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Innovative Treatment Approach Offers New Hope For Eczema Sufferers With Moderate To Severe Disease
Today sees the European launch of the first topical calcineurin inhibitor to be approved for the maintenance treatment of eczema to prevent flares and prolong flare-free intervals. PROTOPIC ointment (tacrolimus monohydrate) is already licensed to treat moderate and severe eczema (atopic dermatitis), often involving the treatment of flares as and when they occur.* It is now also approved for twice-weekly application to previously affected skin to prevent these exacerbations and prolong flare-free periods in PROTOPIC-responsive patients.ò€  Clinical studies have shown that this new approach brings significant benefits with over 40% of patients with moderate to severe eczema remaining flare-free for at least a year.1 Flares are known to place an enormous burden on patients. The International Study of Life with Atopic Eczema (ISOLATE) found that about 55% of these patients worried about the onset of their next exacerbation and that they spent on average over a third of the year (136 days) with their eczema in flare.2
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Pluristem Therapeutics Receives European Regulatory Approval For Placental-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company"s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company"s Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world"s "first-in-man" clinical trial using PLX-PAD.
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Views Sought On European Regulation On Biocides
Views are being sought on European proposals for a revised regime for regulating the placing on the market and use of biocides.
Cardiovascular

Dietary Supplements With Steroids Pose Health Danger: Case Studies

Three cases of patients suffering from the adverse affects of steroid-enriched dietary supplements have been reported by researchers at Henry Ford Hospital. The cases, which include patients with liver injury and renal failure, are discussed in the current issue of The Journal of Clinical Gastroenterology. The U.S. Food and Drug Administration last week issued a warning regarding the use of over-the-counter body-building supplements that are illegally enriched with anabolic steroids. "To date, reports of any deleterious health consequences of purportedly low doses of steroids in dietary supplements are scant but our published cases highlight the potential health consequences of using these supplements, with unwitting subjects becoming the victims," says lead author Stuart C. Gordon, M.D., Division of Gastroenterology and Hepatology at Henry Ford Hospital. The cases of three otherwise healthy adult males, ages 21 to 38, were reported with symptoms including nausea, anorexia, jaundice, severe itching and renal failure. * A 21-year-old previously healthy white male presented with nausea, anorexia, jaundice, and severe itching. He denied alcohol consumption or illicit drug use and took no prescription medications on a regular basis but did acknowledge use of the over-the-counter supplement Superdrol, a bodybuilding agent containing methasteron, for several months before his presentation. He had purchased this compound over the internet, and he discontinued taking the supplement at the onset of his symptoms. * A previously healthy 30-year-old white businessman initially presented to a hospital with a 5-week history of jaundice and severe itching. His medications included omeprazole and herbal supplements including chondroitin sulfate, glucosamine, glutamine, and creatine. He also acknowledged the use of a bodybuilding supplement that contained dehydroepiandrosterone. Concerned about his symptoms, he stopped consuming this supplement just before his hospitalization. * A 38-year-old previously healthy white man initially presented for evaluation of jaundice. He first noticed the onset of scleral icterus 6 weeks previously. His symptoms included intense and worsening itching, generalized fatigue, nausea, decreased energy, and weight loss. His past history was unremarkable. He denied alcohol or illicit drug use and used no prescription medications. Owing to worsening of his symptoms and renal failure, he was admitted to the hospital. The three cases outlined in the article now bring the total of cases reported in the last year to six. "Anabolic steroids have long been known to cause liver damage, but what is not widely known is that over-the-counter health food supplements may actually contain these compounds," says Dr. Gordon. "The buyer of these compounds likely has no idea that he is ingesting these agents, even after reading the small print on the label." Stuart C. Gordon, Division of Gastroenterology and Hepatology, Henry Ford Hospital, is available for interviews. Prolonged intrahepatic cholestasis and renal failure secondary to anabolic androgenic steroid-enriched dietary supplements. Krishnan PV, Feng ZZ, Gordon SC. J Clin Gastroenterol. 2009 Aug;43(7):672-5. Maria Seyrig Henry Ford Health System


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