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Published on 08/06/07 at 12:59pm

Accorda enrols first patient in phase III MS study

Acorda Therapeutics has begun a second phase III clinical study of Fampridine-SR in multiple sclerosis, with the randomisation of its first patient into the treatment phase of the study.

The study is expected to enrol approximately 200 patients at 35 leading multiple sclerosis (MS) clinical centers in the US and Canada. Fifteen centres have been initiated and are in the process of screening subjects for the trial.

The study will evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. An SPA is a process in which the FDA provides guidance on a phase III clinical trial whose data will form the primary basis for an efficacy claim. Pending clinical results from MS-F204, the FDA has agreed that this study together with the previous phase III study would be adequate to support a new drug application for Fampridine-SR, according to the company.

The primary outcome measure for the study will be a walking response criterion, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk. The secondary outcome measure for this study is the Lower Extremity Manual Muscle Test.

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Gilead hepatitis B drug reaches phase III objective

US-based biopharmaceutical company Gilead Sciences has reported that a phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread 300mg as a potential treatment for chronic hepatitis B virus has met its primary efficacy endpoint.

The so-called Study 102 showed that Viread is non-inferior to the company's once-daily antiviral drug Hepsera among patients with chronic hepatitis B virus (HBV) infection. The primary efficacy endpoint was the proportion of patients with a complete response at week 48.

The company said that at 48 weeks, 70.8% of patients being treated with Viread had a complete response, compared to 48.8% of those being treated with Hepsera. The most commonly observed treatment-emergent adverse events of moderate intensity or higher included abdominal pain, back pain, headache and respiratory infections, Gilead added.

"Chronic hepatitis B remains a serious disease that impacts more than one million people in the US and an estimated 400 million people worldwide," said Franck Rousseau, MD, vice president of clinical research at Gilead. "We believe Viread has the potential to be an important treatment option for patients with chronic hepatitis B."

Full study results of the phase III trial of Viread, known generically as tenofovir disoproxil fumarate or tenofovir D, will be submitted for presentation at an upcoming scientific meeting.

Study 102 is one of two phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B. The second study (Study 103), a 48-week trial among patients with hepatitis B 'e' antigen-positive chronic hepatitis B, is expected to be complete later in 2007.

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Johnson & Johnson submits NDA for antibiotic

Johnson & Johnson has submitted a new drug application to the FDA for doripenem, an investigational carbapenem antibiotic for the treatment of hospital-acquired pneumonia.

The data supporting the NDA showed doripenem was an effective treatment for hospital-acquired, or nosocomial, pneumonia. The data also demonstrated the effectiveness of doripenem against infections caused by gram-negative bacteria, such as Pseudomonas aeruginosa and Enterobacteriaceae, including strains of these bacteria that are resistant to other therapies.

Pseudomonas aeruginosa is one of the leading causes of hospital-acquired infections and, because of increasing multi-drug resistance, treatment options are limited. In general, there are few antibiotics available or currently in development to treat the resistant infections - which can be potentially life-threatening - associated with these gram-negative bacteria.

In clinical trials, doripenem was well-tolerated, according to J&J. The most common treatment-emergent adverse events seen were diarrhoea, nausea, constipation, urinary tract infection and decubitus ulcer, commonly known as a bedsore.

The nosocomial pneumonia indication for doripenem had been granted "fast-track" status by the FDA. According to the Centers for Disease Control and Prevention (CDC), two million Americans develop hospital-acquired infections each year, and approximately 90,000 die as a result. Approximately 70% of these infections are resistant to at least one antibiotic. Pneumonia is the second, most-common, hospital-acquired infection in the US and is associated with substantial morbidity and mortality.

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Positive results for Sangamo's HIV therapy in animal study

Sangamo BioSciences has said that its zinc finger DNA-binding protein therapy for HIV/AIDS demonstrates that human T-cells that have been ZFN-modified are protected from HIV infection and have a selective survival advantage in a mouse model of HIV.

As a result of the positive findings, Sangamo expects to initiate a phase I clinical trial to test the HIV ZFP therapy in the second half of 2007.

Sangamo said that its ZFP nuclease (ZFN) technology can be used to make human primary T-cells resistant to HIV infection by permanently modifying the DNA sequence encoding CCR5, an essential co-receptor for the entry of HIV into immune cells.

In this latest stage of the company's programme to develop a zinc finger DNA-binding protein therapy for HIV/AIDS, the modified human T-cells were injected into mice. The research showed that the cells engraft, and suggested that, in the presence of HIV, the ZFN-modified cells have a selective advantage and evade HIV infection and destruction.

"This is the first presentation of in vivo data from our programme to develop a ZFP therapeutic for the treatment of HIV, and it is significant that these animal data confirm our earlier observations in isolated cells," said Dale Ando, Sangamo's vice president of therapeutic development and chief medical officer.

Edward Lanphier, Sangamo's president and CEO, added: "By administering ZFNs to patients' T-cells, the goal is to provide HIV-infected individuals with a reservoir of healthy and uninfectable immune cells that would be available to combat opportunistic infections and HIV itself."

Sangamo's data was presented on June 1, 2007, at the 10th Annual Meeting of the American Society of Gene Therapy, which was held in Seattle, Washington.

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Roche recalls Viracept due to chemical impurity

Swiss pharmaceutical company Roche has recalled all batches of its Viracept powder and tablets for the treatment of HIV in Europe and some other world regions. The recall does not, however, affect the US, Japan and Canada, the company said.

Roche revealed that it is carrying out the recall in agreement and cooperation with the EMEA and Swissmedic health authorities, after receiving several reports that some batches of Viracept 250mg tablets have a strange odour.

The drugmaker said that a detailed chemical analysis of the affected tablets showed that they contain higher than normal levels of methane sulfonic acid ethylester. As a result, Roche decided to recall all batches of Viracept tablets and powder in the interest of patient safety.

In a press release confirming the recall, Roche advised patients being treated with Viracept to contact their doctors to discuss alternative therapies.

Viracept, which is known generically as nelfinavir, is one of a new class of anti-HIV drugs called protease inhibitors that work by blocking a part of HIV called protease. Viracept was first introduced by Roche in 1998.

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