Phase IIb trial shows platinum-resistant ovarian patients treated with PM1183 live longer

Zeltia announces today that its pharmaceutical division PharmaMar has data from a group of 33 randomized patients with platinum-resistant ovarian cancer demonstrating that PM1183 (see structure) shows a significantly superior median overall survival compared to topotecan. In this multicenter Phase IIb randomized trial, platinum-resistant ovarian patients treated with PM1183 lived longer, with a median overall survival of 18.1 months, compared to topotecan, which only achieves 8.5 months. PharmaMar will launch a pivotal Phase III trial to confirm the efficacy of PM1183 in a larger population, and that is expected to be the final step before registration of PM1183 for platinum-resistant ovarian cancer. "The pivotal trial planned for next year will hopefully confirm the effects in survival that we observe in these patients, who are in need of drugs that will reduce the risk of death and extend their lives, without posing major side effects", says Arturo Soto, Director of Clinical Development, PharmaMar.

The Phase IIb trial consisted of a first stage, single arm approach to assess efficacy of PM1183 in platinum-resistant ovarian cancer patients, followed by a second stage, in which patients were randomized to be treated with PM01183 or topotecan as control group.

Results presented at the American Society of Clinical Oncology (ASCO) earlier this year showed a significant improvement in the other secondary endpoint, progression-free survival, as well as in the overall response rate, which was the primary endpoint1. The results found now for the overall survival of patients with platinum-resistant ovarian cancer treated with PM1183 add to the clinical benefit, measured as 70% of overall responses and stable disease, previously observed. The manageable safety profile previously described for these patients has not changed.

Phase IIb trial shows platinum-resistant ovarian patients treated with PM1183 live longer

Resveratrol in red wine inhibits formation of inflammatory factors that activate cardiovascular diseases

In continuation of my update on resveratrol 

A natural substance present in red wine, resveratrol, inhibits the formation of inflammatory factors that trigger cardiovascular diseases. This has been established by a research team at the Department of Pharmacology of the University Medical Center of Johannes Gutenberg University of Mainz (JGU) working in collaboration with researchers of the Friedrich Schiller University in Jena and the University of Vienna. Their results have recently been published in the scientific journal Nucleic Acids Research.

Despite the fact that they eat more fatty foods, the French tend to less frequently develop cardiac diseases than Germans. This so-called French Paradox is attributed to the higher consumption of red wine in France and it has already been the subject of various studies in the past. A number of research projects have actually demonstrated that the natural product resveratrol, present in red wine, has a protective effect against cardiovascular diseases. But what exactly is the reason for this? It seems that at least part of the protective effect can be explained by the fact that resveratrol inhibits the formation of inflammatory factors, a conclusion reached by the research team of Junior Professor Andrea Pautz and Professor Hartmut Kleinert of the Mainz University Medical Center following collaboration in a joint project with Professor Oliver Werz of the Friedrich Schiller University in Jena and Professor Verena Dirsch of the University of Vienna. In fact, the researchers discovered that the natural substance binds to the regulator protein KSRP and activates it. KSRP reduces the stability of messenger RNA (mRNA) in connection with a number of inflammatory mediators and thus inhibits their synthesis.

Resveratrol in red wine inhibits formation of inflammatory factors that activate cardiovascular diseases

New drug offers hope for victims of spinal cord injury

New drug offers hope for victims of spinal cord injury

Antacid medicines improve overall survival in patients with head and neck cancer

Patients with head and neck cancer who used antacid medicines to control acid reflux had better overall survival, according to a new study from the University of Michigan Comprehensive Cancer Center.

-Prevacid  Nexium

 Prilosec 

Reflux can be a common side effect of chemotherapy or radiation treatment for head and neck cancer. Doctors at the University of Michigan frequently prescribe two types of antacids - proton pump inhibitors or histamine 2 blockers - to help treat this side effect.

The researchers looked at 596 patients who were treated for head and neck cancer. More than two-thirds of the patients took one or both types of antacid medication after their diagnosis.

Patients who were taking antacids had significantly better overall survival than those who did not take them. Proton pump inhibitors, which include drugs such as Prilosec, Nexium and Prevacid, had the biggest effect: a 45 percent decreased risk of death, compared to patients who did not take antacids. Patients taking histamine 2 blockers, such as Tagamet, Zantac or Pepcid, saw a 33 percent decreased risk of death.

"We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better," says lead study author Silvana Papagerakis, M.D., Ph.D., research assistant professor of otolaryngology--head and neck surgery at the University of Michigan Medical School and an adjunct clinical assistant professor at the U-M School of Dentistry.

Results of the study are published in the December issue of Cancer Prevention Research.

The researchers are not clear why these medications affect the cancer, although they have begun additional work to understand the mechanisms involved.

Antacid medicines improve overall survival in patients with head and neck cancer

New targeted therapy shows promise in patients with ALK-positive advanced NSCLC

An international study involving Manchester researchers has found that for previously untreated lung cancer patients with a particular genetic change, a new targeted therapy is better than standard chemotherapy.

Some patients with non-small cell lung cancer (NSCLC) have changes in the anaplastic lymphoma kinase (ALK) gene, which can drive the development of their cancer. A drug recently developed by Pfizer, crizotinib (see structure), targets ALK and is currently given to patients with ALK positive lung cancer when their cancer has worsened after initial chemotherapy. Now doctors have investigated the use of crizotinib in patients with ALK positive lung cancer who have not yet received any chemotherapy treatment.

New targeted therapy shows promise in patients with ALK-positive advanced NSCLC

Fructose more toxic than table sugar, mouse study suggests

When University of Utah biologists fed mice sugar in doses proportional to what many people eat, the fructose-glucose mixture found in high-fructose corn syrup was more toxic than sucrose or table sugar, reducing both the reproduction and lifespan of female rodents.

"This is the most robust study showing there is a difference between high-fructose corn syrup and table sugar at human-relevant doses," says biology professor Wayne Potts, senior author of a new study scheduled for publication in the March 2015 issue ofThe Journal of Nutrition.

The study found no differences in survival, reproduction or territoriality of male mice on the high-fructose and sucrose diets. The researchers say that may be because both sugars are equally toxic to male mice.

Both high-fructose corn syrup found in many processed foods and table sugar found in baked goods contain roughly equal amounts of fructose and glucose. But in corn syrup, they are separate molecules, called monosaccharides. In contrast, sucrose or table sugar is a disaccharide compound formed when fructose and glucose bond chemically.

Potts says the debate over the relative dangers of fructose and sucrose is important "because when the diabetes-obesity-metabolic syndrome epidemics started in the mid-1970s, they corresponded with both a general increase in consumption of added sugar and the switchover from sucrose being the main added sugar in the American diet to high-fructose corn syrup making up half our sugar intake."

James Ruff, the study's first author and a postdoctoral fellow in biology, says, "Our previous work and plenty of other studies have shown that added sugar in general is bad for your health. So first, reduce added sugar across the board. Then worry about the type of sugar, and decrease consumption of products with high-fructose corn syrup."

The new study is the latest in a series that used a new, sensitive toxicity test developed by Potts and colleagues. It allows house mice to compete in the seminatural environment of room-size "mouse barns." Previous mouse studies with the test found harmful effects of inbreeding, the antidepressant Paxil and, last year, an added-sugar diet with fructose and glucose in amounts proportional to a healthy human diet plus three cans of soda daily. These health effects had been missed by conventional tests.

More : http://dx.doi.org/10.3945/jn.114.202531

Fructose more toxic than table sugar, mouse study suggests 

Cholesterol Drug Vytorin Linked to Reduced Heart Attack Risk

We know that, Ezetimibe/simvastatin  is a drug combination used for the treatment of dyslipidemia. It is a combination of ezetimibe (known as Zetia in the United States and Ezetrol elsewhere) and the statin drug simvastatin (known as Zocor in the U.S.). The combination preparation is marketed by Merck & Co. under the trade names Vytorin and Inegy. Ezetimibe reduces blood cholesterol by acting at the brush border of the small intestine and inhibiting the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver.

Simvastatin is an HMG-CoA reductase inhibitor or statin. It works by blocking an enzyme that is necessary for the body to make cholesterol.

FDA Approves 'Abuse-Resistant' Narcotic Painkiller

In continuation of my update on Hydrocodone

Seeking to make it tougher for people to misuse prescription painkillers, the U.S. Food and Drug Administration on Thursday approved a new hydrocodone tablet that's designed to help thwart abuse.

Hydrocodone -- best known by the brand name Vicodin (combination of Hydrocodone and Paracetamol) - is a powerful opioid painkiller that has been tied to a surge in dangerous addictions across the United States.

The FDA said that newly approved Hysingla ER (hydrocodone bitartrate) is an extended-release tablet to treat pain severe enough to require daily, round-the-clock, long-term opioid treatment that can't be eased by other pain medications.

The drug is not approved for "as-needed" pain relief, the agency said.

Hysingla has features that are expected to reduce, but not prevent, abuse of the drug. According to the FDA, the tablet is difficult to crush, break or dissolve, making it tougher for abusers to snort or inject it.

FDA Approves 'Abuse-Resistant' Narcotic Painkiller  

Treating Irregular Heartbeat With Digoxin May Come With Risks

In continuation of my update on  Digoxin 

The widely used heart drug digoxin is associated with increased risk of death and hospitalization among patients who have the heart rhythm disorder atrial fibrillation but no evidence of heart failure, a new study finds.

Atrial fibrillation is a common form of irregular heartbeat that has been linked to a rise in risk for stroke among older Americans. Digoxin has been used for more than a century to help treat irregular heartbeat, the authors of the new study said, and many guidelines recommend the drug for the treatment of atrial fibrillation.

However, the new findings "suggest that the use of digoxin should be re-evaluated for the treatment of atrial fibrillation in contemporary clinical practice," study co-author Dr. Anthony Steimle, chief of cardiology at Kaiser Permanente Santa Clara Medical Center, said in a Kaiser news release.

One expert wasn't surprised by the findings.

Treating Irregular Heartbeat With Digoxin May Come With Risks  

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

In continuation of my update on Sofosbuvir (left) and  Simeprevir (right)

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection