NEJM hails vismodegib as ‘the greatest advance in therapy yet seen’ for advanced BCC

In continuation of my update on Vismodegib

NEJM hails vismodegib as ‘the greatest advance in therapy yet seen’ for advanced BCC

Promising preliminary data for axitinib in metastatic kidney cancer

In continuation of my update on Axitinib

Promising preliminary data for axitinib in metastatic kidney cancer: Preliminary study data show that axitinib may be an effective first-line treatment for metastatic renal cell carcinoma, particularly in patients with high therapeutic drug exposure and a rise in blood pressure during the first 2 weeks of treatment, researchers report.

Licensed from Medwire news with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.

Investigational ultra-long-acting insulin degludec reduces rates of nocturnal hypoglycaemia in type 2 diabetes patients versus insulin glargine...

Ultra-long-acting insulin degludec, (see structure) an investigational insulin being developed by Novo Nordisk, significantly reduced the rate of hypoglycaemia^* at night in adults with type 2 diabetes while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period. This phase 3a study was presented  at the 72^nd Scientific Sessions of the American Diabetes Association (ADA). 

The study also found that insulin degludec had significantly lower rates of severe hypoglycaemia compared to insulin glargine.

"Nocturnal, or night-time, hypoglycaemia is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect", said Bernard Zinman, lead author and director of the diabetes centre at Mount Sinai Hospital, and professor of medicine, University of Toronto: "This study demonstrated that treatment with insulin degludec significantly reduced the rate of nocturnal hypoglycaemia". 

This randomised, open-label, non-inferiority, treat-to-target trial compared efficacy and safety of insulin degludec to insulin glargine. Both insulins were given once-daily in 1,030 insulin-naïve type 2 diabetes adults inadequately controlled with oral anti-diabetic medications.

Findings of the study include:

• Nocturnal hypoglycaemic rates were significantly lower by 36% with insulin degludec than with insulin glargine (0.25 versus 0.39 episodes per patient per year; p=0.04).
• Overall confirmed hypoglycaemic rates were 1.52 versus 1.85 episodes per patient per year for insulin degludec and insulin glargine respectively (p=0.11).
• Overall severe hypoglycaemia was infrequent in both treatment populations, but it was significantly lower with insulin degludec than with insulin glargine (0.003 versus 0.023 episodes/patient-year; p=0.02).
• At one year, this noninferiority, treat-to-target trial demonstrated comparable HbA_1c reductions with insulin degludec versus insulin glargine (-1.06% versus -1.19%).^**
• Fasting plasma glucose (FPG) reductions were significantly greater with insulin degludec than with insulin glargine (-67.7 versus -59.5 mg/dl, estimated treatment difference (EDT) -7.7 mg/dl, p=0.005).

Overall adverse event rates were low and similar between groups.

^{More : http://www.novonordisk.com/press/news/news.asp?sShowNewsItemGUID=685ce50c-2c6e-4546-9181-a6add0b0cbe1&sShowLanguageCode=en-GB}

Zafgen announces new data from two Phase 1 studies of beloranib on obesity

Zafgen announces new data from two Phase 1 studies of beloranib on obesity: Zafgen, Inc., the world's first biopharmaceutical company dedicated to addressing the unmet need of severely obese patients, today announced new data from two Phase 1 studies of beloranib, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed significant weight loss and improvements in cardiometabolic risk markers in severely obese women.

Treatment with beloranib (see structure) was associated with improvements in weight loss and triglycerides, LDL cholesterol, waist circumference and diastolic blood pressure, with no evidence of major tolerability or safety issues.  Body composition measured in one study indicated a reduction in fat mass with beloranib.  

Ref : http://zafgen.com/PDF/Zafgen-PR-060912.pdf

Turmeric stopped potentially deadly Rift Valley fever virus from multiplying in infected cells

In continuation of my update on curcumin.....

Curcumin,  found in turmeric  stopped the potentially deadly Rift Valley Fever virus from multiplying in infected cells, says Aarthi Narayanan, lead investigator on a new study and a research assistant professor in Mason's National Center for Biodefense and Infectious Diseases.

Turmeric stopped potentially deadly Rift Valley fever virus from multiplying in infected cells

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes: 

In continuation of my update on dapagliflozin and sitagliptin

The study also demonstrated significant reductions in total body weight and fasting plasma glucose (FPG) levels in patients taking dapagliflozin added to sitagliptin (with or without metformin), with results maintained throughout the duration of the study extension.

Patients were actively questioned at each study visit for signs, symptoms or events suggestive of genital infections and urinary tract infections. These events were more frequent with the dapagliflozin treatment group compared to the placebo treatment group, and were generally mild to moderate in intensity, with most patients responding to standard treatment.

"Type 2 diabetes is a complex disease that often requires patients to take multiple treatments to control their blood sugar levels, with DPP4 inhibitors being some of the most widely prescribed therapies," said Serge Jabbour, M.D., Division Director of Endocrinology, Thomas Jefferson University. "In this study, dapagliflozin, in addition to diet and exercise, resulted in reduced blood sugar levels when added to sitagliptin, a DPP4 inhibitor. These findings add to our understanding of the effect of dapagliflozin in combination with commonly prescribed type 2 diabetes treatments."

Bristol-Myers Squibb Company and AstraZeneca today announced results from a Phase 3 clinical study that showed the investigational compound dapagliflozin 10 mg demonstrated significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with type 2 diabetes.

More..

FDA accepts Avanir IND for AVP-923 to treat agitation in patients with AD

FDA accepts Avanir IND for AVP-923 to treat agitation in patients with AD: Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease (AD).

"This marks the fourth IND for the AVP-923 (AVP-923, a combination of    dextromethorphan  hydrobromide   and quinidine sulfate, see the structures from left to right respectively)

program, reflecting our belief that the unique dual sigma-1 and NMDA receptor pharmacology has significant potential," saidJoao Siffert, MD, senior vice president of R&D at Avanir Pharmaceuticals. "With no approved treatments for agitation in patients with Alzheimer's disease, this remains an area of tremendous unmet medical need. We look forward to initiating our clinical research program later this year." 

Ref : http://ir.avanir.com/phoenix.zhtml?c=61699&p=irol-newsArticle&ID=1704063

Lexicon presents six posters on LX4211 at ADA meeting

 

Lexicon presents six posters on LX4211 at ADA meeting: Lexicon Pharmaceuticals, Inc. will present six posters summarizing the mechanism of action and safety of LX4211, a dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) currently in mid-stage development for type 2 diabetes, at the 72nd Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, Pennsylvania during the Saturday morning poster session on June 9, 2012. 

Lexicon has completed dosing in a Phase 2b study of LX4211 in 299 patients with type 2 diabetes and expects to report top-line results at the end of June.

 

Amylin announces results from SYMLIN clinical studies on type 2 or 1 diabetes

Amylin announces results from SYMLIN clinical studies on type 2 or 1 diabetes: Amylin Pharmaceuticals, Inc. today announced results from new analyses of previously completed clinical studies demonstrating that patients with type 2 or type 1 diabetes achieved a greater proportion of blood glucose measurements in the normal range when SYMLIN (pramlintide acetate, see structure) injection treatment was used along with insulin...

Ref : http://amln.client.shareholder.com/releasedetail.cfm?ReleaseID=681698

Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes

 In continuation of my update on Bydureon

We know that, Exenatide (marketed as Byetta, Bydureon see structure) is a medication approved in April 2005 for the treatment of diabetes mellitus type 2. It belongs to the group of incretin mimetics and is manufactured by Amylin Pharmaceuticals. Exenatide in its Byetta form is administered as a subcutaneous injection (under the skin) of the abdomen, thigh, or arm, any time within the 60 minutes before the first and last meal of the day. A once-weekly injection has been approved as of January 27, 2012 under the trademark Bydureon. 

Now Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.......

 

Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes