New Drug Combo for Hepatitis C Shows Promise...

A new cocktail of two investigational drugs appears to have successfully cleared the hepatitis C virus in people who don't respond to standard treatment. What's more, the approach seems to work without the need for injections with interferon alpha, an onerous medication that causes serious side effects in many patients.

"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped," said study author Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School in Ann Arbor.

The study had two arms:  a group of 10 patients received four medications, including the two investigational drugs, the antivirals daclatasvir (see right structure)  and asunaprevir (see left structure-courtesy: ChemSpider), along with the standard treatment combination of interferon and ribavirin. The other arm of the study included 11 patients who received only the two investigational drugs. Both groups underwent treatment for 24 weeks.

The 10 patients on the four-drug regimen experienced a sustained virologic response with undetectable virus at the end of treatment and again at 12 weeks beyond their treatment, the researchers reported. In the two-drug group, four of the 11 patients also had undetectable levels of the hepatitis C virus in their blood 12 weeks after treatment ended.

"The four-drug arm was very impressive. These patients had not shown a response before and now we get a 90 to 100 percent rate of sustained response," said Lok....

Ref : http://www.nejm.org/doi/full/10.1056/NEJMoa1104430

More Evidence for Oxaliplatin as Colon Cancer Chemotherapy

In continuation of my update on Oxaliplatin 

Adding oxaliplatin to a standard chemotherapy regimen boosts survival rates for patients with advanced colon cancer, according to a new study that bolsters previous research on the drug by looking at a broader group of patients.

In past studies, oxaliplatin, as an adjuvant to the established treatment of 5-fluorouracil (5-FU), improved survival by up to 23 percent. But the new study looked at a different group of colon cancer patients, who were older, sicker, more racially diverse and had never participated in a controlled clinical study.

To determine whether oxaliplatin would show a similar benefit among a "real-world" population of patients, the authors sifted through five cancer registries containing survival information on more than 4,000 people with stage 3 colon cancer. All were younger than 75, and all had begun chemotherapy -- either a standard regimen or in combination with oxaliplatin -- within four months of having surgery between 2004 and 2009.

Researchers lead by Dr.Hanna K. Sanoff compared their survival rates with those of nearly 8,300 patients who had participated in one of five different clinical trials using oxaliplatin.

The addition of oxaliplatin to standard chemotherapy protocols was found to be just as effective in prolonging survival among the community-based set of patients - including the elderly, minorities and those with additional complicating health issues  who were not enrolled in studies.

More....

Voraxaze receives FDA approval for treatment of toxic methotrexate levels

Voraxaze receives FDA approval for treatment of toxic methotrexate levels: The U.S. Food and Drug Administration today approved Voraxaze (see structure, glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.  

Anti-malaria drug synthesised with the help of oxygen and light

In continuation of my update, artemisinin... The most effective anti-malaria drug can now be produced inexpensively and in large quantities. This means that it will be possible to provide medication for the 225 million malaria patients in developing countries at an affordable price. Researchers at the Max Planck Institute of Colloids and Interfaces in Potsdam and the Freie Universität Berlin have developed a very simple process for the synthesis of artemisinin, the active ingredient that pharmaceutical companies could only obtain from plants up to now. The chemists use a waste product from current artemisinin production as their starting substance. This substance can also be produced biotechnologically in yeast, which the scientists convert into the active ingredient using a simple yet very ingenious method..... Look at http://www.mpg.de/4984709/artemisinin_malaria

Dabigatran, New Blood Thinner Linked To Higher Heart Attack Risk

In continuation of my update on Dabigatran...

Researchers lead by Dr.Ken Uchino from the Cleveland Clinic in Ohio looked at seven trials involving Pradaxa (Dabigatran) that included more than 30,000 patients. This process, called a meta-analysis, uses data from published clinical trials to tease out a pattern that might not show up in a single study. Researchers found Pradaxa was associated with an increased risk of heart attack or acute coronary syndrome (heart attack or angina), compared with two other commonly used blood thinners, warfarin (Coumadin, Jantoven) and enoxaparin (Lovenox).

As per the claim by the researchers,  those taking Pradaxa, 1.19 percent had a heart attack or suffered from acute coronary syndrome compared with 0.79 percent of those taking either of the other drugs, they noted. Although there was a 33 percent increase in relative risk for a heart attack among those taking Pradaxa, the absolute increased risk -- that is, the added risk for any one individual of having a heart attack if on Pradaxa -- was 0.27 percent, researchers said.

Pradaxa was approved by the U.S. Food and Drug Administration in October 2010 for people with a common heart rhythm problem called atrial fibrillation. People with atrial fibrillation are at a higher risk for stroke and are often prescribed medication to prevent clotting....

Ref : http://my.clevelandclinic.org/cerebrovascular_center/medical_professionals/clinical_trials.aspx

Idenix Reports Positive Interim Data for HCV Nucleotide Inhibitor, IDX184

Idenix Pharmaceuticals, Inc.  a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, recently announced interim data from a 12-week phase IIb clinical trial of IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection.  IDX184 (below structure), a pan-genotypic oral nucleotide polymerase inhibitor, has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies..

Following are the highlights .....

• No serious adverse events observed in phase IIb study of IDX184; Data Safety Monitoring Board (DSMB) recommends continuation of the clinical trial. 
• In the 100 mg IDX184 arm, 73% of patients achieved a rapid virologic response (RVR) and 87% were undetectable at most recent visit; In the 50 mg IDX184 arm, 63% of patients achieved an RVR and 94% were undetectable at most recent visit.

 

More...

Positive Results from Clinical Study of CVT-301, an Inhaled L-dopa for Parkinson’s Disease..

In continuation of my update on Levodopa....

The Phase 1 study (by Civitas Therapeutics, Inc) showed that CVT-301 achieved sufficient plasma levels of L-dopa through inhaled delivery to the lung, resulting in a pharmacokinetic profile that supports its therapeutic potential.  Immediate absorption and dose proportional pharmacokinetics were seen across all doses tested.  In addition, all doses tested of CVT-301 were safe and well tolerated.  

More....

Ref : http://civitastherapeutics.com/cms/sites/default/files/news/CVT-301%20Clinical%20results%20press%20release%20FINAL%2006Jan2012_0.pdf

Breakthrough in Treatment to Prevent Blindness | www.ucsf.edu

In continuation of my update on Azithromycin....
Breakthrough in Treatment to Prevent Blindness | www.ucsf.edu

A Novel Neurotrophic Drug for Cognitive Enhancement and Alzheimer's Disease

A new drug candidate may be the first capable of halting the devastating mental decline of Alzheimer's disease.  The drug, known as J147 (above  structure), improved memory and prevented brain damage caused by the disease claims the researchers from Salk's Cellular Neurobiology Laboratory, lead by David Schubert. The new compound,  could be tested for treatment of the disease in humans in the near future.Researchers add that, J147 enhances memory in both normal and Alzheimer's mice and also protects the brain from the loss of synaptic connections.

Salk researchers went on to show that it prevented cognitive decline in animals with Alzheimer's and that mice and rats treated with the drug produced more of a protein called brain-derived neurotrophic factor (BDNF), a molecule that protects neurons from toxic insults, helps new neurons grow and connect with other brain cells, and is involved in memory formation.

Because of the broad ability of J147 to protect nerve cells, the researchers believe that it may also be effective for treating other neurological disorders, such as Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis (ALS), as well as stroke.

Although it is yet unknown whether the compound will prove safe and effective in humans, the Salk researchers' say their results suggest the drug may hold potential for treatment of people with Alzheimer's...

Ref : http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0027865

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV: Bristol-Myers Squibb Company announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

Alkermes commences ALKS 9070 phase 3 clinical trial for schizophrenia...

Alkermes plc (NASDAQ: ALKS)  announced the initiation of a phase 3 clinical trial of ALKS 9070 (Aripiprazole) for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole...

Ref : http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-corporateNewsArticle&ID=1640788&highlight=

Lostartan can reduce cigarette smoke-induced lung injury

Researchers from Johns Hopkins University, BaltimoreLostartan, lead by have found that, Dr.Enid R. Neptune Losartan a drug used widely in the clinic (e.g., to treat high blood pressure), reduced lung disease in mice caused by exposure to cigarette smoke. Losartan blocks the protein angiotensin receptor type 1, and its effects on cigarette smoke-induced lung injury were a result of the fact that blocking angiotensin receptor type 1 leads to a decrease in levels of the soluble molecule TGF-beta. The authors therefore suggest that other TGF-beta-targeted therapeutics might also be viable candidates for the treatment of  chronic obstructive pulmonary disease, COPD....

Ref : http://www.jci.org/articles/view/46215?search[article_text]=&search[authors_text]=Enid+Neptune

MK 1775 shows promise against sarcomas..........

   2-Allyl-1-(6-(2-hydroxypropan-2-yl)pyridin-2-yl)-6- (4-(4-methyl- piperazin-1-yl)phenylamino)-1H-pyra -zolo [3,4-d]pyrimidin-3(2H)-one.  

MK 1775 (see structure), a small, selective inhibitor molecule, has been found to be active against many sarcomas when tested by researchers at Moffitt Cancer Center in Tampa, Fla. Researchers found that MK1775 treatment induces apoptopic cell death in four sarcoma cell lines at clinically relevant doses.

To further prove that inhibition of Wee1 by MK1775 leads to mitotic cell death in sarcomas cells, the researchers performed additional studies, including studies on sarcomas related to mutations, such as with the p53 gene. They also showed that MK1775 was an active inhibitor of Wee1 regardless of the p53 mutation status of the tumors in the cell lines tested.

"The cytotoxic effect of Wee1 inhibition on sarcoma cells appears to be independent of p53 mutation status following our testing sarcoma cell lines with different p53 mutations," he said. "All of them were highly sensitive to MK1775, suggesting that Wee1 inhibition may represent a novel approach in the treatment of sarcomas."

Researchers concluded that their laboratory tests on sarcoma cell lines suggest that MK1775 is effective as a monotherapy even in the cell lines that include p53 wild, p53 null and p53 mutant statuses.

More... 

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint

In continuation of my update on gemcitabine

Oncolytics REOLYSIN-Gemzar combination Phase 2 pancreatic cancer clinical trial meets primary endpoint: Oncolytics Biotech Inc. announced the interim data from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar) in patients with advanced pancreatic cancer (REO 017) indicated that the clinical study had successfully reached its primary endpoint, and that the drug combination is active.

New Antibodies Treat Autoimmune Disease like Crohn's in Mice....

 Synthetic drugs treat (below structure)  Crohn's disease in mice.................

[zinc-binding motif (where X is any amino acid) in MMPs, a symmetrical tripodal tris-imidazol–zinc complex (Zn-tripod; ZnC₃₆H₅₉N₁₁O₈)]


New Antibodies Treat Autoimmune Disease in Mice
Ref : http://www.nature.com/nm/journal/vaop/ncurrent/full/nm.2582.html