Alimta regimen didn't meet goal in study

Eli Lilly and Co. said Thursday a drug regimen including its Alimta therapy did not improve the survival of lung cancer patients in a late-stage clinical trial.

Lilly said patients who were treated with a combination of Alimta, Avastin, and the chemotherapy drug carboplatin lived for 12.6 months after the start of treatment. Patients who were treated with chemotherapy and Avastin, a drug that is made by Roche, had median survival of 13.4 months. There was not a statistically significant difference between the results of the two regimens.

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HIV Drug Reduces Transmission Among Men By Over 40%, Study Finds

A daily dose of antiretroviral medication lowered the risk of contracting HIV by more than 40% among men who have sex with men, according to a study published Tuesday in the New England Journal of Medicine, the New York Times reports.

The results of the study -- nicknamed iPrEx -- "are the best news in the AIDS field in years" and "could change the battle" against HIV/AIDS, according to the Times . Experts suspect the medication will be successful in other groups but caution that it must be tested first.

Details of Study

An international team of researchers enrolled 2,499 MSM at 11 sites in six countries to test a prevention strategy known as pre-exposure prophylaxis, which has been successful in preventing other diseases. The team was led by Robert Grant of the University of California-San Francisco Gladstone Institute of Virology and Immunology and Javier Lama of the Investigaciones Medicas en Salud in Lima, Peru . NIH and the Bill and Melinda Gates Foundation funded the study .

Half of the participants received a daily dose of Truvada, an antiretroviral drug containing emtricitabine and tenofovir, while the other half received a placebo. Both groups received counseling about condom use and safer sex practices. The researchers found that 36 participants taking Truvada contracted HIV, compared with 64 in the placebo group, representing a 43.8% reduction. They noted that the decrease was dependent on how frequently the subjects took the medication. Those who adhered to their medication at least half of the time experienced a 50.2% decline in risk, while those who took their medication at least 90% of the time saw a 72.8% risk reduction .

Caveats to Strategy

The researchers noted several limitations to the study, including that it only involved MSM and one combination of antiretroviral drugs. They said additional studies are under way to test Truvada in other high-risk groups, such as commercial sex workers and intravenous drug users, and heterosexual men and women.

Some HIV/AIDS advocates and scientists expressed concern about the cost of the strategy. Truvada costs between $12,000 and $14,000 annually in the U.S. Generic versions in developing countries cost as little as 40 cents per pill. They said they are also concerned that placing people on the drugs will speed the evolution of drug resistant strains of the virus or that people will stop using condoms .

Kevin Fenton, AIDS prevention chief at the Centers for Disease Control and Prevention, said that prophylaxis "should never be seen as a first line of defense against HIV," adding, "It's not time for gay and bisexual men to throw out their condoms" .

Grant said that the findings are "a major advance," but the strategy "will only work if people use it consistently, and the real challenge is how do you use it consistently" .

Advances in Preventive Approach

The findings follow this year's success with a vaginal microbicide gel and a proof-of-concept trial on an HIV vaccine . The microbicide study indicated that the gel protected 39% of all women testing it and 54% of those who used it consistently .

Alan Bernstein, health of the Global HIV Vaccine Enterprise, said, "This is a very exciting, dynamic time in HIV prevention research," adding, "There's clearly a growing realization that we're not going to be able to treat our way out of this epidemic" .

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Breastfeeding While Taking Seizure Drugs May Not Harm Childs IQ, Study Suggests

"While more research is needed with larger numbers of women and their babies, these results are reassuring to women who want to give their babies all the benefits of breastfeeding but also need to remain on their epilepsy medications to avoid devastating seizures," said study author Kimford Meador, MD, of Emory University in Atlanta and a Fellow of the American Academy of Neurology (AAN).

The study followed 194 pregnant women who were taking one epilepsy drug. Of their 199 babies, 42 percent were breastfed. When they were three years old, the children were given IQ tests.

The study found that there was no difference in IQ scores between the children who were breastfed and those who were not. Those who were breastfed scored 99 on the test, while those who were not scored 98, which is not a significant difference.

The women were taking the drugs carbamazepine, lamotrigine, phenytoin, or valproate. Meador noted that more research is needed on the effects of other, newer drugs for epilepsy. The children whose mothers were taking valproate had lower IQ scores, whether or not they were breastfed. American Academy of Neurology guidelines recommend that valproate be avoided during pregnancy due to risks of birth defects and effects on cognitive skills. AAN guidelines also recommend that women avoid taking more than one epilepsy drug at a time during pregnancy since taking more than one drug has been found to increase the risk of birth defects compared to taking only one medication.

Editorial author Autumn Klein, MD, PhD, of Brigham and Women's Hospital and the Harvard Medical School in Boston said that this is one of the first large studies on breastfeeding while taking an epilepsy drug.

"Many women are counseled not to breastfeed due to the lack of information on the effects of these drugs, but breastfeeding has many positive emotional effects for the mother and the baby along with the decreased risks for heart disease, diabetes, and obesity in the child and breast and ovarian cancer in the mother," Klein said. "This study highlights the pressing need for more data on epilepsy drugs in breast milk and the long-term effects."

The study was supported by the National Institutes of Health and the UK Epilepsy Research Foundation.

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No Link Between Heartburn Drugs and Birth Defects: Study

Babies born to women who took a popular class of heartburn drugs while they were pregnant did not appear to have any heightened risk of birth defects, a large Danish study finds.

This class of drugs, known as proton-pump inhibitors (PPIs), include blockbusters such as Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). All were available by prescription-only during most of the study period (1996-2008), but Prilosec and Prevacid are now sold over-the-counter.

While the authors and an editorialist, publishing in the Nov. 25 issue of the New England Journal of Medicine, called the results "reassuring," experts still recommend using drugs as little as possible during pregnancy.

"In general, these are probably safe but it takes a lot of time and a lot of exposures before you see some of the abnormalities that might exist," explained Dr. Eva Pressman, professor of obstetrics and gynecology and director of maternal-fetal medicine at the University of Rochester Medical Center. "My recommendations are always to avoid medication exposure if at all possible. There are very few life-threatening disorders that require these PPIs," she noted.

"There are other ways to get the same effect," added Pressman, who was not involved in the study. "Most pregnant women have heartburn but most of it is relatively easy to treat with simple antacids such as Tums and Maalox and Mylanta, all of which are locally acting and absorbed, and don't pose any risk to the fetus."

Even propping yourself up so you're in a semi-vertical position, as opposed to lying flat, can help, said Dr. Michael Katz, senior vice president for research and global programs at the March of Dimes.

The research was funded by the Danish Medical Research Council and the Lundbeck Foundation.

The authors of the new study used linked databases to glean information on almost 841,000 babies born in Denmark from 1996 through 2008, as well as on the babies' mothers' use of PPIs during pregnancy.

PPI use by expectant women was the highest between 2005 and 2008, when about 2 percent of fetuses were exposed, but exposure during the critical first trimester was less than 1 percent.

Babies were followed until they were one year old.

The proportion of babies with birth defects hovered at about 3 percent in both groups -- 3.4 percent of those who had been exposed to a PPI in utero, and 2.6 percent for unexposed babies.

In an unexpected finding, there was a 39 percent increased risk of major birth defects among children whose mothers had taken PPIs in the month before conception, a finding the authors are attributing to either chance or to another factor, perhaps the reason the mother was taking the medication in the first place. This could have been infection with Helicobacter pylori, the bacteria that causes most ulcers.

In addition to Prilosec, Prevacid and Nexium, the authors also looked at Aciphex (rabeprazole) and Protonix (pantoprazole).

Prilosec was the only drug not associated with an increase in birth defects when taken during the month before conception, leading the editorial author to suggest this drug as a first line of treatment.

A related journal editorial, written by Dr. Allen A. Mitchell, director of the Slone Epidemiology Center at Boston University School of Medicine, also noted some caveats. These included the fact that even this big of a sample may not have been large enough to detect specific birth defects (such as heart defects) or to ascertain the effect of specific drugs within the class. Nor can the influence of other factors be ruled out, Mitchell wrote. Perhaps folic-acid supplementation during pregnancy is hiding the true effects of the PPIs, Mitchell said.

The bottom line, according to the experts, is that it's still not clear whether these drugs are safe or not for pregnant women.

"Having negative observations is never absolutely reassuring," Katz said. "All you can say is that within that range [in this case, 800,000 infants], the probability is that it is safe," he explained.

"The balance in pragmatic terms is how important is it to treat the symptoms that any drug is designed to treat versus the safety of pregnancy," he added. "That's a very difficult decision to make."

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In Early Trial, Targeted Therapy Fights Advanced Melanoma

By probing deeper into the biological mechanisms that go awry in melanoma, scientists have come up with an experimental drug that has had an effect in a surprising number of patients with advanced melanoma.

The drug, PLX4032, just completed a phase 1 clinical trial in which 81 percent of participants with a particular gene mutation had a partial response, meaning at least some shrinkage of the tumor.

The current standard treatments for metastatic melanoma -- chemotherapy and interleukin-2 (IL2) -- only have response rates in about 15 percent of these patients, said Dr. Paul Chapman, senior author of a study in which the findings are described.

The average survival time for someone diagnosed with melanoma is nine to 11 months, added Chapman, who is an attending physician in the Melanoma Sarcoma Service at Memorial Sloan-Kettering Cancer Center in New York City.

One expert cautioned that it's too early to say whether the drug will actually prolong patient's lives, or if it might be helpful to patients in earlier stages of the disease.

"I don't want to say this is going to change survival rates but they're working with the most ill people, so you can't really generalize [to other patient populations]," said Dr. Alice Pentland, chair of dermatology at the University of Rochester Medical Center. "I think the most important part of this breakthrough is the bigger percentage of people who responded."

The study, which is published in the Aug. 26 issue of the New England Journal of Medicine, was funded by drug makers Plexxikon and Roche Pharmaceuticals.

About nine years ago, scientists discovered that the tumors of about half of patients with melanoma have a mutation in a gene called BRAF.

The gene appears to help drive the runaway cell division that is a hallmark of cancer. "It's always on. It's always signaling to the nucleus [of the tumor cells] that it's time to divide," Chapman explained.

That finding opened the door to potential targeted, molecular therapies for melanoma, which has been sorely lacking in effective treatments.

PLX4032 is the first potent inhibitor of BRAF that has made it to the clinical trial stage, Chapman said.

In the trial, 55 patients received escalating doses of the drug. Ten of 16 patients who had the BRAF gene mutation had a partial response to the drug, meaning the tumor shrank by at least 30 percent, while one had a complete response, with the tumor disappearing altogether.

Among 32 patients with BRAF-mutated melanoma in the second phase of the study, 24 had a partial response and two had a complete response.

"It worked: 81 percent had a partial response -- which has never been seen. I don't know of any solid tumors that have a response rate that high," said Chapman. "What's different here is that we've discovered a molecule that is responsible for driving the melanoma cell. It turns out that the melanoma really cares if we block the gene BRAF. It matters. It's addicted to this pathway."

There are some important caveats, however. It's not known at this time if the drug can improve overall survival, and a sizable proportion of participants developed resistance to the drug, the researchers say.

The findings join other recent reports of potential treatments for melanoma in what appears to be an exciting time for the field. Progress in this field has essentially been stalled for decades, experts say.

Recently, scientists reported that another experimental drug, ipilimumab, prolonged median survival in patients with metastatic melanoma from 6.4 months to 10 months.

"[Existing therapy] is not good for melanoma, so this is really a new opportunity that I think may have some importance to people," Pentland said.

However, she stressed that the best defense against melanoma is to get your skin examined regularly by a professional who knows what to look for.

"Our most successful treatment is to get [the lesion] early, get it before it's thick, get it before it spreads," she said.

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Findings May Lead to First Approved Treatment for Myelofibrosis

Myelofibrosis is a rare but serious disorder in which the bone marrow is replaced by scar tissue. There is no currently approved treatment for the disease, but a phase I/II clinical study of an experimental drug produced by Incyte Corp. of Delaware may possibly lead to the first medical option to reduce spleen size.

One of the primary symptoms of myelofibrosis is an enlarged spleen. Because the scarring of the bone marrow causes anemia, both the liver and the spleen attempt to make blood cells, which causes the organs to swell.

The new pill, called INCB18424 was found in a small study of 153 patients to reduce the size of the spleen of over half of the patients by 50% in an average of two weeks to one month, avoiding surgery to remove the organ called a splenectomy.

Also, fewer patients than expected progressed to a more severe form of the disorder called acute myeloid leukemia, a cancer that starts in the bone marrow and affects the normal production of white blood cells.

“This is a disease for which patients don’t have a therapy,” said Srdan Verstovsek, lead author and an associate professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston. The results, particularly the reduction of spleen size, have been “unbelievable,” he said.

The pill was also found to lessen other common symptoms, such as weight loss, fatigue and night sweats. Unfortunately, however, the medicine did not effectively address anemia, which in myelofibrosis patients often requires blood transfusions and medications called recombinant erythropoietin to help stimulate red blood cell production.

Incyte plants to initiate the third and final stage of human trials required for US approval of INCB18424.

If approved, the drug will likely be marketed by Novartis outside the US, according to Reuters.

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Ticagrelor : New hope for heart attack patients

A major drug trial has brought scientists closer to making a drug that could prevent thousands of deaths from heart attacks.

From the past six years, international clinical trials have been going on a new drug, ticagrelor.

The new findings have revealed that the platelet function in patients taking ticagrelor recovered much quicker after the drug is stopped, compared to the current gold standard drug, clopidogrel.

This study has also confirmed that breathlessness occurs as a side effect of ticagrelor but this is not associated with any harmful effects on lung or heart function.

The findings also include a new analysis of a previous trial looking at ticagrelor.

This new examination of the Plato trial, which was completed last year, showed that ticagrelor prevents 1 in 5 deaths after a heart attack, and patients who develop the adverse effect of breathlessness with ticagrelor still benefit from a lower risk of death compared to patients treated with clopidogrel for one year following a heart attack.

This has also confirmed that patients treated with clopidogrel, who have a genetic variant that reduces the effect of this drug have a slightly higher risk following heart attack but ticagrelor is not affected by this variant and is still more effective than clopidogrel, regardless of a patient's genetic make-up.

The study has previously shown for every 1,000 patients treated for one year with ticagrelor instead of clopidogrel, there would be 14 fewer deaths or 11 fewer heart attacks without an increase in bleeding problems.

"The latest results on ticagrelor reinforce the positive data from the PLATO trial and suggest that ticagrelor has the potential to improve the quality of care and save many lives in the year following a heart attack, regardless of adverse effects or genetic differences in the response to clopidogrel," said Robert Storey of the University of Sheffield.

The latest findings were presented at the European Society of Cardiology (ESC) Congress 2010 and appeared in the Lancet.

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The FDA approves new drug for gout

The Food and Drug Administration said Tuesday that it has approved a new drug to treat gout in patients who do not respond to existing therapy. The drug is called Krystexxa and is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J. The FDA had rejected the drug in August of 2009 because of manufacturing problems.

In a letter to the company then, the agency said that the potential commercial supplies of the drug were not identical to the product used in clinical trials.

Gout occurs because of an excess of the metabolic waste product uric acid, which precipitates out of the bloodstream and into joints and soft tissue as needle-like crystals that can be very painful. They also cause intermittent swelling, redness, heat, pain and stiffness in the joints. Although most people tend to associate the disorder with rich foods, it is more commonly linked to obesity, high blood pressure, high cholesterol and diabetes. It is most common in men, post-menopausal women and people with kidney disease.

The conventional treatments include the drugs allopurinol and febuxostat, both of which inhibit the enzyme xanthine oxidase, which produces uric acid from DNA in food. Krystexxa, known generically as pegloticase, is an enzyme that acts directly on uric acid, converting it into harmless chemicals that are excreted in the urine. The drug is given by an intravenous infusion every two weeks.

"About 3% of the 3 million [American] adults who suffer from gout are not helped by conventional therapy," Dr. Badrul Chowdhury, director of the FDA's division of pulmonary, allergy and rheumatology products, said in a statement. "This drug offers an important new option for them."

But the agency cautioned that about 1 in every 4 patients receiving an infusion of the drug suffers a severe allergic reaction and urged physicians to give patients a corticosteroid and an antihistamine before infusing the drug.

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Scientists In Singapore Discover New Drug Against Malaria

Scientists from the Singapore Immunology Network (SIgN) of Singapore’s Agency of Science, Technology and Research’s (A*STAR) led by Dr Laurent Renia have made a breakthrough concerning a drug that is effective against malaria.

Their work, carried out with industry leader Novartis, the Swiss Tropical and Public Health Institute, and The Scripps Research Institute, was published in top scientific journal Science.

The discovery and validation of the new drug, spiroindolone NITD609, is timely as many strains of drug-resistant malaria are emerging.

Dr Renia and his team of scientists from SIgN played a significant role in the testing and validation of the drug. With the help of a pioneering technology, Dr Renia tested spiroindolone NITD609 against field isolates – samples of the parasite isolated directly from patients.

This enabled researchers to obtain a clearer picture of how the drug would perform in a real life situation. In addition, Dr Renia’s team also tested the drug against a strain of malaria, P. vivax, that cannot be cultured in a lab, showing that the drug was also effective against another important species of malaria parasites.

Said Dr Renia, “We are excited to be able to contribute to the fight against malaria with our expertise and know-how. Our technology enabled Novartis to obtain a clearer picture of how their drug might perform in the field, giving them a better idea of the effectiveness of their spiroindolone NITD609. Moving forward, we will continue to collaborate with Novartis in the necessary steps to bring the drug closer to a medical reality. ”

Prof Paola Castagnoli, Scientific Director of SIgN, commented, “Malaria is a threat that kills approximately one child every 45 seconds. This kind of collaboration between SIgN and Novartis represents how the talent and know-how of our researchers can be applied to problems as pressing and urgent as malaria. SIgN will continue to explore ways in which we can work together with the private sector (biotech and pharma companies) to fight against human infectious diseases.”

Dr Renia and his team plan to continue the fight against malaria by assisting Novartis in the further testing of other possible drug candidates against field isolates.

They are also planning to further develop SIgN’s expertise in technologies that can be used in the fight against malaria by developing a new, fast, and robust assay using portable flow cytometer to test drugs in field conditions

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New Drug Speeds Response in multidrug-resistant TB

Patients with multidrug-resistant TB (MDR-TB) given a new anti-TB drug -- TMC207 -- combined with a background regimen, responded almost twice as fast as those on placebo with the background regimen, a researcher reported here.

Final results from the first part of a stage IIb trial among 47 patients, found the median time to culture conversion was 11 weeks for those treated for eight weeks with TMC207 and the five-drug MBR-TB background regimen, according to Andreas Diacon, MD, of the University of Stellenbosch in South Africa.

In contrast, the median time for patients assigned to placebo combined with the five-drug background regimen was 18 weeks, Diacon reported here at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

"Importantly," Diacon said, "these patients were only treated with TMC207 for eight weeks and still there is a significant reduction in the median time to culture conversion compared with placebo."

The drug has been closely followed (See ICAAC-IDSA: Novel Drug Shows Power in MDR-TB) but Diacon presented the final results of the first stage of the trial, which involved eight weeks of therapy with TMC207 and two years of the background regimen alone.

A second stage of the trial, with a different and larger cohort of patients treated for 24 weeks, is currently under way, he added.

TMC207 interferes with synthesis of adenosine triphosphate in Mycobacterium tuberculosis cells, but not in other cells, even those of closely related bacteria. Inhibiting the compound reduces the energy available for the TB bacteria to combat other drugs or to reproduce.

The researchers were looking at the safety and tolerability of the drug, as well as efficacy, in 47 patients with multidrug-resistant TB, defined as a strain resistant to the first-line drugs isoniazid (Nydrazid) and rifampin (Rifadin).

They were treated with a five-drug background regimen, which varied from patient to patient but usually included ethionamide (Trecator), pyrazinamide, kanamycin (Kantrex), and ofloxacin (Floxin). TMC207 was given daily at 400 milligrams for two weeks, followed by 200 milligrams three times weekly for six weeks.

At the end of the first stage of the trial, Diacon said, 81% of those treated with TMC207 were considered cured, defined as two consecutive negative cultures at least 28 days apart and no recurrence of the disease.

In contrast, 57% of those getting the background regimen alone were considered cured, a difference that was significant at P=0.03, he said.

The drug was generally well tolerated, Diacon said. No patients stopped the drug because of adverse events, and the proportions of patients with grade 3 and 4 adverse events were similar between the arms -- 26% for TMC207 and 21% for placebo.

The results are exciting, according to Patrick Charles, MD, PhD, of Austin Health in Heidelberg, Australia, who moderated the session at which the study was presented but who was not involved in the research.

"It's really the first new drug to treat these extremely resistant cases," he told MedPage Today.

For patients with multidrug-resistant TB, he said, treatment options are "very limited and very expensive, so to have a new drug is very exciting."

According to the abstract, preliminary results from the second stage of this trial, involving 161 MDR-TB patients with TMC207 administered for six months, are expected soon.

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Rosuvastatin cuts risk of catching pneumonia, study finds

Patients taking AstraZeneca Plc’s cholesterol-lowering medicine Crestor (Rosuvastatin) in a study were less likely to develop pneumonia, a finding that potentially will broaden use of such drugs.

The result supports earlier research suggesting drugs in this class, called statins, prevent deaths from pneumonia. The latest study, an analysis of a 17,000-person clinical trial that ended in 2008, was presented today, in Boston, at the Interscience Conference on Antimicrobial Agents & Chemotherapy.

Cholesterol drugs, led by Pfizer Inc.’s Lipitor, were the world’s second-best-selling category of medicines last year, with $35.3 billion in sales, according to IMS Health Inc., a health research company in Norwalk, Connecticut. Only cancer drugs exceeded that tally. The latest Crestor finding justifies further research into giving statins to patients with lung disease, scientists said.

“These data are consistent with the hypotheses that statin therapy may reduce incident pneumonia,” supporting further study of the drugs to treat pulmonary disease, the researchers wrote.

Statins work by blocking an enzyme involved in cholesterol production in the liver. Results from a separate study in 2008 showed that people hospitalized with pneumonia were less likely to die if they took a statin. There is also evidence the drugs may help reduce inflammation, the formation of blood clots, and the immune system’s inappropriate attacks on healthy tissue.

Side-Effect Reports

The results released today come from an analysis of a study called Jupiter designed to show whether Crestor was more effective than a placebo at reducing cholesterol levels. Since the original study didn’t set out to measure the effect on pneumonia, researchers went back and examined reports collected during the trial to compare rates of pneumonia and other infections among those getting Crestor and those on a placebo.

The analysis found that 257 patients taking a placebo developed pneumonia compared with 214 patients taking Crestor, researchers said. Patients taking Crestor were also less likely to develop fungal, soft tissue or gynecological infections.

Crestor generated $4.5 billion in revenue last year for London-based AstraZeneca; Lipitor had sales of $11.4 billion.

Pneumonia kills about 52,000 people a year in the U.S., with the elderly and infants being most at risk, according to the Centers for Disease Control and Prevention, based in Atlanta.

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Avandia Continues to Face Scrutiny: Biotech's Latest Mishaps

GlaxoSmithKline’s (GSK) diabetes drug Avandia is once again under regulatory scrutiny—this time it’s in Europe where the European Medicines Agency met to discuss whether Avandia should continue to be marketed. The agency in a press statement said that no final decision has been made about the drug.

It said it has further questions for GSK before deciding whether and what action needs to be taken. A final decision is expected by September 23. The meeting took place as a controversy erupted in the United Kingdom over a recommendation made at the end of July by the UK Commission on Human Medicines, according to TheHeart.Org. The commission unanimously voted that Avandia should be withdrawn. Though it informed the Medicines and Healthcare Products Regulatory Agency, the agency responsible for licensing drugs in the United Kingdom, its decision was not made public. Instead the agency sent letters to doctors restating safety information about the drug and suggesting they consider alternatives. Because the drug was approved by the European Medicines Agency, only it can revoke the license for the drug.

Roche said it halted dosing of patients in a late-stage trial of its experimental diabetes drug taspoglutide because side effects including nausea and vomiting resulted in many participants in the study to drop out of it, Bloomberg reported. The company is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, a spokeswoman told Bloomberg. Because a large number of patients dropped out of the study, the company said it would be difficult to determine whether the drug is effective.

Genzyme is laying off an undisclosed number of staff as part of a restructuring first announced in May, Reuters reported. The company said the move was unrelated to Sanofi-Aventis’ efforts to acquire the company. Genzyme has 12,800 employees. It offered no estimates on how much it expects to save through the restructuring.

Shares of Idenix Pharmaceuticals (IDIX) plummeted after the U.S. Food and Drug Administration ordered the company to halt a mid-stage study of two experimental hepatitis C drugs. Three healthy volunteers testing a combination of the drugs IDX184 and IDX320 showed elevated liver enzyme levels in a routine post-study safety test, the Cambridge, Massachusetts company says. Although liver function returned to nearly normal levels in all three subjects, the FDA placed a clinical hold on the study until it can discuss the results and other relevant data with Idenix. Idenix shares fell to $3.18 from $5.99 on the day it was announced. On top of that punishment, the hold will also likely make Idenix's ongoing search for an outside partner to advance its hepatitis C program more difficult. [see story].

U.S.-based Valeant Pharmaceuticals International and Canada’s Biovail plan to eliminate about 25 percent of their combined workforce once a merger is completed between the two companies, Reuters reported. The company’s said they expect to save more than $300 million through cost synergies with more than $200 million being realized in 2011. The companies have a combined workforce of about 4,400.

Marc Tessier-Lavigne, Genentech’s (DNA) executive vice president of research and chief scientific officer, is leaving the biotech to become president of Rockefeller University in New York, Reuters reported. The departure of Tessier-Lavigne, the second highest executive in research at Genentech, is one of the most significant executive changes since Roche acquired Genentech last year. He takes on his new post in early 2011.

U.S. Food and Drug Administration is requiring that certain contrast agents used in magnetic resonance imaging carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis, if the drug is administered to certain patients with kidney disease.

Nephrogenic systemic fibrosis or NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs. The order pertains to gadolinium-based contrast agents or GBCAs.

The agency said three of the GBCAs—Magnevist, Omniscan, and Optimark— will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

GBCAs are intravenous drugs used to help detect abnormalities of body organs, blood vessels, and other tissues through MRI. Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien (COV).

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Novartis's Experimental Meningitis Vaccine Meets Goals in Late-Stage Study

Novartis AG said an experimental meningitis B vaccine met the goals of a late-stage clinical study.

The vaccine, called 4CMenB, achieved a “robust immune response” in the study of more than 3,600 infants, the Basel, Switzerland-based company said today in an e-mailed statement. The drug also had “an acceptable” side-effect profile, the company said.

Novartis expects the results of additional clinical trials over the next few months and plans to seek European regulatory approval for the vaccine by the end of 2010. The compound may be used in different age groups and alongside other vaccines, the Swiss drugmaker said. Infants are particularly vulnerable to the meningitis B virus which can kill within 48 hours of the first symptoms appearing, according to Novartis.

“Meningitis B can be devastating for affected families and is a major concern for pediatricians who care for children with this serious illness,” said Andrew Pollard, Professor of Pediatric Infection and Immunity at the University of Oxford. “Many cases of meningitis are prevented today by the vaccines we give to our children, but the more complex meningitis B remains as a major threat.”

Novartis pioneered the technology known as “reverse vaccinology’’ to develop the shot after decoding the genetic makeup of a pathogenic meningitis strain.

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Some patients with severe heart disease receiving wrong treatment, study finds

Tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stenting every year when they should be having bypass grafts, and the result is an extra 5,000 or more deaths annually, researchers said Sunday.

Patients and cardiologists frequently prefer angioplasty and the insertion of a stent to keep arteries open because it is quicker and easier; patients go home sooner and return to work more quickly.

But new data from a major European-American study on more than 1,800 patients show that three years after the procedure, those who got stents were 28% more likely to suffer a major event, such as a heart attack or stroke, and 46% more likely to require a repeat procedure to reopen arteries. They were 22% more likely to die.

"This is one of the strongest studies yet demonstrating that, in advanced coronary disease, bypass has a real patient advantage," said Dr. Robert Guyton, chief of cardiothoracic surgery at the Emory University School of Medicine, who was not involved in the study.

"This will change practice," he said. "It may not reverse some of the use of stenting, but it is certainly going to slow it down and make people think. Stenting is a little bit easier on you and the return to work is quicker. But the benefits of surgery are more enduring and tend to emerge as time goes by."

Dr. Richard Shemin, chief of cardiac and thoracic surgery at UCLA's Ronald Reagan Medical Center, echoed that view. "Surgeons have had a strong feeling that, over time, surgery would be better for the most complex forms of heart disease," said Shemin, who also was not involved in the study.

The findings are "very strong, independent data that the public, payers and practitioners need to factor into how we make decisions in taking care of patients," he said.

"Any time that you compare angioplasty and surgery, the longer you go, the better surgery looks," said Dr. Michael J. Mack, first vice president of the Society of Thoracic Surgeons and a co-author of the study.

Coronary artery bypass grafts, commonly called CABG (pronounced cabbage), were the first treatment for blocked arteries. In the procedure, a blood vessel removed from elsewhere in the body, most often the chest or the leg, is used to bypass the blocked area, providing a new channel for blood to flow to the heart.

Hospital stays generally last five or six days, and the patient can return to work after a few weeks.

In recent years, however, cardiologists have turned more and more to balloon angioplasty, in which a catheter is threaded through a blood vessel in the groin to reach the blockage and a balloon is inflated at the site to compress the plaque. Originally, that was all that was done. Then physicians began inserting bare-metal stents, spring-like devices that hold the artery open.

More recently, doctors have begun using drug-eluting stents, which release a drug that helps prevent clot formation. Hospital stays are typically overnight, and the patient can return to work after a couple of days.

More than 1.3 million Americans now undergo angioplasty every year, compared with 448,000 who undergo bypass, according to the National Center for Health Statistics.

The new study, reported Sunday at a Geneva meeting of the European Assn. for Cardio-Thoracic Surgery, is the first large trial to compare stenting and CABG directly. Called SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery), the trial enrolled 1,800 patients at 85 centers in Europe and the United States.

Patients were randomized to receive either angioplasty with stenting or bypass.

Patients were considered to have mild disease if they had a single blocked artery. Their disease was considered moderate or severe if they had a blockage in the left main artery — the primary artery supplying blood to the heart — plus blockage in one of the other three arteries, or if they had blockages in all three other arteries. They were also considered severe if they had very long blockages, arteries that were totally blocked, or "very tortuous, curvy arteries" that make angioplasty difficult, Mack said.

For patients with mild disease, the two procedures produced equivalent results, so angioplasty might be preferred because it is easier on the patient. Previous studies have also shown that such patients can be successfully treated with medical therapy alone. But the differences were much more dramatic for those with more severe disease, which is present in about half of all patients undergoing angioplasty in the U.S.

Dr. John Conte, associate director of cardiac surgery at Johns Hopkins Hospital in Baltimore, noted that it is now incumbent on physicians to make sure patients have all the facts before they undergo any procedure. "It's absolutely amazing that the federal government and private insurers don't insist on it," he said. "Wouldn't it make sense to do the right procedure the first time, rather than do it over and over and drive up the cost of healthcare? To me, it's a no-brainer."

By Thomas H. Maugh II, Los Angeles Times

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New drug hope for pancreatic cancer

A commonly used chemotherapy drug may offer a new lifeline to sufferers of one of the most deadly cancers, research has shown.

Trial results suggest that the drug 5-fluorouracil (5-FU) is an effective alternative for pancreatic cancer patients who fail to respond to standard treatment.

They also raise hopes of providing better therapy by combining the two drugs.

A study now under way is looking at the effect of prescribing a pill version of 5-FU with the more expensive standard chemotherapy drug, gemcitabine.

5-FU is currently used to treat a wide range of cancers including those affecting the bowel, breast and ovaries.

Almost 8,000 people are diagnosed with pancreatic cancer each year in the UK.

The disease is one of the hardest cancers to treat, and only around 3% of patients survive more than five years.

The new findings are published in the Journal of the American Medical Association (Jama).

Study leader Professor John Neoptolemos, director of the Liverpool Cancer Research UK Centre based at the University of Liverpool, said: "Until now the best way to treat pancreatic cancer has been unclear. But these results are the first to directly compare these two chemotherapies and show undoubtedly that they are both as effective as each other.

"Importantly this means patients now have a backup in case their cancer fails to respond to the first line of treatment. A new trial investigating whether combining these two treatments could be even more effective and prolong life is already under way and we look forward to seeing the result."

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Dapagliflozin is a new drug for the treatment of type two diabetes

A strange drug, the premier in its class, gives added blood sugar dominate to mobile vulgus with category 2 diabetes who are already enchanting the glucose-lowering medication metformin.

The budding agent, dapagliflozin, which also helped patients squander weight, is novel in that it does not produce directly on the body’s insulin mechanisms, according to a inspect appearing in the June 26 issue of The Lancet and slated for conferral at the annual gathering of the American Diabetes Association (ADA) in Orlando Noroxin. “It will likely be used as an add-on therapy,” said swotting lead author Clifford Bailey, a chemical pathologist and professor of clinical study at Aston University in Birmingham, UK “If you don’t unreservedly get to quarry with the maiden therapy tried , this approach would put on the market you an opportunity hopefully to maintain improved control”.

Bailey, who could not vaticinate if or when the drug might get final approval from cure-all regulatory authorities, also pointed out that dapagliflozin is flexible, message it can be used with various other treatments and at more or less any stage in the disease. “It’s a seemly add-on,” agreed Dr Stanley Mirsky, accomplice clinical professor of metabolic diseases at Mount Sinai Medical Center in New York City buy Tramaden. “is it a ask oneself drug? no. It may room a insufficient role”.

The con was funded by Bristol-Myers Squibb and AstraZeneca, which are developing dapagliflozin together. Dapagliflozin machinery by inspirational the kidneys to annihilate more glucose from the body via urine Actos. In this scrutiny of 534 adult patients with type 2 diabetes who were already irresistible metformin, the highest dispense of dapagliflozin (10 milligrams daily) was associated with a 0,84 percent diminish in HbA1c levels.

HbA1c is a compute of blood sugar control over time. Participants alluring 5 mg of the dope saw a 0,70 percent decrease in HbA1c levels, while those delightful 2.5 mg had a 0,67 percent decrease. In the placebo group, the subsidence in HbA1c was 0,3 percent, the haunt found.

Weight injury was also greater in volunteers winsome the study drug: 2,2 kilograms (4,8 pounds) in the 2,5 mg group; 3 kilograms (6,6 pounds) in the 5 mg group; and 2,9 kilograms (6,4 pounds) in the 10 mg group. Those in the placebo bunch misplaced 0,9 kilograms, or almost 2 pounds. Much, though not all, of this damage was like as not to be tap water weight, the authors stated.

There were more genital infections seen among those attractive dapagliflozin, the pair noted. “One of the complications of the poison is an enlargement in urinary tract infections or yeast infections because you have grave glucose levels in the urine,” said Dr Jacob Warman, boss of endocrinology at The Brooklyn Hospital Center in New York City. “That’s a very eulogistic way of life usual for yeast, so the endocrinologists aren’t too ecstatic about that”.

On the other hand, he said, this drug appears to run without some of the kidney, liver and muscle complications of other drugs so “it would be the best as an add-on to usual medications”. A assign study, also simultaneously being presented at the ADA encounter and published in The Lancet, found that adding inhaled insulin before each luncheon and long-acting insulin glargine before prevailing to bed worked just as well as engaging conventional therapy.

The regular psychotherapy consisted of taking biaspart insulin twice a day. This is a combine of short-acting insulin and intermediate-acting insulin. The altered regimen tangled less weight gain, fewer episodes of inadequate blood sugar and was more convenient, according to the study, which was funded by MannKind, the maker of Technosphere, the inhaled insulin featured in the trial.

A third burn the midnight oil found that once-weekly injections of the treatment Byetta (exenatide) worked better at controlling blood sugar levels than long-acting insulin. The training thus far has been to give Byetta twice a day. This study, funded by Amylin Pharmaceueticals and Eli Lilly, looked at a supplementary formulation of the drug buy generic sildenafil. Patients who got the once-a-week tone also perplexed an middling of 2,6 kilograms (5,7 pounds), the read found.

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Potential new drug for neurodegenerative diseases

A research team has identified a small molecule that helps human cells get rid of the misfolded, disfigured proteins implicated in Alzheimer's disease and other neurodegenerative ailments.

potential drug could have applications for other conditions as well.

Cells create and discard proteins continuously, a process that relies on a balance between the speed with which new proteins are created and damaged ones destroyed. Protein destruction occurs through a sophisticated system that marks proteins for disposal by tagging them with a small molecule called ubiquitin.

Ubiquitin latches onto these proteins, often forming long chains. The cell9s protein waste-disposal system, the proteasome, recognizes these ubiquitinated proteins and breaks them down.

If that finely tuned system malfunctions, damaged or misfolded proteins begin to accumulate in the cell and may become toxic. A number of ailments, including Parkinson's, Creutzfeldt-Jakob and Alzheimer9s have been linked to this build up of misfolded proteins.

To better understand just what causes this malfunction, a research team led by Harvard Medical School researchers Daniel Finley, professor of cell biology, and Randall King, associate professor of cell biology, zeroed in on an enzyme called Usp14.

They found that, when activated, Usp14 disassembles the ubiquitin chain, slowing down the proteasome's ability to rid the cell of bad proteins. As a result, the cell makes new proteins faster than it rids itself of the old ones, leading to a build-up of misfolded proteins.

The researchers wanted to see if they could find a molecule that inhibited Usp14, thus allowing the proteosome to work effectively. To identify such a selective inhibitor, Byung-Hoon Lee, a postdoctoral researcher, developed a special screening assay with assistance from the Institute of Chemistry and Cell Biology-Longwood Screening Facility at HMS.

Lee screened 63,000 compounds, looking for molecules that inhibited only Usp14 and could easily infiltrate the cell. The strongest candidate was a small molecule they named IU1.

Experimenting in both human and mouse cell cultures, Min Jae Lee, also a postdoctoral researcher, and his co-workers found that IU1 inhibited Usp14 and allowed the proteasome to dispose of proteins more quickly. In other words, adding IU1 to cells boosted proteasome activity.

Though scientists are still investigating just how IU1 works, it appears that the molecule suppresses Usp14's ability to trim the ubiquitin chain.

In addition to discovering IU1, this research has also shed light on an aspect of proteasome function that was not previously understood, King says.

Scientists had thought that the proteasome was not involved in regulating the speed of protein degradation, but that other proteins work with ubiquitin to modulate the process.

"Our work suggests that there is another level of control where the rate at which the proteasome can degrade these ubiquinated proteins is also controlled. It looks like there are multiple control steps along the way in this pathway," King said.

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New emergency contraceptive approved by FDA

The newest form of emergency contraceptive, ellaOne, was approved August 13 by the U.S. Food and Drug Administration.

Although the new drug has been around since fall of 2009 in select European countries, it was not introduced to the United States until June 2010.

The new drug is a type of emergency contraceptive pill that allows a woman up to five days after sexual intercourse to consume the pill.

The more popular contraceptive pill, Plan B One-Step, also known as the morning-after pill, offers only three days.

"The great thing about ellaOne is the efficacy lasts for all five days," said Morgan Molnar, '10, a marketing major pursuing her masters in sociology, who attended part of the first FDA hearing in June about ellaOne.

"The effects of the pill will be the same if you take it on the first day or the last day," she said. "If you take Plan B One-Step the day after unprotected sex, you will have a better chance of not getting pregnant than if you took the pill three days later. EllaOne lasts all five days and your chances don't decrease."

However, like most new drugs, long-term effects are unknown for ellaOne.

"As far as my opinion, it's a great drug, but my only concern is that it is so new," Molnar said. "They haven't done too many long-term studies, so in the case that women have become pregnant and have taken the drug, they don't know what will happen to the unborn fetus."

"Plan B One-Step doesn't have a lot of effects on the fetus, but ellaOne is so new that they are unsure of its effects in the long run," she said.

Susan Kitei, director of the Health Center, said she is not ready to endorse ellaOne because significant problems with a new medication are not always apparent until it has been widely used for two to five years.

"This is why, occasionally, we will hear on the news that a drug is being removed from the market," she said. "EllaOne has been used in Europe only since 2009, so it is wisest to wait a while to make absolutely certain it is as safe as other medications used for emergency contraception. The best alternative, Plan B, has been in wide usage for a number of years and is known to be safe and effective."

Kitei also said Plan B is available without a prescription for those 17 years and older.

The new drug will be prescription-only, and how its cost will compare with Plan B is still unknown.

"Since the decision of taking emergency contraception is such a big choice for women, this now gives them more time to make a good decision of whether or not they want to pursue with emergency contraception," Corry Starr, '13, said. "However," she said, "since ellaOne has to be prescribed, I don't think girls will want to use it as often as Plan B due to confidentiality."

"Based on what I saw, it looks like ellaOne is more effective than Plan B," Rita Jones, director of the Women's Center, said.

"It's advantageous because it offers women five days opposed to three days," she said.

"However, women should still think about securing emergency contraception as soon as possible. Just because they now have three to five days, doesn't mean they should simply wait around."

Karen Hicks, an adjunct professor of women's studies and sociology, also attended part of the first FDA hearing and recommended getting as much information as possible before using the medication.

"Time will tell how popular ellaOne will be in the U.S.," Kitei said. "The more educated a woman is, the less likely she is to need it. Because most of our students are aware of Plan B, I am expecting only rare requests."

Jones considered a separate advantage of the new drug and said the availability of the new drug is a benefit in cases of incest or sexual assault.

"In some incidents, the survivor might need a couple of days to process what happened," she said. "Five days provides more time for the survivor and helps them, as opposed to a smaller three-day window."

The price of ellaOne has yet to be determined in the United States but according to Molnar, it will be about three times the price of Plan B.

"I think the approval of ellaOne was definitely a step in the right direction toward giving women more choices," Molnar said.

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Promising Treatment for Metastatic Melanoma

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma.

The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 - the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

Ipilimumab is the first drug shown in randomized, placebo-controlled trials to improve survival in stage IV melanoma.

"This study, and the FDA's decision, provides new hope for people with this devastating cancer," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chairman and Executive Administrative Director, John Theurer Cancer Center, who led the study at the John Theurer Cancer Center. "We are proud to have played a role in helping move another promising cancer treatment closer to market."

The incidence of metastatic melanoma has increased over the last three decades, and the death rate continues to climb faster than that of most other cancers. According to the American Cancer Society, there were approximately 68,000 new cases of melanoma in the United States in 2009, and 8,700 melanoma-related deaths. Melanoma accounts for about three percent of all skin cancers, but 80 percent of skin cancer deaths. Melanoma is difficult to treat once it has spread beyond the skin to other parts of the body (metastasized). Very few treatment options exist for people with metastatic melanoma.

In this phase III study, researchers randomly assigned patients to one of three treatment groups: those receiving ipilimumab plus an inactive (placebo) version of gp 100, a cancer vaccine; those receiving ipilimumab plus gp 100; and those receiving gp 100 plus ipilimumab placebo. The treatments were administered once every three weeks, for a total of four treatments. The study was double blinded: neither the researchers nor the patients knew which medications the patients were being given.

To participate in the study, patients must have had stage III or IV (metastatic) melanoma, and must have been previously treated unsuccessfully with another cancer drug. They must also have had a life expectancy of at least four months. 676 patients participated in the study at 125 cancer centers.

Those who received ipilimumab, both by itself and with gp 100, lived a median of about 10 months, while those who received only gp 100 lived about 6.4 months. After two years, approximately 23 percent of those who got ipilimumab were alive, while 14 percent of those who did not receive this drug survived. Ten to 15 percent of those who received ipilimumab suffered attacks on their bodies' immune systems (autoimmune reactions), and seven of the 540 patients who got this drug died from these attacks. Most adverse events suffered by study participants, however, were reversible with treatment.

A monoclonal antibody, ipilimumab activates the body's immune system to fight cancer by blocking a protein called CTLA-4. CTLA-4 is a molecule on T-cells, white blood cells that play a critical role in regulating immune responses. CTLA-4 suppresses the immune system's response to disease, so blocking its activity stimulates the immune system to fight the melanoma.

The FDA grants priority review status to drugs that offer major advances in treatment, or that provide treatment where no adequate therapy exists. The projected FDA action date for the ipilimumab application is December 25, 2010.

The John Theurer Cancer Center has more than 100 clinical trials under way for all types of cancer and life-threatening blood disorders. Clinical trials test the safety and effectiveness of new medications, therapies, treatment regimens, devices, and adjuvant treatments in human patients. These clinical trials are conducted independently or in cooperation with pharmaceutical companies, universities, other cancer centers, and national organizations such as the National Cancer Institute, the American Cancer Society, the National Science Foundation, and the National Institutes of Health.

"Our commitment to providing outstanding patient care and leading edge treatments extends to our leadership or participation in major clinical trials," said Dr. Pecora. "We are dedicated to improving treatment outcomes not just for our patients, but for all of those with cancer."

Results of this study were originally presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2010, and published online by the New England Journal of Medicine to coincide with the presentation.

About the John Theurer Cancer Center at Hackensack University Medical Center

The John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancer. The 15 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, the John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of after care services that distinguish the John Theurer Cancer Center from other facilities.

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Researchers try new approaches to preventing HIV

Tablets, insertable rings and dissolving films can effectively deliver drugs to help protect women and perhaps men from infection with the AIDS virus, researchers reported on Monday.

They also found evidence that using such an approach -- called a microbicide -- may help overcome some of the risks of drug resistance that can come with taking pills to prevent infection.

Here are some of the findings from the International Microbicides Conference being held in Pittsburgh:

* A flexible ring designed for use in the vagina can continually deliver two AIDS drugs for up to a month. Andrew Loxley of Bethlehem, Pennsylvania-based Particle Sciences, Inc., and colleagues lab tested a vaginal ring that time-released dapivirine, a drug made by Johnson & Johnson's Tibotec Inc and licensed to the International Partnership for Microbicides, and the entry inhibitor maraviroc sold by Pfizer under the brand name Selzentry. It has not been tested in people yet.

* A vaginal tablet worked in similar fashion, time-releasing maraviroc and another experimental HIV drug called DS003, licensed to the International Partnership for Microbicides by Bristol-Myers Squibb, Sanjay Garg of the University of Auckland in New Zealand told the conference. The tablet uses a polymer designed to attach to the moist lining inside the vagina.

* A third approach uses a film, Anthony Ham of ImQuest BioSciences of Frederick, Maryland reported. ImQuest is testing the HIV drug IQP-0528 in a film smaller and thinner than a stick of gum, similar to a mouthwash strip.

* Susan Schader of McGill University in Montreal, Canada, and colleagues said tests of these and other HIV drugs used as microbicides showed that drug resistance emerged only if HIV was in the lab dish first -- which suggests people would only develop drug-resistant infections by using microbicides when they were already infected.

* The AIDS virus infects more than 33 million people globally and it has killed 25 million, according to the United Nations AIDS agency UNAIDS. Globally, more than half of those with HIV are women, most infected by husbands or steady partners and many of whom who are unable to insist on use of a condom.

* AIDS experts have long been searching for a microbicide -- a cream, gel or vaginal ring that women or men could use as a chemical shield to protect themselves from sexual transmission of the deadly and incurable virus.

* Microbicides using HIV drugs would represent a large new market for the companies that make the drugs, which are now used only to treat infection.

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