Osiris to resume enrollment in Crohn's drug study

Osiris Therapeutics Inc said it is resuming enrollment of patients in a clinical trial to study its lead drug Prochymal in patients with treatment-resistant Crohn's disease, sending its shares up 5 percent in after-market trade.

Data from an interim analysis showed that for the primary endpoint of disease remission, the drug approached statistical significance in the intent to treat population, the adult stem cell research firm said in a statement.

The drug also reached significance in the per protocol population, it added.

Enrollment for the Crohn's program, consisting of two linked trials, was suspended last year over concerns over the trial design.

The decision to resume enrollment was made following discussions with the Food and Drug Administration about the results of the interim analysis, the company said.

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that affects almost one million people in the United States.

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Nymox Pharma's Update On Phase 3 Study Of Benign Prostatic Hyperplasia Drug

Nymox Pharmaceutical Corp., reported new positive results from a long term outcome study of its lead drug candidate to treat benign prostatic hyperplasia, NX-1207. The study, a part of the Phase 3 trial of the drug, evaluated symptomatic progress of U.S. patients involved in the Phase 1 and Phase 2 studies, initially undertaken in 2003. The inclusion criterion was all subjects enrolled in the studies had previously failed conventional drug treatments.

Benign prostatic hyperplasia or BHP is a common affliction of older men, affecting approximately half of men over age 50 and close to 90% of men by age 80, and is associated with growth in prostate size as men age. The condition causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems. The treatment represents a growing market with more than 100 million men worldwide estimated to suffer from BPH symptoms.

Patients treated with NX-1207 were followed-up on an unselected and as available basis and assessed for symptomatic improvement, treatment outcomes, and durability of efficacy 61/2 years after a single treatment with the drug. The data was available for 69% of the patients from the initial studies.

Overall, 55% of the men in the new outcome study reported no subsequent surgical treatment and no current drug treatment for their prostatic hyperplasia or PH and had a mean improvement of 14.3 points in AUA Symptom Score. In addition, 36% of the patients reported no other approved treatments at any time for their BPH since their original treatment with NX-1207, with a mean improvement of 14.5 points.

The sustained improvement in BPH symptom score after treatment with NX-1207 compares favorably with the 3 to 5 points reported in published studies of currently approved BPH drugs, which, unlike NX-1207 treatment, require permanent daily administration to be effective. Currently approved drugs also have undesirable side effects such as loss of libido, impotence, retrograde ejaculation, dizziness, and other problems.

Follow-up trials have also confirmed the excellent safety and side effect profile of the therapy and evidence of enduring benefit for a significant percentage of patients.

On March 30, Nymox had outlined the development program for the drug, currently in Phase 3 trials in the U.S. and had added that positive results from animal studies have shown the potential for the use of high dosages of NX-1207 for the focal treatment of clinically localized prostate cancer and of primary liver cancer.

Paul Averback MD, CEO of Nymox had said that the clinical trials of the drug in humans to date have demonstrated an excellent safety profile with no known serious drug side effects. This favorable safety data will be an advantage in the clinical trials for the treatment of prostate cancer and liver cancer. He had also added that there is a serious unmet need for a safer option for the treatment of localized prostate cancer without causing impotence or other sexual side effects and that the company is looking forward to advancing NX-1207 to treat primary liver cancer.

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Qnexa weight loss drug lowers blood pressure

An experimental weight loss drug that pairs a stimulant with an epilepsy drug helped patients lose weight and keep it off for a year and also lowered blood pressure, a researcher said on Tuesday.

A consultant to Mountain View, California-based Vivus Inc said three separate studies showed patients lost more weight when they took the highest doses of Qnexa, which is up for Food and Drug Administration approval in July.

Shares in Vivus soared 13.6 percent to $11.73 a share in early afternoon trading.

Drops in blood pressure were small but clear and equated with the weight loss, said Dr. Suzanne Oparil of the University of Alabama at Birmingham.

"The weight loss is very impressive, and it is good that there is concomitant reduction in blood pressure," Oparil said in a telephone interview from a meeting of the American Society of Hypertension in New York.

Oparil, a past president of the American Heart Association, pooled and analyzed the results of three separate studies of Qnexa in nearly 8,000 overweight and obese patients.

"At week 58 there is a nice weight reduction," she said. The higher the dose, the more weight loss and the more blood pressure went down, she said.

The patients who got the highest dose along with diet and exercise advice lost about 10 percent of their body weight on average, she said.

Vivus is trying to improve on the notorious "fen-phen" combination pulled off the market in 1997 after it was found to damage the heart and cause sometimes fatal cases of pulmonary hypertension.

Improving Health

Fen-phen combined fenfluramine and phentermine. Phentermine, a stimulant now available generically, appears safe and is used at low doses in Qnexa along with the epilepsy drug topiramate, available generically and sold by Johnson & Johnson's Ortho-McNeil unit as Topamax.

Losing just 10 percent of body weight is enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death. About 68 percent of U.S. adults are overweight or obese.

In the three studies that Oparil analyzed, about 80 percent of the patients were women, most morbidly obese with weights of 220 to 260 pounds (100 to 118 kg).

Most did not have high blood pressure but among those who did and who took the highest Qnexa dose, the systolic or top number in the blood pressure reading went down an average of 9 points, compared to 4 points for the women who got placebos.

Oparil said the most common side effects were tingling and dry mouth, each seen in 19 percent of the patients who took the highest dosages.

Topiramate acts on the nervous system and tends to act as a sedative, said Oparil. This can reduce appetite. In addition, patients said the drug made carbonated drinks taste metallic and that may have helped patients avoid sugary soft drinks.

Doses of both drugs are far lower than those usually used -- when phentermine is used alone to treat obesity, for example, or when topiramate is used for epilepsy, she said.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is tentatively scheduled to review Vivus' Qnexa on July 15, the company said.

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Magnetic stimulation of the brain can ease drug-resistant depression, study shows

Daily application of magnetic stimulation to the brain for about 37 minutes can ease depression in patients who are not responding to antidepressants, researchers reported Monday. The procedure -- in effect, a mild form of electroconvulsive therapy, or ECT, which has been shown to be very effective against severe depression -- has been approved by the Food and Drug Administration since 2008, but critics have questioned its efficacy because of the lack of suitable blinded trials. That problem has arisen because of the difficulty of performing a sham procedure that recipients might think is an active procedure.

Dr. Mark George at the Medical University of South Carolina in Charleston and his colleagues got around this problem by developing an apparatus that mimics the effects of the magnetic stimulator without actually producing a magnetic field. The device causes a tapping on the skull similar to that produced by the real treatment and causes eyes to twitch in the same manner. Even the physicians who were treating patients were unable to tell if a device was real or simulated.

The researchers enrolled 190 patients who had suffered from depression for at least three months but less than five years and who had not responded to antidepressants. Half received the actual treatment every weekday for three weeks, while the rest received the sham treatment on the same schedule. Ninety percent of those in the sham group completed the study, compared with 86% of those in the treatment group.

The team reported in the Archives of General Psychiatry that 14.1% of those in the treatment group had their depression relieved, compared with 5.1% of those in the control group. When both groups were given the treatment for another three weeks, 30% responded.

"This study should help settle the debate about whether [the technique] works for depression," George said in a statement. Now the team can begin to investigate ways to improve its efficacy. One possible solution, as demonstrated in the study, is to extend the treatment period for longer durations.

The device uses a magnetic coil placed on the head that pulses about 3,000 times during each treatment, stimulating a minute electrical current in the brain. In the trial, the field was focused on the top left front part of the brain. The patient is conscious during the procedure and there appears to be no significant side effects. Patients can drive themselves home afterward.

In ECT, in contrast, electrodes placed against the skin emit an electrical current that passes through the brain, causing convulsions. Patients must be sedated and have to be driven home afterward. Clinical trials are testing the new technique against a variety of other problems, including tinnitus [ringing in the ears] and schizophrenia.

The study was funded by the National Institute of Mental Health.

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Transplant drug 2-year study outcomes show superior kidney function

Two-year results from phase III clinical trials show the experimental immunosuppressive drug belatacept can better preserve kidney function in kidney transplant recipients while preventing graft rejection when compared with the standard immunosuppressive drug cyclosporine.

The two-year results from the three-year BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) and BENEFIT-EXT ("extended criteria") studies were presented Sunday at the American Transplant Congress in San Diego. A safety study that pooled long- term data also was presented.

In the BENEFIT trial, 666 patients were randomized to three groups and transplanted at 100 sites around the world, with 493 completing two years on treatment. In the BENEFIT-EXT study, 543 patients were randomized and transplanted, with 347 completing two years on treatment. The three treatment groups were less intensive (LI) and more intensive (MI) belatacept and a standard regimen of cyclosporine (CsA). All patients also received standard transplant regimens of the anti-T cell antibody basiliximab and drugs mycophenolate mofetil and corticosteroids.

Patient and graft survival after two years was similar among the belatacept and cyclosporine groups (94 percent MI; 95 percent LI; 91 percent CsA). The superior renal benefit of belatacept found after the first year of treatment was sustained in the second year, as measured by glomerular filtration rate. The improvement in cardiovascular/metabolic risk profile with belatacept remained in year two, with an additional beneficial effect noted in LDL cholesterol. Eight additional patients experienced an episode of acute rejection in year two (four with belatacept, four with cyclosporine), but in most cases this was successfully treated with drugs and did not lead to graft failure.

The overall incidence rate of malignancies and serious infections remained comparable across the groups. Although in the second year there remained a higher incidence of post-transplant lymphoproliferative disorder (PTLD)–five belatacept patients vs. one cyclosporine patient–the overall safety profile remained similar across the groups. No additional benefits were seen in the MI vs. the LI belatacept group.

"Our goal in transplantation is to achieve a normal life span for our patients, and to have them survive dialysis-free with a functioning transplanted organ for that life span," says Christian P. Larsen, MD, DPhil, director of the Emory Transplant Center and chair of the Department of Surgery in Emory University School of Medicine.

"Today, the median survival of a transplant remains about 8-10 years, far short of what we'd like," Larsen adds. "While the calcineurin inhibitors, cyclosporine and tacrolimus, are potent immunosuppressant drugs, they are associated with multiple toxicities that limit transplant success. We have been working for years to develop new therapies that avoid the main complications and causes of death, including cardiovascular events, infections and malignancies. Our data with belatacept indicate it can better preserve kidney function while improving the risk for these complications."

Larsen, along with fellow Emory University transplant surgeon and researcher Thomas C. Pearson, MD, DPhil, Emory professor of surgery and co-director of the kidney/pancreas transplant program at the Emory Transplant Center, made significant research contributions to the development of belatacept, in collaboration with other investigators at Emory, the Yerkes National Primate Research Center, and Bristol Myers Squibb.

A third study, which pooled safety data from phase II and phase III studies over 2.4 to 7 years, found that longer-term treatment with belatacept-based regimens was generally safe. The incidence of deaths and serious adverse events were lowest in the belatacept LI group. The overall incidence of malignancies remained low, but was slightly higher in the MI group. The incidence of herpes infections and tuberculosis (mostly in endemic areas) was low overall, but higher in the belatacept groups. Fifteen cases of PTLD occurred (13 with belatacept, 2 with cyclosporine), mainly in patients not previously exposed to Epstein-Barr virus, which many humans have as a low-level chronic infection. The researchers say PTLD might be reduced by avoiding use of belatacept in Epstein-Barr-naïve patients.

Belatacept is a "costimulation blocker" that inhibits one of two signals T cells require to trigger an immune response. It is a modified version of a fusion protein known as CTLA4-Ig, which mimics a regulatory molecule found on T cells and acts as a decoy. CTLA4-Ig (commercial name: abatecept/Orencis) is FDA approved to treat rheumatoid arthritis.

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Anabolic steroid users may face heart trouble

Bulking up with anabolic steroids appears to damage and weaken the heart, a new study shows, in principle increasing the odds of heart failure.

While it's nothing new that steroids have bad health effects, the new findings show they may be more harmful than previously thought. In heart failure, a weakened heart can't pump enough blood around the body.

The study did not find heart failure itself, just the signs of it, but in severe cases, the condition creates a backlog of blood in the lungs that makes breathing difficult, and may be fatal.

"What makes this scary is that the full magnitude of the problem may not declare itself until after 20 or 30 years," said Dr. Harrison G. Pope of Harvard University, who worked on the new study, published in the journal Circulation.

Pope, who has studied anabolic steroids for over 20 years, said the drugs began to crop up in gyms around the country in the 1980s, and quickly flourished. Today, as many as two million Americans may have abused the controlled substances at one point or another.

"We may be seeing just the beginning of something that could become a huge public health problem," Pope said.

With his colleagues, he advertised for weightlifters who could bench more than 275 pounds. That way, he got both steroid users and "clean" bodybuilders without having to disclose the study's purpose, which could have biased the results.

The researchers measured the recruits' heart function using ultrasound. Among the 12 steroid users, 10 turned out to have hearts that pumped less blood into the body than they should. In contrast, only one of the seven non-users had this problem.

"That is a stunning statistical difference, far greater that could possibly be explained by chance," Pope told Reuters Health. "The heart becomes more flappy and cannot contract with the same force as it usually does, and it also becomes less flexible."

"There have been case reports of athletes collapsing on the floor," Dr. Nora Volkow, director of the National Institute on Drug Abuse in Bethesda, Maryland, told Reuters Health. "If I was a cardiologist, I would be very concerned."

But she added that because the study is small, it is still too early to predict what will happen to the large group of steroid users now moving into middle age.

In addition to boosting muscle growth, anabolic steroids -- which mimic testosterone, the male sexual hormone -- also affect the brain in unpredictable ways: In some people, they produce aggression, in others depression.

With prolonged use, steroids also limit natural testosterone production in the testicles, which can make men more feminine.

While law enforcement has cracked down on illegal production of steroids in the U.S., the drugs are sold over-the-counter in some countries and can be purchased easily on the internet.

Pope, himself a psychiatrist, said the behavioral effects are worrisome, but that his biggest concern is the heart. Heart failure is already a major killer in developed nations. How much steroids will be adding to that death toll is still unclear.

"It is very hard for the (Drug Enforcement Administration) to intercept this stuff, it just pours into the country," said Pope. "We need to get more data and we need it fast."

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Blood test helps target Roche/OSI lung cancer drug

Testing for specific cancer protein markers in lung cancer patients' blood helps find those more likely to respond to Tarceva, a drug sold by Roche and OSI Pharmaceuticals , data showed on Friday.

A study presented at the European Lung Cancer Conference in Geneva showed that a relatively simple blood analysis known as a proteomic test can identify patients whose tumours are likely to shrink with the drug -- one of a class called EGFR-blockers.

"The bottom line is that the proteomic test -- comparing 'good' and 'poor' profiles -- was strongly prognostic," David Carbone from Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, who led the study, said in a statement.

"Proteomics 'good' patients also had a significantly higher response rate than proteomics 'poor' patients."

Tarceva, known generically as erlotinib, is sold by OSI and Roche and is designed to block EGFR, a gene that is overactive in many types of cancer cells.

Other drugs in the same class include AstraZeneca's lung cancer medicine Iressa, and colon cancer drugs Vectibix from Amgen and Erbitux -- sold by Bristol-Myers Squibb , Eli Lilly and Merck KGaA .

Lung cancer is the biggest cancer killer around the world, killing 1.2 million people a year. Only 15 percent of people diagnosed with lung cancer are still alive five years later.

Patients can already be tested to see if they have the right type of genetic profile to respond well to EGFR-blocking drugs, but the methods involve gene sequencing, which is complex and expensive, or a technique called fluorescence in-situ hybridization (FISH), which requires a sample of tumour tissue.

Carbone said FISH was a better predictor of benefit for Tarceva, but noted it can only be done with enough of a tissue sample.

In this study, tumour samples were only available in 22 percent of patients, he said, while 99 percent of patients were able to be successfully assessed with the proteomic test. "This (proteomic) test ... may be of particular value for those in whom tumour tissue is inadequate or unavailable," Carbone said.

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Santaris Plans Phase II Trial of miRNA-Targeting HCV Drug

Santaris Pharma is close to completing a second phase I study of its microRNA-targeting hepatitis C therapy SPC 3649, and expects to move the drug into phase II development later this year, a company official told RNAi News.

The official, CSO Henrik Orum, also said Santaris has dropped its near-term plan to seek a partner for the therapy, which it will instead carry on its own at least through the first phase II trial in HCV-infected patients

SPC3649 targets miR-122, the most abundantly expressed miRNA in the liver and one linked to cholesterol regulation and lipid metabolism. It is based on Santaris' locked nucleic acid technology, which comprises nucleic acid analogs in which the ribose ring is locked by a methylene bridge connecting the 2'-O atom with the 4'-O atom.

In mid-2008, Santaris moved the drug into a phase I study, making it the first to test a miRNA-targeting drug in man. According to Orum, that single ascending dose trial enrolled 64 healthy volunteers and initially examined doses of the drug up to 6.4 mg/kg.

"With the initial top dose of 6.4 [mg/kg], we didn't see anything in terms of the safety issues," he said. As such, the company amended the trial to include 9 and 12 mg/kg doses.

In addition to observing no significant adverse events associated with SPC3649, Santaris saw evidence of a pharmacological effect as measured by reductions in serum cholesterol — a biomarker for miR-122, Orum explained this week during a presentation at the IBC Life Sciences' Oligonucleotide Therapeutics Discovery conference held here.

The company also initiated a second phase I study, this time examining multiple ascending doses of the drug, which it expects to wrap up shortly, he said.

Because data from this trial have not been publicly disclosed, Orum declined to comment on them. He did say, however, that Santaris is "happy with the results" and that the company is slated to begin a phase II study in HCV-infected patients "later this year."

Both phase I studies were conducted in Denmark. He noted that the company is considering in which countries it will run the phase II trial.

Meanwhile, Santaris has made the decision to keep SPC3649 in-house after partner GlaxoSmithKline opted against licensing the drug.

In late 2007, the companies inked a deal to develop and commercialize antiviral drugs based on the LNA technology (RNAi News 12/20/2007). As part of that arrangement, GlaxoSmithKline had the option to in-license SPC3649.

But as reported by RNAi News, GlaxoSmithKline let that option expire (RNAi News 12/3/2009), leaving Santaris free to host licensing negotiations with other interested parties.

Notably, GlaxoSmithKline later said it had partnered with rival miRNA drug firm Regulus Therapeutics on a miR-122-targeting drug for indications including HCV (RNAi News 2/25/2010).

This week, however, Orum said that despite "considerable interest … [in SPC3649] we've elected to keep it as a Santaris asset until we have conducted the first trials in patients with HCV. We think there is significant value creation in that phase, and we'd obviously like to retain that within Santaris … we have patient data."

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Study sharpens focus on Glaxo's heart drug hope

A scientific study provided support on Friday for a way of fighting heart disease being pioneered by GlaxoSmithKline, likely to boost interest in drugs that target an enzyme involved in clogging arteries.

A study published in The Lancet medical journal suggests that the enzyme, known as lipoprotein-associated phospholipase A2, or Lp-PLA2, plays as much of a role in the risk of heart disease as high blood pressure and bad cholesterol.

Alex Thompson and John Danesh of Cambridge University, who conducted the research, said their findings would sharpen focus on an experimental drug called darapladib being developed by Glaxo and currently being studied in two large-scale clinical trials involving 27,000 patients worldwide.

"This reinforces interest in this enzyme, and reinforces the need to see the results from these clinical trials," Thompson said in a telephone interview.

Results of the trials are expected between 2012 and 2014.

Coronary heart disease is the leading cause of death worldwide, responsible for around 7 million deaths a year.

Smoking, diabetes, high blood pressure and high levels of "bad" cholesterol known as LDL are known to cause heart disease, but they do not entirely explain its incidence, so scientists and drug companies have been investigating other links.

Glaxo discovered darapladib through the use of gene technology from Human Genome Sciences, which has an agreement with Glaxo to receive clinical development milestone and royalty payments for such compounds.

It is the first in a new class of drugs targeting Lp-PLA2 and is designed to offer something beyond the hugely successful class of cholesterol-lowering statin drugs like Pfizer's Lipitor and AstraZeneca's Crestor.

Darapladib seeks to cut the risk of artery-clogging plaques rupturing, blocking blood vessels and triggering heart attacks. Thompson and Danesh looked at links between Lp-PLA2 and risk of heart disease, stroke and death in almost 80,000 people in 32 previous studies.

They found that higher blood levels of Lp-PLA2 were associated with increased risk. For heart disease, the size of the increased risk was similar to that from higher blood pressure or bad cholesterol, they said.

But they added that their analysis, which was mostly of data for people studied in North America and Europe, also showed weaker than expected links between heart disease and blood pressure and bad cholesterol.

"This enzyme in this study was as strongly associated with heart disease as blood pressure and cholesterol, but we need to be cautious in interpreting that because the associations of blood pressure and cholesterol were themselves substantially lower than we would have expected," Thompson said.

He said this may be because many patients in the studies were already taking heart medications that would alter their blood pressure or cholesterol levels.

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Vitamin E shows promise for treating liver disease

People with a common, obesity-related liver disease that has no known treatment got a surprising benefit from vitamin E pills, researchers reported Wednesday.

It appears to be the first time that a vitamin supplement has been shown to help treat a major ailment not caused by a nutrient deficiency. However, doctors warned that this does not mean people should automatically take vitamin E since some research suggests it might raise the risk of other problems.

The latest study tested it for nonalcoholic fatty liver disease. Fat buildup can cause the liver to become inflamed and scarred over time and in severe cases, to fail.

The disease usually develops in people who are middle-aged and overweight or obese. Up to 5 percent of Americans have the most serious form of it, and as many as 20 percent have fat in their livers but no organ damage.

In the study published online in the New England Journal of Medicine, 247 adults with advanced fatty liver disease were randomly assigned to take a high dose of vitamin E (800 international units), the diabetes drug Actos or dummy pills for nearly two years.

The vitamin and drug were tested because earlier research suggested liver cell deterioration and insulin resistance might be involved in the development of the disease.

Biopsies before and after treatment showed that liver function improved in 43 percent of those in the vitamin E group compared with 19 percent in the placebo group.

"In all honesty, I was surprised," said the lead researcher, Dr. Arun Sanyal of Virginia Commonwealth University. "A vitamin has not been previously used to cure a serious disease" that is not caused by a deficiency.

Vitamin deficiency has been blamed for a range of health problems from rickets and osteoporosis from a lack of vitamin D to scurvy from not enough vitamin C.

Study participants on the diabetes drug Actos also improved, but to a lesser degree and with a drawback: gaining 10 pounds on average, which remained even after they stopped taking the drug. Four people who took vitamin E developed diabetes, but the study was too small to determine if the vitamin played any role.

The National Institutes of Health was the study's main sponsor. A U.S. subsidiary of Japan-based Takeda Pharmaceutical provided the drug and California-based supplement maker Pharmavite supplied the vitamin E capsules. Sanyal, the lead researcher, has received consulting fees from Takeda and other drug companies.

Liver expert Dr. Sammy Saab at the University of California, Los Angeles, believes vitamin E could potentially become the initial treatment for advanced cases of the liver problem.

"For patients who are really at risk of progressive liver disease, I think it's worthwhile. For the vast majority who just have fatty liver, I'm not sure it will help them at all," said Saab, who had no role in the study.

Dr. Zobair Younossi, executive director of research at the nonprofit Inova Health System in Virginia, said people with nonalcoholic fatty liver disease at the very least should make lifestyle changes such as eating a healthy diet and exercising to shed the pounds.

While vitamin E may help certain people with obesity-related liver disease, "I wouldn't get started on high-dose vitamin E without discussing it first with a doctor," said Younossi, who has no connection to the research.

In recent years, hype over vitamin supplements in treating major diseases has not panned out. A 2008 study found that vitamins C and E pills do not ward off heart disease in men and vitamin E even appeared to raise the risk of bleeding strokes. Another study found the same supplements do not help prevent cancer in men.

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Migraine Patients to Wait for Triptan Alternative

Scandinavian researchers writing in The Lancet gave a warm review to an investigational drug for migraine, but patients in the United States, at least, will have a wait before it reaches them.

Merck manufactures the drug, called telcagepant, and was initially expected to seek approval from the U.S. Food and Drug Administration last year.

An online Lancet review by researchers from Sweden and Norway touted telcagepant as holding out hope for migraine patients with acute attacks that fail to respond to migraine medications known as triptan drugs, such as Zomig and Imitrex. One major concern of these drugs has been their tendency to cause narrowing of the blood vessels, a process known as vasoconstriction.

"Telcagepant does not cause vasoconstriction, a major limitation in the use of triptans," wrote Dr. Lars Edvinsson of University Hospital in Lund, Sweden, and Dr. Mattias Linde of Norwegian University of Science and Technology in Trondheim.

"Telcagepant might provide hope for those who have a poor response to, or are unable to use, older drugs."

But elevations in certain liver enzymes among some telcagepant trial participants caused Merck to hold back in the U.S., fearing an application would be rejected. In September, the company announced that it was meeting with FDA officials to discuss how to proceed.

As a result, a Merck spokeswoman told MedPage Today, the company will sponsor another clinical safety study to begin this year. She said the trial was still being designed, and the protocol would be posted to the Clinicaltrials.gov Web site about the time enrollment begins.

No other information, such as the projected completion date, is available at this time, the spokeswoman said.

The group of drugs called CGRP receptor antagonists, to which telcagepant belongs, represents a new front in the war on migraine, as Edvinsson and Linde explained.

The receptor appears throughout the nervous system, both central and peripheral, and researchers believe it helps regulate vascular tone, pain signaling, motor function, and other activities with neurologic components.

A variety of studies have implicated it specifically in migraine, notably findings that CGRP levels rise in cranial blood and saliva during attacks.

But the two researchers said the clinical findings with telcagepant were marred by the liver abnormalities, which they called "slightly disturbing."

A 12-week phase IIa trial was stopped a year ago when some patients showed these liver problems toward the end of the study.

Edvinsson and Linde also noted that relatively high doses of the drug are needed to reduce migraines -- more than 100 mg, compared with 5 mg for zolmitriptan.

"Outstanding questions include whether CGRP receptor antagonists can be combined with triptans to give more effective therapy and whether they will be of value in patients who do not respond to a triptan," the researchers wrote.

"Additionally, effectiveness of triptans in children has not been proven, a group that might benefit after such research."

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Tamoxifen, raloxifene cut breast cancer risk in half

Women at high risk can take either drug as preventive therapy, researchers in a seven-year study say.

Two drugs taken by women at high risk for breast cancer — tamoxifen and raloxifene — both reduce the risk of the disease by about 50% in high-risk post-menopausal women while they are taking the medications, researchers said Monday. The benefits of raloxifene fall off more quickly once women stop taking them, however, and the increased benefits of tamoxifen come at a price: a higher risk of uterine cancer, blood clots and cataracts — although the absolute risks of all three remain low.

"These are relatively inexpensive drugs that reduce breast cancer by about 50% with side effects that are modest," said Dr. Gabriel N. Hortobagyi of the University of Texas M.D. Anderson Cancer Center in Houston, one of the researchers. "We need to reassess why we are not using these drugs more broadly," he said at a news conference at a meeting of the American Assn. of Cancer Research, where the results were presented.

The new results represent an extension of a clinical trial that was first reported in 2007 and allow refinement of the researchers' earlier conclusions. But the basic message is that women can confidently take either drug to sharply reduce their risk of dying from breast cancer.

"If they can't tolerate their first choice, they can take advantage of the second drug," said Dr. Larry Wickerham of Allegheny General Hospital in Pittsburgh, another researcher on the team.

The trial enrolled 19,747 post-menopausal women over the age of 35 who had an above-normal risk of breast cancer because they had breast cancer genes or a family history of the disease. While the average 60- to 64-year-old woman has about a 1.66% risk of developing breast cancer over a five-year period, the women in the study averaged twice that risk, and some had an even higher risk. (Women can calculate their own risk at http://www.cancer.gov/bcrisktool).

Women who had uncontrolled diabetes or hypertension were excluded from the trial, as were those at a high risk for stroke or blood clots.

The women were given either tamoxifen (brand name Nolvadex, also available generically) or raloxifene (brand name Evista) daily for five years.

The initial results released after the end of that five years showed that both drugs reduced the risk of breast cancer by 50%. Based on those findings, the Food and Drug Administration approved the use of raloxifene to prevent breast cancer in high-risk post-menopausal women. Tamoxifen was already approved in both pre- and post-menopausal high-risk women.

The new report, which provides an additional 21 months of follow-up, shows that the benefits of tamoxifen continued after the women stopped taking it, but those of raloxifene fell off quickly. Over the nearly seven years of the study, tamoxifen reduced risk by 50%, but raloxifene reduced it by only 38%. That translates to 247 cases of invasive breast cancer (tumors that are likely to spread beyond the breast) among 9,736 women who took tamoxifen and 310 cases in the 9,754 women who took raloxifene.

Previous studies have shown that tamoxifen provides protection for at least seven to 10 years after women stop taking the drug.

About half the women in the trial had previously had hysterectomies and were not at risk of uterine cancer. Among the rest, 65 of 4,739 women in the tamoxifen group developed uterine cancer, compared with 37 of the 4,717 in the raloxifene group.

The raloxifene group also had 28% fewer blood clots in a major vein and 20% fewer blood clots in the lungs, but the absolute number of events was low in both groups.

The fact that raloxifene has fewer side effects may induce more women to adopt preventive therapy, said Dr. Jack Jacoub, an oncologist at Memorial Care Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, who was not involved in the research.

In the United States, "we have actually had difficulty getting women to accept preventive measures for breast cancer, and the primary deterrent has been the toxicity" of tamoxifen, Jacoub said. If these results are presented to women properly, "I think we will see more women receiving this therapy."

The study was funded by the National Cancer Institute, which provides more information about the results at http://www.cancer.gov/newscenter/STARresultsQandA.

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Cancer Drug Seems to Work by Activating Virus

The cancer drug cyclophosphamide activates a viral infection that helps anti-viral medications eliminate a virus-linked cancer, says a new study.

The drug is used to treat Burkitt lymphoma, an aggressive, fast-growing type of non-Hodgkin lymphoma that often occurs in children. In Africa, the cancer is caused by the Epstein-Barr virus (EBV), which typically remains dormant inside tumor cells.

This study of 21 patients, ages 5 to 15, who were being treated with cyclophosphamide, found that the drug triggers an active EBV infection. Increased replication of the virus in cancer cells makes the cells more susceptible to antiviral drugs, which kill cells containing the replicating virus.

The study was published in the April issue of the journal Clinical Cancer Research.

"What we have learned from this work is a potential means of capitalizing on presence of viral genomes within tumor cells to alter those tumor cells in a way that makes them more susceptible to treatment. Our findings have implications for other EBV-related malignancies that, overall, are among the most common cancers worldwide," Dr. Margaret Gulley, a professor of pathology and laboratory medicine at the University of North Carolina at Chapel Hill School of Medicine, said in a news release.

EBV infects more than 90 percent of people worldwide and is associated with a number of diseases including lymphomas, gastric cancer, and nose and throat cancer.

The next step in this research is a clinical trial to test the use of a cancer drug and an antiviral drug simultaneously, Gulley said.

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Clinical Trial of Experimental Mesothelioma Drug Promising

Researchers announced positive results from tests of an experimental anti-cancer drug known as NGR-hTNF in controlling the cancer of patients with malignant pleural mesothelioma. Mesothelioma is an incurable cancer of the lining of the lung associated with asbestos exposure.

NGR-hTNF is a novel drug compound that includes a peptide—a chain of amino acids—that homes in on cancer cells—and a type of protein known as tumor necrosis factor that helps regulate the immune system response to cancerous tumors. Developed by an Italian pharmaceutical company, MolMed S.p.A., the drug is designed to better permeate cancerous tumors and act directly on blood vessels that feed a tumor’s growth.

In an article published this week in the Journal of Clinical Oncology, Italian researchers said NGR-hTNF was given to 57 mesothelioma patients either every three weeks or every week. The patients had previously undergone chemotherapy and had a relapse. The results showed the drug temporarily stopped the advance of the cancer in 26 patients for about five months on average. Median survival was 12 months.

The researchers said the disease control provided by NGR-hTNF and patients’ ability to tolerate the drug warranted further study with patients with advanced pleural mesothelioma.

The drug is being studied as an alternative treatment for patients whose cancer is not responding to the more standard chemotherapy regimen involving permetrexed. A phase III clinical study is underway. Researchers are exploring it use by itself or in combination with other medications.

On the basis of the latest results, the drug was granted orphan drug designation for treatment of malignant mesothelioma in the United State and in Europe, MolMed S.p.A., announced.

The federal Orphan Drug Act provides special status to drugs used to treat a rare disease or condition at the request of the drug sponsor. MolMed S.p.A., an Italian pharmaceutical company, is developing the drug. The orphan designation provides tax credits and government incentives to sponsors that bring develop drugs to treat rare diseases. About 2,000 to 3,000 people die of mesothelioma in the United States each year, but incidence of the disease has increased significantly in recent decades.

The drug must go through the Food and Drug Administration marketing approval process like any other drug. Orphan drugs often receive expedited review because they are for serious or life threatening diseases, according to the Food and Drug Administration.

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Diabetes Drug Metformin May Reduce Risk of Breast Cancer

Metformin, a medication commonly used in the treatment of type 2 diabetes, may reduce the risk of breast cancer when used for more than five years, according to a new study published by the American Diabetes Association. The study adds fuel to increasing evidence of metformin's potential anti-cancer effects.

The study, led by Dr. Christoph R. Meier of Switzerland, followed more than 1,000 women in the U.K. using the drug to treat diabetes. Women using metformin for more than five years were at a 56 percent lower risk of breast cancer than those who never took the drug.

The study was relatively small, and while a direct cause and effect link between the drug and the reduced risk has not been established, researchers believe the connection may be related to metformin's actions on a key metabolic enzyme known as AMP-activated protein kinase as well as its insulin-reducing activity.

The study comes just days after researchers at the American Association for Cancer Research presented findings suggesting metformin may lower the risk of lung cancer in smokers.

During its 15 years in use, metformin has become a popular drug for the treatment type 2 diabetes, a condition in which insulin does not properly carry sugar out of the bloodstream and into cells. Metformin helps regulate blood sugar levels and prevent complications in patients with the disease by reducing the amount of glucose absorbed in the stomach and produced in the liver while also enhancing the performance of insulin.

As the evidence for metformin's anti-cancer effects rises, additional studies addressing the medication's potential in cancer reduction are in the works.

Additional information about drugs and drug side effects may be found on Drugwatch.com.

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Pfizer liver cancer trial halted on safety concern

Pfizer Inc said on Thursday it has discontinued a late stage liver cancer study of its drug Sutent because of high incidence of serious adverse events suffered by patients taking the medicine.
Following a review by the independent Data Monitoring Committee the trial was halted over safety issues, Pfizer said.

Sutent is already approved to treat advanced kidney cancer and gastrointestinal stromal tumors following disease progression and had worldwide sales of $964 million in 2009.

Pfizer is testing Sutent against a wide range of cancers in hopes of significantly expanding sales of the drug.

The liver cancer failure represents the latest in a long list of clinical setbacks for the world's largest drugmaker, including a Sutent failure in a late stage advanced breast cancer study announced last month.

The company has been widely criticized by analysts for its inability to deliver products based on its own research despite the industry's largest research and development budget.

The company last year acquired Wyeth for $67 billion in large part to gain that company's promising portfolio of drugs in development.

The halted open label trial tested Sutent against Nexavar, a liver cancer drug sold by Bayer AG and Onyx Pharmaceuticals Inc .

Safety monitors found higher incidence of serious side effects in patients taking Sutent, known chemically as sunitinib, compared with those who received Nexavar.

Sutent also failed to demonstrate that it was either superior or non-inferior to Nexavar in extending the survival of liver cancer patients, the company said.

"The disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease," Mace Rothenberg, head of clinical development for Pfizer's oncology unit, said in a statement.

Pfizer is still testing the drug against non-small cell lung cancer, prostate cancer and for kidney cancer following surgery.

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Novo's Victoza beats Merck drug in diabetes study

Novo Nordisk's new diabetes drug Victoza proved more effective than Merck & Co's Januvia in a head-to-head study, boosting prospects for a product that has got off to a strong start in key markets.

Daily injections of both high- and low-dose Victoza reduced blood sugar levels by more than a daily tablet of Januvia in people with type 2 diabetes who had not responded adequately to the older drug metformin, researchers said on Friday.

The results may help the Danish drugmaker, which funded the study published in the Lancet journal, to differentiate its medicine in a highly competitive marketplace.

Victoza is Novo's biggest new drug hope and is expected to generate annual sales of more than $1.4 billion by 2014, according to consensus forecasts compiled by Thomson Reuters.

After a delayed path to market, prescription trends suggest it is now doing well in both Europe and the United States, in contrast to disappointing sales of some other recently launched new drugs, such as Eli Lilly's bloodthinner Effient.

Mads Krogsgaard Thomsen, Novo's chief scientific officer, said the results followed other positive comparative studies and would bolster Victoza's reputation among medical experts.

"The fact that Novo Nordisk has now done most, if not all, of the major comparator studies against different classes of oral and injectable anti-diabetic drugs really shows our commitment to showing comparative efficacy in a serious way," he said in a telephone interview.

Novo demonstrated two years ago that Victoza controlled blood sugar better than Byetta, a drug from the same class of medicine that is sold by Eli Lilly and Amylin Pharmaceuticals.

Progress Report

With investors awaiting a progress report on Victoza's sales prospects when Novo reports first-quarter results on April 27, Thomsen said demand for the new drug was following the company's own "optimistic" expectations.

"We have overtaken Byetta in several European markets in the first nine months post launch and in the U.S. we are already seeing, nine weeks into the launch, a rather sizeable uptake," he said.

In the latest study, 1.8 milligrams of Victoza, or liraglutide, lowered levels of HbA1c -- a standard blood measure that is indicative of a patient's glucose levels -- by 1.5 percentage points against 0.9 percent for Januvia, or sitagliptin.

The lower dose of 1.2 mg of Victoza cut HbA1C by 1.2 points in the six-month trial.

Researcher Dr Richard Pratley of the University of Vermont College of Medicine and colleagues said the difference was "clinically relevant," adding that patients on Victoza, which caused some nausea, also lost more weight.

In an accompanying comment, Dr Andre Scheen and Dr Regis Radermecker of Belgium's University of Liege said 1.2 mg of Victoza should be considered as a starting dose in most cases, with patients moving up to 1.8 mg if necessary.

On the downside, they noted that Januvia was cheaper, caused fewer gastrointestinal upsets and "one pill of sitagliptin daily might be judged as easier to administer than one subcutaneous injection of liraglutide daily."

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New malaria pill matches Novartis drug in study

A new drug for malaria proved as effective as Novartis's leading treatment Coartem in a clinical trial, researchers said on Friday, although an outside expert said the findings had limitations.
Coartem is the current "gold standard" for people infected with the mosquito-borne disease. The two-in-one Novartis drug needs to be taken twice a day and requires a fatty diet for optimum absorption.

Pyramax from South Korean drugmaker Shin Poong Pharmaceuticals is taken just once daily.

A randomized Phase III study of Pyramax -- a fixed-dose combination of pyronaridine and artesunate -- showed a treatment response of 99.5 percent compared to 99.2 percent among patients on Coartem, which combines artemether and lumefantrine.

Researchers involved in the study wrote in the Lancet medical journal that a three-day course of Pyramax should be considered for inclusion in malaria treatment programs, especially given its low cost of less than $1 for adults and 50 cents for children.

In an accompanying comment, however, Dr Francois Henri Nosten of the Mahidol-Oxford University Tropical Medicine Research Programme said a limitation of the study was that it consisted of many older African children and adults who had probably acquired some malaria immunity.

He also raised concerns about patients on Pyramax having raised liver enzymes, a possible signal of liver toxicity.

The Pyramax study was sponsored by Shin Poong and the non-profit Medicines for Malaria Venture (MMV).

MMV argues it is vital to have multiple anti-malaria drugs available to ensure innovation and guarantee competition in the marketplace, thereby driving down prices for life-saving medicines in poor countries.

Pyramax was submitted to the European Medicines Agency for regulatory approval earlier this year.

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FDA approved leukemia drugs shows promise in ovarian cancer cells

The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA's Jonsson Comprehensive Cancer Center found.

The drug, when paired with a chemotherapy regimen, was even more effective in fighting ovarian cancer in cell lines in which signaling of the Src family kinases, associated with the deadly disease, is activated.

The study appears in the Nov. 10, 2009 edition of the British Medical Journal.

Ovarian cancer, which will strike 21,600 women this year and kill 15,500, causes more deaths than any other cancer of the female reproductive system. Few effective therapies for ovarian cancer exist, so it would be advantageous for patients if a new drug could be found that fights the cancer, said Gottfried Konecny, an assistant professor of hematology/oncology, a Jonsson Cancer Center researcher and first author of the study.

"I think Sprycel could be a potential additional drug for treating patients with Src dependent ovarian cancer," Konecny said. "It is important to remember that this work is only on cancer cell lines, but it is significant enough that it should be used to justify clinical trials to confirm that women with this type of ovarian cancer could benefit."

Recent gene expression studies have shown that about one-third of women have ovarian cancers with activated Src pathways, so the drug could potentially help 7,000 ovarian cancer patients every year.

In this study, the UCLA team tested the drug against 34 ovarian cancer cell lines and they conducted genetic analysis on all cell lines. Through these analyses, the researchers were able to identify genes that predict response to Sprycel. If the work is confirmed in human studies, it may be possible to test patients for Src activation and select those who would respond prior to treatment, personalizing their care.

"We were able to identify markers in the pre-clinical setting that would allow us to predict response to Sprycel," Konecny said. "These may help us in future clinical trials in selecting patients for studies of the drug."

Sprycel is what is known as a "dirty" kinase inhibitor, meaning it inhibits more than one pathway. Konecny said it also inhibits the focal adhesion kinase and ephrin receptor, also associated with ovarian cancer.

The next step, Konecny said, would be to test the drug on women with ovarian cancer in a clinical trial. The tissue of responders would then be analyzed to determine if the Src and other pathways were activated. If that is confirmed, it would further prove that Sprycel could be used to fight ovarian cancer. In studies, women would be screened before entering a trial and only those with Src dependent cancers could be enrolled to provide further evidence, Konecny said, much like the studies of the molecularly targeted breast cancer drug Herceptin enrolled only women who had HER-2 positive disease.

"Herceptin is different because we knew in advance that the only worked in women with HER-2 amplification," he said. "In this case, we don't clearly know that yet. The data reassure us that the drug works where the targets are over-expressed but we need more testing to confirm this."
The tests combining the drug with chemotherapy are significant because chemotherapy currently is the first line treatment for ovarian cancer patients following surgery. Because Sprycel proved to have a synergistic effect when combined with chemotherapy both made the other work better it may be possible to add the targeted therapy as a first line treatment if its efficacy is confirmed in future studies, adding a new tool to an oncologist's arsenal.

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New study may deal final blow to acne drug Accutane

The study bolstered evidence of a link between the drug, pulled from the market in June, and inflammatory bowel disease. No medication is as effective in treating severe cases of acne.

Teenagers and young adults suffering from severe, scarring acne may ultimately lose the most effective treatment for the condition.

Swiss-based Roche Holding quietly pulled its blockbuster drug Accutane off the market in June amid early signs that the drug may be linked to inflammatory bowel disease. And last week, a study was released that quantified those risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as nonusers.

For now, generic versions are still available, but the latest troubles could lead to the withdrawal of the controversial medication considered the treatment of last resort for acne so damaging it can lead to pitting of the face and a lifetime of anguish.

In its tumultuous 27-year history, the drug, also known as isotretinoin, has been found to cause serious birth defects if taken during pregnancy and to possibly increase the risk of depression, including suicidal behavior. Women who take it must register with the government, sign a consent form saying that they understand the medication's risks, use two forms of birth control, and submit to monthly pregnancy tests.

The fact that it's still on the market puzzles some former users and consumer advocates -- and reflects the profound lengths to which doctors, pharmacists, pharmaceutical companies, regulatory agencies and patients have gone to ensure its survival.

"It would be a true disaster if this medication would become unavailable," said Dr. Steven Stone, chairman of an American Academy of Dermatology committee that has reviewed the drug's safety.

"People don't die of acne, so it's easy to say, 'This is a drug that causes inflammatory bowel disease; let's take if off the market.' But that ignores the psychological harm of severe acne."

A form of vitamin A, isotretinoin is usually taken daily for three to six months, resulting in lasting improvements in 99% of patients and a cure in about 70%.

It is also used occasionally for psoriasis, lupus and cancer.

Accutane has been used by more than 13 million people worldwide and was one of Roche's best-selling drugs, with about $200 million a year in sales before its patent expired in 2002.

When approved in 1982, the drug was known to cause birth defects if taken during pregnancy and was labeled with warnings to that effect. In 2005, the Food and Drug Administration implemented the stringent iPledge program, requiring patients, doctors and pharmacists to join a risk-management registry to try to ensure that women didn't become pregnant while on the drug.

The program has kept isotretinoin on the market, although the system is so cumbersome that some doctors and patients have given up trying to obtain the medication, says Dr. Amy Forman Taub, a dermatologist and assistant clinical professor at Northwestern University in Chicago.

"This drug has had so many fears associated with it over the years," she said. "There are no other medications other than thalidomide where there is a registry. But we've mastered it, and it works."

Isotretinoin can cause other side effects, including increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol and liver toxicity.

The drug has been publicly and emotionally linked to an increased risk of depression, including suicides, and some families of suicide victims have pressed the FDA for its removal -- among them Rep. Bart Stupak (D-Mich.), whose teenage son committed suicide after taking Accutane.

A study published in January in the Annals of General Psychiatry, however, found that the relationship between isotretinoin and psychiatric problems is unproved. Now research has found a possible link to inflammatory bowel disease. Last week at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of bowel disorders in isotretinoin users. Before the study, the connection was largely anecdotal.

In inflammatory bowel disease, the intestines become chronically red and swollen, producing pain, cramping, diarrhea, weight loss and bleeding. Surgery to remove all or part of the colon is sometimes required.

Dr. Seth Crockett and his colleagues compared 8,189 cases of inflammatory bowel disease with 21,832 healthy individuals and found the odds of developing such diseases were 1.68 times higher among isotretinoin users. People who had filled four or more prescriptions had 2.67 times the risk. The odds of having ulcerative colitis, a type of bowel disease that causes open sores in the lining of the rectum and colon, were 4.36 times higher among isotretinoin users. (No increased risk was found for Crohn's disease, perhaps the most severe such ailment.)

But only about 5 to 10 people in 100,000 are diagnosed with inflammatory bowel disease each year, Crockett said.

"The absolute risk of getting inflammatory bowel disease is very low," he said. "So if someone has disfiguring acne that was affecting their quality of life, it might be a risk they are willing to take."

Because the data have not yet been published in a peer- reviewed journal, Crockett noted, they must be considered preliminary.

And a similar study, published in July in the American Journal of Gastroenterology by University of Manitoba researchers, found no such association. That study examined a large database in Canada and found that 1.2% of people diagnosed with inflammatory bowel disease had used the drug before diagnosis, compared with 1.1% who had not used isotretinoin.

There is no biological explanation for why isotretinoin might increase the risk of bowel disease, Crockett said, adding: "There are a lot of things that are not understood."

A statement by Roche said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits, not safety concerns.

Accutane costs about $1,200 a month, and many consumers choose the generics, which cost 25% to 50% less. Meanwhile, plaintiffs have won an estimated $33 million in judgments against Roche for bowel disorders, according to an industry publication, Dermatology Times.

The new data are certain to spark renewed opposition to the drug, said Michael S. Brown, an Encino-based lawyer who specializes in personal-injury claims.

The intent of the lawsuits is to drive the medication off the market, he said. "That has been our goal for several years or, in the alternative, to make full disclosure in a way in which the public is properly informed," he said. The isotretinoin patients he represents were not told of a potential increased risk of bowel disease, Brown said.

Taub, the Northwestern dermatologist, says she will include the most recent information on risk in her long discussions with patients who are candidates for the medication. But she worries about a future with nothing to offer people with severe acne.

"If it's financially draining, companies are going to pull out," she said.

"I would hate for anyone to develop ulcerative colitis while treating them for something like acne. But the flip side is that most people who take Accutane have suffered terribly" from acne, she added.

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