"We at Roche are proud to be able to offer some hepatitis-C patients the prospect of such a positive outcome with our currently available therapies, but we also recognize the urgent need to further improve response rates," said Tom Klein, vice president for hepatology at Roche. "In addition to ongoing research with Pegasys, Roche has the most comprehensive pipeline in the area, with four compounds currently in human development that target the virus in a number of different ways. The development of R1626 and partnerships with InterMune, Maxygen, and Pharmasset underscore our long-term commitment to finding effective new therapies with the goal of successfully treating more patients with chronic hepatitis C." M Businesswire

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Tamoxifen works for years

 

WASHINGTON

Women who took the drug tamoxifen had one-fourth less cases of breast cancer-even years after they stopped taking the drug, said two studies released recently.

    Tamoxifen is used both to treat estrogen-receptor-positive breast cancer and to prevent it. In 2002, a study found that the drug reduced the incidence of breast cancer by 32 percent four years into a trial among 7,145 women.

    A new study shows that five years later, even women who stopped taking tamoxifen were still protected, with the cancer rate down by 27 percent, or nearly five fewer cancers in every 1,000 women, according to an article in the Journal of the National Cancer Institute.

    What is more, the side effects of tamoxifen, such as blood clots and stroke, ceased when the dosage did, while the protection lasted for years.

    "The benefits of tamoxifen extend beyond the active treatment period, but the side effects do not," said the authors led by Jack Cuzick of the Wolfson Institute of Preventive Medicine in London.

    A second new report used data from a 1998 study, which followed 2,471 women taking 20 milligrams of tamoxifen daily, and found no difference between the women taking the drug and a placebo over a 13-year period.

    However, after a 20-year follow-up, researchers found that tamoxifen was effective in preventing estrogen-receptor-positive breast cancer, by 39 percent, according to researchers at the Royal Marsden Hospital in London.

    In an editorial in the journal, Umberto Veronesi of the European Institute of Oncology in Milan wrote that tamoxifen is useful only against estrogen-receptor-positive breast cancer, and so must be prescribed accordingly. M AFP

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New drugs offer hope v. arthritis

 

PARIS

Three new drugs for rheumatoid arthritis signal the start of a "new era" of treatment for this sometimes-crippling disease of the joints, Austrian researchers say in a paper published by The Lancet.

    Josef Smolen, a professor of rheumatology at the Medical University of Vienna, investigated trial data on rituximab and abatacept, which have already been authorized for use against rheumatoid arthritis, and tocilizumab, which is in the final phase of tests.

    The drugs, when used either alone or in combination with existing treatments, slowed the progression of the disease, and reduced joint pain, swelling, and stiffness by around half for up to 40 percent of patients.

    Rheumatoid arthritis affects between 0.5 and one percent of people. It happens when the immune system attacks the joints, causing inflammation and damage to the cartilage and bone.

    The three drugs aim to destroy or disrupt different cells that unleash this cannibalistic attack.

    "The emerging agents show that a new era has started in the treatment of rheumatoid arthritis," according to the paper.

    It notes, though, that some patients had varying side effects, including headache, skin eruption, and fever, while others failed to respond to the novel treatments, highlighting the need for further efforts against this disease. M AFP

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Tykerb effective v. breast cancer

 

ATLANTA, Georgia

An experimental drug combined with chemotherapy has proved effective in slowing down advanced breast cancer, which no longer responds to other medicines like trastuzumab (Herceptin).

    Lapatinib (Tykerb), when used in combination with the chemotherapy drug capecitabine (Xeloda) of Roche, doubled the time a tumor was stabilized, according to a study financed by GlaxoSmithKline (GSK).

    The research, led by Dr. Charles Geyer of Allegheny General Hospital in Pittsburgh, Pennsylvania, showed that those treated with a Tykerb-Xeloda combination experienced no growth of their tumors for 36.9 weeks on average, compared with 19.7 weeks for those getting only the Xeloda chemotherapy.

    "These results indicate that lapatinib can be effective in helping control the growth of breast cancers that are not being controlled by trastuzumab," Geyer said.

    Tykerb, like Herceptin, belongs to a new generation of promising anticancer drugs that target the genetic and biochemical mechanisms of the disease.

    All the women in the clinical trial had advanced cancer or had experienced tumor growth despite treatment, including with Herceptin, which neutralizes the protein HER-2/neu. The overexpression of HER-2/neu is responsible for 20 to 25 percent of all breast cancers.

    Tykerb could offer an alternative to women whose breast cancer no longer responds to Herceptin, Geyer said.

    Herceptin, the most prescribed treatment for advanced breast cancer, is marketed by Genentech and Roche and generates almost US$2 billion in sales annually.

    GSK is studying whether Tykerb can block breast cancers linked to HER-2/neu earlier in their development, challenging the blockbuster Herceptin. Tykerb is taken in pill form while Herceptin is administered intravenously.

    None of the women treated with Tykerb in the trial showed symptoms of heart weakness, a serious potential side effect of Herceptin, Geyer said. M AFP

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Revised Pegintron/Rebetol dosing

 

 

The European Commission has approved revised dosing for Pegintron-Rebetol combination therapy for patients suffering from chronic infection of hepatitis C virus genotype 1 with a low viral load (less than 600,000 IU/ml) and who have achieved rapid virologic response, defined as undetectable virus (HCV-RNA negative) at week four of treatment maintained through week 24.

    Schering-Plough Corporation said the revised dose schedule of 1.5 mcg/kg once weekly for Pegintron and 800 to 1,200 mg daily of Rebetol for a 24-week therapy cuts the duration by half.

    "Physicians now have the opportunity to consider a shorter course of therapy for their patients with hepatitis C genotype 1 who meet specific criteria," said lead Prof. Stefan Zeuzem of Saarland University, Homburg, Germany, who led the study supporting the approval. "Tailoring treatment so that those with an early response are treated for only 24 weeks rather than 48 weeks may make therapy more appealing to patients, providing comparable efficacy with better tolerability," he said.

    Dr. Robert Spiegel, chief medical officer and senior vice president for medical affairs at Schering-Plough Research Institute, said the approval reflects the ongoing commitment of Schering-Plough to define optimal dose and treatment schedules to better meet the needs of hepatitis-C patients.

    The approval was based on results of clinical studies in which 92 percent of patients who met the criteria for early response achieved a sustained virologic response (SVR) with 24 weeks of treatment. The high SVR was identified in an interim analysis and prospectively confirmed.

    The study involved 235 patients with HCV genotype 1 and low viral load who received 24 weeks of combination therapy with Pegintron (1.5 mcg/kg once weekly) and Rebetol (800 to 1,400 mg daily). Results showed that 41 percent of patients (97/235) had undetectable plasma HCV-RNA levels at week four and week 24 of therapy.

    The approval results in marketing authorization with unified labeling valid among the 25 EU member as well as in Iceland and Norway. Pegintrol and Rebetol combination therapy was previously approved in the EU for a 48-week therapy for patients genotype 1 who exhibit virological response at week 12.

    Genotype 1 virus is the most common worldwide, the most difficult to treat, and accounts for about 70 percent of HCV infections among European patients. The approved treatment is 24 weeks for patients with HCV genotypes 2 or 3 and 48 weeks for those with genotype 4. M

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Betaseron delays multiple sclerosis

 

PARIS

Early use of the drug interferon beta-1b (Betaseron) can significantly delay progression of multiple sclerosis (MS). Swiss doctors conducted a trial among 468 patients diagnosed with early symptoms of MS, of whom 292 received the drug and 176 received placebo.

    Each volunteer was given an injection every other day for two years or until he or she was diagnosed with a clinically definite case of MS, a judgement based on worsening disability. Using an internationally accepted scale of symptoms, the researchers found that among the "early treatment" group the drug reduced the risk of developing clinically definite MS by 41 percent.

    The research published in The Lancet was led by Ludwig Kappos of the University Hospital Petersgraben in Basel. Betaseron is a member of the interferon family of drugs. It is already licensed for treating MS, and works by apparently reducing inflammation. M AFP

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Cervarix 90-percent effective

 

PARIS

A new vaccine protects nine out of 10 women against cervical cancer linked to two strains of the deadly human papillomavirus (HVP). In a clinical trial, more than 9,000 women were vaccinated with Cervarix, with a control group receiving a vaccine for hepatitis A. Over a 15-month follow-up period, the vaccine showed a 90.4-percent efficacy against the kind of precancerous lesions that are a precursor to full-blown cervical cancer. Side effects were minimal, the study found.

    "The vaccine is effective, well tolerated, and immunogenic in a broad population of young adult women," said University of Helsinki professor Jorma Paavonen, who led the study.

    More than half of the women in the phase-III trial were from Finland, with the rest coming from 13 other countries, including many in the developing world, where 90 percent of new cases occur.

    "The vaccine is not therapeutic but prophylactic," Paavonen said, explaining that it would not benefit women who already test positive for both of the targeting virus strains. But those who were exposed to only one of the strains would be protected from the other, and even those who had been exposed to both "received some cross-protection from other strains," he said.

    Cervical cancer is the second most common type of cancer among women. HPV types 16 and 18 account for 70 percent of cervical cancer cases worldwide, which number about 500,000 per year.

    Cervarix is manufactured by GlaxoSmithKline, which funded the study. M

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FDA panel wants to keep Avandia

 

WASHINGTON

A panel of independent experts told United States drug regulators to keep rosiglitazone (Avandia) on the market despite an increased risk of heart problems. By a 20 to three vote, the Food and Drug Administration (FDA) advisory committee agreed that current clinical trials showed Avandia, produced by GlaxoSmithKline (GSK), increased the risk of heart attack in people suffering from type 2 diabetes, said Sandy Walsh. "Data suggest there is an increased risk," said committee president Clifford Rosen.

    However, the experts also voted 22 to one that the therapeutic benefits of Avandia outweighed its risks and justified keeping it on the market. The panel's decision is nonbinding, although the FDA usually follows its recommendations.

    A study in the May 21 issue of the New England Journal of Medicine showed Avandia users-more than seven million around the world-had 43-percent greater risk of heart attack. Based on a review of 42 earlier studies, the preliminary results of the research conducted by renowned Cleveland Clinic cardiologist Steven Nissen were disputed by GSK, even though it funded the research.

    FDA scientist David Graham urged the committee to withdraw Avandia from the market to prevent 2,200 people from being exposed each month to its serious side effects while more research was being conducted. He said Avandia's higher risk for heart problems together with its lack of any special therapeutic value in helping diabetics control blood-sugar levels justified removing it from the market.

    GSK chief of clinical development Murray Stewart told the panel Avandia should remain a viable choice for diabetics, since many require a variety of drugs to control their blood-sugar levels while for a few others there is no alternative treatment.

    Several committee members suggested the FDA demand stronger warning labels on Avandia packages, but a doctor on the panel said the proposal was dropped because it lacked consensus.

    Avandia is GSK's second-top-selling drug. M AFP

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Phenobarbital stops seizures

 

PARIS

Medicine costing less than three dollars a year per patient could spare 30 millions poor people, many of them children, from the trauma and torment of epilepsy, a new study published in the British Medical Journal (BMJ) has found.

    Some 85 percent of epilepsy patients in the developing world go without any treatment whatsoever because they cannot afford the drugs most often prescribed to impede the terrible seizures associated with the illness. The least expensive of these medications, phenobarbital, has been recommended by the World Health Organization for victims of convulsive seizures in poor countries, but has been otherwise shunned because it is thought to have more serious side effects, especially on children.

    A drug trial of 108 children in Bangladesh, however, comparing phenobarbital with carbamazepine-commonly prescribed for epilepsy-showed the less-expensive drug to be equally effective. The study led by pediatric neurophysiologist Selina Banu also concluded it did not provoke more behavioral problems, such as hyperactivity and restlessness. A follow-up study a year later confirmed the initial findings.

    The researchers cautioned that the conditions of the drug trial, carried out at the Children's Hospital in Dhaka, Bangladesh, were not ideal. Some children dropped out of the follow-up studies and there was a sex-ratio imbalance for one of the drug groups. But even with these shortcomings, the study showed that most children tolerated phenobarbital well and behavior even improved in many, they reported. M AFP

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EMEA restricts Acomplia use

 

BRUSSELS

The European Medicines Agency (EMEA) said it had maintained authorization of weight-loss pill rimonabant (Acomplia) in the European Union, but had ordered it to be withheld from people suffering from depression.

    A panel of experts from the US Food and Drug Administration concluded in June that the drug, which can also be used to treat diabetes, was unsafe because it caused suicidal thoughts as a side effect.

    EMEA recommend-ed that Acomplia should not be given to patients with depression or those taking antidepressants because of the risk of psychiatric side effects. The agency said that depression was known as the main side effect of the drug and this had been signaled at the time of its approval in June 2006.

    However, the agency's Committee for Medicinal Products for Human Use had recommended upgrading the warning about depression. Sanofi-Aventis, the maker of the drug, said it had changed its labeling to take into account EMEA's comments. M AFP

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Chantix could help treat alcoholism

 

WASHINGTON

A recently approved antismoking medication could also serve to repress an alcoholic's desire for drink, according to a new study by researchers at the University of California San Francisco published in the Proceedings of the National Academy of Sciences. Varenicline (Chantix/ Champix), manufactured by Pfizer and approved as a smoking-cessation aid in the United States and Europe in 2006, has been shown to reduce nicotine consumption by affecting the brain's reward system for addictive substances.

    The research team, noting that cigarettes and alcohol are often abused together, wanted to see if the drug had the same affect on drinking. The researchers tested the impact of varenicline on laboratory rats that had consumed high amounts of ethanol over a long period.

    Rats were trained to drink ethanol in consistent amounts over five months before they were given varenicline. After the drug was administered steadily, the rats consistently showed less interest in the ethanol. The results suggested the drug helped in modulating the rats' desire to consume the ethanol or to enjoy its effects, the study said. When the rats were later cut off from varenicline, they did not resume the intake of ethanol at previous levels. M AFP

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Vaccine v. cholera made from rice

 

CHICAGO

A new rice-based vaccine could give developing nations a cheap and effective treatment against the killer disease cholera. In preliminary tests on mice, the new vaccine induced a superior "two-tier" immunity, provoking normal resistance from the body but also producing antibodies in the "mucosal" surfaces of the nose, mouth, and urinary tract.

    A team of Japanese scientists led by Tomonori Nochi at the University of Tokyo's Institute of Medicine created the vaccine by inserting part of the cholera bacterium, Vibrio cholerae, into the Kitaake rice plant. The transgenic rice was then fed to mice in the form of powder. Subsequent tests showed the mice had developed immunity to the cholera strain, which is typically spread through contaminated food and water.

    Unlike conventional cholera shots, which have to be refrigerated right up to the point of delivery, the genetically modified rice vaccine has a shelf life of several years at regular room temperature. That would make the experimental treatment not only cheaper but much easier to distribute in cholera hotspots like Africa, Latin America, and parts of Asia.

    "Rice-based mucosal vaccines offer a highly practical and cost-effective strategy for orally vaccinating large populations against mucosal infections, including those that result from an act of bioterrorism," the researchers wrote in their study published in the Proceedings of the National Academy of Sciences. M AFP

 

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