Compound makes imipenem 16 times more effective against antibiotic-resistant K. pneumoniae

North Carolina State University chemists have created a compound (see structure above - when used in conjunction with the antibiotic imipenem (below structure), increased the antibiotic's effectiveness against the antibiotic-resistant K. pneumoniae 16-fold. The researchers believe that these early results are very promising for future treatments.)  that makes existing antibiotics 16 times more effective against recently discovered antibiotic-resistant "superbugs." 

These so-called superbugs are actually bacterial strains that produce an enzyme known as New Delhi metallo-β-lactamase (NDM-1). Bacteria that produce this enzyme are practically impervious to antibiotics because NDM-1renders certain antibiotics unable to bind with their bacterial targets. Since NDM-1 is found in Gram-negative bacteria like K. pneumoniae, which causes pneumonia, urinary tract, and other common hospital-acquired infections, it is of particular concern. NC State chemist Dr. Christian Melander had found that a compound derived from a class of molecules known as 2-aminoimidazoles "recharged" existing antibiotics, making them effective against Gram-positive antibiotic-resistant bacteria like the Staphylococcus strain MRSA. So Melander, Worthington and graduate students Cynthia Bunders and Catherine Reed set to work on a variety of the compound that might prove similarly effective against their Gram-negative brethren.

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Prescription Shampoo (with Ivermectin) Approved to Treat Head Lice

In continuation of my update on ivermectin                                    

Sklice Lotion, a prescription-strength shampoo to treat head lice, has been approved by the U.S. Food and Drug Administration for people six months and older, the French product maker Sanofi said.

The shampoo contains ivermectin, which traditionally is prescribed in pill form to treat worm infections.   The product's safety and effectiveness were evaluated in clinical studies involving more than 780 people. After two weeks, most participants who had been lice infested did not require daily combing to remove lice eggs, the wire service reported.

The most common adverse reactions included eye infection and irritation, dandruff and dry skin.

Lice are small, blood-sucking insects that cause itching from the saliva they inject into the scalp and nearby areas to prevent premature clotting. Infestations are spread by direct contact or by shared use of brushes and other items that touch the scalp, such as pillows and hats.

Case Western Reserve University - One of the nation's top universities and the best college in Ohio

Neuroscientists at Case Western Reserve University School of Medicine have made a dramatic breakthrough in their efforts to find a cure for Alzheimer's disease. The researchers' findings, published in the journalScience, show that use of a drug in mice appears to quickly reverse the pathological, cognitive and memory deficits caused by the onset of Alzheimer's. The results point to the significant potential that the medication, bexarotene, has to help the roughly 5.4 million Americans suffering from the progressive brain disease. 

Bexarotene has been approved for the treatment of cancer by the U.S. Food and Drug Administration for more than a decade. These experiments explored whether the medication might also be used to help patients with Alzheimer's disease, and the results were more than promising. Landreth and his colleagues chose to explore the effectiveness of bexarotene for increasing ApoE expression. The elevation of brain ApoE levels, in turn, speeds the clearance of amyloid beta from the brain. Bexarotene acts by stimulating retinoid X receptors (RXR), which control how much ApoE is produced.

In particular, the researchers were struck by the speed with which bexarotene improved memory deficits and behavior even as it also acted to reverse the pathology of Alzheimer's disease. The present view of the scientific community is that small soluble forms of amyloid beta cause the memory impairments seen in animal models and humans with the disease. Within six hours of administering bexarotene, however, soluble amyloid levels fell by 25 percent; even more impressive, the effect lasted as long as three days. Finally, this shift was correlated with rapid improvement in a broad range of behaviors in three different mouse models of Alzheimer's.

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Case Western Reserve University - One of the nation's top universities and the best college in Ohio

Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol

The U.S. Food and Drug Administration (FDA) has approved Mitosol (mitomycin for solution) for use in glaucoma surgery.

"The approval of Mitosol for use in glaucoma surgery represents the culmination of more than five years of work on the part of Mobius Therapeutics," said Ed Timm, President of Mobius Therapeutics.

It will provide surgeons, hospitals, and patients with enhanced convenience, safety, and consistency in the surgical treatment of glaucoma. 


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FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis

The U.S. FDA approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. 

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “

The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development. 

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

Ref : http://investors.vrtx.com/releasedetail.cfm?ReleaseID=644158

Clazosentan reduces risk of blood vessel spasm in patients with brain aneurysm

Clazosentan reduces risk of blood vessel spasm in patients with brain aneurysm: An experimental drug, clazosentan, reduced the risk of blood vessel spasm in patients with a brain aneurysm, according to research presented at the American Stroke Association's International Stroke Conference 2012.

Genentech receives FDA approval for Vismodegib to treat skin cancer

In continuation of my update Vismdegib

Genentech receives FDA approval for Vismodegib to treat skin cancer: A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable accomplishment in new drug development.

Colchicine, another weapon against cancer

In continuation of my update on Colchine

 Colchicine, another weapon against cancer: Finding a drug that targets only the diseased cells in our body and is otherwise harmless to healthy tissue is a goal for cancer researchers. It's driven the work of Professor Laurence Patterson, Director of the Institute of Cancer Therapeutics at the University of Bradford, and his team of researchers.

Scientists discover new mechanisms by which RNA drugs can control gene activity

 In continuation of my update on RNAi

Short strands of nucleic acids, called small RNAs, can be used for targeted gene silencing, making them attractive drug candidates. These small RNAs block gene expression through multiple RNA interference (RNAi) pathways, including two newly discovered pathways in which small RNAs bind to Argonaute proteins or other forms of RNA present in the cell nucleus, such as long non-coding RNAs and pre-mRNA. 

Keith T. Gagnon, PhD, and David R. Corey, PhD, University of Texas Southwestern Medical Center, in Dallas, review common features shared by RNAi pathways for controlling gene expression and focus in detail on the potential for Argonaute-RNA complexes in gene regulation and other exciting new options for targeting emerging forms of non-coding RNAs and pre-mRNAs in the article "Argonaute and the Nuclear RNAs: New Pathways for RNA Mediated Control of Gene Expression." 

"The field of RNA mediated control of gene expression is rapidly evolving and the article by Gagnon and Corey provides a highly informative and up to date review of this exciting and often surprising area of biomedical research. We are delighted to publish this important review for the field," says Co-Editor-in-Chief Bruce A. Sullenger, PhD, Duke Translational Research Institute, Duke University Medical Center, Durham, NC.

Ref : http://www.liebertpub.com/global/pressrelease/new-rna-based-therapeutic-strategies-for-controlling-gene-expression/987/

Researchers identify fexinidazole as potential new therapy for visceral leishmaniasis

Researchers at the University of Dundee have identified fexinidazole as a possible, much-needed, new treatment for the parasitic disease visceral leishmaniasis.

Fexinidazole is already in phase 1 clinical trials for a related disease - African sleeping sickness - but a research team at Dundee including Dr Susan Wyllie, Professor Alan Fairlamb and colleagues has identified it as having potential in treating leishmaniasis.

Their research has been published by the journal Science Translational Medicine, and was funded by the Wellcome Trust.

Tests in mice showed that the drug has a greater than 98% rate of suppressing infection of leishmaniasis, comparable to current treatments such as miltefosine and Pentostam.

These and other existing treatment options all suffer from disadvantages; they are not always safe, effective or easy to administer. The only oral drug miltefosine cannot be given to women of child-bearing age due to a substantial risk of birth defects; other drugs are costly and have to be given by injection. Thus there is a continuing need for safe and cost-effective drugs suitable for use in resource-poor settings.

Ref : http://www.dundee.ac.uk/pressreleases/2012/february12/leishmaniasis.htm

Erivedge Approved to Treat Basal Cell Carinoma

Erivedge(vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday.

The drug was approved for people for whom surgery or radiation aren't options, and for people with basal cell that has spread to other parts of the body, according to an FDA news release. Erivedge was evaluated in clinical studies involving 96 people with basal cell carcinoma. The most common side effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted taste, loss of appetite and constipation.

The drug was approved with an FDA's label warning that pregnant women who take Erivedge could have babies at greater risk of severe birth defects or death. "Pregnancy status must be verified prior to the start of Erivedge treatment," the agency release advised.

Ref : http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13827

Pertuzumab plus trastuzumab and docetaxel has competitive advantages in efficacy over our current proprietary clinical gold-standard treatment...

In continuation of my update docetaxel

"Pertuzumab plus trastuzumab and docetaxel has competitive advantages in efficacy over our current proprietary clinical gold-standard treatment, trastuzumab plus docetaxel," said Decision Resources Analyst Amy Duva"l. 

Decision Resources' analysis of the breast cancer drug market also finds that Roche/Genentech/Chugai's Trastuzumab-DM1 (T-DM1) is likely to initially enter later-lines of treatment before receiving approval for the first-line setting, which means it will gain use across all lines of therapy, fragmenting its patient share across lines of treatment and restricting its uptake in the first-line setting. 

Additionally, according to insights from interviewed thought-leaders, pertuzumab plus trastuzumab and docetaxel and T-DM1 plus pertuzumab have demonstrated the potential to increase patients' overall survival, which has not been improved by drug-treatment since the approval of trastuzumab over a decade ago. 

Findings also reveal that the overall breast cancer drug market declined from $10 billion in 2010 to $9.3 billion in 2011 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Decision Resources forecasts that the market will increase from $9.3 billion in 2011 to $10.8 billion in 2020. Significant declines in sales, due to generic and biosimilar price erosion and a substantial reduction in the prescribing of Roche/Genentech/Chugai's Avastin, particularly in the U.S., will be offset by the launch and uptake of premium-priced emerging therapies, particularly in the metastatic HER2-positive setting. 

Ref : http://decisionresources.com/News-and-Events/Press-Releases/Breast-Cancer-Drug-Market-020212

Clot-Busting Drug, tPA, May Work for Those Who Have Strokes While Asleep

New research suggests that it may be safe to give the clot-busting drug tPA  to people who wake up with stroke symptoms, even though there is a short time window in which to use the treatment and doctors have no idea when these patients first started experiencing their stroke.

The powerful medication can save lives and stave off lasting disability after a stroke, but experts believe it needs to be given within 4.5 hours of the start of symptoms. Almost 25 percent of people who have strokes have them while they are asleep, the study authors noted, and doctors typically err on the side of caution, assume the stroke happened when the patient first went to bed and do not treat with tPA....

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New Anti-Clotting Drug May Cut Brain Bleeding Risk: Study

In continuation of my update on rivaroxaban (Xarelto)

In a new study, researchers led by Dr. Graeme Hankey, a neurologist at the Royal Perth Hospital and University of Western Australia, followed more than 14,000 people who took anti-clotting drugs for a median of two years. Of those patients, 136 had bleeding in the brain.

People who took a new anticoagulant called rivaroxaban (Xarelto) and suffered from the most common type of atrial fibrillation and didn't have heart valve damage were about one-third less likely to experience bleeding in the brain than those who took warfarin, the investigators found...

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Experimental Drug-apixaban (Eliquis) : Might Beat Aspirin in Preventing Repeat Strokes: Study

An investigational drug called apixaban (Eliquis) appears to be better than aspirin at preventing blood clots in certain patients who have already suffered a stroke or so-called "mini-stroke" due to an abnormal heart rhythm, according to the results of a new study.

For patients with the dangerous irregular heart rhythm known as atrial fibrillation who can't tolerate the standard drug treatment, daily apixaban seems to be more effective at warding off a stroke or blood clot than aspirin, the study found.

More....

FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer

In continuation of my update on imatinib...

FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer: The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in...

FDA Approves Jentadueto ((linagliptin/metformin hydrochloride)).....

In continuation of my update on linagliptin and metformin hydrochloride

U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets....

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FDA Approves Jentaduet ((sitagliptin and metformin hydrochloride (HCl) )...

In continuation of my update on sitagliptin and metformin hydrochloride (HCl)

U.S. Food and Drug Administration (FDA) approved JANUMET^® XR    ((sitagliptin and metformin hydrochloride (HCl) ) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA^® (sitagliptin), with extended-release metformin. JANUMET XR provides a convenient once-daily treatment option for healthcare providers and patients who need help to control their blood sugar.

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Study shows grape seed extract kills head and neck squamous cell carcinoma cells

A study by researchers lead by Dr.Rajesh Agarwal,  shows that in both cell lines and mouse models, grape seed extract (GSE) kills head and neck squamous cell carcinoma cells, while leaving healthy cells unharmed. "It's a rather dramatic effect," says Rajesh Agarwal, PhD, investigator at the University of Colorado Cancer Center and professor at the Skaggs School of Pharmaceutical Sciences.

Grape seed extract creates these conditions that are unfavorable to growth. Specifically, the paper shows that grape seed extract both damages cancer cells' DNA (via increased reactive oxygen species) and stops the pathways that allow repair (as seen by decreased levels of the DNA repair molecules Brca1 and Rad51 and DNA repair foci).

 "Yet we saw absolutely no toxicity to the mice, themselves," Agarwal says.

Interestingly,  the grape seed extract killed the cancer cells but not the healthy cells. As per the lead reseacher,  the  cancer cells have a lot of defective pathways and they are very vulnerable  and one can  target those pathways. The same is not true of healthy cells," adds Agarwal.

The Agarwal Lab hopes to move in the direction of clinical trials of grape seed extract, potentially as an addition to second-line therapies that target head and neck squamous cell carcinoma that has failed a first treatment.

Ref :  http://carcin.oxfordjournals.org/content/23/11/1869.abstract?sid=90421d40-8cea-478e-8d70-f5a17c4158b7

Tea could help lower high blood pressure: Study

In continuation of my update on tea and its effect....

A new study suggests that taking tea daily could help in lowering blood pressure.The study shows that people who drank three cups of black tea a day were able to lower their blood pressure. This was seen when compared to those who drank a placebo similar in taste and caffeine content. Those who drank the tea saw a slight drop in both systolic and diastolic blood pressure over six months.

Experts however warned that drinking tea is not a substitute for blood pressure-lowering medication, but researchers said the findings show tea could still provide a benefit.

Researchers note that although the study cannot identify specific components of the tea that might lead to a drop in blood pressure, past studies have shown flavonoids, compounds found in many plants such as tea, are good for heart health.

“The message really isn't for an individual to go out and drink a lot of tea,” said Jonathan Hodgson,

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Preliminary findings suggest a drug used to treat   cryopyrin-associated periodic syndromes  disease might also reduce painful flare-ups in gout patients starting new medication regimens.

In a new study, the protein-inhibitor drug rilonacept (Arcalyst) appeared to markedly lower the risk of gout flare-ups during the first few months of treatments aimed at lowering uric acid levels.

"To reduce deposits of crystals in the joints, we advise patients to initiate treatment with medications that lower levels of uric acid in the blood," study author Dr. H. Ralph Schumacher 

The researchers wanted to learn if rilonacept could lower this short-term risk for by neutralizing a specific target protein -- interleukin 1 or IL-1 -- before it initiates inflammation.

They looked at 83 gout patients in 27 U.S. study centers who had a history of gout flare-ups and high levels of uric acid. All were placed on a chronic uric-acid lowering regimen of the standard drug allopurinol.

About half were also given an initial double-dose injection of rilonacept (320 milligrams) followed by a single dose for 16 weeks. The other half received sugar pills.

Rilonacept patients were less likely to have flare-ups, with 15 percent experiencing flare-ups three-months into the study compared with 45 percent among the non-rilonacept group, the researchers found....

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FDA Approves Inlyta for advanced kidney cancer (renal cell carcinoma)

The U.S. FDA,  approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. 

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

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FDA Approves BYDUREON™ -- The First and Only Once-Weekly Treatment for Type 2 Diabetes

In continuation of my up date on Exenatide...

Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon  (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings....

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Drug May Slow Early Prostate Cancer: Study

In continuation of my update on Dutasteride (Avodaart)

New research suggests that Avodart, a drug used to treat an enlarged prostate gland, may help slow the progression of early stage prostate cancer, reducing the need for aggressive treatment in some men. 

Avodart belongs to a class of drugs called 5-alpha reductase inhibitors. These drugs work by interfering with the effects of certain male hormones on the prostate. In the three-year study, prostate cancer progressed in 38 percent of 144 men with early prostate cancer who were treated with Avodart and 48 percent of the 145 men who received a placebo....

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Could 'Magic' Mushrooms Ease Depression?

Psychedelic mushrooms (see above picture) may point to new ways to treat depression, suggest two small brain imaging studies that seem to show how psilocybin (see right structure) the active ingredient in such mushrooms -affects the brain. 

One study included 30 healthy people who had psilocybin inserted into their blood while magnetic resonance imaging (MRI) scanners measured changes in their brain activity. The scans revealed that psilocybin caused decreased activity in what the researchers described as the brain's "hub" regions -- areas especially well-connected with other areas.

The second study included 10 healthy volunteers and found that psilocybin boosted their recall of personal memories and their emotional well-being for up to two weeks. The researchers said this suggests that psilocybin might prove useful as an adjunct to psychotherapy.

"Psychedelics are thought of as 'mind-expanding' drugs, so it has commonly been assumed that they work by increasing brain activity, but surprisingly, we found that psilocybin actually caused activity to decrease in areas that have the densest connections with other areas," Nutt said....

Researchers lead by Dr.David Nutt, add that result is consistent with earlier finding that psilocybin decreases mPFC activity, as many effective depression treatments do. The effects need to be investigated further and this study was only a small study, and  are interested in exploring psilocybin's potential as a therapeutic tool.....

Experimental Drug Might Help Some a Bit With Colon Cancer

In continuation of my update on regorafenib

 

The experimental cancer drug regorafenib appears to extend survival slightly in patients with metastatic colorectal cancer, a new trial indicates.

 

Regorafenib is a so-called multikinase inhibitor, which targets several of the ways cancer develops and grows, researchers said.

"The drug was tested on patients with metastatic colorectal cancer who had progressed after standard therapies, meaning they had no treatment options available," lead researcher Dr. Axel Grothey, a professor of oncology at the Mayo Clinic. 

The investigators found that patients taking regorafenib survived an average of 6.4 months, compared with five months for those receiving a placebo -- an increase in survival of 29 percent.

In addition, 44 percent of the patients taking regorafenib responded to the drug or had their cancer slowed, compared with 15 percent of the patients receiving placebo, they reported.

 

Ref : http://gicasym.org/GastrointestinalCancersSymposiumDailyNews/GI385.aspx

New Drug Combo for Hepatitis C Shows Promise...

A new cocktail of two investigational drugs appears to have successfully cleared the hepatitis C virus in people who don't respond to standard treatment. What's more, the approach seems to work without the need for injections with interferon alpha, an onerous medication that causes serious side effects in many patients.

"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped," said study author Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School in Ann Arbor.

The study had two arms:  a group of 10 patients received four medications, including the two investigational drugs, the antivirals daclatasvir (see right structure)  and asunaprevir (see left structure-courtesy: ChemSpider), along with the standard treatment combination of interferon and ribavirin. The other arm of the study included 11 patients who received only the two investigational drugs. Both groups underwent treatment for 24 weeks.

The 10 patients on the four-drug regimen experienced a sustained virologic response with undetectable virus at the end of treatment and again at 12 weeks beyond their treatment, the researchers reported. In the two-drug group, four of the 11 patients also had undetectable levels of the hepatitis C virus in their blood 12 weeks after treatment ended.

"The four-drug arm was very impressive. These patients had not shown a response before and now we get a 90 to 100 percent rate of sustained response," said Lok....

Ref : http://www.nejm.org/doi/full/10.1056/NEJMoa1104430

More Evidence for Oxaliplatin as Colon Cancer Chemotherapy

In continuation of my update on Oxaliplatin 

Adding oxaliplatin to a standard chemotherapy regimen boosts survival rates for patients with advanced colon cancer, according to a new study that bolsters previous research on the drug by looking at a broader group of patients.

In past studies, oxaliplatin, as an adjuvant to the established treatment of 5-fluorouracil (5-FU), improved survival by up to 23 percent. But the new study looked at a different group of colon cancer patients, who were older, sicker, more racially diverse and had never participated in a controlled clinical study.

To determine whether oxaliplatin would show a similar benefit among a "real-world" population of patients, the authors sifted through five cancer registries containing survival information on more than 4,000 people with stage 3 colon cancer. All were younger than 75, and all had begun chemotherapy -- either a standard regimen or in combination with oxaliplatin -- within four months of having surgery between 2004 and 2009.

Researchers lead by Dr.Hanna K. Sanoff compared their survival rates with those of nearly 8,300 patients who had participated in one of five different clinical trials using oxaliplatin.

The addition of oxaliplatin to standard chemotherapy protocols was found to be just as effective in prolonging survival among the community-based set of patients - including the elderly, minorities and those with additional complicating health issues  who were not enrolled in studies.

More....

Voraxaze receives FDA approval for treatment of toxic methotrexate levels

Voraxaze receives FDA approval for treatment of toxic methotrexate levels: The U.S. Food and Drug Administration today approved Voraxaze (see structure, glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.  

Anti-malaria drug synthesised with the help of oxygen and light

In continuation of my update, artemisinin... The most effective anti-malaria drug can now be produced inexpensively and in large quantities. This means that it will be possible to provide medication for the 225 million malaria patients in developing countries at an affordable price. Researchers at the Max Planck Institute of Colloids and Interfaces in Potsdam and the Freie Universität Berlin have developed a very simple process for the synthesis of artemisinin, the active ingredient that pharmaceutical companies could only obtain from plants up to now. The chemists use a waste product from current artemisinin production as their starting substance. This substance can also be produced biotechnologically in yeast, which the scientists convert into the active ingredient using a simple yet very ingenious method..... Look at http://www.mpg.de/4984709/artemisinin_malaria

Dabigatran, New Blood Thinner Linked To Higher Heart Attack Risk

In continuation of my update on Dabigatran...

Researchers lead by Dr.Ken Uchino from the Cleveland Clinic in Ohio looked at seven trials involving Pradaxa (Dabigatran) that included more than 30,000 patients. This process, called a meta-analysis, uses data from published clinical trials to tease out a pattern that might not show up in a single study. Researchers found Pradaxa was associated with an increased risk of heart attack or acute coronary syndrome (heart attack or angina), compared with two other commonly used blood thinners, warfarin (Coumadin, Jantoven) and enoxaparin (Lovenox).

As per the claim by the researchers,  those taking Pradaxa, 1.19 percent had a heart attack or suffered from acute coronary syndrome compared with 0.79 percent of those taking either of the other drugs, they noted. Although there was a 33 percent increase in relative risk for a heart attack among those taking Pradaxa, the absolute increased risk -- that is, the added risk for any one individual of having a heart attack if on Pradaxa -- was 0.27 percent, researchers said.

Pradaxa was approved by the U.S. Food and Drug Administration in October 2010 for people with a common heart rhythm problem called atrial fibrillation. People with atrial fibrillation are at a higher risk for stroke and are often prescribed medication to prevent clotting....

Ref : http://my.clevelandclinic.org/cerebrovascular_center/medical_professionals/clinical_trials.aspx

Idenix Reports Positive Interim Data for HCV Nucleotide Inhibitor, IDX184

Idenix Pharmaceuticals, Inc.  a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, recently announced interim data from a 12-week phase IIb clinical trial of IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection.  IDX184 (below structure), a pan-genotypic oral nucleotide polymerase inhibitor, has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies..

Following are the highlights .....

• No serious adverse events observed in phase IIb study of IDX184; Data Safety Monitoring Board (DSMB) recommends continuation of the clinical trial. 
• In the 100 mg IDX184 arm, 73% of patients achieved a rapid virologic response (RVR) and 87% were undetectable at most recent visit; In the 50 mg IDX184 arm, 63% of patients achieved an RVR and 94% were undetectable at most recent visit.

 

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Positive Results from Clinical Study of CVT-301, an Inhaled L-dopa for Parkinson’s Disease..

In continuation of my update on Levodopa....

The Phase 1 study (by Civitas Therapeutics, Inc) showed that CVT-301 achieved sufficient plasma levels of L-dopa through inhaled delivery to the lung, resulting in a pharmacokinetic profile that supports its therapeutic potential.  Immediate absorption and dose proportional pharmacokinetics were seen across all doses tested.  In addition, all doses tested of CVT-301 were safe and well tolerated.  

More....

Ref : http://civitastherapeutics.com/cms/sites/default/files/news/CVT-301%20Clinical%20results%20press%20release%20FINAL%2006Jan2012_0.pdf

Breakthrough in Treatment to Prevent Blindness | www.ucsf.edu

In continuation of my update on Azithromycin....
Breakthrough in Treatment to Prevent Blindness | www.ucsf.edu

A Novel Neurotrophic Drug for Cognitive Enhancement and Alzheimer's Disease

A new drug candidate may be the first capable of halting the devastating mental decline of Alzheimer's disease.  The drug, known as J147 (above  structure), improved memory and prevented brain damage caused by the disease claims the researchers from Salk's Cellular Neurobiology Laboratory, lead by David Schubert. The new compound,  could be tested for treatment of the disease in humans in the near future.Researchers add that, J147 enhances memory in both normal and Alzheimer's mice and also protects the brain from the loss of synaptic connections.

Salk researchers went on to show that it prevented cognitive decline in animals with Alzheimer's and that mice and rats treated with the drug produced more of a protein called brain-derived neurotrophic factor (BDNF), a molecule that protects neurons from toxic insults, helps new neurons grow and connect with other brain cells, and is involved in memory formation.

Because of the broad ability of J147 to protect nerve cells, the researchers believe that it may also be effective for treating other neurological disorders, such as Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis (ALS), as well as stroke.

Although it is yet unknown whether the compound will prove safe and effective in humans, the Salk researchers' say their results suggest the drug may hold potential for treatment of people with Alzheimer's...

Ref : http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0027865

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV: Bristol-Myers Squibb Company announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

Alkermes commences ALKS 9070 phase 3 clinical trial for schizophrenia...

Alkermes plc (NASDAQ: ALKS)  announced the initiation of a phase 3 clinical trial of ALKS 9070 (Aripiprazole) for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole...

Ref : http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-corporateNewsArticle&ID=1640788&highlight=