FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based Therapy.

8/6/2010

Here are some highlights from current pharma and clinical research news, views and data

FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based Therapy.
The USFDA has approved "the world's first authorized test in people of a therapy derived from human embryonic stem cells." The clinical trial "could offer the first glimpse of the safety and possible effectiveness of a technology that has been hailed for its vast medical promise but also embroiled in political and ethical controversy." The trial "will test cells developed by the Geron Corporation and the University of California, Irvine in patients with new spinal cord injuries." Geron "plans to enroll eight to 10 patients in the study at sites nationwide. The trial" for its GRNOPC1 therapy "will take about two years, with each patient being studied for one year."

The Wall Street Journal noted that Geron began the study in early 2009, but it was stopped due to concerns in an animal study showing an increased frequency of small cysts within the injury site. Thomas Okarma, Geron's president and chief executive officer, said the FDA's decision strengthens the company's ability to start similar trials in the future.

Scientists Create New Family Of "Super-Antibotics."
A new family of "'super-antibotics' capable of beating MRSA (Methicillin resistant Staph. aureus) and other deadly infections” reports a study published in the journal ‘Nature’. In tests, one of the drugs killed strains of the hospital superbug resistant to antibiotics already in use. Others were more than a match for other potentially lethal germs, including food poisoning bug E. coli, and acinetobacter, [which] is even harder to treat than MRSA." The drugs have been heralded as "an important step forward in the race against antibiotic resistance." The new drugs work in a similar way to quinolones. However, the new drugs attach to an enzyme needed for reproduction in a different place, "meaning they can kill bugs that are resistant."

New Antibiotic Designed To Circumvent Drug Resistance.
GlaxoSmithKline Plc, the UK's biggest drugmaker, said it has come up with a new antibiotic designed to circumvent the drug resistance that makes many hospital-acquired infections difficult to treat." Glaxo's new compound "latches onto topoisomerase, which helps bacteria produce proteins and replicate," according to the paper published in Nature. It "connects at a different location on the enzyme from existing drugs." Glaxo's "finding, still years from being commercialized, is significant" at a time "few pharmaceutical companies are producing new medicines to combat rising rates of drug-resistant infections in hospitals”.

Misoprostol May Revolutionize Abortion Around The World.
Researchers are finding an alternative" to abortions "that is safe, cheap, and very difficult for governments to restrict -- misoprostol." Misoprostol "pills are beginning to revolutionize abortion around the world, especially in poor countries." The drug "is very widely available and can't easily be banned, because it is also used for ulcers and can save lives of women with postpartum hemorrhages."

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