FDA approves Romidepsin for CTCL....

We knew that, Romidepsin (Istodax), is an anticancer antibiotic undergoing clinical trials as a treatment for cutaneous T-cell lymphoma, peripheral T-cell lymphoma, and a variety of other cancers.

About Romidepsin :

Romidepsin, is a natural product obtained from the bacteria Chromobacterium violaceum, and works by blocking enzymes known as histone deacetylases and inducing apoptosis in tumor cells. It is sometimes referred to as depsipeptide, after the class of molecules to which it belongs.

FDA Approval ( Nov. 6, 2009) : The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL). Patients with localized CTCL on the skin are treated with topical agents or phototherapy, but chemotherapy may be used if the cancer advances. Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used. Other drugs approved for CTCL are Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene). More...

Yoga practitioners have a healthy heart

Yoga practitioners have a healthy heart

Results of Phase 3 study of fidaxomicin...

We know that Fidaxomicin (also known as lipiarmycin, lipiarmycin A3, tiacumicin B, clostomicin B1, and OPT-80) is a new narrow spectrum macrocyclic antibiotic drug and being developed by Optimer Pharmaceuticals for treatment of Clostridium difficile infection. It works by inhibiting the bacterial enzyme RNA polymerase. It is active against gram positive bacteria especially clostridia.

Recently, Optimer Pharmaceuticals, Inc. (2. Nov, 2009) announced the presentation of new data from fidaxomicin's North American phase 3 study at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, PA. The results are really encouraging and as per the claim by the company fidaxomicin is associated with faster resolution of diarrhea. In patients with more pronounced diarrhea (ie. not resolving in the first 24 hours of therapy), fidaxomicin was associated with a faster time to resolution of diarrhea than vancomycin (79 hrs vs. 105 hrs). The company claims that the faster time to resolution of diarrhea and improved outcomes for patients requiring concomitant antibiotics are important factors for physicians to consider when selecting a treatment for CDI more interesting factor is the significantly lower recurrence rate and higher global cure rate..

Ref : http://www.optimerpharma.com/news.asp?news_story=100&page_num=

Clinical Trial Confirms Single-Agent Efficacy of Rexin-G in Metastatic Pancreas Cancer...

Epeius Biotechnologies, confirms the first real breakthrough for pancreatic cancer seen in years; publishes a landmark report of tumor-targeted Rexin-G as stand-alone therapy in chemotherapy-resistant pancreatic cancer.

By meeting all primary and secondary study endpoints of safety and efficacy, Rexin-G has succeeded in an area of clinical oncology where many promising biologics have simply failed to deliver. By achieving both progression-free survival and overall survival benefits in pancreas cancer, while avoiding untoward systemic or dose-limiting toxicities, Rexin-G has raised the bar for the entire biopharmaceutical industry, as it inaugurates the emerging field of precision-targeted genetic medicine. The outstanding results of this advanced U.S. clinical trial confirm the results of previous preclinical and clinical studies conducted in the Philippines (where Rexin-G is approved for all solid tumors), and demonstrate beyond contestation that Rexin-G, at these effective dose levels, exhibits profound anti-tumor activity when administered as a single therapeutic agent in otherwise intractable Stage IV pancreatic cancer..

Interested one can see the mechanism of action ib this video.

Ref : http://www.epeiusbiotech.com/press-101409.asp

FDA advisory committee reviews 'azfibrocel-T' for treating wrinkles...

We know about the modern day innovative treatments for wrinkle reduction like laser skin resurfacing treatments, facelift surgery and dermal fillers such as Restylane and Botox. However, cell therapy may be on more option claims Fibrocell Science Inc (formerly Isolagen, Inc).

The company has focused on developing regenerative fibroblast cells for aesthetic, medical and scientific application. As per the claim by the company, the fibroblasts are extracted, multiplied and then re-injected into the skin as a personalized treatment, allowing for the formation of new cells and stronger connective tissue fibers. Over time, this results in a significant reduction of wrinkles and fine lines, and creates a healthier, more rejuvenated appearance. Recently (12th Oct, 2009), FDA has reviewed "azfibrocel-T, an autologous cell therapy" and the company is expecting to get green signal by January 4, 2010....

Ref : http://www.fibrocellscience.com/10_09_09.htm

Positive results from Phase 3 trial of wieght reducing drug Lorcaserin...

We knew that Lorcaserin, is a serotonergic weight-loss drug developed by Arena Pharmaceuticals. It is currently undergoing the final phase of clinical trials in preparation for submission for FDA approval.

Lorcaserin is a selective 5-HT2C receptor agonist and in vitro testing of the drug showed reasonable selectivity for 5-HT2C over other related targets 5-HT2C receptors are located almost exclusively in the brain, and can be found in the choroid plexus, cortex, hippocampus, cerebellum, amygdala, thalamus, and hypothalamus.

Mode of action : Arena believes that the activation of 5-HT2C receptors in the hypothalamus promotes weight loss through appetite suppression, and this is supported by animal studies, but it is unclear whether the dose range used in human trials will be sufficient to demonstrate the same level of weight loss. While it is generally thought that 5-HT2C receptors help to regulate appetite as well as mood, motor behavior, and endocrine secretion, the exact mechanism of appetite regulation is not yet known.

Arena reported positive, highly significant top-line results in September 2009. Arena will also present new data analyses from lorcaserin's successful Phase 3 pivotal program in oral and poster sessions. In an independent clinical symposium, expert academic scientists and physicians will spotlight the 5HT-2C mechanism for weight management. As per the claim by the company, the positive results from the Phase 3 pivotal program highlight lorcaserin's potential to provide physicians with a treatment option that combines three important attributes - efficacy, safety and tolerability. Hope in the days to come will have a drug to treat obesity too...

Ref : http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=417902

Antisense Therapeutics completes repeat-dosing toxicology studies for ATL1103

Antisense Therapeutics completes repeat-dosing toxicology studies for ATL1103

One can see the products under development...(by the same co)..

Positive Phase 2 results of Telaprevir...

I did mention about telaprevir (structure) in my earlier blog, and following other developments for hepatitis C (blogs). Now Vertex Pharmaceuticals has announced the results of Phase 2.

The results are really encouraging and as per the claim by the company "more than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis".

Across the four arms, SVR rates were 82 and 83 percent in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively) and 81 and 85 percent in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen.

Ref : http://investors.vrtx.com/releasedetail.cfm?ReleaseID=420611

DNA barcoding- a new window into the relations between hunter and prey in the wild ....

The scientific ability to quickly and accurately identify species through DNA "barcoding" is being embraced and applied by a growing legion of global authorities - from medical and agricultural researchers to police and customs authorities to palaeontologists and others.

More.......Third International Barcode of Life conference ......

Methacetin breath test predicts long-term survival in patients with chronic viral hepatitis

Methacetin breath test predicts long-term survival in patients with chronic viral hepatitis