Saturday, May 5, 2012

MOCK GPAt test

GPAT mock test 
1
http://www.mediafire.com/file/2y637j9m5vfl33z/MINOR%201.pdf

2
http://www.mediafire.com/file/6mn90oud0o2hr8u/MINOR%202.pdf

3
http://www.mediafire.com/file/0lkgpj1bl7hg1ha/MINOR%203.pdf
4
http://www.mediafire.com/file/bxfm0bmxvuv4oh4/MINOR%204.pdf
5
http://www.mediafire.com/file/ealqxb534vxz8fi/MINOR%205.pdf
6
http://www.mediafire.com/file/35ytmb45zunz2t7/MINOR%207.pdf
7
http://www.mediafire.com/file/smkxf7syk17ofza/MINOR%208.pdf
8
http://www.mediafire.com/file/35ytmb45zunz2t7/MINOR%207.pdf

9
http://www.mediafire.com/file/rtlb9h2gf7up2rh/MINOR%209.pdf
10

http://www.mediafire.com/file/vghlrlasgdmaj6h/MINOR%2010.pdf
11
http://www.mediafire.com/file/z99sxp6146b2fuy/MINOR%2011.pdf
12 for Pharmaceutics
http://www.mediafire.com/file/a61gqou7jtz61p0/MINOR%2013%20%20%20P%27ceutics.pdf

13 for Pharmacology
http://www.mediafire.com/file/hbb28x098rxs9h8/MINOR%2015%20P%27cology.pdf

14 for Pharmacognosy

http://www.mediafire.com/file/y7pd8no3xdv3bdp/MINOR%2014%20P%27cognosy.pdf

15
http://www.mediafire.com/file/pb0a2btlz8r1thg/GRAND%20TEST.pdf

Sunday, September 11, 2011

SPX-106T Treatment Yields Significant Reductions in Serum VLDL and LDL Cholesterol in Mice

SPX-106T Treatment Yields Significant Reductions in Serum VLDL and LDL Cholesterol in Mice

 

Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced that its drug candidate, SPX-106, achieved statistically significant reductions in VLDL and LDL cholesterol when administered in combination with Dtagatose (SPX-106T) for nine weeks to genetically engineered mice prone to dyslipidemia.  The aortas of these mice also showed reductions in the extent of atherosclerotic lesions as measured by lesion area in response to treatment.  These lipoprotein analysis and lesion measurement results represent the final data from the study whose earlier triglycerides outcome was first announced on June 2, 2011.

Treatment of animals using a range of low doses of SPX-106T twice-daily significantly reduced VLDL by 35% (from 127 mg/dl to 82 mg/dl) and LDL by 18% (from 141 to 116 mg/dl) (p=0.05).  Importantly, the same therapy also reduced atherosclerotic lesion area in the aortic arch to less than one-half the value of the untreated group (graphic available at http://www.spherix.com/pdf/press/PRgraphic9-12-11.pdf).  The aortic arch is generally the region where vessel disease first develops.  In longer studies and in models in which high serum triglycerides fully develops, disease spreads in the vessel from the aortic arch to include the thoracic aorta.  The study was not powered for an atherosclerosis endpoint and the aortas were obtained for post hoc analysis when the effectiveness of SPX-106T in lowering triglycerides and cholesterol became apparent.  

Earlier this year Spherix initiated the preclinical development of SPX-106T as a treatment for hypertriglyceridemia in one arm of a study designed to evaluate both D-tagatose alone and the combination.  The first studies designed specifically to test SPX-106T are nearing completion and results will be announced this fall. The Company plans to start an initial human efficacy study in the first quarter of 2012.  Rapid progression to the clinic is made possible by the experienced team in place at the Company.  

"Having just successfully completed two global clinical trials for a diabetes indication, Spherix has the personnel to design and execute new dyslipidemia trials much faster than other companies of a similar size," notes Dr. Claire Kruger, Chief Executive Officer of Spherix. "The preclinical pipeline of our Biospherics subsidiary can be advanced to the clinical stage rapidly because the Company is able to successfully execute multiple studies simultaneously."

About Spherix

Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research.  The Company now leverages its scientific and technical expertise and experience through its two subsidiaries – Biospherics Incorporated and Spherix Consulting, Inc.  Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis.  Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction and stroke.  Spherix's Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides.  For more information, please visit www.spherix.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

SOURCE Spherix Incorporated

Web Site: http://www.spherix.co

Sunday, September 4, 2011

P38 alpha MAP Kinase inhibition: possible therapeutic target for depression

P38 alpha MAP Kinase inhibition: possible therapeutic target for depressionPreclinical Study: A research team from St. Louis and Seattle reports in the Aug. 11 issue of the journal Neuronthat in mice exposed to stress, a protein called p38α mitogen-activated protein kinase (MAPK) influences the animal's behavior, contributing to depression-like symptoms and risk for addiction. The researchers demonstrate that p38α MAPK protein is activated by kappa-opioid receptors on neurons to regulate serotonin, a key neurotransmitter that helps regulate mood. When exposed to stress, the brain releases hormones that specifically interact with kappa-opioid receptors on neurons. Those receptors, in turn, activate p38α MAPK, which then interacts with the serotonin transporter in the cells to reduce the amount of available serotonin and triggering depression-like behaviors as well as drug-seeking behavior in the mice. http://www.cell.com/neuron/abstract/S0896-6273(11)00515-0

How Fatty Diets Cause Diabetes

How Fatty Diets Cause Diabetes Newly diagnosed type 2 diabetics tend to have one thing in common: obesity. Exactly how diet and obesity trigger diabetes has long been the subject of intense scientific research. A new study led by Jamey D. Marth, Ph.D., director of the Center for Nanomedicine, a collaboration between the University of California, Santa Barbara and Sanford-Burnham Medical Research Institute (Sanford-Burnham), has revealed a pathway that links high-fat diets to a sequence of molecular events responsible for the onset and severity of diabetes. These findings were published online August 14 in Nature Medicine. In studies spanning mice and humans, Dr. Marth's team discovered a pathway to disease that is activated in pancreatic beta cells, and then leads to metabolic defects in other organs and tissues, including the liver, muscle and adipose (fat). Together, this adds up to diabetes. "We were initially surprised to learn how much the pancreatic beta cell contributes to the onset and severity of diabetes," said Dr. Marth."The observation that beta cell malfunction significantly contributes to multiple disease signs, including insulin resistance, was unexpected. We noted, however, that studies from other laboratories published over the past few decades had alluded to this possibility." In healthy people, pancreatic beta cells monitor the bloodstream for glucose using glucose transporters anchored in their cellular membranes. When blood glucose is high, such as after a meal, beta cells take in this additional glucose and respond by secreting insulin in a timed and measured response. In turn, insulin stimulates other cells in the body to take up glucose, a nutrient they need to produce energy. In this newly discovered pathway, high levels of fat were found to interfere with two key transcription factors -- proteins that switch genes on and off. These transcription factors, FOXA2 and HNF1A, are normally required for the production of an enzyme called GnT-4a glycosyltransferase that modifies proteins with a particular glycan (polysaccharide or sugar) structure. Proper retention of glucose transporters in the cell membrane depends on this modification, but when FOXA2 and HNF1A aren't working properly, GnT-4a's function is greatly diminished. So when the researchers fed otherwise normal mice a high-fat diet, they found that the animals' beta cells could not sense and respond to blood glucose. Preservation of GnT-4a function was able to block the onset of diabetes, even in obese animals. Diminished glucose sensing by beta cells was shown to be an important determinant of disease onset and severity. "Now that we know more fully how states of over-nutrition can lead to type 2 diabetes, we can see more clearly how to intervene," Dr. Marth said. He and his colleagues are now considering various methods to augment beta cell GnT-4a enzyme activity in humans, as a means to prevent and possibly cure type 2 diabetes. "The identification of the molecular players in this pathway to diabetes suggests new therapeutic targets and approaches towards developing an effective preventative or perhaps curative treatment," Dr. Marth continued. "This may be accomplished by beta cell gene therapy or by drugs that interfere with this pathway in order to maintain normal beta cell function." In the United States, more than 24 million children and adults -- nearly eight percent of the population -- have diabetes. In adults, type 2 diabetes accounts for about 90 to 95 percent of all diagnosed cases of diabetes. This study was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH). Co-authors of this study include Kazuaki Ohtsubo at Sanford-Burnham and Mark Z. Chen and Jerrold M. Olefsky from the University of California, San Diego. Source: http://www.sciencedaily.com/releases/2011/08/110814141432.htm Journal Reference: Kazuaki Ohtsubo, Mark Z Chen, Jerrold M Olefsky, Jamey D Marth. Pathway to diabetes through attenuation of pancreatic beta cell glycosylation and glucose transport. Nature Medicine, 2011; DOI: 10.1038/nm.2414

Wednesday, August 31, 2011

Possible Trigger Point of Epileptic Seizures Identified

Possible Trigger Point of Epileptic Seizures Identified

Researchers at the Stanford University School of Medicine have identified a brain-circuit defect that triggers absence seizures, the most common form of childhood epilepsy.

 

In a study to be published online Aug. 21 in Nature Neuroscience, the investigators showed for the first time how defective signaling between two key brain areas -- the cerebral cortex and the thalamus -- can produce, in experimental mice, both the intermittent, brief loss of consciousness and the roughly three-times-per-second brain oscillations that characterize absence seizures in children. Young patients may spontaneously experience these seizures up to hundreds of times per day, under quite ordinary circumstances.

The new findings may lead to a better understanding of how ordinary, waking, sensory experiences can ignite seizures, said John Huguenard, PhD, the study's senior author.

Epilepsy, a pattern of recurrent seizures, will affect about one in 26 people over their lifetime. Absence, or petit-mal, seizures -- the form that epilepsy usually takes among children ages 6-15 -- feature a sudden loss of consciousness lasting 15 seconds or less. These seizures can be so subtle that they aren't noticed, or are mistaken for lack of attention. The patient remains still for several seconds, as if frozen in place. Usually, a person who experiences an absence seizure has no memory of the episode.

"It's like pushing a pause button," said Huguenard, professor of neurology and neurological sciences and of molecular and cellular physiology.

Inside the brain, however, things more resemble an electrical storm than a freeze-frame.

The brain is, in essence, a complicated electrochemical calculating machine employing circuits that process information and share it with other, often-remote circuits, resulting in networks of sometimes staggering complexity. A nerve cell can be thought of as a long, branching wire that can transmit electrical signals along its length and then relay these signals to up to thousands of other nerve cells by secreting specialized chemicals at points of contact with other "wires." Depending on the nature of the signaling interaction, the result can be either excitatory (increasing the likelihood that the next nerve cell in the relay will fire its own electrical impulse) or inhibitory (decreasing that likelihood).

During an absence seizure, the brain's electrical signals spontaneously coalesce into rhythmic oscillations, beginning in the neighborhood of two important brain areas, the cortex and the thalamus. Exactly where or how this pattern is initiated has been a source of controversy, said the study's lead author, Jeanne Paz, PhD, a postdoctoral researcher in Huguenard's lab.

"In order to develop better therapies, it is important to understand where and how the oscillations originate," Paz said.

The cortex and thalamus share an intimate relationship. The cortex, like a busy executive, assesses sensory information, draws conclusions, makes decisions and directs action.

To keep from being constantly bombarded by distracting sensory information from other parts of the body and from the outside world, the cortex flags its activity level by sending a steady stream of signals down to the thalamus, where nearly all sensory signals related to the outside world are processed for the last time before heading up to the cortex. In turn, the thalamus acts like an executive assistant, sifting through sensory inputs from the eyes, ears and skin, and translating their insistent patter into messages relayed up to the cortex. The thalamus carefully manages those messages in response to signals from the cortex.

These upward- and downward-bound signals are conveyed through two separate nerve tracts that each stimulate activity in the other tract. In a vacuum, this would soon lead to out-of-control mutual excitement, similar to a microphone being placed too close to a P.A. speaker. But there is a third component to the circuit: an inhibitory nerve tract that brain scientists refer to as the nRT. This tract monitors signals from both of the other two, and responds by damping activity. The overall result is a stable, self-modulating system that reliably delivers precise packets of relevant sensory information but neither veers into a chaotic state nor completely shuts itself down.

In bioengineered mice that the Stanford team studied with Wayne Frankel, PhD, of the Jackson Laboratory in Bar Harbor, Maine, this circuit is broken because the GluA4 receptor, a protein component of cells critical to the stimulation of nRT cells, is missing. Notably, these mice are prone to intermittent absence seizures. The researchers aimed to find out why, by separately studying the mouse's key corticothalamic-circuit components. Using a technique called optogenetics, they were able to selectively switch each of the two stimulatory tracts' signal transmissions on or off at will.

The researchers observed that, as expected, signals from one of the two tracts failed to excite the receptor-deficient mice's inhibitory nRT cells. Oddly, though, signals from the other tract continued to get through to the nRT tract just fine -- "a paradoxical and totally surprising result," said Huguenard.

This leaves nRT receiving signals from one tract, but not the other, which upsets the equilibrium usually maintained by the circuit. As a result, one of its components -- the thalamocortical tract -- is thrown into overdrive. Its constituent nerve cells begin firing en masse, rather than faithfully obeying the carefully orchestrated signals from the cortex. This in turn activates the nRT to an extraordinary degree, because its contact with the thalamocortical tract is not affected in these mice.

Huguenard estimates that, typically, only a very small percentage of nRT cells are firing at a given time. In the face of over-amped signaling from the thalamocortical tract, however, the fraction of excited nRT nerve cells rose much higher, perhaps as much as 50 percent -- enough to effectively silence all signaling from the thalamus to the cortex -- a key first step in a seizure.

But the shutdown was transitory. A property of thalamic cells (like other nerve cells) is that when they've been inhibited they tend to overreact and respond even more strongly than if they had been left alone. After a burst of nRT firing, this tract's overall inhibition of the thalamocortical tract all but halted activity there for about one-third of a second. Like boisterous schoolchildren who can shut up only until the librarian leaves the room, the thalamocortical cells resumed shouting in unison as soon as the inhibition stopped, and a strong volley of signaling activity headed for the cortex. Then the nRT's inhibitory signaling recommenced, and the stream of signals from the thalamus to the cortex ceased once again.

This three-Hertz cycle of oscillations consisting of alternating quiet and exuberant periods repeated over the course of 10 or 15 seconds was the electrophysiology of a seizure.

Whether the specific nRT defect in the bioengineered mice is important in human absence seizures is not yet known, Huguenard cautioned. Most individuals who suffer from these seizures appear to have "normal" nerve cells (individually indistinguishable from those of non-epileptics) and normally formed circuits as well. But now his group has a model experimental system with which they can try to determine why ordinary experiences can trigger these seizures in everyday life. Behavioral experiments are under way in his lab to see what kinds of common sensory exposures can trip off a similar circuit malfunction in normal mice. The resulting observations may someday help patients control their own exposures to minimize seizures, Huguenard said.

Tuesday, August 23, 2011

sjogren's syndrome

What is Sjogren's Syndrome?Sjogren's syndrome is a chronic, slowly progressive, inflammatory autoimmune disorder characterized by the infiltration of specialized cells of the immune system called lymphocytes (T-cells in the majority of cases), monocytes, and plasma cells into the parotid (salivary) glands and lacrimal (tear) glands. These glands are part of a group of exocrine glands whose secretions pass into a system of ducts that lead ultimately to the exterior of the body. This chronic lymphocytic...

Read More "sjogren's syndrome"

Monday, August 15, 2011

Anticholinergics linked to cognitive impairment, increased risk of death

Anticholinergic medications, which are used for a variety of indications including incontinence, may cause cognitive impairment and may increase the risk of death, according to the results of a large study in the UK. A total of 13,004 patients, aged 65 years and older, were evaluated as part of the Medical Research Council Cognitive Function and Ageing Study (MRC CFAS), a 2-year longitudinal multicenter study investigating health and cognitive function in older adults. At baseline, 9,850 patients (79 percent) reported taking any medication, 5,709 (47 percent) admitted use of medication with possible anticholinergic properties, and 508 (4 percent) said they definitely used anticholinergics. The most frequently used anticholinergic agents were furosemide (N=1,384), dextropropoxyphene (N=955), atenolol (N=992) and nifedipine (N=752), with women more likely to report taking anticholinergic agents than men (7,420 versus 5,003, respectively). [J Am Geriatr Soc 2011 Jun 24. doi: 10.1111/j.1532-5415.2011.03491.x.] At follow-up, the researchers found that patients taking medications with definite anticholinergic effects had a significantly greater 0.33-point decline in their Mini-Mental State Examination (MMSE) score compared to patients not taking anticholinergics (P=0.03). Of particular concern, patients taking definite anticholinergics and possible anticholinergics had a significantly higher mortality rate than patients not using anticholinergics (both P<0.001). “Our findings make it clear that clinicians need to review the cumulative anticholinergic burden in people presenting with cognitive impairment to determine if the drugs are causing decline in mental status,” said Dr. Malaz Boustani, co-author of the study and associate professor at the Indiana University School of Medicine in Indianapolis, Indiana, US. “Physicians should review with older patients all the over-the-counter and prescription drugs they are taking to determine exposure.” “We found that medications with definite anticholinergic effects are independently associated with a greater risk of cognitive decline and death,” added study author Dr. Chris Fox, a psychiatrist from the University of East Anglia, Norwich, UK. While the results of this study are consistent with those of previous trials, the authors said that further research would be needed to determine the effect of of different doses of medicines with anticholinergic activity on mortality. Anticholinergics affect the brain by blocking the central nervous system neurotransmitter acetylcholine. Many drugs with anticholinergic activity are available over-the-counter or by prescription that are taken by adults for a variety of indications, from sleep problems to incontinence.

Monday, July 25, 2011

Important topics for Drug delivery system

Important topics for Drug delivery

1. Fast Dissolving Drug Delivery Systems : A Review Of The Literature L. H Reddy, Bijaya Ghosh

http://www.ijpsonline.com/temp​/IndianJPharmSci644331-429498_​115549.pdf

2. Topical Ocular Drug Delivery- A Review Shyamala Bhaskaran, P. K Lakshmi, C. G Harish

http://www.ijpsonline.com/temp​/IndianJPharmSci674404-4312588​_115845.pdf

3. Nanoparticles As Drug Delivery Systems Shobha Rani R Hiremath, A Hota

http://www.ijpsonline.com/temp​/IndianJPharmSci61269-4338807_​120308.pdf

4..Multiple Emulsions : An Overview Of Formulation, Characterization, Stability And Applications V. R Sinha, A Kumar http://www.ijpsonline.com/temp​/IndianJPharmSci643191-4343144​_120351.pdf

5. Poloxamers : Promising Block Co-Polymers in Drug Delivery D. S Singhare, Shagufta Khan, P. G Yeole http://www.ijpsonline.com/temp​/IndianJPharmSci675523-4347218​_120432.pdf

6.Mucoadhesive drug delivery system: An overview Bindu M Boddupalli, Zulkar N.K Mohammed, Ravinder A Nath, David Banji http://www.japtr.org/temp/JAdv​PharmTechRes14381-4352382_1205​23.pdf

7. Pectin-based colon-specific drug delivery Shailendra Shukla, Deepak Jain, Kavita Verma, Shiddarth Verma http://www.cysonline.org/temp/​ChronYoungSci2283-4371243_1208​32.pdf

8. Novel drug delivery systems in topical treatment of psoriasis: Rigors and vigors Om Prakash Katare, Kaisar Raza, Bhupinder Singh, Sunil Dogra http://www.ijdvl.com/temp/ijdv​l766612-4375785_120917.pdf

Agent used to treat tapeworm infection inhibits colon cancer metastasis

Agent used to treat tapeworm infection inhibits colon cancer metastasis Elvira Manzano Niclosamide, an agent which has been around for more than half a century and which is approved for the treatment of intestinal parasite infections from tapeworms, may also be effective against colon cancer metastasis, new research suggests. Scientist Professor Ulrike Stein and colleagues from the Experimental and Clinical Research Center at Charité University Medicine at the Max Delbrück-Center for Molecular Medicine, Berlin, Germany, in collaboration with Professor Robert H. Shoemaker of the National Cancer Institute (NCI) in Frederick, Maryland, US, made the discovery while screening a library of 1,280 compounds for their ability to block the S100A4/metastasin gene, which can trigger colon cancer metastasis. Using high-throughput screening, niclosamide was identified as an S100A4 transcription inhibitor and found to efficiently inhibit the β-catenin-driven expression of the S100A4/metastasin gene both in mice and in cell culture. [J Natl Cancer Inst 2011; 103(12)] S100A4, a calcium binding protein originally identified as metastasin 1 (MTS1), is overexpressed in colon cancer and can initiate metastasis. Overexpression of this gene is also associated with tumor aggressiveness and poor survival in patients. Five years ago, Stein, working with Professor Peter Schlag, of the Charité Comprehensive Cancer Center, Charité University Medicine, in Berlin, Germany, and Professor Walter Birchmeier from MDC, showed how this gene is regulated. They found that the β-catenin gene, when mutant, activates the S100A4 gene, thus triggering colon cancer metastasis. In their latest studies, treatment with niclosamide significantly reduced liver metastasis formation in mice with xenografted intrasplenic tumors compared with controls (P<0.01). More importantly, inhibition of metastasis was still evident 26 days after discontinuation of niclosamide and overall survival was significantly higher in the active treatment group (P=0.001). In vitro, niclosamide-treated colon cancer cells showed reduced S100A4 mRNA and protein levels. The drug also inhibited S100A4-induced migration, invasion, proliferation and colony formation of colon cancers. The researchers said the new anti-metastatic function of niclosamide bears great potential for the treatment and prevention of colon cancer metastasis. Colon cancer is one of the most frequent causes of cancer death worldwide. Despite intensive healthcare programs for early diagnosis, many patients are still diagnosed at an advanced stage of the disease. In Germany alone, about 73,000 new cases of colon cancer are being diagnosed each year, with only about half of these patients cured. In patients with metastatic colon cancer, the 5-year survival rate is only about 10 percent.

Wednesday, July 20, 2011

Heart drugs best taken at bed time, says researcher

Medications for heart patients may do a better job if they are taken at night, just before bed time, according to a researcher in Canada. “Heart drugs are often given to patients in the morning for convenience, without considering biological rhythms or time-related risks of adverse effects,” said Professor Tami Martino from the department of biomedical sciences at the University of Guelph, Ontario, Canada. However, it is better if such drugs are given at bed time, she added, because they are better able to counter the peaking actions of the renin-angiotensin-aldosterone system (RAAS) which is associated with cardiac remodeling. Martino was the lead author of a study which showed that the short-acting ACE inhibitor captopril improved cardiac function and structure in hypertensive mice when given at sleep time, versus placebo or captopril when given during wake time. [J Am Coll Cardiol 2011;57(20):2020-2028] “The sleep-time benefit of giving the ACE inhibitor correlates with the biological rhythm of this hormone,” she said. “By targeting those hormones when they’re highest during sleep, you’re dropping their levels so they’re not doing so much damage.” In the study, mice were administered intraperitoneal captopril 15 mg/kg or placebo at either murine sleep time or wake time for a period of 8 weeks, starting 1 week after surgery to induce cardiovascular pressure overload by transverse aortic constriction. The results also suggest that physicians might consider using a short-acting version of the drug, said Martino. “Since the drug is most effective during sleep hours, it’s not necessary to have its effects last throughout the entire day. Using a short-acting version of the drug may help to reduce its side effects.” It has long been known that diurnal variations exist for the functioning of the human body, and that biological and physiological rhythms play an important role in health and disease. “RAAS is an important pathway in the pathogenesis of cardiac remodelling and hypertrophy,” said Dr. Tang Hak Chiaw, a consultant with the department of cardiology at the National Heart Centre, Singapore. “By targeting the pathway at the time when it is most active, the authors have successfully shown differences in the treatment outcome in an animal model. This paves the way for clinical studies in human subjects.” However, Chiaw said it would be too premature to advise patients when to take their medication based on this study alone. “In our current practice, clinicians would usually choose a medication that has a longer duration of action to give 24-hour coverage [or] protection if there is an option. Of course, this study [will] generate interest and, as the authors have appropriately concluded, their findings will “provide new opportunities for the effective treatment of cardiovascular disease.” – GT

Excessive bottle feeding can lead to childhood obesity

Children who still drink from bottles at age two are at risk of becoming obese by age five, a new study shows. The American Academy of Pediatric Dentistry recommends weaning children from bottles at 12 to 14 months. Prolonged bottle use, particularly at bed time, can cause tooth decay and bacterial infections like caries. However, 22 percent of 6,750 children involved in a large national US study were still drinking primarily from a bottle or were put to bed with a bottle at 24 months of age. Almost 23 percent of these children were obese (in the 95th percentile for body mass index [BMI]) by age 5.5 years, compared with 16 percent of children who had been weaned from bottles earlier. [J Pediatr. 2011 Apr 27. Epub ahead of print] “Drinking from a bottle beyond infancy is a behavior that could contribute to obesity by encouraging the child to consume excess calories,” commented the study authors, led by Rachel Gooze, a doctoral candidate in public health at Temple University’s Center for Obesity Research and Education in Philadelphia, US. For example, they noted that an average weight (about 12 kg) 2-year-old girl put to bed with an 8-ounce bottle of whole milk gets 12 percent of her daily caloric needs from the bottle. Weight gain would depend on how much excess these calories represent. In general, children should begin eating a variety of solid foods at about 6 months in addition to about 16 ounces of milk and no more than about 4 ounces of juice, plus more water. Prolonged bottle use is often a comfort issue for children and parents. Smaller, cross-sectional studies have suggested an association between prolonged bottle use, particularly at bed time, and weight gain but this is the first prospective study of size to do so. This latest study was limited by confounders such as physical activity and diet, where over-fed children may have had a higher caloric intake of nutrition-poor foods like sugary drinks as well as being less likely to have breastfed. The researchers did control for confounders including socioeconomic status, maternal obesity, breast feeding, age at introduction of solid foods and weight at birth and at 9 months. Under-reporting by parents of prolonged bottle use among heavier children may also have falsely decreased the association with obesity. It is unclear whether the association holds beyond 5.5 years. “A multilevel obesity prevention strategy is considered optimal because it alters children’s social and physical environments in multiple settings, such as the home, child care, school, and neighborhood,” the researchers said, and noted that discontinuing bottle use after one year will not be harmful and may help prevent obesity.

Friday, June 3, 2011

Lupin inks strategic deal with NeuClone for cell line technology

 Lupin has entered into a strategic licensing agreement with Sydney based private specialty life science company NeuClone Pty Ltd for their cell line technology. Under the terms of the agreement, NeuClone will provide an exclusive proprietary mammalian CHO cell line which will express a specific recombinant protein of interest in oncology to its partner.

The agreement will also entail the Lupin Biological Research Programme scientific research staff working with NeuClone teams at their facility as a part of the overall technology transfer arrangements as specified within the agreement. NeuClone is an Australian biotech company specializing in cell line engineering for the biopharmaceutical and biomanufacturing industries. It has developed technology in recombinant protein production.

Dr Cyrus Karkaria, president, Lupin and Head of the Lupin Biological Research Programme said, “the multi-billion dollar opportunity with blockbuster biologics going off patent in the next 5-8 years is something that Lupin is pursuing aggressively. This exclusive licensing arrangement with NeuClone is a part of that strategy and would enable us to capitalize on cutting edge technology to address the biologicals market. This agreement and such similar agreements, coupled with our own pipeline will go a long way in helping us address the impending opportunity and develop a substantial differentiated biological pipeline.”

Dr Noelle Sunstrom, CEO of NeuClone, said, “This is an exciting time for NeuClone and our stakeholders as our investment in mammalian CHO cell lines is commercialized. In particular, we are enthusiastic about further developing the relationship with Lupin, an important global generic manufacturer.”

Source: Pharmabiz

US FDA approves Solesta to treat patients with life-altering fecal incontinence

 Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, announced that the US Food and Drug Administration (FDA) has approved Solesta as a treatment for fecal (bowel) incontinence in adult patients who have failed conservative therapy such as dietary control.

“This is a pivotal development, one that advances Oceana Therapeutics to an exciting new growth stage,” said John T Spitznagel, chairman & CEO, Oceana. “Moreover, Solesta epitomizes our corporate mission to commercialize specialty therapeutics for unmet medical needs and to achieve optimal outcomes and enhanced patient quality of life” he added.

David S Tierney, president & COO, Oceana said “Solesta was developed in collaboration with Q-Med AB* as a minimally invasive injectable gel that can be administered, relatively quickly, in an outpatient setting without the need for anaesthesia. This is a significant new treatment option for the many underserved patients who fail conservative therapy and face a life of potential social humiliation and the possibility of severe invasive treatment such as surgery.”

“I also want to commend everyone involved in the speedy responses to the items raised about a month ago in the FDA’s approvable letter for Solesta,” said Tierney. “The turnaround time between the FDA’s approvable letter and today’s announced marketing approval of Solesta has been, in our view, remarkably fast.”

Oceana intends to focus Solesta marketing and medical educational support on colorectal surgeons, specialists in treating bowel incontinence. The company is also moving expeditiously to put in place marketing materials, build product inventory, and be prepared to ship and launch Solesta during the second half of 2011. “The sooner we get Solesta into the hands of the physicians, the sooner it will be available to patients who can benefit from the product,” said Tierney. “So, we intend to push hard for a 3rd quarter US launch, although we realize that is an aggressive target.”

Solesta is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anaesthesia. Solesta is injected in the deep submucosal layer in the proximal part of the anal canal. While the exact mechanism of action has not been identified, it is hypothesized that the Solesta injections may narrow the anal canal and allowing for better sphincter control.

The Solesta PMA was submitted to the FDA in April 2010 for the treatment of fecal incontinence in adult patients who have failed conservative therapy (i.e., diet, fibre therapy, anti-motility medications). The PMA was reviewed by the FDA’s Gastroenterology and Urology Devices Advisory Panel which met on December 2, 2010 and which voted that Solesta was safe and effective, and that its benefits outweighed its risks.

The main body of clinical evidence in the Solesta PMA submission involved a multi-centre, prospective, randomized, Sham (placebo) controlled study of the product’s effectiveness and safety. The study included 206 patients (136 Solesta, 70 Sham) and consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: demonstrating a statistically significant Solesta effect after 6 months of treatment; meeting a pre-defined threshold for clinical significance; and showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met.

Results from this clinical trial of Solesta as a treatment for fecal incontinence were published in The Lancet (March 19, 2011; 377: 997-1003). In general, the authors of the article noted that the treatment not only met its safety and efficacy endpoints, but also was easily administered.

Oceana Therapeutics is committed to commercializing best-in-class therapeutics to address unmet and under-satisfied medical needs with a focus on colorectal, gastroenterology and urological diseases.

Source: Pharmabiz

Himalaya partners with Karnataka govt to rehabilitate prisoners by roping them into herbal cultivation

 Himalaya Herbal Healthcare signed an agreement with the Department of Prison Rehabilitation, Government of Karnataka, to create employment opportunities for prisoners, with the objective of rehabilitating them.

According to the agreement, the prisoners will cultivate medicinal herbs for Himalaya. This will help in skill-building and employment generation. The program will target prisoners charged with minor offences, who have shown good behaviour and a desire to rebuild their lives.

In phase I of the project, the herb cultivation will be undertaken at the Open Air Prison at Avathi village in Devanhalli Taluk. Initially, cultivation will be carried out on a small plot of land, approximately one to two acres. While the open air prison has a large tract of land available for cultivation, the first phase of the project will start small, in order to strengthen logistics.

Inmates of the open air prison will participate in the herb cultivation project, earning a regular monthly income and acquiring essential skills. Himalaya will provide seeds and technical assistance along with training to the prisoners. Once the system begins to operate smoothly and efficiently, Himalaya will explore the possibility of scaling up the project and expanding scope to other prisons across the state.

According to Dr Babu, Head – Agrotech Department, The Himalaya Drug Company, said “Society can be very unforgiving to prisoners. We stereotype them as criminals and never really give them a chance to rehabilitate themselves. Himalaya’s corporate social responsibility program focuses on reaching out to underprivileged sections of society through livelihood development. That is why when the Government of Karnataka approached us with this proposal, we were very excited. With the right support and encouragement, some of these prisoners can be effectively rehabilitated. This project will give prisoners an opportunity to earn a decent income and acquire new skills. In a small way, our efforts will help them rebuild their lives by giving them a fair chance.”

Prison reform is essential. Equipping prisoners with basic skills through such initiatives will help them in future employment, build their self-esteem and assist their re-integration into society.

Source: Pharmabiz

Orthocon receives US FDA clearance to market Hemasorb Apply

 Orthocon Inc., a privately-held therapeutic device company, announced that the Food and Drug Administration cleared Hemasorb Apply for clinical use and sale in the United States.

Hemasorb Apply is a proprietary, custom-designed applicator preloaded with Hemasorb Absorbable Bone Haemostat Matrix. The product is provided ready-to-use and enables precise application of Hemasorb to stop bone bleeding during surgical procedures and in treating traumatic injuries. Currently marketed bone haemostat products require surgeons to use their fingers or surgical instruments for application. Unlike bone waxes, Hemasorb is putty-like in consistency, does not require preparation, and is now provided in a syringe-like applicator. Furthermore, Hemasorb is absorbable, biocompatible, and water resistant.

Commenting on the significance of the Hemasorb Apply clearance, John J Pacifico, president and chief executive officer, Orthocon said the following: “This regulatory clearance is an important achievement for Orthocon. There has been very little innovation in the bone haemostat field since bone wax was first introduced in the late 1800s. We believe that the widespread adoption of flowable surgical haemostats has created new opportunities for advanced surgical products that more efficiently and effectively control bone bleeding, and we are confident that Hemasorb Apply will help secure Orthocon’s leadership position in this therapeutic category. Both Hemasorb and Hemasorb Apply are clearly differentiated from wax-like haemostats, and they are changing the way surgeons think about surgical haemostasis.”

Since its initial market introduction in 2010, Hemasorb has been approved for sale at leading hospitals throughout the United States and has been used successfully by hundreds of surgeons. Orthocon is confident Hemasorb Apply will provide surgeons with an innovative and cost effective tool to assist in their management of intra-operative bone bleeding, and the company fully expects Hemasorb to become the standard of care for bone haemostasis.

Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopaedic, craniomaxillofacial, and cardiac surgeries. Excessive bleeding during surgery may impair the surgeon’s view of the operative field, may result in the need for blood transfusions, and may be associated with postoperative complications. Orthocon estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of Hemasorb.

Orthocon develops, manufactures, markets, and sells implantable products that stop bone bleeding.

Source: Pharmabiz

Thursday, June 2, 2011

FDA approves new treatment for a type of late-stage skin cancer

FDA approves new treatment for a type of late-stage skin cancer Melanoma patients lived longer with treatment The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute. “Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment." Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously. Yervoy’s safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed. The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone. Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months. Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks. Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects. Yervoy is marketed by New York City-based Bristol-Myers Squibb.

admission: Guru Jambheshwar University of Science & Technology

Institute: Guru Jambheshwar University of Science & Technology Programme: GROUP 1: M.Sc. (Applied Psychiology), M.Sc. (Development communication), M.Sc.(Advertising Management & Public Relations), M.Sc. (Mass Commmunication), P.G. Diploma in Web Advertising & Animation, P.G. Diploma in Tourism PR, P.G. Diploma in Defence Journalism. GROUP 2: M.Sc. (Chemistry), M.Sc. (Physics), M.Sc. (mathematics), M.Sc. (Biotechnology), M.Sc. (Environmental Sciences), M.Sc. (Food Technology), M.Sc. (Industrial Microbiology), P.G. Diploma in Pigment and Paint Technology. OTHER COURSES M.Pharma Programmes M.Pharma (Pharmaceutical Chemistry), M.Pharma (Pharmaceutics) M.Pharma (Pharmocolgy), M.Pharma (Pharmacognosy), M.Tech.(Computer Science & Engineering), M.Tech.(Environmental Science & Engineering), M.Tech.(Electronics & communication Engineering), M.Tech.(Machanical Engineering), M.Tech.(Printing Technology), M.Tech.(Nano Science & Technology), M.Tech.(Optical Engineering), M.Tech.(Computer Science & Engineering), M.Tech.(Food Engineering), M.Tech.(Geo- Informatics). Masters of Physiotherapy M.Pth. (Musculoskeletal Disorders), M.Pth. (Sprots Phisiotherapy), M.Pth.(Neurological Disorders), M.Pth.(Pediatric physiotherapy), Bachelor of physiotherapy. Eligibility: Click here for more details Selection process: For detailed selection process click here How to apply: The candidates are required to apply only on the prescribed Admission Form given in this Prospectus or the downloaded one from the University website (with requisite fees in case of downloaded admission form). Important dates: Availability of prospectus/ Admission form on University website: May 29, 2011 On-the-Counter sale of prospectus: June 03, 2011 Last date for receiving request for issue of University prospectus by post: June 24, 2011 Last date for counter sale of University prospectus and submission of filled in application forms: July 04, 2011 Address: Guru Jambheshwar University of Science & Technology, Hisar - 125001 Haryana (India) Phone: 01662-263139 Website: www.gjust.ac.in http://www.gjust.ac.in/downloads/downloads.htm

Optimer's Clostridium difficile drug

The US Food and Drug Administration has given the green light to Optimer Pharmaceuticals' antibiotic Dificid. Dificid (fidaxomicin) has been approved for the treatment of Clostridium difficile–associated diarrhoea (CDAD), making it the first antibacterial indicated for the disease to be approved by the FDA in nearly 30 years. CDAD rates have steadily risen over the past decade and it is estimated that more than 700,000 cases of the infection occur in the USA each year. The infection is a significant problem for the elderly in hospitals and care homes. Related Links Astellas signs antibiotic deal with Optimer The thumbs-up is based on two Phase III trials involving 564 patients and compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with vancomycin in both studies. However, the FDA noted that in some patients with CDAD, symptoms can return and in the Dificid trials, a greater number of patients treated with the Optimer drug had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin. Last month, Optimer signed a two-year co-promotion deal for Dificid with Cubist Pharmaceuticals, which is best-known for Cubicin (daptomycin), approved for the treatment of complicated skin infections and bacteremia caused by MRSA. The latter firm will receive $15 million a year for its services and can earn up to $17.5 million over the two years if certain sales levels are achieved. Optimer plans to hire 100 sales reps to promote Dificid to the 1,100 hospitals that account for 70% of CDAD cases in the USA. Chief executive Pedro Lichtinger said that "the recognition in our label of the Dificid superiority in sustained clinical response will allow the Optimer and Cubist field force to educate the medical community" about the advantage the product offers.

Monday, May 23, 2011

Cancer nanotechnology: current scenario

 Cancer is one of the leading causes of mortality worldwide. Every year, a large number of patients suffering from cancer die. This number is continuously rising with an estimation of about 12 million deaths from cancer by 2030. The current treatment given to cancer patients primarily includes chemotherapy (where anticancer drugs are used to kill the cancer cells) and radiation therapy (where radiations are focused on the infected areas to kill the cancer cells). However, both the therapies are associated with severe toxicities due to their inability to differentiate between cancer cells and normal cells. Hence, to overcome this, many laboratories are trying to develop an arsenal based on nanotechnology to fight against this dreadful disease. In this article, the nanotechnologies used for treating cancer have been discussed briefly.

Why nanotechnology?

Over the past few years, many pharmaceutical companies, institutions and R&D laboratories all over the world are trying to develop nanotechnology based drug delivery systems. Nanotechnology, as defined, is the creation and application of devices, drugs or any materials that are in the size range of 1-100 nm in size. This extremely small size of such appliances offers several advantages in drug delivery while treating diseases like cancer. The major advantage is the ability of such systems to penetrate the biological membranes with ease and become available at the target site. As a result, nanotechnology has found very wide applications in drug delivery systems.

Current cancer nanotechnologies

Nanobiosensors have found to have diagnostic applications in cancer. A biosensor is basically made up of several components including sensitive biological element, a transducer and a detector with the help of which they detect the analyte. Typically when such a device is in nano dimensions, they are termed as nanobiosensors. Many different types of nanobiosensors have been produced which are claimed to be of use in early cancer detection. The cancer specific ligand or antibody present in such sensors selectively captures cancer cells thereby producing signals, which are ultimately detected by the detector. Such devices are projected to be of utmost importance for cancer diagnostics in future.

Liposomes have been used to deliver drugs in various cancer indications. With its help, the concentrations of anticancer agents at the target site have found to increase and thereby better efficacy and bioavailability can be expected from such systems. For instance, many anticancer drugs like Doxorubicin and Docetaxel have been used using liposomes as the drug delivery system. One of the most important advantages of liposomes as a carrier system is that they are made up of lipids which are biocompatible and non toxic to the human body.

Dendrimers are a class of macromolecules, which are repeatedly branched. They have found their applications in many fields including engineering, medicine, nanobiotechnology, to name a few. More than 5000 patents and publications have been reported on this novel class of molecules regarding their synthesis and potential applications. They have been projected to be a potential MRI contrast agent that can be utilised for diagnosis and treatment in cancer therapy. One of the research groups at the University of Michigan have successfully synthesised dendrimer-based MRI contrasting agent, which successfully targeted tumors in animal models.

Nanoparticles, including polymeric nanoparticles and lipid nanoparticles are used in research for their applications in drug delivery for cancer. Many biodegradable polymeric nanoparticles like PLGA (poly lactide co glycolic acid) and PEG (poly ethylene glycol) have been utilised as drug delivery carriers for anticancer agents. Being biodegradable they are non-toxic and can be degraded within the human body to release the drug. With the help of such polymeric nanoparticulate systems, sustained release of drugs have obtained a reduction in the associated toxicities. A large number of anticancer agents like Docetaxel, Doxorubicin, Cisplatin, Doxorubicin have been successfully encapsulated in such carrier systems. In addition, such polymeric nanoparticles have also shown to simultaneously encapsulate two drugs, thereby aiding in dual drug delivery and better efficacy. Such systems also help in better targeting of the drugs at the infected areas, thereby minimising toxicities.

Besides this, many different types of quantum dots, nanoshells, nanocantilevers, nanowires, nanotubes and fullerenes have been synthesised, characterised and researched for their potential applications. Quantum dots-based nanobiosensors have been developed. Nanoshells have also found applications in cancer treatment. Hollow Gold NanoShells (HGNS) have shown to be of use in photothermal therapy wherein such systems, after they reach the infected areas, are irradiated due to which they get heated and kill the cancer cells. Such systems have shown great promise for future cancer treatments.

Currently, many scientists are also trying to combine and integrate different systems in one system. For instance, many scholars at Nanobios laboratory at Indian Institute of Technology Bombay, are trying to encapsulate one or two anticancer drugs in a polymeric system to which gold nanoshells are attached. Such systems may be given intravenously directly to the infected areas. After reaching the target site, they can be irradiated as a result of which gold nanoshells get heated up and kill the cancer cells. Also due to the heat generated, polymeric particles may get degraded or thermoresponsive polymeric system may release the anticancer agents encapsulated within it. Such systems seem to be a great breakthrough in cancer therapy where radiation therapy and chemotherapy is combined into one system. Such systems are also projected to reduce the side effects and associated toxicities due to the conventional radiation therapy or chemotherapy.

To conclude, we can say that current cancer nanotechnologies have shown great promise for their practical applications in the diagnosis and treatment of cancer. However, plenty of research is still required especially focusing upon their toxicities and efficacy.

Source: ExpressPharma

Venus Remedies completes phase I & II trials of cancer molecule

 

Venus Remedies recently announced that it has successfully completed phase I and II clinical trials for VRP1620, Tumatrek, which could become a cost effective diagnostic tool for cancer. The clinical study has shown excellent results in detection of breast cancer. With this molecule, detection of breast cancer would be possible with a simple X-ray using dye and the sensitivity of other detection devices such as coloured doppler, PET would be increased several times.

Dr Manu Chaudhary, Research Director, Venus Remedies said, “VRP 1620 (Tumatrek) is a unique and cost effective diagnostic tool for cancer which can also detect malignancy even through X-ray. It can detect cancer at a lower cost and at the primary stage itself.” Detection of cancer in the early stage can increase the cure rate and scientists believe that after phase III trials of this product VRP-1620 may also help in locating proliferation of cancer sites.

For the past few years, a team of scientists from Venus Medicines Research Center (VMRC), the R&D wing of the company, were working on a novel peptide VRP 1620, which is a highly selective ETB receptor agonist and is involved in selective vasodilation in solid tumours. “Phase III will be completed this year and the product will be ready for market launch in early 2012,” Chaudhary added.

Venus Remedies has completed and submitted the report of phase I and II study on breast cancer patients for VRP 1620 after due permission from the IND committee and DCGI, Government of India. Phase I was conducted at Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh to find the maximum tolerable dose. Later phase II clinical study was conducted at multiple institutions throughout India including PGIMER, Chandigarh and Central India Cancer Research Institute, Nagpur, Maharashtra.

This clinical study documented the pharmacokinetic profile and appropriate dose range for the drug. It also described the efficacy for its use as a diagnostic agent for breast cancer. The efficacy was gauged by observing increase in diameter and the corresponding change in resistive index of tumour vessel. An increase of 17.31 per cent in tumour vessel diameter was observed compared to baseline 12-15 minutes after drug administration of VRP-1620 at dose levels 0.8 µg / kg body weight. Corresponding to this increase in tumour vessel diameter there was a decrease in RI (resistive index) 7.15 per cent. These changes indicate an increase in tumour blood perfusion causing the contrast media to deeply penetrate, creating a better tumour silhouette.

Tolerability of VRP 1620 was also assessed by the investigators and subjects at the end of study treatment period, which showed that the product is well tolerated.

Cancer prevalence in India is estimated to be around 2.5 million, with over 8,00,000 new cases and 5,50,000 deaths occurring each year due to this disease. More than 70 per cent of the cases report for diagnostic and treatment services in the advanced stages of the disease, which has lead to a poor survival and high mortality rate. The product has huge potential in urban and semi urban belts where advanced technologies of cancer detection are not available. This technology will provide a cutting edge in timely detection of cancer and has tremendous need especially in under developed and developing countries.

The global cancer market was worth $56.7 billion in 2007, growing at 16.8 per cent over 2006, and is forecast to reach a value of $76.9 bn by 2013 representing a CAGR of 5.1per cent (2007-13). Oncology is one of the leading therapeutic categories in the global pharma market. The Indian oncology market is estimated to be about Rs 7,000 to 8,000 million, growing at a CAGR of more than 30 per cent in the last three years. The economic toll from cancer, estimated to be $895 billion, is nearly 20 per cent higher than heart disease, the second leading cause of economic loss ($753 billion).

 

Source: ExpressPharma