The researchers compared MS brain lesions with weather patterns

The severity of multiple sclerosis (MS) may change with the seasons, say US researchers.

Brain scans of patients compared with weather patterns at the time showed higher levels of disease activity in the spring and summer.

The US researchers said the findings had implications for testing new medicines, which may show up different results depending on the time of year.

It is not clear why warmer weather would have this effect.

Other studies have shown that vitamin D from exposure to sunlight may have a protective effect against MS – a long-term inflammatory condition of the central nervous system.

For the study, researchers compared MRI brain scans of 44 people taken from 1991 to 1993 to daily temperature, solar radiation and precipitation measurements over the same time.

The adults in the study, who had untreated MS, had eight weekly scans followed by eight scans every fortnight then six monthly check-ups – an average of 22 scans per person.

After one year, 310 new brain lesions were found in 31 people, they reported in Neurology.

The lesions were up to three times more likely to appear in the warmer spring and summer months.

Further analysis also showed that there was a link between both new disease activity and intensity of disease activity and the warmer months.

Trial results

Study leader Dr Dominik Meier, from Brigham and Women’s Hospital in Boston, said: “Not only were more lesions found during the spring and summer seasons, our study also found that warmer temperatures and solar radiation were linked to disease activity.”

He pointed out that clinical trials often use MRI (magnetic resonance imaging) to assess the effectiveness of a drug and studies commonly last between six and 12 months, which may have implications for how effective a new medication seems.

In an accompanying editorial Dr Anne Cross, from Washington University School of Medicine, added: “This is an important study because it analyses records from the early 1990s, before medications for relapsing MS were approved, so medicines likely could not affect the outcome.

“Future studies should further explore how and why environmental factors play a role in MS.”

Dr Susan Kohlhaas, research communications officer at the MS Society, said more research was needed.

But added: “This small study is intriguing and, if validated in larger studies, has the potential to influence the way clinical trials are designed.”

Source: BBC News

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Study will evaluate oligodendrocyte progenitor cell therapy in spinal cord injury.

Geron will be able to start what it claims is the world’s first human trial with a human embryonic stem cell (hESC)-based therapy now that FDA has lifted a nearly year-long clinical hold on the firm’s IND application for its acute spinal cord injury therapy, GRNOPC1. The Phase I trial will evaluate the hESC-derived oligodendrocyte progenitor cell therapy in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries. The primary study endpoint is safety, but additional secondary endpoints will assess efficacy of the treatment in terms of improved neuromuscular control or sensation in the trunk or lower extremities, Geron points out.

Looking forward, Geron says once the safety of GRNOPC1 has been confirmed in this first patient population it will look to increase the treatment dose, enroll additional subjects with complete cervical injuries, and expand the trial to include patients with severe incomplete injuries classified as ASIA Impairment Scale grade B or C.

“Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged; to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord,” states Thomas B. Okarma, M.D., Geron’s president and CEO. “Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis, and Canavan disease.”

GRNOPC1 comprises hESC-derived oligodendrocyte progenitor cells that published studies have shown demonstrate remyelinating and nerve growth stimulating properties that lead to restoration of function in animal models of acute spinal cord injury, Geron explains.

FDA placed a clinical hold on the IND for GRNOPC1 during August 2009 when it was found that in one preclinical study animals treated using GRNOPC1 developed a higher frequency of small cysts at the injury site than animals treated in previous studies. Geron subsequently developed new markers and assays as additional release specifications for the treatment and has completed a separate confirmatory preclinical animal study to test the markers and assays.

The firm’s regenerative pipeline includes GRNCM1, an hESC-derived cardiomyocyte treatment in development for the potential treatment of heart disease. The product is currently undergoing large-scale animal testing. Geron is separately developing an hESC-based islet cell therapy GRNIC1 for the treatment of diabetes and is working with collaborators on a degenerative joint disease program based on the development of hESC-derived chondrocytes. The firm says its collaborators aim to start large-scale animal studies with the treatment during 2010.

Source: GEN

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Final decision will be based on Phase III ALS trial data, due by the end of 2011.

Swiss biopharma firm Actelion is paying Trophos €10 million (about $12.6 million) for an exclusive option to buy the company and get its hands on the late-stage amyotrophic lateral sclerosis (ALS) drug olesoxime. The Phase III study evaluating the mitochondrial pore modulator is due to report by the end of 2011. At this point Actelion will be able to exercise its option and purchase Trophos outright for between €125 million (roughly $158 million) and €195 million (some $246 million) in cash, dependent on regulatory approvals and the clinical progress of Trophos’ CNS drug pipeline.

The firms also agreed on a research collaboration that will give Actelion access to Trophos’ CNS assay technology and compound library. Trophos says its in vitro technology mimics neuronal degeneration pathways and can be used to screen compounds for their ability to impact on neurodegenerative processes.

Trophos is developing a pipeline of candidates for the treatment of diseases including ALS, spinal muscular atrophy (SMA), chemotherapy-induced peripheral neuropathy, and cardiac ischemia reperfusion injury. The pipeline is based on the firm’s cholesterol-oxime chemistry and comprises drug candidates that Trophos claims enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria through interactions at the permeability transition pore (mPTP).

The development of lead compound olesoxime has been supported by €6 million (about $7.6 million) in funding from the EU’s Seventh Framework program. The drug is in addition poised to start in Phase II development as a treatment for SMA. It is being progressed through development for this indication with funding support from the French Association Française contre les Myopathies. Trophos’ second mitochondrial pore modulator candidate TRO40303 is reportedly poised to start in clinical development as a treatment for cardiac ischemia-reperfusion injury. The company has additional preclinical programs focused on disorders including multiple sclerosis and Parksinon disease.

Source: GEN

Popularity: 2% [?]

German pharmaceuticals and chemicals company Merck KGaA is banking on an experimental multiple sclerosis (MS) pill to lift operating margins at its embattled drugs unit, it said on Wednesday.

Earnings before interest, tax and special items at its Merck Serono prescription drugs unit could rise to 25 percent of sales in the long term, up from 22.4 percent in the first quarter, analysts at Exane BNP Paribas quoted the unit’s head, Elmar Schnee, as saying in remarks confirmed by a Merck spokesman.

Merck resubmitted the U.S. application for its MS pill cladribine on June 8, trying to catch up with Novartis AG in the race to bring to market the first oral treatment against the debilitating disease.

If key pipeline drugs such as cladribine get rejected by regulators the margin could be 20 percent in the long term, Schnee said.

Merck’s drug unit, which accounts for about three quarters of group sales, is in need of a morale booster after it failed last year to win regulatory approval for the use of its blockbuster-hopeful Erbitux against lung tumors, the most common form of cancer.

In addition, prospects remain uncertain for U.S. approval of its experimental multiple sclerosis pill cladribine and for its cancer vaccine Stimuvax.

Schnee also told the BNP analysts he expected the U.S. Food and Drug Administration (FDA) to formally accept its reworked request for regulatory approval of cladribine in early August.

The pill could still win U.S. priority review status, as long as Novartis’ rival product Gilenia has not yet come to U.S. markets, he added.

Schnee also said he expected rival Gilenia to have only limited impact on demand for the current standard treatment of MS, so-called interferon beta injections, citing concern about Gilenia’s side effects.

Interferon betas, which account for much of the $8.6 billion spent each year on MS treatments, include Merck’s best-seller Rebif, Biogen Idec Inc’s Avonex, Bayer AG’s Betaferon and Novartis’ Extavia.

Schnee’s assessment contrasts with a ringing endorsement from U.S. experts for Gilenia this month, which cemented the pill’s blockbuster potential and suggested consensus sales estimates need to rise.

Gilenia is likely to be approved to treat U.S. patients with relapsing multiple sclerosis (MS) as early as the third quarter.

Some investors had been skeptical about Gilenia due to its side effects, but feedback from a panel of experts advising the FDA was more positive than many had expected.

Source: Reuters

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Novartis announced that the US Food and Drug Administration (FDA) has extended by three months, to September 2010, its review period for the regulatory approval of FTY720 (fingolimod). FTY720 once-daily 0.5 mg has the potential to be the first oral therapy for relapsing multiple sclerosis (MS).

A meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee remains scheduled for June 10, 2010, to discuss the benefit/risk profile of this new active ingredient (New Molecular Entity).

The FDA granted priority review status for FTY720 in February 2010, reducing the standard 10-month review period to six months, which was set to end on June 21, 2010. The extension was based on the FDA’s request for further analysis of available data, which Novartis responded to and which triggered the three-month extension. The agency did not ask for additional clinical trials. Priority reviews are granted by the FDA for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists.

“The announcement of this revised timeline is in line with our expectations, and reflects the comprehensive clinical program and resulting large amount of data to be reviewed in the NDA,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “MS is a leading cause of neurological disability in young adults and we are very committed to bringing new therapies to patients with this disabling condition.”

Data from the FTY720 MS clinical trial program, the largest ever submitted to the FDA to support approval of a new medicine in this therapeutic area, have demonstrated the significant benefits of FTY720 in reducing relapses in people with MS.

Source: World Pharma News

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A University of Bristol study has demonstrated that stem cell therapy could slow the progression of multiple sclerosis, lending hope to patients with the disease. In the trial, six MS subjects were injected with their own PCT stem cells collected from their bone marrow. Researchers then injected the stem cells into each patient’s blood stream.

Results from the trial indicate that the treatment could stabilize the disease. But researchers were quick to point out that the therapy isn’t some miracle cure, and that much more study is needed before they can conclusively determine the treatment’s utility for treating MS. ”We didn’t see patients throwing away their wheelchairs, throwing away their walking sticks, the symptoms that the patients had didn’t change a great deal,” said trial leader Prof Neil Scolding. “They didn’t get a lot worse over the 12-month period–and you might have expected them to–but neither was there a great difference in what patients could actually do. So this is just a beginning.” A Phase II/III study is expected to get under way later this year.

Source: FierceBiotech

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Follow-up data from a Phase II trial of Campath (alemtuzumab) for multiple sclerosis revealed that about 71 percent of patients remain free the disease for up to three years after receiving their last dose of the drug. The study compared Campath to the Merck KGaA’s approved MS therapy Rebif in early, active, relapsing-remitting multiple sclerosis patients who had received no prior therapy. Genzyme presented the positive data at the American Academy of Neurology annual meeting.

The study results are terrific news for the beleaguered biotech. Genzyme has been locked in battle with Carl Icahn following problems at one of its manufacturing plants last year. Those problems have interfered with production of the company’s top-selling drug and cut into Genzyme’s bottom line. That’s brought about calls for a change in Genzyme’s management, including the resignation of CEO Henri Termeer.

Icahn, who holds a 1.8 percent stake in Genzyme, managed to get himself and three associates nominated to the biotech’s board this year. But the foursome are also stakeholders in Biogen Idec, which has its own MS treatments–Avonex and Tysabri–that would compete with Campath if the blood cancer drug were approved for MS. Non-Icahn appointed board members also are concerned that there’s a conflict of interest if Icahn’s nominees are making decisions about an MS drug that could compete with one from their other companies.

“Directors owe shareholders a duty of loyalty and a duty of care,” Peter Wirth, head of Genzyme’s legal department, said in a telephone interview with BusinessWeek. “When you have people who are on the board of a competitor or have a billion-dollar stake of a competitor, they can’t satisfy either.”

Icahn’s board member Alexander Denner fired back at Wirth, saying that Genzyme is raising possible conflict-of-interest problems to distract shareholders from problems elsewhere in the company. “To the extent that conflicts do come up at the board level, which we don’t expect very often, we obviously will not participate,” said Denner.

Two Phase III trials of Campath are currently under way, with data expected by 2011.

Source: FierceBiotech

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Swiss drugmaker Novartis AG moved closer to bringing the first oral multiple sclerosis treatment to market after new data showed its Gilenia cut relapse rates in the disease on Tuesday.

Novartis pulled further ahead of rival Merck KGaA’s pill cladribine to treat the debilitating nervous disease last February when Gilenia, FTY720, was given U.S. priority review status.

Data presented at the American Academy for Neurology (AAN) showed the annual relapse rates were reduced by 62 percent in newly treated patients, while relapse rates were lowered by 44 percent in previously treated patients, Novartis said.

New extension data also showed that Gilenia worked over two years, with patients taking the drug for the period having a significant reduction in relapses and MRI brain lesions compared to the group which first took interferon beta-1a and later switched to Gilenia.

U.S. and EU regulatory reviews are underway for Gilenia.

Source: Reuters

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The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:

• Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.

• Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the drug.

• Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.

Update: A Biogen spokeswoman told Dow Jones Newswires that the company believed “the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency.” Gilead said in a statement that takes the FDA’s concerns regarding the advertisements seriously “and we will be working to respond to the FDA promptly,” according to DJ Newswires.

Source: The Wall Street Journal

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Multiple sclerosis patients won’t have to wait for the government say what drug works best against their disease: Biogen Idec and Elan, makers of Tysabri, hope to do it first. The two companies started enrollment in a 1,800-patient study pitting their drug against two other MS treatments, Copaxone from Teva and Merck Serono’s Rebif.

Known as SURPASS, the study aims to identify the drug that works best at staving off relapses, as measured by the annualized relapse rate. The trial will also look at lesion growth and at disease progression to identify the drug that best halts disease activity, and check up on the safety of switching to Tysabri from another treatment.

Safety has been an issue with Tysabri; the drug was pulled off the U.S. market several years ago when patients developed a potentially fatal brain infection called progressive multifocal leukoencephalopathy. The drug came back into use under a risk-management program, and Biogen has been regularly updating the PML case count, which most recently stood at 42 .

Source: FiercePharma

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