Jul 30, 2009

UCB Receives CHMP Positive Opinion On Keppra(R) For Infants And Young Children With Partial-onset Epilepsy

UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grant marketing authorisation for Keppra® as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years.

The CHMP decision is based on the results of a Phase III, double-blind, randomised, multi-centre, placebo-controlled study evaluating the efficacy and tolerability of Keppra® oral solution (20-50 mg/kg/day) in 116 paediatric patients with refractory partial-onset seizures, aged from one month to under four years. Infants and children in this study were experiencing partial-onset seizures with or without secondary generalisation that were inadequately controlled despite treatment with one or two other antiepileptic drugs.

"This is the first well-controlled study providing information on the efficacy and tolerability of levetiracetam in infants and young children with inadequately controlled partial-onset seizures. The results of this study suggest that levetiracetam will be a valuable new treatment option in very young patients with partial-onset epilepsy." said Associate Professor Jesus Eric Pina-Garza, Children's Hospital at Vanderbilt, Nashville, Tennessee, U.S.

In this clinical trial Keppra® was shown to significantly reduce the frequency of partial-onset seizures with 43.1% of Keppra®-treated patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients (p=0.013). Keppra® was generally well-tolerated in this paediatric population. The most commonly reported treatment-emergent adverse events (>5%) that occurred more frequently in the Keppra® group were somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0% for placebo).

"For parents of very young children with partial-onset seizures that are poorly controlled with their current medication, the CHMP positive opinion is encouraging news. We look forward to the final determination of the European Commission and extending the availability of Keppra® as adjunctive therapy to children from one month to under four years with partial-onset seizures", said Troy Cox, President, CNS Operations, UCB.

Since its first launch in 1999, an innovative research and clinical trials programme has enabled Keppra® to realise its potential as a broad spectrum antiepileptic drug. As a result, it is available for a range of seizure types and in a range of formulations (250 mg, 500 mg, 750 mg and 1 000 mg tablets, 100 mg/ml oral solution and 100 mg/ml concentrate for solution for infusion, an alternative for patients when oral administration is temporarily not feasible.

In Europe Keppra® is approved as:

- Monotherapy in the treatment of partial-onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy

- Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults and children from four years of age with epilepsy

- Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

- Adjunctive therapy for the treatment of primary generalised tonic clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy

Keppra® provided the foundation for UCB's growing epilepsy franchise which has now been extended to include Vimpat® (lacosamide) which is marketed in Europe as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older and in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy, aged 17 years and older. In the U.S. Vimpat® is a Schedule V controlled substance. Also, in the U.S. in 2008, Keppra® XR was approved as an add-on to other antiepileptic treatments for people with partial-onset seizures aged 16 years of age and over.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting 50 million people worldwide. It is caused by abnormal, excessive electrical discharges of the nerve cells or neurons in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes and effective classification guides treatment and prognosis.

About Keppra® in Europe

Keppra® film coated tablets were first approved Europe in 2000 as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Since this time, Keppra® has received several additional indications.

Important U.S. Keppra® Safety Information

Keppra® tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age or older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Keppra® tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, and coordination difficulties, as well as hematological abnormalities. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, asthenia, infection and dizziness. In patients 12 years of age and older experiencing myoclonic seizures with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older experiencing PGTC seizures with idiopathic generalized epilepsy, the most common adverse event associated with Keppra® in combination with other AEDs was nasopharyngitis.

Keppra® injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy, myoclonic seizures in adults with JME, and PGTC seizures in adults with idiopathic generalized epilepsy. Keppra® injection is an alternative for patients when oral administration is temporarily not feasible. The adverse events that result from Keppra® injection use include all of those associated with Keppra® tablets and oral solution. Keppra® XR extended-release tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Keppra XR™ causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra® XR in combination with other AEDs were somnolence and irritability. The adverse reactions that may be seen in patients receiving Keppra® XR are expected to be similar to those seen in patients receiving immediate-release Keppra® tablets. Keppra® XR should be gradually withdrawn to minimize the potential of increased seizure frequency.

For all Keppra® formulations, dosing must be individualized according to the patient's renal function status. In patients with end-stage renal disease on dialysis, it is recommended that immediate-release Keppra® be used instead of Keppra XR™.

Please see http://www.Keppra.com for U.S. full prescribing information and Medication Guide. Please see http://www.keppraxr.com for U.S. full prescribing information and Medication Guide.

Important U.S. Vimpat®safety information

Vimpat® (lacosamide C-V) is a medicine that is used with other medicines to treat partial onset seizures in patients 17 years of age and older with epilepsy. Vimpat® is generally well-tolerated, but may not be for everyone. Patients should discuss with their doctor if Vimpat® is right for them.

The most common side effects with Vimpat® are dizziness, headache, nausea and double vision. Vimpat® may also cause problems with coordination and balance. Patients should not drive, operate machinery or do other dangerous activities until they know how Vimpat® affects them. Patients should not stop taking Vimpat® without first talking to their doctor. Stopping Vimpat® suddenly can cause serious problems. Vimpat® could make patients feel faint. Patients should tell their doctor if they have a heart condition or if they are taking other medicines that affect the heart. In rare cases, Vimpat® may cause reactions that could affect the heart, liver or kidney. The patient should contact their doctor immediately if they are tired, have jaundice (yellowing of skin or eyes), and have dark urine. Antiepileptic drugs, including Vimpat®, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare provider right away if they have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self harm that they have never had before or may be worse than before. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 866-822-0068 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see additional patient information including the Vimpat® Medication Guide at the end of the full prescribing information on http://www.Vimpat.com

Source
UCB

Jul 25, 2009

News From The Journals Of The American Society For Microbiology

"Single-Shot" Vaccines May Protect Against H5N1 Influenza Virus

Two newly developed "single-shot" H5N1 influenza vaccines protected ferrets against lethal infection with the H5N1 influenza virus and may allow for mass vaccination in humans in the event of a pandemic outbreak. The researchers from Australia report their findings in the August 2009 issue of the Journal of Virology.

As the highly infectious H5N1 influenza A virus continues to persist in bird populations and infect humans through poultry, concerns of a pandemic outbreak remain high. Although human-to-human transmission has remained limited, the fatality rate among those reported human cases is greater than 60%. The threat that the virus will mutate and achieve efficient human-to-human spread emphasizes the need for effective preventative therapies.

Vaccination is considered the optimal method for controlling an influenza pandemic. Vaccines must be rapidly available to reach mass populations and they must include the minimal antigen dose (substance that promotes the generation of antibodies) to result in full immunity. The use of adjuvants (substances to improve the immune response) in vaccine development may lower the antigen dose required and ultimately ease the demand on vaccine supply during a pandemic.

Clinical trials on prepandemic vaccines containing adjuvant suggested that two injections were necessary to induce protective immunity. In this study researchers first inoculated ferrets twice with two H5N1 influenza virus adjuvant vaccines (Iscomatrix and AIPO4) and observed for protective efficacy following a lethal challenge with the H5N1 virus. Results showed that ferrets were completely protected against death and disease for at least 15 months. More significantly, a secondary study found that both adjuvant vaccines also protected ferrets from death following only a single inoculation. Specifically, ferrets receiving a single shot of the Iscomatrix adjuvant vaccine displayed fewer signs of infection and remained highly active.

"Our data provide the first indication that in the event of a future influenza pandemic, effective mass vaccination may be achievable with a low-dose 'single shot' vaccine and provide not only increased survival but also significant reduction in disease severity," say the researchers.

(D. Middleton, S. Rockman, M. Pearse, I. Barr, S. Lowther, J. Klippel, D. Ryan, L. Brown. 2009. Evaluation of vaccines for H5N1 influenza virus in ferrets reveals the potential for protective single-shot immunization. Journal of Virology, 83. 15: 7770-7778.)

Infection-Causing Amoeba May be Resistant to Multiple Contact Lens Solutions

A new study suggests that some contact lens solutions do not properly disinfect against Acanthamoeba, a free-living organism in the environment that can cause a painful vision-threatening infection. The researchers from the Centers for Disease Control and Prevention, Public Health Service, and the U.S. Department of Health and Human Services, Atlanta, Georgia, report their findings in the July 2009 issue of the Journal of Clinical Microbiology.

Acanthamoeba are found in a variety of environmental sources including soil, freshwater, brackish water and seawater, as well as hot tubs and Jacuzzis. The species is associated with many different human diseases such as central nervous system infections and Acanthamoeba keratitis (AK), an infection of the cornea that can ultimately lead to blindness. 85% of AK cases in the United States are attributed to contact lens wear, with some specific risk factors being improper contact lens care and contact with nonsterile water during wear.

Insufficient anti-Acanthamoeba activity in Advanced Medical Optics Complete MoisturePlus multipurpose contact lens solution was brought to attention following a recent multistate outbreak of AK. While investigating that outbreak, researchers also compared the effectiveness of 11 other contact lens solutions against cysts of Acanthamoeba castellanii, Acanthamoeba polyphaga, and Acanthamoeba hatchetti, all of which were sample specimens collected during the outbreak. Results indicated that only the two contact lens solutions containing hydrogen peroxide showed any disinfection ability against A. castellanii and A. polyphaga after 6 or 24 hours. No significant disinfection efficacy was noted among the 11 solutions against A. hatchetti.

"The prevention of future cases of AK will require contact lens solutions that are effective against Acanthamoeba species and continued emphasis on proper lens care hygiene," say the researchers. "Educating contact lens wearers about the risk factors for AK, including the improper use of contact lens solutions, is important; but a systematic method for evaluating contact lens solutions will reduce the chance that inefficacious solutions are available."

(S.P. Johnston, R. Sriram, Y. Ovarnstrom, S. Roy, J. Verani, J. Yoder, S. Lorick, J. Roberts, M.J. Beach, G. Visvesvara. 2009. Resistance of Acanthamoeba cysts to disinfection in multiple contact lens solutions. Journal of Clinical Microbiology, 47. 7: 2040-2045.)

New DNA Vaccine Inhibits Deadly Skin Cancer in Mice

A new DNA vaccine inhibited malignant melanoma, a deadly form of skin cancer, in mice by eliciting antibodies that target a gastrin-releasing peptide which is known to play a key role in cancer development. The researchers from China and the U.S. report their findings in the July 2009 issue of the journal Clinical and Vaccine Immunology.

Gastrin-releasing peptide (GRP) is an important human peptide that regulates gastric acid secretion and motor function as well as elicits gastrin release. Previous research has shown that GRP plays a significant role in human cancers through atypical expression of the GRP receptor and GRP binding that activates cellular signaling and results in increased cell production and tumor formation. Anti-GRP antibodies have displayed promising antitumoral activity and DNA vaccines targeting GRP are a hopeful therapeutic approach.

In the study researchers developed a novel anti-GRP DNA vaccine including various immunoadjuvants (substances to improve the immune response) and monitored anti-GRP antibody levels in vaccinated mice. Intramuscular injections induced high levels of specific antibodies against GRP as well as suppressed the growth of melanoma cells. Additionally, researchers intravenously injected cells in the lungs and found that cells were highly diminished indicating that the vaccine may also inhibit cancer from spreading.

"In conclusion, we have demonstrated for the first time that immune responses which are elicited by a novel anti-GRP DNA vaccine suppress the proliferation and growth of melanoma tumors in mice," say the researchers. "The antiangiogenesis and antimetastastic activities of this DNA vaccine suggest a novel approach against various cancers, especially malignant melanoma."

(J. Fang, Y. Lu, K. Ouyang, G. Wu, H. Zhang, Y. Liu, Y. Chen, M. Lin, H. Wang, L. Jin, R. Cao, R.S. Roque, L. Zong, J. Liu, T. Li. 2009. Specific antibodies elicited by a novel DNA vaccine targeting gastrin-releasing peptide inhibit murine melanoma growth in vitro. Clinical and Vaccine Immunology, 16. 7: 1033-1039.)

Source:
Carrie Slijepcevic
American Society for Microbiology

Jul 24, 2009

What Is Amoxicillin? What Does Amoxicillin Treat?

Amoxicillin - better known by brand names such as Amoxil, Dispermox, Trimox, and Alphamox - is an antibiotic drug in the penicillin group that fights bacteria and bacterial infections.

Like other antibiotics in the penicillin category, amoxiciillin does not kill bacteria but rather prevents bacteria from forming walls that surround them, which are necessary for bacteria to multiply and survive.

Amoxicillin is only intended to treat bacterial infections and is not known to be effective against viral infections.

Since the patent for amoxicillin has expired, the drug is available as a generic in the form of several brand names.
What conditions are treated with amoxicillin?
Amoxicillin is prescribed to treat infections due to specific strains of common bacteria such as Streptococci, E. coli, Staphylococcus, H. pylori, P. mirabilis, H. influenzae, N. gonorrhoeae, and S. pneumoniae. These bacteria cause the following diseases:

* Infections of the middle ear, nose and throat
* Infections of the tonsils, throat, and larynx (laryngitis)
* Infections of the bronchi (bronchitis) and lungs (pneumonia)
* Urinary tract infections
* Infections of the skin
* Gonorrhea

Amoxicillin may also be prescribed to reduce the risk of duodenal ulcer recurrence in the gastrointestinal tract or to prevent an infection after surgery.
How is amoxicillin taken?
Amoxicillin is available in capsules, tablets, chewable tablets, powder for oral suspension, drops for oral suspension, and intravenous use. It can be taken with or without food. It is important to take amoxicillin for the entire length of time prescribed by your doctor even if symptoms get better before the prescription is finished. This will increase the effectiveness of immediate treatment and will decrease the likelihood that the bacteria will develop a resistance to the medicine.

Patients who miss a dose of amoxicillin should take the missed dose as soon as he or she remembers. If the time for the next dose is approaching, skip the missed dose and take the next dose at the scheduled time. Taking extra medicine to make up for the missed dose is dangerous. It is possible to overdose on amoxicillin, and emergency medical attention may be required.

Often, amoxicillin is combined with lansoprazole or with lansoprazole and clarithromycin to treat certain infections.
What are the side effects of amoxicillin?
Do not take amoxicillin if you are allergic to it or related drugs in the penicillin family such as ampicillin, carbenicillin, dicloxacillin, and oxacillin. In addition, amoxicillin use can result in dangerous complications if you have an allergy to drugs called cephalosporins, asthma, liver or kidney disease, a blood clotting disorder, mononeucleosis, or any other type of allergy.

Severe allergic reactions to amoxicillin will present hives, difficulty breathing, and swelling in the face, lips, tongue, or throat. Other side effects associated with amoxicillin include:

* Diarrhea
* Fever
* Chills
* Dizziness
* Heartburn
* Insomnia
* Nausea and vomiting
* Itching
* Confusion
* Abdominal pain
* Easy bruising
* Bleeding
* Rash
* Allergic reactions
* Urinating less than usual or not at all
* Seizure
* Vaginal itching or discharge
* Thrush (white patches in the mouth)

What drugs should not be taken with amoxicillin?
Amoxicillin is rarely associated with important drug interactions. However, women on birth control pills who use amoxicillin may become pregnant due to a reduction in effectiveness of the birth control. Drugs such as methotrexate, probenecid, sulfa drugs, other antibiotics, and tetracycline antibiotics also may interact with amoxicillin. In addition, antibiotics such as amoxicillin may cause diarrhea. Do not use any medicines to stop the diarrhea unless directed by your doctor. If the diarrhea is watery or bloody, contact your physician.

Disclaimer: This is a brief overview of a very complicated drug that has several indications, directions, warnings, and side effects. This document in no way reflects all of the benefits or dangers of amoxicillin. Always discuss treatments with a physician and follow your doctor's orders.

Written by Peter Crosta M.A.
View drug information on Amoxil; Clarithromycin.
Copyright: Medical News Today

Jul 15, 2009

New Technique May Lead To More Efficient Treatment Of Brain Cancer

For patients with brain cancer, treatment options - and ultimately survival rates - are limited by the inability of most anti-cancer drugs to cross the blood-brain barrier, a natural cluster of cells that prevents toxic substances from reaching the brain.

In a study published this month by the Journal of Neuro-Oncology, a team of researchers from UNLV, Nevada Cancer Institute and University of California, Irvine reveal the effectiveness of photochemical internalization (PCI), a promising new technique that allows for targeted chemotherapeutic treatment of brain tumor cells by selectively opening the blood-brain barrier. The study, though years away from human clinical trials, is the first step toward addressing an issue that has stymied advancements in brain cancer treatment for decades.

In many cases, malignant brain tumors recur close to where they are surgically removed; 80 percent of the time they recur within a few centimeters of their site of origin.

According to Steen Madsen, UNLV Health Physics professor and one of the lead investigators on the study, current techniques to disrupt the blood-brain barrier inadvertently expose the entire brain to other potentially harmful toxins. PCI, on the other hand, allows for targeted disruption of the barrier by combining light activated drugs, or photosensitizers, with drugs known to disrupt the blood-brain barrier. This limits the flow of harmful toxins and paves the way for chemotherapy to reach the brain more efficiently.

"PCI is different than many current cancer treatment approaches in that it addresses the blood-brain barrier issue by delivering therapeutic agents to targeted areas of the brain," said Madsen. "This targeted delivery could make PCI potentially useful as a treatment not only for brain cancer but for a variety of neurological conditions, such as Alzheimer's and Parkinson's diseases."

In PCI, photosensitizers are injected into the patient. This is followed by an injection of a drug known to disrupt the blood-brain barrier. The photosensitizers surround the drug molecules and prevent them from infiltrating the entire brain. Then, a specific wavelength of light therapy is focused on the target area, activating the photosensitizers and releasing the barrier-busting molecules. With the barrier now selectively, yet temporarily, opened, chemotherapy can be administered to the targeted areas.

To test the effectiveness of chemotherapy treatment combined with PCI, researchers used rats segmented into three groups; one receiving PCI and chemotherapy, one receiving traditional chemotherapy treatment without PCI, and one receiving no treatment. Of the group administered PCI and chemotherapy, more than 60 percent survived more than 70 days, far surpassing either of the other two groups. The findings suggest that, under the appropriate conditions, PCI is a promising method to selectively disrupt the blood-brain barrier for treatment.

Researchers note that while PCI-aided delivery of chemotherapy to the brain has proven effective in laboratory tests, additional testing prior to human clinical trials is needed to identify other less-toxic blood-brain barrier agents to be used in tandem with the photosensitizer in the PCI process.

The study was funded through the Nevada Cancer Institute's Collaborative Grant Program and appeared in the Online First section of the Journal of Neuro-Oncology: http://bit.ly/wyff6. Participating in the study with Madsen were Henry Hirschberg, UNLV health physics adjunct professor and research professor with the University of California, Irvine's Beckman Laser Institute; UNLV graduate researchers Michelle Zhang and David Chighvinadze; Michael Gach from Nevada Cancer Institute; Francisco Uzal from the University of California, Davis; Qian Peng from the Norwegian Radium Hospital; and Chung Ho-Sun of the University of California, Irvine.

Source
University of Nevada

Dramatic Drop In Deaths From Most Common Cancers

The death toll from three of the UK's most common cancers has dropped to its lowest level for almost 40 years* - according to new figures released by Cancer Research UK.

Mortality rates for breast, bowel, and male lung cancer** are at their lowest since 1971 even though more than 100,000 people are now diagnosed with these kinds of cancers every year.

Breast cancer deaths peaked in 1989 with 15,625 women dying from the disease. The latest figures for 2007 show that figure has dropped to 11,990 which is equivalent to a drop in mortality rates of 36 per cent.

Bowel cancer deaths peaked in 1992 with 19,598 men and women dying from the disease. In 2007 16,007 died - equivalent to a drop in mortality rates of 31 per cent.

And the number of men dying from lung cancer peaked in 1979 at 30,391 but dropped to 19,637 in 2007 - a drop in mortality rates of 53 per cent.

Although more people are getting cancer because the population is living longer, Cancer Research UK believes that fewer are dying from the disease because new and better treatments and screening are making a real difference. And deaths from lung cancer have been falling as more people give up smoking.

While the new figures show that great progress is being made in the battle to beat cancer, there is still much more to be done. And that is the theme of the charity's new national TV advertising campaign launching on Sunday July 12th to improve awareness of the disease and to raise money for further research.

Appearing in the TV advertisement is Audrey Williams - a 50 year old artist and mother of two from Streatham in London who was diagnosed with breast cancer in 2002.

"I just feel so lucky to be here," she said. "I want everyone to know that more and more people are surviving cancer thanks to the work being done by Cancer Research UK. I found a lump in my breast when I was having a shower. After a mastectomy I had reconstruction but my body rejected the implants. It was a difficult time but I think it helps to stay cheerful and to try and keep your sense of humour to get through.

"The important thing about the TV advertisement is that we aren't actors; we are all real people who have gone through cancer and we can reach out to others and tell anyone who is worrying about symptoms to make that trip to the doctor because if they do have cancer the chances of surviving it are greater than ever."

Harpal Kumar, chief executive of Cancer Research UK, said: "Years of research are behind the dramatic progress being made in the fight against Britain's common cancers. Survival rates have doubled in the last thirty years and the work of Cancer Research UK has been at the heart of that progress.

"Our research is behind 19 of the top 20 drugs used to treat cancer patients worldwide today. Our work has underpinned the huge progress we are now seeing in preventing more deaths from lung cancer. And our progress over decades has helped to develop radiotherapy as a major form of treatment for half of all cancer patients.

"But research is expensive and - because we rely completely on donations from the public - we can only continue this vital work with people's support."

Scientists at Cancer Research UK have been responsible for vital discoveries in the quest to understand how cancer develops and how best to treat the disease.

Cancer Research UK funded large trials that proved the benefits of tamoxifen for breast cancer patients and other trials have shown how to prevent the disease in high risk post-menopausal women. In 1995, the charity showed that two X-rays were better than one in detecting more breast cancers and reducing recall rates. This contributed to a widespread change in clinical practice with two-view mammography now used by all the national screening centres.

The charity's laboratory work is behind many life-saving drugs, such as Herceptin, which has given hope to thousands of women with a particular type of breast cancer. Early work on aromatase inhibitors paved the way for anastrozole, a new gold standard of care for the most common type of breast cancer.

Cancer Research UK scientists contributed to key trials of the drug capecitabine, used to treat both bowel and breast cancer. And they showed that Taxol is an effective treatment for breast cancer; it is now also used for advanced lung cancer.

Cancer Research UK has also made a series of breakthroughs pinpointing new regions of the genome linked to breast, bowel, prostate, lung and brain cancer as well as funding more than 100 clinical trials in the UK at any time.

The charity's chief scientist, Professor Sir David Lane, discovered the p53 protein which is faulty in many cancers and this paved the way for many treatments being tested in clinical trials today.

Cancer Research UK scientists helped to develop the drug cisplatin and later discovered carboplatin which has fewer side effects than cisplatin and is widely used in treating ovarian, lung and head and neck cancers.

Temozolomide, now used worldwide to treat the most common form of brain cancer, is another drug discovered in the charity's laboratories and developed through early clinical trials.

Notes

*UK figures routinely collated by Cancer Research UK since 1971

Breast cancer deaths in women were 12,472 (rate = 37.5 per 100,000 women) in 1971; 15,625 (rate = 41.6) at the peak in 1989; and 11,990 (rate = 26.7) in 2007.

Bowel cancer deaths were 18,110 (rate = 28.9 per 100,000 persons) in 1971; 19,598 (rate = 25.5) at the peak in 1992; and 16,007 (rate = 17.7) in 2007.

Male lung cancer deaths were 28,395 (rate = 106.9 per 100,000 men) in 1971; 30,391 (rate = 108.5) at the peak in 1979; and 19,637 (rate = 51.5) in 2007.

**Lung cancer mortality rates in women under 75 increased by seven per cent over the last 30 years but have fallen by four per cent in the last 10 years.

The difference in lung cancer trends between men and women reflect variations in past smoking behaviour.

Source
Cancer Research UK

Jul 6, 2009

Smoking More Than Five Cigarettes A Day Provokes Migraine Attacks

Tobacco acts as a precipitating factor for headaches, specifically migraines. This is indicated in a study which shows that smokers have more migraine attacks and that smoking more than five cigarettes a day triggers this headache. The work has appeared in The Journal of Headache and Pain.

The influence of tobacco as a precipitating, non-causal factor of migraine attacks has produced contradictory data in scientific literature. The limited research prior to the work published in The Journal of Headache and Pain indicated that smoking could improve migraines by reducing anxiety, one of the factors that triggers an attack.

"This study is groundbreaking in Spain as there are few studies on this topic, and all are very biased. This is due to the complexity and need for prior training of the participants", Julio Pascual, one of the authors of this research and doctor at the Neurology Unit of Marqués de Valdecilla, University Hospital (Santander), explains to SINC.

One advantage of this study is that the sample used, 361 medicine students from the University of Salamanca, were fully aware what a migraine was. The experts, who enquired about the presence or absence of migraine (and its characteristics) and whether or not they smoked, guaranteed the reliability of the results obtained, as most surveys for this type of study are done over the phone, randomly and in people without knowledge of the illness.

The results show that 16% of students fulfilled migraine criteria, while 20% smoked. The percentage of smokers was higher (29%) in those who were also migraine sufferers and migraine frequency in those students who were migraine sufferers and smokers was clearly higher than in those who were non-smokers and migraine sufferers.

According to Pascual, "smoking is a precipitating factor of this type of headache, as the prevalence of active smokers is one third higher in migraine sufferers and there is a direct relationship between the number of cigarettes consumed and the frequency of migraine attacks".

The researchers stressed the importance of the dosage. The results of the interviews reveal that the migraine sets in after five daily cigarettes. Furthermore, although the percentage of those who smoked was higher in people with migraines, they smoked less than those who did not suffer migraines.

"This is because they themselves knew that if they exceeded five cigarettes a day, they were more likely to have a migraine attack. The pain itself acts as a limiting factor", explains the neurologist, who maintains that "in no case should a migraine sufferer be advised to smoke thinking that it is going to improve their migraines. What's more, if you smoke a lot you should reduce the dose drastically".

90% of affected people self-medicate

"The supposed migraine cure ends up becoming its cause because of self-medication". Feliu Titus, an honorary member of the Spanish Neurological Society, explained last May in the paper Migraine treatment. The role of non-pharmacological methods, in Barcelona.

In Spain, this illness affects five million people and 2% of the population suffers attacks for more than 15 days a month. According to Titus, "more than 20% have never consulted a specialist". 90% of migraine sufferers self-medicate, without being aware of the risk that this entails. Anyone who suffers from migraines and abuses drugs ends up suffering adverse effects and a worsening of the illness due to a "rebound effect", according to specialists.

Chronic headaches are a separate illness and one of the most frequent chronic diseases. Although the causes are still not clear, in some migraine cases it is already demonstrated that there is a genetic basis. In fact, most patients with migraines have a history of it in their family.

"Nowadays it is believed that migraines are a state of hyperexcitability of the neurons that control headaches. Migraine sufferers are born with ion channels in the membrane of the neurons which are much more permeable and excitable. The brain of migraine sufferers is therefore able to link an attack with precipitating stimuli such as tobacco", Julio Pascual concludes.

To a large extent, the cause of this hyperexcitability has a genetic basis. In fact, some specific mutations are already known to be responsible for the hyperexcitabilty of these membrane ion channels.

Source: Plataforma SINC

Jul 3, 2009

Light Therapy Offers New Hope For Breast Cancer Patients

A groundbreaking non-invasive breast cancer treatment will be unveiled at this year's Royal Society Summer Science Exhibition . Scientists led by world-renowned breast cancer expert, Mr Mo Keshtgar, are the first to use photodynamic therapy (PDT) to treat what is now the most common cancer in the UK.*

PDT uses light to destroy cancer cells, doing away with the need for invasive surgery, and possibly offering an alternative to radiotherapy in some cases. PDT works by giving the patient a drug that makes the target area sensitive to light. The drug is activated when light - a low power red laser - is beamed at the area. The process starves the cells of oxygen, causing them to die.

Trials will be conducted at London's Royal Free Hospital, where Mr Keshtgar has been working with a technical and scientific team that includes Professor Stephen Bown of the National Medical Laser Centre, University College London and Professor Tayyeba Hasan of Harvard Medical School, Boston USA.

Mr Keshtgar says:

"The key appeal of photodynamic therapy is that it attacks and destroys cancer cells while retaining the viability of the surrounding normal cells. Breast cancer can be particularly traumatic, with more invasive treatments leaving physical and emotional scars. Our treatment will keep the structure of the connective tissue intact meaning the breast does not become deformed or lose shape."

The treatment is already available for skin cancer (non-melanoma), mouth cancer, and some other cancers. But the team is the first to apply it to breast cancer. Trials are also underway with PDT for prostate and bile duct and pancreatic cancer.

The team will be exhibiting an array of breast cancer tools used and developed by clinicians and researchers at the Royal Free, UCL and University College Hospital, including an award-winning elastic scattering spectroscopy (ESS) scanner.

ESS is an optical diagnostic technique which uses light to diagnose cancer in the lymph glands of breast cancer patients. The lymph glands drain and filter fluids from all parts of the body. The first lymph gland in the armpit to receive breast fluid from cancer is called the sentinel lymph node (SLN).

Mr Keshtgar says:

"Using the ESS scanner, we will be able to identify cancer in the SLN during operations and avoid second surgeries as well as further psychological trauma to patients. It will also have significant costs benefits to the NHS. We're literally diagnosing cancer by shining flashes of light."

The Royal Society Summer Science Exhibition, which opens to the public at 10.00hrs today (Tuesday 30 June), showcases cutting edge research in science and engineering from across the UK. It runs until Saturday 4 July and is free and open to the public. The Exhibition is held annually at the Royal Society, the UK's national academy of science.

Source
Royal Society Summer Science Exhibition

New MRI Technique Could Mean Fewer Breast Biopsies In High-Risk Women

A University of Wisconsin-Madison biomedical engineer and colleagues have developed a method that, applied in MRI scans of the breast, could spare some women with increased breast cancer risk the pain and stress of having to endure a biopsy of a questionable lump or lesion.

The universal technology will give radiologists greater confidence in visually classifying a lesion as malignant or benign.

The American Cancer Society recommends that women with certain breast cancer risk factors including inherited genetic mutations, family or personal history of breast cancer, or previous radiation therapy to the chest receive an annual MRI screening in addition to their yearly mammogram.

During a breast MRI, which lasts about a half hour, the technician injects a contrast agent into a vein in the patient's arm. Over time, the contrast agent flows throughout the body, including the breasts. Because they are growing quickly, cancerous lesions often have immature vasculature, and the contrast agent flows in and "leaks" out quickly. Conversely, benign lesions show more gradual in and out flow.

"The tricky ones are the ones that enhance quickly and then fall off more slowly," says Wally Block, a UW-Madison associate professor of biomedical engineering and medical physics. "Many of these lesions turn out to be difficult to classify and lead to biopsy."

Yet, it turns out that with the right kind of MRI scan, radiologists can visually identify a cancerous lesion based on characteristics about its shape. For example, breaks or interruptions in a lesion can indicate a benign fibroadenoma. Lumps with smooth edges often are benign, while those with jagged edges can signal cancer.

To generate the kind of crisp, three-dimensional images necessary for such a diagnosis, Block, UW-Madison radiology associate professor Fred Kelcz and graduate student Catherine Moran are capitalizing on their unique MRI data-acquisition method.

An MR image is made up of thousands of smaller pieces of information. The conventional data-acquisition method gathers that information slowly, and it's designed to be viewed from a single imaging plane. "What people do now is they compromise," says Block. "They don't get resolution in the other planes to make it a reasonable scan time. We found a way around that."

With the team's powerful technique, an MRI machine acquires data radially and generates a high-resolution, three-dimensional image that radiologists can turn, slice and view from many perspectives enabling them to study a lesion's physical characteristics more carefully. Machines equipped with the technique also acquire more data in less time.

In addition, the method also makes it possible for radiologists to view fat images and water images separately, which is particularly useful because fat composes a large portion of the breast. "Rarely is disease associated with fat," says Block. "Most of the time radiologists are concentrating on water images, but sometimes our fat images of the breast are also useful. The boundaries of a lesion often stand out very clearly when embedded in fat."

Block and his colleagues currently are gathering data on the efficacy of the technique. They have tested the method on 20 patients at the University of Wisconsin Hospital and have shared it with colleagues at the University of Toronto for additional assessment. They also are working with Michigan State University researchers to test the technique.

Collaborating with Scott Reeder, a UW-Madison assistant professor of biomedical engineering and radiology, Block and colleagues also are refining ways to image both breasts simultaneously a development that could slash scan time and free valuable MRI space for additional patients. "If you have a screening procedure that you want people to participate in regularly, you want to make it convenient for them," says Block.

Funding from the Walter H. Coulter Translational Research Partnership in biomedical engineering at UW-Madison supported the research, as well as grants and in-kind support from GE Healthcare. In addition to Block, Kelcz, Moran and Reeder, UW-Madison collaborators also include research scientist Alexey Samsonov and assistant researcher Ethan Brodsky.

Source: University of Wisconsin-Madison

Potential Mislead And Uselessness In Monitoring Bone Density In Older Women

A study published on bmj.com reports that monitoring bone mineral density in postmenopausal women taking osteoporosis drugs, such as bisphosphonates, is pointless and could be misleading. A major public health problem, osteoporosis particularly affects older women. Bone density drops after menopause because estrogen levels decline. Low bone mineral density importantly increases risk factor for fractures.

Several guidelines advise that is necessary to monitor bone mineral density in postmenopausal women. However, it is expensive and many experts argue that those screenings fail to show how patients are responding to treatment.

Researchers from Australia and the USA evaluated the need for monitoring by studying the effects of the drug alendronate which is a widely used bisphosphonate. They looked at the variations between individuals.

They evaluated the data from the Fracture Intervention Trial (FIT), a large randomized trial that compared the effects of alendronate with placebo. The trial included over 6,000 postmenopausal women with low bone mineral density. There were measurements of the bone density of the hip and spine taken at the start of the study and every year for three years.

Results showed that after three years of therapy, 97.5 percent of the women treated with alendronate had a slight increase in hip bone mineral density. In addition, the effects of the treatment did not vary significantly between individuals. The authors explain that those results make the monitoring of individuals´ response to the treatment, useless.

Improving adherence to the treatment is another common motive to carry on with monitoring. But, the authors explain that most problems occur within three months of starting treatment, prior to the first measurement. There is indication that discussing problems with a healthcare professional a few months after starting treatment improves adherence.

The authors conclude that monitoring bone mineral density in postmenopausal women in the first three years after starting treatment with a bisphosphonate is unnecessary. It is wiser to avoid it because of the potential confusing information.

In an associated editorial, Juliet Compston, Professor of Bone Medicine at the University of Cambridge, writes that these findings reinforce the case against routine monitoring of bone mineral density during the first few years of treatment. The apparent allegation for clinical practice is that patients may be given improper advice if treatment is monitored by the changes in bone mineral density.

She writes in conclusion: "Routine monitoring of bone mineral density during the first few years of antiresorptive treatment cannot be justified because it may mislead patients, lead to inappropriate management decisions, and waste scarce healthcare resources."

Written by Stephanie Brunner (B.A.)

Patients With Rheumatoid Arthritis Who Had Poor Response To Other Drugs Could Have Better Results With Golimumab

An article published Online First and in this week's edition of reports information about Golimumab, a new tumour necrosis factor-α (TNF-α) inhibitor. It reduces the signs and symptoms of rheumatoid arthritis in patients who have previously received any other TNF-α inhibitor. This drug might be a good alternative for patients who have inadequate responses to one or two other TNF-α inhibitors.
Over three million people in Europe and about 1.3 million in the US are affected by rheumatoid arthritis which is a chronic inflammatory disease. TNF-α inhibitors are frequently used to treat rheumatoid arthritis. But thirty to fifty percent of the patients receiving these drugs are intolerant to the therapy or have an inadequate response. These patients are usually treated with more than one TNF-α inhibitor. Yet, no controlled trial has examined information to establish whether patients who do not respond to one TNF-α inhibitor might gain from switching to another.
In order to find out more, Josef Smolen and his team undertook the GO-AFTER trial. They assessed the safety and efficacy of golimumab in patients with active rheumatoid arthritis who had been treated earlier with one or more TNF-α inhibitor (such as etanercept, adalimumab, or infliximab).
There were in total 461 patients recruited from eighty-two sites in ten countries. They received at random injections of placebo (155), 50mg of golimumab (153), or 100mg of golimumab (153) every four weeks for twenty four weeks. After fourteen weeks, patients were assessed to evaluate if they had reached a 20 percent or superior improvement. The American College of Rheumatology criteria for assessment of rheumatoid arthritis (ACR 20) was used.
The results indicated that considerably more patients receiving golimumab had achieved at least a 20 percent improvement in arthritis symptoms (ACR 20) than those on placebo. At week fourteen, 35 percent of patients on 50mg of golimumab and 38 percent of patients on 100mg of golimumab achieved ACR 20. Only 18 percent of patients receiving placebo achieved ACR 20.

An important fact was that among the 58 percent of patients who had discontinued previous TNF-α inhibitor treatment due to lack of effectiveness, 36 percent on 50mg golimumab and 43 percent on 100mg golimumab achieved ACR 20. Only 18 percent of patients on placebo achieved ACR 20.

After twenty four weeks, there was record of serious adverse events in 5 percent (14) of patients on 50mg golimumab, 4 percent (8) on 100mg golimumab, and 10 percent (15) of patients on placebo.

The authors explain: "Golimumab reduces the signs and symptoms of active rheumatoid arthritis and improves physical function in patients who had previously received TNF-α inhibitors, which suggests that switching patients from one TNF-α inhibitor to golimumab is effective and generally well tolerated."

In an associated note Yusuf Yazici from NYU Hospital for Joint Diseases in New York debates if these findings will change the way rheumatoid arthritis patients are treated. He concludes: "For those patients who have failed or had an inadequate response to etanercept, infliximab, adalimumab, or abatacept, golimumab might be a good option."

Written by Stephanie Brunner (B.A.)