Arena Pharmaceuticals and Eisai Announce FDA Approval of BELVIQ® (lorcaserin HCl) for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese (NASDAQ:ARNA)

In continuation of my update on lorcaserin

Arena Pharmaceuticals and Eisai Announce FDA Approval of BELVIQ® (lorcaserin HCl) for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese (NASDAQ:ARNA)

Enoxaparin prevents PVT in advanced cirrhosis

In continuation of my update on Enoxaparin

Enoxaparin (see structure) significantly reduces portal vein thrombosis (PVT) and increases overall survival in patients with advanced cirrhosis, the results of an Italian study show. The authors also found additional benefits beyond the drug's established effect on PVT.

The study included 70 cirrhosis patients with a Child-Pugh score of 7-10, aged 18-75 years who received enoxaparin 4000 IU/day for 48 weeks or no treatment. Patients were followed up for a mean of 58 weeks in the control group and 89 weeks in the enoxaparin group, with ultrasound evaluation of the portal vein system every 3 months.

As reported by the authors, patients receiving enoxaparin were 90% less likely to experience PVT than those who did not. Overall, 8.8% of enoxaparin-treated patients developed PVT compared with 27.7% in the control group, and no cases developed in the enoxaparin group within the first 2 years.

While decompensation occurred at an equal rate in both groups during the follow-up period, significantly fewer patients experienced progression during active treatment (11.7 vs 59.4%).

 Enoxaparin prevents PVT in advanced cirrhosis

FDA Approves Myrbetriq...

“Myrbetriq (see below structure) is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago,” said Steven Ryder, MD, president, Astellas Pharma Global Development. “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.”....

FDA_Approval_Press_Release_FINAL 6.28.12.pdf (application/pdf Object)

Lexicon announces results from two initial trials of LX4211 for type 2 diabetes

Thirty-six patients with type 2 diabetes mellitus (T2DM) were randomized 1:1:1 to receive a once-daily oral dose of placebo or 150 or 300 mg of the dual SGLT1/SGLT2 inhibitor LX4211 for 28 days. Relative to placebo, LX4211 (see structure) enhanced urinary glucose excretion by

inhibiting SGLT2-mediated renal glucose reabsorption; markedly and significantly improved multiple measures of glycemic control, including fasting plasma glucose, oral glucose tolerance, and HbA1c; and significantly lowered serum triglycerides. LX4211 also mediated trends for lower weight, lower blood pressure, and higher glucagon-like peptide-1 levels. In a follow-up single-dose study in 12 patients with T2DM, LX4211 (300 mg) significantly increased glucagon-like peptide-1 and peptide YY levels relative to pretreatment values, probably by delaying SGLT1-mediated intestinal glucose absorption. In both studies, LX4211 was well tolerated without evidence of increased gastrointestinal side effects. These data support further study of LX4211-mediated dual SGLT1/SGLT2 inhibition as a novel mechanism of action in the treatment of T2DM.

SGLT1/SGLT2 inhibition

Lxicon announces results from two initial trials of LX4211 for type 2 diabetes: Lexicon Pharmaceuticals, Inc. announced today the publication of results from two initial trials of LX4211 in patients with type 2 diabetes in the online edition of the journal Clinical Pharmacology & Therapeutics.

Provectus Pharmaceuticals - ASCO 2010

 We know that,

Rose Bengal (4,5,6,7-tetrachloro-2',4',5',7'-tetraiodofluorescein) is a stain. Its sodium salt is commonly used in eye drops to stain damaged conjunctival and corneal cells and thereby identify damage to the eye. The stain is also used in the preparation of Foraminifera for microscopic analysis, allowing the distinction between forms that were alive or dead at the time of collection.

A form of Rose Bengal is also being studied as a treatment for certain cancers and skin conditions. The cancer formulation of the drug, known as PV-10, (see the structure) is currently undergoing clinical trials for melanoma and breast cancer. The company also has formulated a drug based on Rose Bengal for the treatment of eczema and psoriasis; this drug, PH-10, is currently in clinical trials as well.

 Top-line final data from Provectus’ PV-10 phase 2 trial on metastatic melanoma

Provectus Pharmaceuticals - ASCO 2010

Study links carcinogens to cancer stem cells – but spinach can help | News & Research Communications | Oregon State University

In continuation of my update on spinach

Study links carcinogens to cancer stem cells – but spinach can help | News & Research Communications | Oregon State University

Xalkori Helps Lung Cancer Patients | News | Drug Discovery and Development Magazine

In continuation of my update Crizotinib/Xalkori 

Pfizer Inc. said its lung cancer drug Xalkori helped lung cancer patients who had previously been treated for the disease.

Pfizer said Xalkori (see the structre)  worked better than two older cancer drugs in the late-stage clinical trial. All patients had a rare type of non-small cell lung cancer and had previously been treated. The Food and Drug Administration approved Xalkori in August for use in patients whose cancer had not been treated.

In the study, patients took Xalkori, Alimta, or Taxotere. Pfizer said patients who took Xalkori had greater progression-free survival, or time from the start of treatment until they died or experienced disease progression. Xalkori is a pill taken twice per day while Alimta and Taxotere are given intravenously.

Xalkori is approved for use against non-small cell lung cancer in patients who have an abnormal gene that causes tumor growth. Xalkori blocks that gene, which is found in 1 percent to 7 percent of non-small cell lung cancer. About 85 percent of lung cancers are the non-small cell variety...

More...

Xalkori Helps Lung Cancer Patients | News | Drug Discovery and Development Magazine

Anacardic acid can rescue some ALS phenotypes in vitro...

A research group at the Center for iPS Cell Research and Application (CiRA) at Japan's Kyoto University has successfully recapitulated amyotrophic lateral sclerosis (ALS)-associated abnormalities in motor neurons differentiated from induced pluripotent stem cells (iPSCs) obtained from patients with familial ALS, a late-onset, fatal disorder which is also known for Lou Gehrig's disease. In a drug screening assay using the disease model, the team further found that the chemical compound anacardic acid (see structure)  can rescue some ALS phenotypes in vitro. 

Ref : http://www.cira.kyoto-u.ac.jp/e/pressrelease/news/120801-195947.html

Green coffee beans show potential for losing weight..

In  a  study  presented,  at  the  American  Chemical  Society’s  spring     national meeting in San Diego, 16 over weight young adults took, by turns, a low dose of green coffee bean extract, a high  dose  of  the supplement, and a placebo. Though the study was small, the results were striking: Subjects lost an average of 17.5 pounds in 22 weeks and reduced their overall body weight by 10.5%.If green coffee extract were a medication seeking approval from the Food and Drug Administration, these results would make it a viable candidate — more than 35% of subjects lost more than 5% of their body weight, and weight loss appeared to be greater while subjects were taking the pills than when they were on the placebo.

Joe Vinson, the University of Scranton chemist who conducted the pilot study, said the findings should pave the way for more rigorous research on coffee bean extract’s effects. A larger trial involving 60 people is being planned.Vinson, whose research focuses on plant polyphenols and their effects on human health, said it appears that green coffee bean extract may work by reducing the absorption of fat and glucose in the gut; it may also reduce insulin levels, which would improve metabolic function. There were no signs of ill effects on any subjects, Vinson reported.

The study used a “cross-over” design, which allowed each subject to serve as his or her own comparison group. For six weeks, volunteers swallowed capsules three times a day, ingesting either 700 or 1,050 milligrams of green coffee extract a day or taking a placebo. After a two-week break, they moved, round-robin style, to another arm of the trial.Subjects did not change their calorie intake over the course of the trial. But the more extract they consumed, the more weight and fat they lost. Altogether, they reduced their body fat by 16%, on average.Of the 16 volunteers, six wound up with a body mass index in the healthful range.One downside is that the extract is “extremely bitter.” It would be difficult to take without a lot of water, Vinson reported.....

Ref : Detailed article read at

I found the following link more informative...

 http://greencoffeebeanreviews.com/

‘Orphan drug’ used to treat sleep disorders may be a potent cancer-fighting agent used for many malignancies, study finds

An inexpensive "orphan drug" used to treat sleep disorders appears to be a potent inhibitor of cancer cells, according to a new study led by scientists at Fred Hutchinson Cancer Research Center. Their novel approach, using groundbreaking technology that allows rapid analysis of the genome, has broad implications for the development of safer, more-effective cancer therapies.  

A research team led by corresponding author Carla Grandori, M.D., Ph.D., an investigator in the Hutchinson Center's Human Biology Division, used a high-speed robotic technology called high-throughput screening and a powerful genetic technique called siRNA genesilencing to uncover fatal weaknesses in cancer cells driven by an oncogene known as "Myc," which is hyperactive in many cancers, including those of the brain, breast, lung, ovary and liver.

‘Orphan drug’ used to treat sleep disorders may be a potent cancer-fighting agent used for many malignancies, study finds

Exelixis reports data from cabozantinib phase 3 trial on MTC

Exelixis, Inc. reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The trial, known as EXAM, met its primary endpoint of improving progression-free survival (PFS), with patients in the cabozantinib (see structure) arm achieving a median PFS of 11.2 months compared with 4.0 months for patients in the placebo arm. Overall response rate (ORR), a secondary endpoint, was 28% in the cabozantinib arm and 0% in the placebo arm. Estimated PFS at one year was 47.3% with cabozantinib vs. only 7.2% with placebo. Data for overall survival (OS), another secondary endpoint, are not yet mature. Patients on the cabozantinib arm of the trial received a dose of 140 mg (free base equivalent). Adverse events were generally manageable allowing for treatment with cabozantinib for prolonged periods of time. Exelixis recently submitted a New Drug Application (NDA) for cabozantinib in MTC to the U.S. Food and Drug Administration (FDA).

More...

Exelixis reports data from cabozantinib phase 3 trial on MTC: Exelixis, Inc.  reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).

Experimental drug tested against multi-drug resistant TB

"Researchers who tested a novel type of antibiotic against multi-drug-resistant tuberculosis [MDR-TB] are reporting that nearly half of patients who got the new drug cleared the bacteria from their lung fluid in two months," according to a study published  in the New England Journal of Medicine. Japanese pharmaceutical company Otsuka developed the experimental drug, delamanid (see structure), and "also designed and financed the clinical trial, which took place in 17 medical centers across nine countries." 

 "'We've invested a lot of time and money to develop this drug, but we are not seeking robust sales growth immediately,' Masuhiro Yoshitake, Otsuka's head of tuberculosis projects, said in an interview," Bloomberg Businessweek reports. "We want to begin selling to people who know how to use the drug," he added, the news service notes. "Doctors must balance the need to fight hard-to-treat cases against prolonging the medicine's potency,"

More : http://www.nejm.org/doi/full/10.1056/NEJMoa1112433

Experimental drug tested against multi-drug resistant TB

GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia

GlaxoSmithKline plc  and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant® (gabapentin enacarbil see structure below) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults. 

 The efficacy and safety of Horizant for the management of PHN was evaluated in a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. 

The recommended dosage for the management of PHN in adults is 600 mg twice daily. Treatment should be initiated at a dose of 600 mg in the morning for three days followed by 600 mg twice daily (1,200 mg/day) beginning on day four. Doses must be adjusted in patients with impaired renal function. In the 12-week, controlled study in patients with PHN, somnolence and dizziness were the most frequently reported side effects. Somnolence was reported in 10% of patients treated with 1,200 mg of Horizant per day compared with 8% of patients receiving placebo. Dizziness was reported in 17% of patients receiving 1,200 mg of Horizant per day compared with 15% of patients receiving placebo.

GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia

Combination [of Vismodegib (GDC-0449) and Gemcitabine] therapy may help defeat pancreatic cancer

 In continuation of my update on (GDC-0449) Visodegib and Gemcitabine

GDC-0449 targets the Smoothened (SMO) protein in the Hedgehog signaling pathway. It was approved for use in basal cell carcinoma and is marketed as vismodegib. Kim and his colleagues felt that treating patients with pancreatic cancer first with GDC-0449 and then with the standard chemotherapeutic drug gemcitabine might disrupt the desmoplastic stroma and improve the efficacy of the chemotherapy. 

They evaluated this strategy in treatment-naive patients with advanced pancreatic cancer. Patients underwent needle biopsies of the cancer before and after taking GDC-0449 for three weeks to study the effects of GDC-0449 on the Hedgehog pathway signals, tumor stroma and pancreatic cancer stem cells. Gemcitabine was added to GDC-0449 following the second biopsy.

Combination therapy may help defeat pancreatic cancer

Keryx Biopharmaceuticals Announces Top-Line Data from the Perifosine (KRX-0401) X-PECT Phase 3 Clinical Trial

Keryx Biopharmaceuticals, Inc. reported today that the Phase 3 "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

This Phase 3 trial was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.  468 patients at sixty-five U.S. sites participated in this study. 

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are all extremely disappointed with the results of the study.  We thank the investigators who participated in what we believe was a well-run study, despite the outcome.  We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned."

Mr. Bentsur commented further, "With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter."

KRX-0401 (perifosine) is in-licensed by Keryx from AeternaZentaris Inc. in the United States, Canada and Mexico.

Ref : http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-newsArticle&ID=1678920&highlight=

Cancer publishes Aeterna Zentaris' perifosine Phase 2 trials in RCC

RESULTS:

In the Perifosine 228 trial, 1 patient achieved a partial response (objective response rate, 4%; 95% confidence interval, 0.7%-20%), and 11 patients (46%) had stable disease as their best response. The median progression-free survival was 14.2 weeks (95% confidence interval, 7.7-21.6 weeks). In the Perifosine 231 trial, 5 patients achieved a partial response (objective response rate, 10%; 95% confidence interval, 4.5%-22.2%) and 16 patients (32%) had stable disease as their best response. The median progression-free survival was 14 weeks (95% confidence interval, 12.9, 20.7 weeks). Overall, perifosine was well tolerated, and there were very few grade 3 and 4 events. The most common toxicities included nausea, diarrhea, musculoskeletal pain, and fatigue.

CONCLUSIONS:

Although perifosine demonstrated activity in patients with advanced RCC after failure on VEGF-targeted therapy, its activity was not superior to currently available second-line agents. Nonetheless, perifosine may be worthy of further study in RCC in combination with other currently available therapies. 


Ref : http://onlinelibrary.wiley.com/doi/10.1002/cncr.27668/abstract

 Cancer publishes Aeterna Zentaris' perifosine Phase 2 trials in RCC//

Drug shows promise as skin cancer treatment

In continuation of my update on Vismodegib

Drug shows promise as skin cancer treatment: A new vismodegib, drug for a type of skin cancer caused by a rare genetic disease can not only substantially shrink the tumors, but can also prevent the growth of new cancers, US investigators have discovered.

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia

In continuation of my update on Lurasidone..

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia: Sunovion Pharmaceuticals Canada Inc. today announced that the New Drug Submission (NDS) for LATUDA (lurasidone HCl), for the treatment of adult patients with acute schizophrenia has been approved by Health Canada.

Insomnia Drug Closer to Approval | News | Drug Discovery and Development Magazine

Merck & Co. said that its experimental insomnia drug suvorexant (see structure) helped patients fall asleep faster and stay asleep longer in two late-stage tests of the drug, seen as a potential blockbuster in a multibillion-dollar market. 

Merck said the drug worked better than a placebo at measurements including total sleep time, time to falling asleep, and continuous sleep after one month and three months of treatment. The company said patients reported better results on suvorexant compared with placebo, and their sleeping habits also were measured electronically.

Suvorexant is a new type of insomnia drug designed to help patients sleep while minimizing morning grogginess. It is one of Merck's major drug candidates. The company plans to file for U.S. marketing approval this year, and it is one of six planned product filings for Merck in 2012 and 2013.

The two trials involved more than 2,000 patients who had insomnia that was not caused by another medical problem. The most common side effects of suvorexant were tiredness and headache.
 

Insomnia Drug Closer to Approval | News | Drug Discovery and Development Magazine

Two Possible Treatments for Bipolar Disorder Found

Researchers at the University of Leeds investigating the genetic causes of bipolar disorder have identified two new drugs – one of which has already been found safe in clinical trials – that may be effective in treating the disorder.

Bipolar disorder is characterised by mood swings between mania and depression. Like autism, it is thought to be a spectrum of disorders and, although its causes are not well understood, it seems to run in families and is thought to be caused by both genetic and environmental factors.

Dr Steve Clapcote, of the Institute of Membrane and Systems Biology at the University of Leeds, who led the study, says: "We suspected from published studies of bipolar patients that levels of enzymes known as NKA or sodium pumps may be abnormal in bipolar disorder, but so far the evidence has not been convincing enough to warrant detailed clinical investigations."

The research, published today in the US journal Proceedings of the National Academy of Sciences (PNAS), used a strain of genetically modified mice that exhibit symptoms very similar to humans in the manic phase of the disorder.

The mice were bred with a particular mutation that prevents the NKA enzyme from functioning normally. When tested, the mice showed characteristics closely associated with bipolar disorder, such as increased tendency to take risks, hyperactivity, and disturbed sleep patterns. They also exhibited reduced mania when treated with anti-manic drugs.

Current drugs available to treat bipolar disorders, although usually successful, are limited to either Lithium or Valproate. They can't be matched to specific types of bipolar disorder, and can sometimes cause unpleasant side effects. There is therefore a need for treatments which can be better targeted, and which are more effective and better tolerated by patients.

The Leeds researchers found that the mice showed decreased activity of the NKA enzyme, as well as increased activity of a protein called ERK. Drugs known to have an effect on these two elements were administered to the mice, including Rostafuroxin and SL327 (see structure right), and both reduced their mania-like behaviour.

"Rostafuroxin (see structure left) has been found to be safe in clinical trials for treating high blood pressure," explained Dr Clapcote. "No one has previously looked at this drug's effects on the brain, but our mouse studies show there's a possibility that it might also be suitable for people with mania. Similarly, SL327, which is known to inhibit ERK activity, was also found to reduce manic behaviour in the mice."

"We think there is enough evidence now to start screening people with bipolar disorder to look for genetic mutations in the same NKA enzyme as that affected in our mice," says Dr Clapcote. "This will help us identify whether there is a group of bipolar patients that may be responsive to the novel treatments we have tested in the mice."....

Reformulated Copaxone Meets Goals........

Teva Pharmaceutical Industries Ltd. said that a new version of its multiple sclerosis drug Copaxone met its goals in a late-stage clinical trial.....

We know that, COPAXONE is the brand name for glatiramer acetate (formerly known as copolymer-1). Glatiramer acetate, the active ingredient of COPAXONE (glatiramer acetate) , consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.

Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:

(Glu, Ala, Lys, Tyr)_x•xCH₃COOH

(C₅H₉NO₄•C₃H₇NO₂•C₆H₁₄N₂O₂•C₉H₁₁NO₃)_x•xC₂H₄O₂

CAS - 147245-92-9

COPAXONE (glatiramer acetate) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of solution contains 20 mg of glatiramer acetate and 40 mg of mannitol. The pH range of the solution is approximately 5.5 to 7.0. The  biological activity of COPAXONE (glatiramer acetate) is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.

Reformulated Copaxone Meets Goals | News | Drug Discovery and Development Magazine

New action for ancient heart drug

New action for ancient heart drug

Since the 13th century, the herb and poisonous plant Foxglove has been used to cleanse wounds and its dried leaves were carefully brewed by Native Americans to treat leg swelling caused by heart problems. Digoxin (see structure), the active ingredient in digitalis, or the poisonous plant Foxglove, can enhance the body's own protective mechanism against high blood pressure and heart failure.

 

High blood pressure can be prevented by reducing salt intake, being active and keeping a healthy weight, but about 1 in 3 Americans has high blood pressure, also called hypertension, which can damage the body in many ways.  Most current treatments prevent excess hormone and stress signals that can lead to high blood pressure and heart failure.

But recent studies have found that the body has the ability to keep excess stimulation in check through production of a family of inhibitors called RGS proteins. Researchers looked for ways to "re-purpose" old drugs to tap into this protective mechanism which is lost among some individuals with high blood pressure and heart failure. 

Ref; http://www.uofmhealth.org/news/digoxin-0613

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

Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease

Post-hoc analysis evaluated more than 200 patients with CKD stages one through four (n=34, 74, 80, 23, respectively) who were randomized to receive treatment with KRYSTEXXA (pegloticase, see structure) 8 mg every other week, 8 mg every four weeks or placebo. Baseline CKD stage was similar across treatment arms, and there was no significant difference in rates of response to KRYSTEXXA by CKD stage (p<0.311). Additionally, treatment with KRYSTEXXA did not impact estimated GFR levels in patients with or without CKD. Similar results were seen in a 24-month open-label extension study.                 

In another study presented as a poster at EULAR, 35 percent of patients diagnosed with gout in Western Europe reported experiencing pain in the last 30 days (versus 20 percent in the control group of those who did not report gout; p<0.05).  Of those patients, 23 percent reported severe daily pain (versus 13.5 percent in control group; p<0.05), which impacted quality of life as assessed by the SF-12 health outcome measurement tool.  Based on study data, it is estimated that one in five gout patients in Western Europe experiences moderate to severe daily pain, one of the symptoms of gout.

Ref : http://investor.savient.com/releasedetail.cfm?ReleaseID=680494

Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease: Savient Pharmaceuticals, Inc. announced new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA (pegloticase) regardless of baseline CKD stage.

AB Science announces data from development program of masitinib in GIST

In continuation of my update on Masitinib

AB Science announces data from development program of masitinib in GIST: AB Science SA, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), announces today that data from the development program of masitinib in gastrointestinal stromal tumors (GIST) have been presented as part of three presentations delivered at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting, 1-5 June in Chicago, Illinois.

Three-drug regimen provides rapid, durable responses for multiple myeloma

In continuation of my update on three drug combination

A three-drug treatment for the blood cancer multiple myeloma provided rapid, deep and potentially durable responses, researchers report today online in Blood, the Journal of the American Society of Hematology, and yesterday, Sunday, June 3, 2012, at the American Society of Clinical Oncology's Annual Meeting in Chicago, IL, USA.

The researchers, led by Andrzej J. Jakubowiak, MD, PhD, professor of medicine and director of the multiple myeloma program at the University of Chicago Medical Center, found that combining carfilzomib, a next generation proteasome inhibitor, with two standard drugs -- lenalidomide and low-dose dexamethasone compared favorably to other frontline regimens.
The longer patients stayed on the therapy, the better their response. After at least eight 28-day cycles of treatment, 61 percent of the 36 patients who remained on the therapy had a stringent complete response, defined as no detectable tumor cells or myeloma protein in the blood or bone marrow; 78 percent had at least a near complete response. More than 90 percent of patients had no progression of their disease at two years.

"These rapid and durable response rates are higher than those achieved by the best established regimens for newly diagnosed multiple myeloma," said Jakubowiak. "We have observed excellent efficacy, the best reported to date, and very good tolerability, including limited peripheral neuropathy that has been problematic with other drug combinations."

 Ref : http://www.uchospitals.edu/news/2012/20120604-myeloma.html

 Three-drug regimen provides rapid, durable responses for multiple myeloma