DNA targeting could pinpoint early cancers or deliver radiotherapy straight to the tumor. U.K. researchers have found a way to test for a protein that could become a biomarker for many different types of cancer. The DNA damage-signaling protein, γH2AX (gamma-H2AX), signposts the points where both strands of the DNA double helix have broken, one of the first steps in development of cancer (known as tumorigenesis).
 
The team from Oxford University's Gray Institute for Radiation Oncology and Biology has built an imaging probe that targets this protein. The  probe is in three parts--an anti-γH2AX antibody that targets the biomarker, a  peptide (TAT) that penetrates the cell, and 111In, a radioactive marker used as an imaging agent.
 
To test out the concept, the researchers used the probe and SPECT imaging to find DNA damage in a type of genetically modified mice that tend to develop breast cancer lumps that can be felt after around 17 weeks. The test  spotted potential cancers in mice up to 5 weeks before they developed these  lumps. The same marker is also seen in lung, skin, kidney and bladder cancer. 
 
Katherine Vallis of the institute told BBC News: "If larger studies confirm this, the protein could provide a new route to detect cancer at its very earliest stage--when it is easier to treat successfully."

As well as being a biomarker for many cancers, this finding could also lead to a way to deliver radiotherapy directly to the damaged cells and monitor its effects, treating established tumors or even heading off cancers almost before they start. As Vallis explained to BBC News, the system is "self-amplifying" because the radiotherapy will cause further damage to the cells, therefore attracting more antibodies that will deliver more radiation, eventually killing the cancer cells. However, the technology has only been studied in mice so far, and it is a long way off use in  humans.

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data.
 
Misoprostol May Be As Effective As Oxytocin In Speeding Labor For Women With Inadequate Contractions.
"Titrated oral doses of misoprostol (Cytotec) may be as effective as intravenous oxytocin in speeding labor in women who have inadequate contractions, according to" a study published in J. Obstetrics & Gynecology. Taiwanese researchers found that in "a randomized trial of more than 200 Chinese women, the median times from treatment to vaginal delivery were virtually identical at 5.2 hours whether oral misoprostol or intravenous oxytocin was used." They also noted that there "were also no differences in adverse effects and birth outcomes, allaying concerns that oral misoprostol might not be as safe as intravenous oxytocin." 

Trastuzumab May Help Extend Stomach Cancer Patients' Survival By Nearly Three Months.
Patients with HER2-positive advanced gastric cancer might benefit from a drug produced by Roche Holding AG. “Use of the drug trastuzumab in addition to chemotherapy can extend stomach cancer patients' survival by nearly three months," researchers in Seoul found after evaluating "584 patients at 122 centers in 24" nations. The "addition of trastuzumab to standard cisplatin/fluoropyrimidine chemotherapy resulted in a median survival of 13.8 months, compared with 11.1 months for patients who received chemotherapy alone -- a 26 percent difference." But, an editorial accompanying The Lancet paper questions the cost-effectiveness of that treatment.  

"In the 24 countries that contributed to the study, yearly health expenditure per citizen varies from $40 (£25) to $5,500, which reiterates the important moral question -- what is the justification for introducing a treatment that might enable one individual to live a few months longer, but will consume, for each person treated, the total yearly health expenditure for scores of their fellow citizens?" 

Breast Cancer Drug Fulvestrant Appears More Effective In The Presence Of CK8 And CK18.
Women’s responsiveness to the second-line breast cancer drug fulvestrant may depend on whether the cancer cells are expressing two key proteins, Indiana University Bloomington scientists report in this month’s Cancer Biology & Therapy.

Fulvestrant appeared to exert maximum anti-cancer effects in vitro when cells produced normal or elevated quantities of the cytokeratins CK8 and CK18, structural proteins that help give the nucleus its shape.  

For fulvestrant to work well, the cells must also be responsive to estrogen, and producing the estrogen receptor ER-alpha. ER-alpha’s importance to fulvestrant’s anti-estrogenic action had been established in previous reports. The present study confirms fulvestrant’s binding relationship to ER-alpha, while also showing two other proteins, cytokeratins 8 and 18, can strongly enhance fulvestrant’s anti-estrogenic activity. Testing for the presence of these three proteins, and perhaps many others, could help doctors decide whether fulvestrant should be prescribed to their patients.

Eprotirome May Lower Cholesterol Levels Without Feared Side Effects Of Thyroid-Based Drugs.
"A thyroid-derived cholesterol-lowering drug," called eprotirome, "that could be an alternative to the widely used statin medications has done well in a small, early trial, Swedish and American researchers report." For the 12-week trial, various doses of eprotirome "were added to statin treatment for 168 people whose high levels of LDL cholesterol had not been lowered by previous use of statins," and the combination was found to "lower cholesterol levels" and "did not cause the feared side effects...that have plagued similar thyroid-based treatments." Eprotirome, which is still several years away from the market, is unlikely to replace statins. 

Third Study Shows Bisphosphonates May Cut Risk Of Breast Cancer.
According to a study appearing in the British Journal of Cancer, researchers "found a reduction in the risk for breast cancer among postmenopausal women taking bisphosphonates for the treatment of osteoporosis." The study showed that "the use of bisphosphonates was associated with a 30% reduction in the risk for breast cancer." The findings back results "reported in two other studies." Still, researchers remain unclear "how bisphosphonates could prevent breast cancer." 

Intravitreous Dexamethasone Effective Treatment For DME.
According to a study published in the Archives of Ophthalmology, "intravitreous treatment with dexamethasone is well tolerated and significantly improves visual acuity in patients with persistent diabetic macular edema (DME)." In a trial in which 315 DME patients were randomized to intravitreous "dexamethasone 700 µg (n=105) or 350 µg (n=105) to one eye, or observation (n=105)," researchers found that "at day 90, a BCVA improvement of 10 letters or more was seen in 33.3%, 21.1%, and 12.3% of the dexamethasone 700 µg, 350 µg, and observation groups, respectively."  

Anti-TNF Therapy For Psoriatic Arthritis May Improve Physical Disability, Quality Of Life.
According to a study published in the March issue of Arthritis Care & Research, "treatment with anti-tumor necrosis factor (TNF) agents can significantly improve physical disability and quality of life for patients with psoriatic arthritis." In a study of 596 patients, researchers found that "at six months, patients undergoing anti-TNF therapy had improved on the physical component scale of the Short Form (SF)-36 health survey instrument from a mean score of 19.1 to a mean of 29.3." In addition, scores "on the mental component scale...had risen from a mean of 41.7 to 48.8." Anti-TNF therapy drugs included in the study were etanercept, infliximab, and adalimumab. 

Combination Therapy For Some Alzheimer's Patients May Help Ease Caregiver Distress.
According to research presented at a geriatric psychiatry meeting, "caregiver distress is significantly attenuated when patients with moderate to severe Alzheimer's disease (AD) are treated with a combination of extended-release memantine plus a cholinesterase inhibitor (ChEI) vs. ChEI monotherapy." Researchers came to this conclusion after randomizing "335 patients with a diagnosis of probable AD who had been undergoing stable ChEI therapy for at least three months...to extended-release memantine, 28 mg daily, and another 342 patients" to placebo, then following them for 24 weeks.

Quetiapine Associated With More Rapid Onset Of Metabolic Disturbances In Elderly Patients.
According to a study presented at a geriatric psychiatry meeting, "the antipsychotic quetiapine (Seroquel, AstraZeneca) is associated with a more rapid onset of metabolic disturbances than other antipsychotics in elderly patients with no baseline metabolic abnormalities before treatment initiation." In a study of 231 outpatients aged 70 and older treated for "psychosis, depression, bipolar disorders, or dementia," researchers found that "time to onset of hyperglycemia was significantly shorter among patients treated with quetiapine at 17.5 months, compared with patients who were treated with olanzapine at 32.6 months or risperidone at 36.3 months." 

References:
http://www.medscape.com/viewarticle/718261
http://www.medpagetoday.com/OBGYN/Pregnancy/21833
http://online.wsj.com/article/BT-CO-20100819-715016.html
http://consumer.healthday.com/Article.asp?AID=642267
http://www.guardian.co.uk/society/2010/aug/20/price-cancer-drug-herceptin
http://newsinfo.iu.edu/news/page/normal/13738.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

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The Wall Street Journal reported that the FDA proposed to remove brand and generic versions of low-blood pressure drug ProAmatine (midodrine hydrochloride) from the market because required post-marketing studies on the drug's effectiveness have yet to be conducted. The drug was approved under the FDA's accelerated approval program, and according to the Journal, this is the first time the agency is requesting a drug to be removed from the market because a company failed to conduct the follow-up studies that are required.  

Patients who use midodrine should stop taking it and consult their doctors about other types of anti-hypotension treatment, the FDA said in a statement." Norman Stockbridge, an FDA official said, "Since, evidence to confirm the drug's benefit has not be yet provided to the FDA, it is pursuing a withdrawal of the product." Shire "has been given 15 days to respond in writing or lose its right to appeal. Makers of the generic versions of the drug were given 30 days."  

The FDA "letter does not cite any safety or effectiveness problems with the drug, and suggests the action is primarily aimed at enforcing drug approval regulations that have not always been enforced." The drug was approved to treat "orthostatic hypotension." 

Malaria sufferers might be able to protect themselves against life-threatening bouts of the disease by taking a single course of antibiotics, research in mice has shown.
Preventive treatment with 'needle-free' antibiotic vaccines could be used to control the infection in areas with high levels of transmission, a study published in Science Translational Medicine suggests. There are still no available vaccines against malaria. And although some antibiotics with anti-malarial properties, such as doxycycline, that kill the parasites directly are already in use as one-off, short-term prophylaxis, their prolonged use is not an option for millions of people in the developing world where malaria is endemic. 

Now, azithromycin and clindamycin, two common antibiotics, have been shown to provide additional and long-term protection against malaria, even after they are no longer taken. 

"The combination of the prophylactic effect with the subsequent immune-mediated protection may be enough to protect population groups at risk, such as infants and young children, from severe forms of malaria," according to Steffen Borrmann, a lead author of the study and parasitologist at the Kenya Medical Research Institute, told SciDev.Net.

The team treated mice with the antibiotics before infecting them with malaria. After taking the drugs, the mice developed vaccine-like immunity lasting at least 40 days, and almost all were protected from complications that are often lethal.

It is still not clear how long the immunity would last in humans, but Borrmann told SciDev.Net that "life-long would be the ultimate goal but we would be happy to achieve 1-2 year protection, [to last] during the most critical years in early childhood in high transmission areas". 

The antibiotics work by causing small cavities in malaria parasites during their passage into the liver of the infected host. This stops the parasites from entering the blood stream, giving time for the immune system to launch a sustained defence against the parasites.This mode of action is similar to experimental vaccines that use weakened whole parasites to elicit an immune response. The tested antibiotics are available as safe, generic drugs and there are no patent issues preventing their use in clinical trials or in clinical practise. But they would likely not work in areas with low transmission levels since the degree of immunity to subsequent infections depends on the quantity of malarial parasites already infecting the patient.

Oral Contraceptives May Reduce Risk Of Death From Any Cause In Women.
"Women who have taken the Pill at any stage in their life are less likely to die from any cause -- including heart disease and all types of cancer -- than those who have never taken the oral contraceptive," according to research published online in the British Medical Journal. The study of "more than 46,000 women...revealed a slightly higher risk of dying among under-45s." 

But, the slightly increased risk in younger women disappears within 10 years of stopping the pill. Researchers calculated that "there were 52 fewer deaths per 100,000 'women years' -- a composite measure of the number of women and the lengths of their lives -- among all women who had ever used the pill compared with those who had never used it. The effects may only be true for women who have taken older-style pills rather than those on newer type drugs." In younger women, "the effects...were also mainly seen in those who smoked, had high blood pressure, or were otherwise at risk of heart disease." "Women on the pill did have higher rates of violent and accidental death, through the researchers said they couldn't explain the findings." Notably, "the risk was seen in earlier analyses of the data, and has persisted through the years.
 
Hormonal Contraceptives May Not Be Effective In Overweight Or Obese Women.
Hormonal contraceptives may not be effective for contraception in overweight or obese women," according to a review published online in the Cochrane Database of Systematic Reviews. After performing a literature review encompassing "11 trials enrolling a total of 39,531 women," researchers found that "pregnancy risk for overweight or obese women was higher in one of three studies using BMI." In fact, "compared with women with a BMI of less than 25 kg/m2, women with a BMI of 25 kg/m2 or more had higher risk for pregnancy in this trial of two combination oral contraceptives."  

Osteoporosis drug linked to irregular heart beat.
Women who take popular osteoporosis drug alendronate, known more commonly as Fosamax, are twice as likely to develop a common form of irregular heartbeat compared to those who have never taken it, suggests a new study published in the journal Archives of Internal Medicine.   

Researchers analyzed data from more than 700 women who had been diagnosed with atrial fibrillation, or irregular heartbeat, in a three-year period and compared them to a control group of more than 900 randomly selected women. They found a nearly two-fold increase in risk for developing atrial fibrillation among those women who had ever taken alendronate.

The findings were compiled by researchers from Group Health and the University of Washington by analyzing records of patients enrolled in Group Health, a Seattle-based non-profit health-care centre. Alendronate is part of a family of drugs known as bisphosphonates, which are widely used to protect against bone loss and prevent bone fracture in osteoporosis patients. However, the researchers did not find a difference in risk among those who had taken Fosamax in the past versus current users. “We do not conclude that the risk is higher for past use than current use. We conclude that the risk is higher for ever use than for never use, which was our original hypothesis,” reported lead study author Dr. Susan Heckbert, a professor of epidemiology and scientific investigator in the cardiovascular health research unit at the University of Washington.  

Heckbert stated that the next step would be for scientists to investigate the mechanism for how alendronate may influence the onset of atrial fibrillation. Marlene Gauthier, manager of public affairs for Merck Frosst Canada, responded to the findings by saying that a clinical trial, rather than an observational study such as this one, is the best way to evaluate a drug’s benefits and risks. 

“While observational analyses are usually conducted in as rigorous a manner as possible, they are associated with inherent limitations, including factors that cannot be adequately controlled for and an ability to fully account for differences in risk factors between groups. this underscores why data from randomized, controlled clinical trials are considered to be the most reliable source of information about the efficacy and safety of medicines.” The statement continued: “We strongly recommend that if patients have concerns about Fosamax that they talk to their physician. Osteoporosis is a serious medical condition and requires appropriate treatment with physician oversight. Their physician is in the best position to understand the needs of the patient and explain the benefits and risks of any given therapy to the patient.” 

“This is an observational study. It is not as strong a design as a clinical trial,” Heckbert acknowledged.

“But on the other hand, it does represent what’s happening in actual clinical medicine.” Heckbert stated that her team knew of previous study findings that suggested a link between bisphosphonates and an increased risk for atrial fibrillation. In fact, in the United States there are more than 400 cases pending against Merck in both state and federal court, in which people who have taken Fosamax claim that the drug has contributed to the development of osteonecrosis of the jaw. This happens when bone tissue dies after it loses its blood supply, and can occur after trauma to the bone, such as a dental procedure.

However, Heckbert warned that patients who take alendronate should not stop taking it due to her study’s findings. If individuals are concerned they should speak with their physician or their health-care provider. For patients who are at high risk of fracture, the benefits of alendronate or other bisphosphonates will generally outweigh the risk of atrial fibrillation.” 

References:

http://online.wsj.com/article/SB10001424052748704868604575433703888376436.html
http://www.google.com/hostednews/afp/article/ALeqM5gX0oxFR_ZpHn-RyPL8JkXqWD4PNg
http://www.usatoday.com/news/health/2010-08-16-fda-unproven-drug_N.htm
http://www.medpagetoday.com/ProductAlert/Prescriptions/21699
http://www.latimes.com/health/boostershots/la-heb-hypotension-drug-20100816,0,53066.story?track=rss
http://www.startribune.com/business/100813309.html?elr=KArks8c7PaP3E77K_3c::D3aDhUMEaPc:E7_ec7PaP3iUiD3aPc:_Yyc:aU7DYaGEP7vDEh7P:DiUs
http://www.bizjournals.com/philadelphia/stories/2010/08/16/daily8.html
http://www.theheart.org/article/1110411.do
http://www.medscape.com/viewarticle/725103
http://www.ncbi.nlm.nih.gov/pubmed/20614470?dopt=Abstract
http://stm.sciencemag.org/content/2/40/40ra49.full?ijkey=OAfu5Q9bUdH4Q&keytype=ref&siteid=scitransmed
http://www.pharm-education.com/2010/08/malaria-sufferers-might-be-able-to.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
Do you have questions for the author? 

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.  Shruti brings to you 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." 

References-

http://www.nytimes.com/2010/08/01/opinion/01kristof.html?src=mv
http://www.dailymail.co.uk/health/article-1300484/MRSA-E-Coli-treated-new-breed-antibiotics.html http://www.bloomberg.com/news/2010-08-04/glaxo-antibiotic-finding-looms-large-in-drug-market-with-few-new-products.html http://www.nytimes.com/2010/07/31/health/research/31stem.html?_r=1&ref=us
http://www.google.com/hostednews/ap/article/ALeqM5gON1ck-mYcLt7R0U9XC_71Lzo1LQD9H9HQB80
http://online.wsj.com/article/SB10001424052748703999304575399312648917190.html
http://www.bloomberg.com/news/2010-07-30/geron-cleared-by-fda-to-test-embryonic-stem-cell-treatment-shares-climb.html
http://pagingdrgupta.blogs.cnn.com/2010/07/30/landmark-embryonic-stem-cell-study-to-proceed/
http://content.usatoday.com/communities/sciencefair/post/2010/07/stem-cell-spinal-cord-injury-clinical-trial-human-fda/1
http://www.ft.com/cms/s/322baf24-9c01-11df-a7a4-00144feab49a,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2Fs%2F0%2F322baf24-9c01-11df-a7a4-00144feab49a.html%3Fftcamp%3Drss&_i_referer=http%3A%2F%2Fsn129w.snt129.mail.live.com%2Fmail%2FInboxLight.aspx%3Fn%3D757275366&ftcamp=rss
http://www.politicsdaily.com/2010/07/30/fda-oks-embryonic-stem-cell-trials-for-humans/
http://www.pharm-education.com/2010/08/scientists-create-new-family-of-super.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10