Friday, October 22, 2010

FDA and EMA accept regulatory submissions of vandetanib for advanced medullary thyroid cancer

We know that, Vandetanib (proposed trade name Zactima), also known asZD6474, is an antagonist of the vascular endothelial growth factor receptor (VEGFR) and the epidermal growth factor receptor (EGFR). It is a tyrosine kinase inhibitor. Drug has a third target: inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer and is being developed by AstraZeneca. It is a medication currently undergoin  clinical trials as a potential targeted treatment for non–small-celllung cancer.

Now US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011. More...

Thursday, October 21, 2010

Turmeric component (curcumin) enhances chemotherapy's suppression of head and neck cancer

In continuation of my update on Curcumin, I found this info interesting to share with.., i.e.,  researchers with UCLA's Jonsson Cancer Center have found, when combined with the drug Cisplatin, turmeric enhances the chemotherapy's suppression of head and neck cancer cell growth. Previous studies have shown it can suppress the growth of certain cancers. The study, done in cells in Petri dishes and then in mouse models is of great importance.

A 2005 study by Wang and Srivatsan first showed that curcumin suppressed the growth of head and neck cancer cells, first in cells and then in mouse models. In the animal studies, the curcumin was applied directly onto the tumors in paste form because it did not dissolve in saline, which would have allowed it to be injected. n need of a better way to deliver the curcumin, the team collaborated with Dr. Kapil Mehta of M.D. Anderson Cancer Center and found that encapsulating the curcumin in a liposome, an artificially prepared vehicle that enclosed the spice component within its membrane, made the treatment injectable. The curcumin was injected into the tail vein of a mouse, where it circulated into the blood stream, slowing down and eventually stopping the cancer growth, a study in 2008 found.

"This was a very positive finding, developing an efficient way to deliver the treatment," Wang said. "Our study also showed that the curcumin was very well tolerated."

In this study, the team wanted to combine the curcumin with the chemotherapeutic drug Cisplatin, which is very toxic at the doses needed to fight head and neck cancers, damaging kidneys, the ears and the bone marrow. They hoped that if they added curcumin to the mix, they might be able to lower the Cisplatin dose and cause less organ damage. Their finding, that the curcumin made the Cisplatin work better, was very promising.


Friday, October 15, 2010

Sanofi-Aventis’ Teriflunomide Comes Up Trumps in Two-Year Phase III MS Trial ....

Sanofi-aventis reported positive two-year data from a Phase III trial with its oral disease-modifying multiple sclerosis (MS) drug teriflunomide. Results from the international thousand-patient TEMSO study showed that both evaluated doses of teriflunomide reduced the annualized MS relapse rate by 31% in comparison with placebo. The 14 mg and 7 mg teriflunomide doses resulted in a reduction in the risk of disability progression by 30% and 24%, respectively, when compared with placebo.  

Wednesday, October 6, 2010

FDA approves fingolimod drug for multiple sclerosis...

Fingolimod (see structure), a drug modified from a fungus  (Isaria sinclairii), a structural analogue of sphingosine and gets phosphorylated by sphingosine kinases in the cell originally found in Asian wasps, prevents autoimmune attacks by trapping white blood cells in the body's lymph nodes. Two large Phase III clinical studies published in February found that fingolimod was at least twice as effective in preventing MS attacks when compared to placebo or current treatments. 

Research on additional uses for fingolimod continues at the University of Chicago, including a new clinical trial in patients with progressive MS, for which there are no available treatments. With fingolimod adding to the recent boom of new MS therapies, and with a number of clinical trials for new therapies in progress, patients should be sure to seek out an experienced MS center for their care.
As per the claim by the lead researcher, Anthony Reder, MD, Professor of Neurology at the University of Chicago Medical Center,  fingolimod is first oral medication for multiple sclerosis was approved  by the Food & Drug Administration. He also claims that'
"We have six drugs right now, and they all involve injections. So the convenience alone of a pill is a major change in how we treat MS."
Hope people suffering from MS, (A chronic, neurologic disorder, which affects roughly 400,000 Americans and 2.5 million people around the world.  MS can cause issues with walking and movement, fatigue, weakness, pain, and loss of vision. Patients with relapsing-remitting MS suffer from intermittent and unpredictable immune system attacks that can damage the brain, spinal cord, and eyes) breathe a sigh of relief..


Sunday, October 3, 2010

Rufinamide therapy is effective in reducing partial seizure frequency...

Rufinamide(see structure) is an anticonvulsant medication and a triazole derivative, was developed in 2004 by Novartis Pharma, AG, and is manufactured by Eisai. It is used in combination with other medication and  therapy to  treat  Lennox–Gastaut  syndrome and various other seizure disorders. Rufinamide.

Rufinamide was approved by the US FDA on November 14, 2008 as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. Its official FDA-approved labeling does not mention use in the treatment of partial seizures inasmuch as clinical trials submitted to the FDA were marginal.

Interestingly, now researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

Researchers found that treatment with rufinamide resulted in a statistically significant reduction in total partial seizure frequency compared with placebo. Results also showed a 50% reduction in responder rate and total partial seizure frequency rate in patients treated with rufinamide. Several exploratory efficacy variables, including at least 75% responder rate and increase in the number of seizure-free days, were also associated with notably better results for rufinamide.

With respect to efficacy by seizure type, rufinamide was significantly superior to placebo for complex partial seizures, the most common seizure type, and numerically superior to placebo for simple partial seizures and secondarily generalized partial seizures. The median reduction in secondarily generalized partial seizures of 40% in this study is consistent with that previously observed at identical rufinamide dosage. As per the claim by the lead researcher Dr. Victor Biton,

"Overall, there were no significant pharmacokinetic (PK) effects on either rufinamide or any second-generation AED when given with other medications."

The research team confirmed PK results found in previous studies-showing lower oral bioavailability of rufinamide at higher doses, increased clearance of rufinamide with increasing body weight, and no effect of prolonged rufinamide dosing on the PK of rufinamide.