Thursday, July 31, 2014

FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma

The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program...


FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma

Wednesday, July 30, 2014

Protein once seen as promising anti-cancer compound helps to stabilize neural circuits

Researchers at UC San Francisco (UCSF) have discovered that endostatin, a protein that once aroused intense interest as a possible cancer treatment, plays a key role in the stable functioning of the nervous system.


A substance that occurs naturally in the body, endostatin potently blocks the formation of new blood vessels. In studies in mice in the late 1990s, endostatin treatment virtually eliminated cancer by shutting down the blood supply to tumors, but subsequent human clinical trials proved disappointing.

"It was a very big surprise" to find that endostatin, through some other mechanism, helps to maintain the proper workings of synapses, the sites where communication between nerve cells takes place, said Graeme W. Davis, PhD, Hertzstein Distinguished Professor of Medicine in the Department of Biochemistry and Biophysics at UCSF and senior author of the new study. "Endostatin was not on our radar."

Tuesday, July 29, 2014

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.

Monday, July 28, 2014

High-dose fluticasone effective against eosinophilic esophagitis, study shows...

I continuation of y update on Fluticasone..

Results from a clinical trial show that high doses of the corticosteroid fluticasone propionate safely and effectively induce remission in many people with eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus characterized by high levels of white blood cells called eosinophils. However, some trial participants did not respond to fluticasone even after six months of high-dose treatments, providing evidence that certain people with EoE are steroid-resistant. By analyzing gene expression -- the degree to which certain genes are turned on or off -- in esophageal tissues, the scientists identified a cluster of genes that may help predict steroid responsiveness.


Ref :Read more

Friday, July 25, 2014

Bowel cancer breakthrough may benefit thousands of patients

Researchers at Queen's University have made a significant breakthrough that may benefit
patients with bowel cancer. 

Dr Sandra van Schaeybroeck and her team have discovered how two genes cause bowel cancer cells to become resistant to treatments used against the disease. The research, which was funded by Cancer Research UK, was published this month in the international journal CellReports.

The activity of the two genes, called MEK and MET, was uncovered when the researchers looked at all the different pathways and interactions taking place in bowel cancer cells.

Dr van Schaeybroeck and her group found that these bowel cancers switch on a survival mechanism when they are treated with drugs that target faulty MEK genes. But when the researchers added drugs that also block the MET gene, the bowel cancer cells died.

The team are now testing a new approach to target these two genes in the most aggressive forms of bowel cancer in a European Commission funded clinical trial that is being led by Dr van Schaeybroeck.

Thursday, July 24, 2014

Zydelig Approved for Three Types of Blood Cancer

 Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL), the FDA said Wednesday in a news release.
The approval for the three forms of blood cancer covers instances when the cancer returns despite treatment with at least one other therapy, the agency said.
The drug's label will include a boxed warning that the medication could cause liver toxicity, diarrhea, high blood sugar, elevated liver enzymes, high blood triglycerides [a blood fat] and inflammation of the colon (colitis). Other side effects noted during clinical testing included fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills and rash.
Zydelig is marketed by Gilead Sciences, based in Foster City, Calif.

Wednesday, July 16, 2014

New combination drug controls tumor growth, metastasis in mice...

Researchers at UC Davis, University of      Massachusetts  and Harvard  Medical  School  have
created a combination drug that controls both tumor growth and metastasis. By combining a COX-2 inhibitor, similar to Celebrex, and an epoxide hydrolase (sEH) inhibitor, the drug controls angiogenesis (blood vessel formation), limiting a tumor's ability to grow and spread. The study appears today in the journal Proceedings of the National Academy of Sciences.

"We've   been   studying  the  effects of  COX  and  sEH  inhibitors, both    by themselves  and in combination, for several years," said senior author and UC Davis Distinguished Professor Bruce Hammock. "We were surprised to find that the dual inhibitor was more active than higher doses of each compound, either individually or together. By combining the two molecules into one we got much greater potency against several diseases and completely unique effects in terms of blocking tumor growth and metastasis."

Both COX and sEH enzymes control lipid signaling, which has long been associated with inflammation, cell migration, proliferation, hypertension and other processes. COX inhibitors block production of inflammatory and pain-inducing lipids, while sEH inhibitors preserve anti-hypertensive, anti-inflammatory and analgesic compounds. Separate COX and sEH inhibitors were previously found to work together in reducing inflammation and neuropathic pain.

After testing individual COX-2 and sEH inhibitors, the team synthesized the drug (PTUTB), the first combined COX-2/sEH inhibitor. They then tested the dual inhibitor against human lung and breast tumors, both in vitro and in mice. They found that PTUTB blocked angiogenesis, inhibiting the proliferation of endothelial cells, which are critical to blood vessel formation. This in turn limited tumor growth and metastasis, reducing lung and breast tumor growth by 70 to 83 percent. 

In breast and lung cancers, the dual inhibitor blocked angiogenesis, which blocked the growth of solid tumors," said Hammock. "This represents a new mechanism to control blood vessel and tumor growth."

Robert Weiss, a co-author and professor of nephrology at UC Davis, added that the combination drug achieved the results with minimal side effects and no cardiovascular or gastrointestinal effects.

"This is particularly important when administering COX-2 inhibitors, which have well-known cardiovascular risks," he said. "However, the added sEH  inhibitor appears to block COX-2's side effects."

The research was initiated by first author Guodong Zhang when he was a postdoctoral fellow in the Hammock laboratory. Zhang previously demonstrated that sEH inhibitors improve the power of omega-3 fatty acid (fish oil) diets to reduce tumor growth and metastasis, and implicated epoxides of the dietary supplement DHA as the causative agent.























Monday, July 14, 2014

Liver Cancer Drug Fails to Live Up to Early Promise...

In continuation of my update on everolimus

Although it looked promising in early studies, the drug everolimus didn't improve survival for people with advanced liver cancer in its latest trial, a new study found.
The findings from the phase 3 clinical trial are disappointing because earlier research suggested that everolimus (Afinitor) prevented tumor progression and improved survival for in advanced liver cancer. Normally, these patients can expect a median overall survival of less than one year.
The only drug currently shown to significantly improve survival of advanced liver cancer patients is sorafenib (Nexavar). But that drug's benefits are temporary and the cancer eventually progresses, according to background information in the new study.
The current study included 546 adults with advanced liver cancer whose disease progressed during or after treatment with sorafenib, or who could not take sorafenib. The patients were divided into two groups, with 362 given everolimus and 184 given a placebo.

Saturday, July 12, 2014

New Inhaled Drug Shows Promise Against Asthma, Allergies...........

A new inhaled medication has the potential to treat mild asthma and allergies by interrupting the production of an immune system protein that triggers allergic reactions, a new study reports.
The drug, quilizumab, targets the blood cells that produce a protein called immunoglobulin type E (IgE), that serves a key role in allergies.
Quilizumab lowered total levels of IgE in the blood of people with allergies and mild asthma, and kept them low for a month, researchers report in the July 2 issue of the journal Science Translational Medicine.
"The subjects who received the drug not only had a reduction in their total IgE level, it also seemed to block production of new IgE in response to the allergen they inhaled," said study co-author Dr. Jeffrey Harris, principal medical director of immunology, tissue growth and repair for the drug manufacturer Genentech, which produces quilizumab and funded the study.
However, one expert noted that the drug has yet to prove itself against moderate to severe asthma.

New Inhaled Drug Shows Promise Against Asthma, Allergies - Drugs.com MedNews

A new inhaled medication has the potential to treat mild asthma and allergies by interrupting the production of an immune system protein that triggers allergic reactions, a new study reports.
The drug, quilizumab, targets the blood cells that produce a protein called immunoglobulin type E (IgE), that serves a key role in allergies.
Quilizumab lowered total levels of IgE in the blood of people with allergies and mild asthma, and kept them low for a month, researchers report in the July 2 issue of the journal Science Translational Medicine.
"The subjects who received the drug not only had a reduction in their total IgE level, it also seemed to block production of new IgE in response to the allergen they inhaled," said study co-author Dr. Jeffrey Harris, principal medical director of immunology, tissue growth and repair for the drug manufacturer Genentech, which produces quilizumab and funded the study.
However, one expert noted that the drug has yet to prove itself against moderate to severe asthma.

Friday, July 11, 2014

Breast Cancer Drug May Help Women Fight a Leading Cause of Infertility: Study

Women with polycystic ovary syndrome have a better chance of getting pregnant if they take a breast cancer drug instead of the currently preferred medication, a new study suggests.
Polycystic ovary syndrome -- the most common cause of female infertility in the United States -- causes higher than normal levels of the male hormone androgen, infrequent periods and small cysts on the ovaries. It affects 5 to 10 percent of reproductive-age women, according to background information in the study.
Currently, doctors typically prescribe clomiphine (Clomid) to boost fertility for women with polycystic ovary syndrome. However, this new study suggests the drug letrozole (Femara) results in better ovulation, conception and birth rates.
"We found a simple and comparatively safe and vastly more effective treatment for [polycystic ovary syndrome]," said lead researcher Dr. Richard Legro, a professor of obstetrics and gynecology at Penn State University's College of Medicine in Hershey, Penn.
Clomiphine, which works by stimulating ovulation, has been the standard treatment for years, but has a high rate of multiple births, Legro said.


Letrozole, a treatment for breast cancer in postmenopausal women, works by blocking estrogen production, tricking the ovaries into producing more of the hormone, he explained.
The new study, funded by the U.S. National Institutes of Health, was published July 10 in the New England Journal of Medicine.

Wednesday, July 9, 2014

First drug candidate from NIH program acquired by biopharmaceutical company



A drug candidate developed by researchers at the NIH’s National Center for Advancing Translational Sciences (NCATS) and its collaborators to treat sickle cell disease has been acquired by Baxter International’s BioScience business. The drug candidate, Aes-103, is the first specifically developed to target the underlying molecular mechanism of sickle cell disease. Baxter now will advance the clinical development activities required for regulatory approval and commercialization.
Sickle cell disease is a genetic blood disorder that affects millions worldwide, including approximately 100,000 people in the United States — among them, 1 in 500 African-Americans.
This is the first time a company has acquired a drug candidate developed with NCATS’ Therapeutics for Rare and Neglected Diseases (TRND) program resources. Baxter International recently acquired AesRx, LLC, Newton, Massachusetts — the TRND program collaborator — including Aes-103. TRND and AesRx researchers worked together to develop Aes-103 through a Phase II clinical trial to evaluate safety and effectiveness. The trial data indicated that Aes-103 significantly reduced patients’ pain. 


“This is a wonderful example of why NCATS was created,” said NIH Director Francis S. Collins, M.D., Ph.D. “The progress made thus far in the development of Aes-103 demonstrates NCATS’ catalytic role in bringing together the necessary players, whether academic, nonprofit or industry, to overcome obstacles to translation and advance badly needed treatments to patients.”

Chemical Structure of Aes-103