Dr. Ferran J. García

PONTE AL DÍA SOBRE EL SFC

Simposio Internacional sobre el SFC y los Virus. Baltimore Mayo 2008
(Gracias a Carlos González por la traducción)

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El estudio del Dr José Montoya (EEUU) sobre el antiviral Valcite para el SFC:
El Dr José Montoya está llevando a cabo un estudio de doble ciego, controlado con placebo, sobre el uso de Valganciclovir (Valcite) en pacientes con el SFC que tienen un número elevado de anticuerpos del virus del HHV6 y del Virus de Epstein Barr (EBV).

DIA 18,DOMINGO, TELEMADRID, 20:00 horas

'AISLADOS'

Unas gotas de perfume, un resto de detergente en la ropa, la polución que se respira en un atasco de tráfico, un tomate cultivado con fertilizantes... cualquiera de estas causas puede provocar una grave crisis en un paciente del Síndrome de Sensibilidad Química Múltiple (SQM); se trata de una enfermedad de reciente descubrimiento para la cual no existe una cura definitiva; sus efectos sólo pueden paliarse con una solución extrema: el aislamiento. Treinta Minutos ha querido adentrarse esta semana en la vida de varias personas que, padeciendo SQM u otras patologías en las cuales el medio ambiente les resulta hostil e incluso letal, han tenido que recurrir a un aislamiento radical respecto al mundo exterior. El reportaje "Aislados" es la crónica de sus vidas y de su lucha por recuperar la normalidad y su calidad de vida.

A decision on Hemispherx BioPharma’s new drug application for Ampligen, twice delayed by the FDA earlier this year, is still in limbo.

William A. Carter, CEO of the Center City biotech company, said last week the company is responding to issues raised by the Food and Drug Administration during its review of Ampligen, an experimental treatment for chronic fatigue syndrome.

Hemispherx has spent more than $500 million and more than three decades developing the drug.

Carter last week provided an update on the status of the FDA’s review of Ampligen to BioMedReports, a Web site that provides information on life sciences firms.

“We continue to be in contact with the [FDA] concerning certain requests they have made over the last year that have to do with toxicology,” Carter said. “This is nonclinical work on the drug. We have continued to complete reports and we expect to sometime this quarter, the fourth quarter, complete a set of requirements [from the FDA] that have to do with preclinical toxicology.”

In its latest quarterly report filed with the Securities and Exchange Commission, Hemispherx noted it is working with the Lovelace Respiratory Research Institute in Albuquerque, N.M., on animal toxic studies in support of its Ampligen application.

The August filing noted the studies were requested by the FDA and that the studies were “substantially completed,” with summary reports issued to the agency during the third quarter.

“Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010,” the company stated in the filing.

Carter told BioMedReports the FDA has also “done a number of audits” of the company’s clinical sites and manufacturing facility during the past 12 months.

“The clinical inspections resulted in no findings that required [major] corrective action by the company,” he said, adding that the agency did note compliance issues at its facility in New Brunswick and at a contract facility in Spokane, Wash.

The manufacturing plant in Spokane is where Ampligen is packaged.

Carter said over this past summer the company addressed the FDA’s compliance issues at its New Jersey facility and submitted a report to the agency for review. He said the company expects to complete remediation efforts at the Spokane facility within the next several weeks.

“Until all those reports are completed and filed, the agency can withhold a final decision on the commercialization of the product,” said Carter.

Earlier this week, the company announced the discovery of a novel retrovirus in chronic fatigue syndrome patients.

A study published in the Oct. 8 issue of Science Express by a consortium of researchers found a new retrovirus in the blood cells of 67 percent of chronic fatigue syndrome patients and in 3.7 percent of healthy control subjects.

Hemispherx is collaborating with the Whittemore Peterson Institute, in Reno, Nev., to evaluate the potential role of Ampligen in the clinical treatment of chronic fatigue syndrome patients who have a specific immune deficiency in cell activity.

The company plans to provide an update on its programs targeting the disorder at a November Health and Human Services Chronic Fatigue Syndrome Advisory Committee meeting in Washington, D.C.

A new study conducted in Germany contradicts at least two earlier studies by finding no link between prostate tumors and a virus that had been found in some tumors. University of Utah researchers recently reported that they found traces of a virus called xenotropic murine leukemia virus-related virus, or XMRV, in more than quarter of human prostate tumors, particularly those that are most aggressive. Antibodies against the virus have also been found in as many as 95% of patients with chronic fatigue syndrome, suggesting that the mysterious virus, discovered only three years ago, may be at the root of several diseases of unknown etiology.

German researchers led by Dr. Reinhard Kurth and Dr. Norbert Bannert of the Robert Koch Institute in Berlin studied 589 prostate tumor samples collected in Germany. They reported today in the journal Retrovirology that they found no traces of the virus in any of the samples. Bannert suggested that "a possible geographic restriction of XMRV and its association with prostate cancer should be studied closely" -- in other words, that it may cause the disease in some places but not in others.

Readers Ask: A Virus Linked to Chronic Fatigue Syndrome

En esta sección del NYT, LA DOCTORA NANCY G. KLIMAS DA RESPUESTAS A LOS LECTORES SOBRE ESTE ASUNTO. MUY INTERESANTES Y ACLARATORIAS OPINIONES DE UNA GRAN EXPERTA EN SINDROME DE FATIGA CRONICA.

LINK: ARTICULO