Taking pills with food, grapefruit juice may be promising way to cut prescription costs for cancer patients

New studies reveal a promising new ways to keep prescription drug costs down for cancer patients — and it could be just as easy as taking pills on a full stomach rather than an empty one as prescribed.

In general, patients who are advised to take drugs on an empty stomach are done so because it helps physicians better predict effects without having to worry about multiple variables. However, new clinical studies have revealed that certain drugs that are taken with food could be found at much higher blood levels than they are when taken on an empty stomach. Also, some drugs may be more effective at lower doses when taken with grapefruit juice by taking advantage of changes in blood composition. Changes like these can help save patients $1700 or more on their costly cancer drug costs.

From The New Scientist:

The approach, which might also work for other drugs, is based on the fact that certain foods can delay the breakdown of medications in the body. Doctors stress, however, that people should not yet attempt this cost-cutting method until studies demonstrate its safety. In general, taking pills with food against the label’s advice can lead to an overdose. For this reason, pharmaceutical companies must provide the US Food and Drug Administration (FDA) with information on how eating a meal can influence the absorption of their products.

While physician researchers warn patients not to experiment with their own drug routines before further studies are made, they hope that these recent studies help create cheaper cancer treatment alternatives for patients.

               

Multiple Sclerosis Drug Combined with Lipitor May Stop or Reverse Disease - Dosages Cut in Half with Fewer Negative Side Effects

March 16th 2006

Combining treatments may improve outcomes for patients with Multiple Sclerosis (MS), according to research done on mice and published online by the Journal of Clinical Investigation. Scott S. Zamvil and colleagues at the University of California, San Francisco found that mice treated with a combination of Glatiramer acetate (GA) and atorvastatin (Lipitor) demonstrated “a significant prevention and reversal of clinical MS severity” of MS symptoms.

Lipitor is a cholesterol lowering drug that has previously been shown to improve MS symptoms. Glatiramer acetate (Teva Pharmaceutical Industries Ltd.’s Copaxone) is a drug currently approved for MS treatment. The researchers found that treating MS with combinations of immune modulating drugs can greatly reduce MS disease.

According to the researchers, treating EAE (experimental autoimmune encephalomyelitis) mice with the combination therapy caused the animals to lose less myelin, prevented CNS inflammation, and MS disease incidence.

The researchers then treated isolated inflammatory cells called macrophages with these drugs and found that the combination therapy mediated its effects by promoting the secretion of the anti-inflammatory molecule IL-10 and suppressed production of the proinflammatory molecules IL-12 and TNF-alpha.

The researchers believe that the combined delivery of drugs, which act through different mechanisms, may enhance the therapeutic efficacy of MS and reduce the negative side effects. Also the drug dosages were less than the dosages used in regular single drug treatments.

Copaxone has been shown to be 30 to 35 percent effective alone. According to Bloomberg News, all MS drugs have to be injected, and have “severe side effects”. None of the MS drugs are very potent.

Lipitor on the other hand can be taken orally and is considered relatively safe. Lipitor, the best selling drug in the world, appears to block production of immune system agents, called cytokines, involved in the disease process. Currently the University of California, San Francisco is looking for 152 patients at 14 hospitals to participate in clinical trials. These trials will investigate the effect Lipitor alone has on MS. Contact the office of Scott Zamvil, associate professor of neurology at University of California, San Francisco, for more information.

There are 400,000 MS sufferers in the US. The illness causes neurological symptoms that include loss of motor control, blindness and temporary recurring paralysis. The condition occur when the body’s natural defenses are over stimulated and begin stripping the protective insulation, called myelin, from nerve fibers in the central nervous system, which includes the brain, optic nerves and spinal cord.

Dan Wilson
Best Syndication

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Copyright 2005 Best Syndication
Last Updated Thursday, March 16, 2006 06:07 PM

               

FDA Advisers Endorse Return of Multiple Sclerosis Drug

03.08.06, 12:00 AM ET

WEDNESDAY, March 8 (HealthDay News) — A U.S. Food and Drug Administration advisory panel voted unanimously Wednesday to allow the promising but controversial multiple sclerosis drug Tysabri back on the market.

The advisers continued to discuss certain controls on who could use the drug, which has been linked to a rare but potentially fatal brain infection. The panel members agreed to a manufacturer plan for a mandatory patient registry; they were scheduled to decide later in the day who would be allowed to enroll in the registry, and how tightly drug use would be limited, the Associated Press reported.

While the full FDA generally follows the recommendations of its advisory panels, it is not required to do so. The agency is expected to render its final decision on the drug by the end of the month.

Physicians and MS patients alike were heartened by the decision, which came during the second day of two days of deliberations.

“Tysabri is a very important step forward despite the fact that there are some concerns and limitations concerning its safety, but the safety risk at the moment, in the range of about one in 1,000, is probably well worth taking for patients with more severe or unstable disease,” said Dr. Joseph Herbert, director of the Multiple Sclerosis Care Center and chief of neurology at New York University/Hospital for Joint Diseases in New York City.

“Patients with rapidly progressive or aggressive MS are probably at far greater risk because of the disease than they are from a potential rare side effect of the drug,” Herbert said.

MS patient and attorney Karen Miller, 49, told the committee that Tysabri “is as close as it comes” to a miracle drug. Miller credited the drug with a renewed ability to ride her bike, wash her windows and run daily errands, the AP said.

“I am at the end of my road, in terms of what I can take. I want it to be my choice,” another MS patient, Barbara Crooks, 48, told the news service.

Tysabri’s manufacturers, Biogen Idec Inc. and Elan Corp, pulled the drug off the market in February 2005 after three patients taking it developed progressive multifocal leucoencephalopathy (PML), a progressive, neurodegenerative disease. Two of those patients died.

The removal took place just three months after the FDA had granted accelerated approval of the drug for the treatment of relapsing forms of MS.

In February, the FDA announced that Biogen and Elan could resume clinical trials for MS patients who were previously treated with the drug under an investigational study.

According to the National Institute of Neurological Disorders and Stroke, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling to devastating. Most MS patients experience their first symptoms between the ages of 20 and 40, and most suffer muscle weakness in their extremities and difficulty with coordination and balance. These symptoms may be bad enough to hamper walking or even standing; in worst cases, MS can produce partial or complete paralysis.

Tysabri is a monoclonal antibody, engineered to attach itself to white blood cells called lymphocytes and prevent them from entering the brain, where they do damage that causes the disabling symptoms of MS. Tysabri had also been used to treat Crohn’s disease.

One of the biggest issues in bringing the drug back to market is what kind of risk-management plan should be implemented. An initial plan submitted to the FDA by the manufacturers was considered insufficient.

“There’s no question with this kind of essentially lethal risk that there is going to have to be some kind of risk-management program,” Dr. Robert Temple, director of the FDA’s Center for Drug Evaluation and Research, said at a Tuesday news conference.

Other features of a risk-management plan could include restrictions on who gets the drug, administering the drug at a registered infusion center, and monitoring all patients on the drug for at least five years. The drug may be restricted only to individuals with more severe forms of the disease, patients who have failed other therapies, and patients who are not taking other immunosuppressants.

“The three cases that did develop PML were all patients who were on other immune modulator drugs,” Herbert noted. “If we use Tysabri judiciously and as a monotherapy, it is possible that the risk will turn out to be lower than we imagine.”

Tysabri is only the second prescription drug to be returned to the market after being taken off. The other was Lotronex, used for irritable bowel syndrome, which was withdrawn in 2000 but allowed back on the market two years later.

“Lotronex was a unique drug with value for some people,” Temple said. “The drugs that disappear permanently tend to be drugs that tend to have substitutes.”

More information

Find out more about Tysabri at the U.S. Food and Drug Administration.

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Genetic Technologies Reports Breakthrough in the Genetic Basis of Drug Addiction

3/14/2006 9:24:00 AM EST

Genetic Technologies Limited (”GTG”) (Nasdaq:GENE) (ASX:GTG) is pleased to refer to a “breaking news” item released in London yesterday by BBC News. BBC reported a significant breakthrough had been made in understanding the genetic basis of cocaine addiction, quoting a scientific paper just published online by the prestigious Proceedings of the National Academy of Science (”PNAS”).

The report announced a genetic variation had been identified which could significantly increase the risk of an individual developing cocaine addiction or dependence. The discovery also validates the logic of a new basis for the design and use of novel drugs to treat cocaine abuse in the future.

The BBC article stated that this research was funded by the British Medical Research Council.

What is especially relevant to GTG stockholders is that this research was in fact co-funded by GTG, that the genetic variations identified by this project are non-coding, that new patents have just been filed on the relevance of these genetic variations to cocaine addition and that GTG has secured world-wide exclusive rights to commercialize these new discoveries. Indeed, this whole project arose from the foresight of King’s College London, who took a license to the GTG non-coding patents in 2004.

This project is yet another example of the original GTG non-coding patents today spawning new research, new discoveries and new patents and creating new opportunities for GTG into the future.

By way of further background information, the UN Office for Drug Control estimates the number of illegal drug users now exceeds 150 million worldwide. However, other studies suggest this is an under-estimate. Until now, the global pharmaceutical industry has not made treatment of substance abuse a priority. The current market is estimated to exceed US$1.1 billion, and is expected to grow to US$1.3 billion by 2008. Industry experts see this market as having great potential. It is also an area where fundamental patents are likely to prove extremely valuable, especially when combined with new genetic testing methods (genotyping), which will permit cheap and efficient whole genome scanning for susceptibility to cocaine addition.

About Genetic Technologies Limited

Genetic Technologies was an early pioneer in recognizing important new applications for “non-coding” DNA (DeoxyriboNucleic Acid). The Company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all multicellular species. Its three-pronged business strategy includes: 1) the global commercialization of its patents through an active licensing program; 2) the expansion of its dominant commercial genetic testing business in Australia; and, 3) the commercialization of its various research and development projects aimed at generating further intellectual property of global commercial significance.

This announcement may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Genetic Technologies Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as “should,” “expects,” “anticipates,” “estimates,” “believes” or similar expressions, as they relate to Genetic Technologies Limited, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Genetic Technologies’ current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations.

CONTACT:
Genetic Technologies Limited Dr. Mervyn Jacobson or Tom Howitt, +61-3-9415-1135 tom.howitt@gtg.com.au www.gtg.com.au or Investor Relations Contacts: Lippert/Heilshorn & Associates Kim Sutton Golodetz / Lisa Lindberg, 212-838-3777 kgolodetz@lhai.com / llindberg@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com www.lhai.com

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© 2006 Genetic Engineering News, All Rights Reserved