrees the study does suggest that a woman who currently drinks coffee may be receiving benefit in terms of reducing her risk of endometrial cancer.

“If not, there are other important ways to reduce the risk of endometrial cancer, such as maintaining a healthy body weight and staying physically active,” she tells WebMD.

source:webMD

Microbicide Use Discontinued in HIV Prevention Trial

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But the devil’s in the details.

Just 2 months after the use of oral tenofovir was discontinued in the VOICE trial , study investigators have announced that the use of vaginal tenofovir gel is also being discontinued. The decision is based on an interim review at 2 years, showing similar rates of HIV acquisition in women assigned to a daily tenofovir-based vaginal microbicide and those assigned to placebo gel (6.0% and 6.1%, respectively). Notably, the review did not identify any safety concerns.

The VOICE trial originally included five study arms — oral tenofovir (Viread), oral tenofovir/FTC (Truvada), oral placebo, vaginal tenofovir gel, and vaginal placebo gel — with each intervention prescribed for daily use. About 1000 HIV-uninfected women were assigned to each arm. At this point, only those receiving oral tenofovir/FTC or oral placebo will continue as planned. The trial is expected to be completed by mid-2012, with final results available by early 2013.

Comment: In the past 18 months, HIV prevention research has yielded both tremendously exciting results and extremely disappointing ones, and this news from the VOICE trial is clearly in the latter category. Not only was the trial intended to clarify the comparative effectiveness of oral versus vaginal-gel strategies for HIV prevention in women, but it was also intended to be the second study required by regulatory bodies for approval of tenofovir gel — assuming the results of the CAPRISA 004 study could be replicated or improved upon. The negative results of the VOICE trial confirm the complexity of using medication-based HIV prevention strategies. Of note, the CAPRISA 004 study used a coitus-dependent dosing regimen (12 hours prior and 12 hours after intercourse), whereas VOICE used daily dosing. If an analogy can be made to the iPrEx trial (and it remains to be seen if such analogy is appropriate), it’s that participants in HIV prevention studies seem to adhere poorly to daily dosing and thus potentially leave some episodes of intercourse “uncovered” by protective antiretrovirals. Details on adherence levels, drug levels in vaginal tissues, and risk behaviors are critical for understanding the vastly different results of VOICE and CAPRISA 004 — and also the conflicting results of various tenofovir/FTC trials in women (Partners PrEP, TDF2, and FEM-PrEP). Until the detailed results of all these trials are fully presented, it is virtually impossible to proceed with much-needed implementation research and demonstration projects in female populations.

Source: Journal Watch HIV/AIDS Clinical Care

 

HPV-16/18 AS04-Adjuvanted Vaccine Shows High Efficacy Against Cervical Neoplasia

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It also provided cross-protection against several nonvaccine oncogenic HPV types.

The two human papillomavirus (HPV) vaccines currently available were licensed based on trials showing protection against HPV infection and cervical intraepithelial neoplasia grade 2 or greater (CIN 2+), which may be a precursor to invasive cervical cancer. Two research groups now report 4-year end-of-study data from PATRICIA — a manufacturer-funded, multinational, double-blind trial of one of these preparations (HPV-16/18 AS04-adjuvanted vaccine; Cervarix). In this trial, healthy women aged 15 to 25 with six or fewer lifetime sexual partners were randomized to receive either HPV or hepatitis A vaccine at 0, 1, and 6 months. Gynecological examinations were performed, and cervical specimens obtained, at baseline and periodically thereafter.

Lehtinen and colleagues assessed vaccine efficacy against CIN 3+ (an immediate precursor to invasive cervical cancer) and adenocarcinoma in situ in two groups: the total vaccinated cohort (TVC; all women who received ≥1 vaccine dose) and the TVC-naive (women who received ≥1 vaccine dose and who, at baseline, had negative cytology, were HPV DNA negative for all 14 HPV types tested for, and were seronegative for HPV-16 and HPV-18). Vaccine efficacy against adenocarcinoma in situ was 76.9% in the TVC and 100% in and TVC-naive group; efficacy against all CIN 3+ (irrespective of HPV type in the lesion) was 45.6% and 93.2%, respectively. In the TVC, vaccine efficacy against CIN 3+ was highest in the youngest age group (15–17 years) and progressively declined in older age groups, whereas in the TVC-naive group, efficacy was >90% in all age groups. Antibody concentrations against HPV-16 and HPV-18 remained high throughout the 48 months. The incidence of serious adverse events was similar between the study vaccine and control groups.

Wheeler and colleagues assessed cross-protection against 12 nonvaccine oncogenic HPV types, which together account for approximately 30% of cervical cancers. Their analysis involved three cohorts: according-to-protocol for efficacy (ATP-E; women who at baseline were not infected with the HPV type under analysis and who received all 3 vaccine doses), TVC-naive, and TVC. In the ATP-E cohort, vaccine efficacy against the composite of 12 nonvaccine HPV types was 46.8% for CIN 2+ and 73.8% for CIN 3+. In analyses excluding cases with HPV-16 and HPV-18 coinfection, efficacy was 24.1% and 62.1%, respectively. Efficacy against CIN 3+ associated with the composite of 12 nonvaccine HPV types was higher in the TVC-naive group (91.4%) — and lower in the TVC (47.5%) — than in the ATP-E cohort. The vaccine showed cross-protective efficacy against 6-month persistent infection and CIN 2+ associated with four individual nonvaccine oncogenic types: HPV-33, HPV-31, HPV-45, and HPV-51.

Comment: Taken together, these analyses provide compelling evidence for the efficacy of this prophylactic vaccine against HPV types that cause about 85% of cervical cancers. The size and duration of the study — approximately 68,000 person-years of follow-up — and the diversity of the study population bolster the findings. The authors attribute the decreasing efficacy in the older age groups in the TVC to the presence of preexisting HPV infection, which argues strongly for vaccine administration before women become sexually active.

As noted by editorialists, neither this vaccine nor the other available preparation (Gardasil) has a therapeutic effect against existing HPV infections and associated lesions, but either one will likely offer protection against vulvar and vaginal cancer, anal cancer, and possibly oropharyngeal cancer. The duration of protection (and of cross-protection against nonvaccine types) is unknown and must be assessed in long-term follow-up studies. The challenge now will be finding ways to deliver HPV vaccine to populations who will benefit most from it.

source: Journal Watch Infectious Diseases

Global Financial Crisis Hits Disease Prevention Funding

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It seems that every day another area of the economy is depressed because of the global financial crisis in the banks and governments around the world. This time it’s The Global Fund to Fight Aids, TB and Malaria, which has announced it will make no new grants until 2014; and there is a possibility of some existing projects being cut. The fund, which is based in Geneva, said that only “essential” programs in low or middle-income countries would receive more funding to keep them going until 2014 and hopes that new management can improve efficiency.

It seems ironic that the two sectors of the economy: banking and government, which add little to the world in terms of technology or innovation, the real drivers of economic growth, have been able to stymie and depress almost all areas of activity. The fund is asking international donors for $20BN, but has received little more than half that, which misses even their baseline target of $13BN.

The problem is compounded by the historically low interest rate scenario which has chopped a valuable source of income. In addition, some smaller countries that would normally contribute are facing their own budgetary battles and simply don’t have available funds. The cash is obviously not flowing the way it did before the crisis.

The HIV/Aids Alliance, whose member organizations draw on The Global Fund for many projects across the world, said that it was the worst possible time for money to be withdrawn. It has wide ranging plans to tackle high rates of HIV in areas of China and South Sudan which might well be affected by the funding cut.

Alvaro Bermejo, Director of The Global Fund, said:

“These should be exciting times – the latest scientific developments are showing us that HIV treatment can have a powerful HIV prevention effect … Never again must we reach a position where life-saving programs are cancelled or delayed.”

Médecins Sans Frontières, another charity relying on funding, described the financial situation as “dire”. Dr Tido von Schoen-Angerer, one of its executive directors, said:

“Donors are really pulling the rug out from under people living with HIV/Aids at precisely the time when we need to move full steam ahead and get life-saving treatment to more people.”

There is a call for governments to make up the shortfall, but this may prove unrealistic, since the governments themselves are a large part of the financial slow down, and many simply don’t have cash.

The deep pockets of government seem to have shrunk, and it’s not surprising really, since governments can only take money through taxes; they don’t have too many other ways to raise funds. If their citizens are feeling the pinch, tax revenues will drop in tandem. This time around its been compounded by government cut backs that have slashed thousands of jobs.

The Global Fund is planning a restructuring to make its management more efficient.

Board Chair Simon Bland said :

“The five-year strategy and transformation plan adopted at the meeting together commit the Global Fund to shift to a new funding model that focuses on investing strategically in countries, populations and interventions with high potential for impact and strong value for money …

It will provide its funding in a more proactive, flexible and predictable way. It will better manage risk and it will work more actively with countries and partners to facilitate grant implementation success. In doing so, I believe the Global Fund will shift from an institution that has successfully provided emergency funding to allow countries to cope with the runaway pandemics, to become a sustainable, efficient funder of the global efforts to control them and eventually win the battle against AIDS, TB and malaria.”

 

Source: Wall Street

 

fMRI Reveals Functional Brain Pathways Disrupted In Children With ADHD

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Using functional magnetic resonance imaging (fMRI), researchers have identified abnormalities in the brains of children with attention deficit/hyperactivity disorder (ADHD) that may serve as a biomarker for the disorder, according to a study presented at the annual meeting of the Radiological Society of North America (RSNA).

ADHD is one of the most common childhood disorders, affecting an estimated five to eight percent of school-aged children. Symptoms, which may continue into adulthood, include inattention, hyperactivity and impulsivity behaviors that are out of the normal range for a child’s age and development.

According to the National Institute of Mental Health, there is no single test capable of diagnosing a child with the disorder. As a result, difficult children are often incorrectly labeled with ADHD while other children with the disorder remain undiagnosed.

“Diagnosing ADHD is very difficult because of its wide variety of behavioral symptoms,” said lead researcher Xiaobo Li, Ph.D., assistant professor of radiology at the Albert Einstein College of Medicine in New York. “Establishing a reliable imaging biomarker of ADHD would be a major contribution to the field.”

For the study, Dr. Li and colleagues performed fMRI on 18 typically developing children and 18 children diagnosed with ADHD (age range 9 to 15 years). While undergoing fMRI, the children engaged in a test of sustained attention in which they were shown a set of three numbers and then asked whether subsequent groups of numbers matched the original set. For each participant, fMRI produced a brain activation map that revealed which regions of the brain became activated while the child performed the task. The researchers then compared the brain activation maps of the two groups.

Compared to the normal control group, the children with ADHD showed abnormal functional activity in several regions of the brain involved in the processing of visual attention information. The researchers also found that communication among the brain regions within this visual attention-processing pathway was disrupted in the children with ADHD.

“What this tells us is that children with ADHD are using partially different functional brain pathways to process this information, which may be caused by impaired white matter pathways involved in visual attention information processing,” Dr. Li said.

Dr. Li said much of the research conducted on ADHD has focused on the impulsivity component of the disorder.

“Inattention is an equally important component of this disorder,” she said, “and our findings contribute to understanding the pathology of inattentiveness in ADHD.”

source:Lancet

Novartis and collaborators discover new dual-acting class of antimalarial compounds with potential to both prevent and treat malaria infections

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The discovery of a new class of dual-acting antimalarial compounds – the imidazolopiperazines (IZPs) – was published in the journal Science online, at the Science Express website today. The findings report on compounds that target both liver and blood infections, attacking the Plasmodium parasite at both stages in its reproduction cycle.

The findings describe how scientists developed a novel assay to determine liver stage activity of candidate small molecules, then used the assay and other tools to identify and optimize a chemical scaffold with activity on both blood- and liver-stage parasites in malaria mouse models. Several other compound classes, also with dual activity, are described and released by Novartis through ChEMBL – Neglected Tropical Disease at https://www.ebi.ac.uk/chemblntd.

“For over a decade, Novartis has engaged in the front ranks of combating malaria, pioneering the not-for-profit supply of our antimalarial treatment Coartem® to the public sector of endemic countries,” commented Joseph Jimenez, CEO of Novartis. “These new findings further demonstrate our innovative and sustainable research commitment in this important area which has become integral to our corporate strategy for social responsibility.”

Scientists from the Novartis Institutes for BioMedical Research (NIBR), through the Genomics Institute of the Novartis Research Foundation (GNF) and the Novartis Institute for Tropical Diseases (NITD), collaborated with the Scripps Research Institute and Swiss Tropical and Public Health Institute. Research was supported by the Wellcome Trust, Singapore Economic Development Board, and Medicines for Malaria Venture. This is the second new class of antimalarials discovered by the same group in the last two years and holds promise as a next-generation treatment for malaria if confirmed.

 

“Novartis is committed to the elimination of malaria. Programs with our current anti-malarial treatment have helped save more than one million lives[2] to date, but there remains much to be done,” said Mark Fishman, NIBR President. “Concerns of potential future resistance to current medicines, and the need to treat liver forms of malaria, propel our scientists to devise new medicines. The chemical data from this successful study, and the methods of chemical analysis, have all been released to the public domain. Hopefully, such sharing will facilitate broad-based discovery efforts across the globe towards elimination of this disease.”

 

Researchers believe that future antimalarials will need to work against both blood and liver stages to bring us closer to the goal of eliminating malaria globally. The malaria parasite first infects the liver before moving to red blood cells and causing symptoms. However, after clearance in the blood, reservoirs of parasites can linger in the liver causing relapse and hampering efforts toward complete elimination of the disease. Each year there are about 250 million cases of malaria and nearly one million deaths – mostly among children living in Africa[3].

It is important to develop new classes of treatment that are one step ahead of the parasite should parasite resistance to current therapies occur, according to researchers. In collaboration with research partners, NIBR is working on developing a pipeline of potential new treatment candidates for drug-resistant malaria. Last year’s development of the spiroindolone class, represented by NITD609[4], is now in Phase I human clinical trials, with Phase II expected to commence in early 2012.

“Compounds with dual activity are rare among current antimalarials,” said Martin Seidel, GNF Institute Director.  “The activity of the IZP compound class on liver-stage parasites, if it can be confirmed in clinical trials, gives promise to this class as a first-line therapy for the prevention and treatment of malaria.”

According to Elizabeth Winzeler, GNF Department Head and lead investigator, “Little was known about malaria liver stages when we started this work and as a consequence, we didn’t have a good idea about how to approach the problem. Eventually we decided to develop an automated microscopy method to look for compounds that would alter the appearance of the developing liver stages. We are excited that by publishing the full set of compounds active in both blood and liver stages, new targets might be identified.”

sourceNovartis newsletter

 

Anti-HIV gel fails to prevent infection

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Trials of a vaginal gel in South Africa have failed to prove conclusively that it prevents HIV transmission from men to women.

The microbicide, Carraguard, underwent phase III clinical trials in 6000 women between 2004–2007. But this month (14 February) The Population Council, the US-based nongovernmental organisation that ran the trials, announced that the microbicide had been found to be safe but not effective.

“With Carraguard there was not a big enough difference between the number of women who contracted HIV on the placebo and those using Carraguard to prove that the microbicide had a significant impact,” Sumen Govender, clinical study manager for the Population Council in South Africa, told SciDev.Net.

Most women enrolled on the Carraguard trial reported only using the gel before sex some of the time, which could have affected the results, say the researchers. Govender said researchers were now analysing social aspects of the Carraguard data.

Researchers will report the results of the Carraguard trial at the International Microbicide 2008 Conference in New Delhi, India, this week (24–27 February).

But Carraguard will continue to be used in further trials. The Population Council will commence phase I safety trials of a new microbicide, PC-815 — which comprises Carraguard and an antiretroviral drug called MIV-150 — this year.

Carraguard contains carrageenan, a chemical derived from seaweed that is effective against HIV in the laboratory. The addition of an antiretroviral drug to the microbicide should also prevent the HIV from multiplying.

Research into PC-815 will begin with safety testing on 50 participants in June this year in the Dominican Republic, pending government approval.

The failure of Carraguard represents another setback to microbicide research, following the termination of trials of the microbicide cellulose sulphate in 2007 (see Safety concerns halt trials of HIV microbicide).

Ayesha Kharsany, project director at the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and head of a team developing a microbicide called Tenofovir, says researchers are united in their efforts to find a product that works.

Govender says a microbicide could never completely prevent infection but could reduce it by between 30–40 per cent and would be most effective when used with another preventive measure.

Source:SciVX

 

Treatment Shows Promise for Premature Ejaculation

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Freezing Overactive Nerves Helped Men Last Longer in Small Study

An experimental approach in which penile nerve tissue is frozen to knock out overactive nerves helped men with premature ejaculation last three times longer.

Researchers tested the technique on 24 men who hadn’t been helped by standard treatments. They lasted an average of 110 seconds before ejaculation, or nearly two minutes, over the three months they were followed, compared with 36 seconds before treatment.

“That’s about what you see with standard drug therapy,” says researcher J. David Prologo, MD, assistant professor of interventional radiology at Case Western Reserve University’s School of Medicine in Cleveland. A time to ejaculation of more than two minutes is normal, he tells WebMD.

Its supporters say the technique, or a similar one involving heat therapy, could someday become a standard treatment for the condition.

But other experts tell WebMD that questions about the long-term consequences remain. Also unknown: whether men would opt for the treatment.

The findings were presented here at the annual meeting of the Radiological Society of North America. Prologo consults for Galil Medical, which funded the study.

Premature ejaculation affects 20% to 38% of men, making it among the most common forms of male sexual dysfunction worldwide.

Treatment options include certain antidepressants such as Celexa (citalopram), Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (sertraline), as well as anesthetic ointments and cream, and behavioral therapies.

But many men aren’t helped by the treatments, Prologo says.

The new technique involves inserting a tiny, hollow needle into the skin near the belly button.

Using computerized imaging for guidance, the doctor snakes it down to one of the two dorsal penile nerves. Overactivity of these nerves has been implicated as a cause of premature ejaculation.

“Then we knock out the nerve by freezing it,” Prologo says.

“It’s not painful, though some men feel a cold sensation,” he says.

The procedure takes about 45 minutes, and men can go home the same day. While still experimental, Prologo estimates the cost at $3,500.

After the procedure, men were asked five questions relating to their sexual satisfaction. All improved on at least one sexual-related symptom.

There were no side effects from the procedure. However, three men reported their erections weren’t as firm afterward, for reasons Prologo can’t explain.

Unknown is how long the treatment will last. In the third month of the study, some men started ejaculating more quickly again.

Prologo says repeat injections may be necessary, and he is following the men for six months to see what happens.

Paula Novelli, MD, clinical assistant professor of radiology at the University of Michigan in Ann Arbor, says that could be a problem. “How many times can you repeat it before you do damage?” she says. Novelli moderated the session at which the findings were presented.

Prologo says he doesn’t think there will be long-term problems because only one of two nerves is destroyed.

Still, he is testing a similar but less aggressive technique that uses heat to decrease the activity of overactive penile nerves without destroying them.

The researchers plan a study comparing one or both techniques to placebo in larger numbers of men.

Source:webMD