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© 2011, 2012 Health Futures Digest
The prospects for artificial blood look anaemic in light of apparently negative results of a clinical trial, though there remains some fight in the company that struggled for 20 years to develop the tested product.
A patent has been issued for a way to make nanoparticles for drug delivery.
A slew of new drug approaches to lupus, including several monoclonal antibody drugs, promise the first major advance in treatment in 50 years.
An implanted electrical stimulator appears to have partially repaired some of the nerve damage caused in a recent (within 18 days) spinal cord injury. It could soon be on the market under expefited FDA approval, and its maker is working to make the device effective in long-term SCI patients and in the peripheral nerves as well.
An anti-obesity chewing gum is in the works.
A drug that takes the fun out of drink and drugs seems possible. It could cure alcoholism and other drug addictions, and potentially over-eating as well.
A Phase III clinical trial of the experimental blood substitute Polyheme showed that it performed worse than standard treatments in patients who suffered traumatic injuries. A venture capitalist called it a “disaster” for Northfield, the company that developed the product over more than 20 years.
The company’s president said that the study’s data were “preliminary” and needed to be “reanalyzed,” noting that Polyheme worked better in a smaller patient population of the trial that was free of “discrepancies” and “protocol violations.” He said Northfield believed Polyheme still had benefits to patients and could win approval.
“Recently,” wrote Chicago Tribune reporter Bruce Japsen, “an FDA panel decided against endorsing a clinical trial of Biopure Corp.’s Hemopure blood substitute, the only other major contender in the market, because it was going to use the same disputed method of testing without the patient’s consent as Northfield did.”
In light of the trial results, the controversy over the use of non-consenting patients, and the FDA’s new caution following the Vioxx scandal, “It would be shocking to see the FDA even consider this,” the venture capitalist concluded.
University of Kentucky (UK) College of Pharmacy researchers have received a patent for “nanotemplate engineering,” a way to make nanoparticles for use in drugs and for other purposes. The process has been licensed to a UK for-profit spinoff in Kalamazoo, Michigan, to produce nanoparticles to deliver proteins, diagnostic agents, and other materials to specific tissues, cells and tumors.
“After a 50-year stretch without a major advance, there are finally some promising treatments on the horizon,” writes Heather Won Tesoriero in the Wall Street Journal . She is speaking of the disease lupus.
Her optimism is sparked by the recent initiation of the largest ever late-stage lupus trial of Lymphostat-B, following positive results in earlier testing; trials of rheumatoid arthritis drug Orencia to treat lupus; and late-stage trials of cancer drug Rituxan to treat lupus. Epratuzumab is also being developed as a potential lupus treatment.
Most of these drugs are monoclonal antibodies, which attempt to target the cells that contribute to the damaging antibodies. Orencia targets T-cells. Anti-organ-rejection treatment CellCept is also in trials for lupus nephritis. The drug Riquent, specifically developed to treat lupus nephritis, was found ineffective in early trials, but new trials are planned using bigger doses. The results of the current trials are likely a couple of years away.
Source articles 2 and 3 list lupus drugs in the pipeline, including their developers and trial status.
Implantable Stimulator for SCI Patients
Source: Advisory Board Technology Watch (subscription service), November 10, 2006.
A lipstick tube sized, battery-powered oscillating field stimulator (OFS) called Andara applies a rotating, low-voltage current of electricity to neural fibers surrounding the site of a spinal cord injury (SCI). In dogs, the device was shown to stimulate neural growth across the area and re-establish connections, which could restore sensory and motor function.
The device’s manufacturer, Cyberkinetics, has applied to the US Food and Drug Administration for market clearance under a Humanitarian Device Exemption, which allows distribution based on probable benefits standards rather than on proven effectiveness, based on promising animal trials and a 10-patient phase I human trial in which most patients (who had acute complete SCIs between the C5 and T10 vertebrae) saw improved light-touch sensation, pinprick sensation, and motor function after one year.
Researchers are now conducting pre-clinical animal trials to test OFS’s efficacy if implanted more than 18 days after the injury, in an effort to determine whether the use of Andara OFS in conjunction with neurotrophic factors—protein compounds that encourage neural tissue growth—could reverse the damage caused by acute SCI regardless of when the injury occurred. Human testing is expected to begin in 2007.
Researchers have also begun investigating OFS’s potential to treat peripheral nerve injury in the limbs; although a device for this utilization will likely have a different configuration than the Andara OFS system,
Imperial College London researchers are developing a drug that makes a person feel full. It could be available in injectible form in five to eight years, and in oral form (the researchers are considering as chewing gum) after that.
The drug mimics the effect of the natural gut hormone pancreatic polypeptide (PP), which the body produces after a meal to ensure eating does not run out of control. Some people appear to have more of the hormone than others. Becoming overweight reduces its natural level, which results in further over-eating, further weight gain, and less of the hormone – a vicious cycle.
Researchers at the Howard Florey Institute in Australia have found that blocking the action of the brain’s orexin system can prevent an alcoholic’s craving for a drink and might also help treat eating disorders. Orexin, present in the hypothalamus, is involved in creating the euphoric effects of alcohol and other drugs.
Rats that had alcohol freely available to them stopped drinking it after receiving the orexin blocker. Rats that had gone through a detox program and were then given the orexin blocking drug did not show any interest in alcohol when they were re-exposed to the kind of environment which they had been conditioned to associate with alcohol use.
There remains much more work to be done, but the research suggests that an orexin-blocker drug could one day be developed that would cure alcoholism and possibly eating disorders.
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