Andy Health blog

Buy generic cipro Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc.
(NYSE: KG) announced today that they have delayed plans for the initiation
of Phase 3 clinical trials with bremelanotide, a first in class
melanocortin agonist drug candidate, for the treatment of male erectile
dysfunction (ED). The decision follows responses from representatives of
the U.S. Food and Drug Administration (FDA), which raised serious concerns
about the acceptable benefit/risk ratio to support the progression of the
proposed program into Phase 3 studies for ED.
After reviewing the data generated in the Phase 1 and 2 studies, the
FDA questioned the overall efficacy results and the clinical benefit of
this product in both the general and diabetic ED populations, and cited
blood pressure increases as its greatest safety concern. Though not
supportive of the proposed Phase 3 studies for ED with bremelanotide, the
FDA stated that it was amenable to proposals for a different drug
development pathway, such as for a second-line therapy in non-responders to
currently approved PDE-5 inhibitors.
"The safety of patients in our clinical program has always been our
number one priority and we will work closely with the FDA, King, and our
advisors to determine the next steps for the program," stated Carl Spana,
Ph.D., President and Chief Executive Officer of Palatin.
Palatin and King plan to review the FDA comments in the overall context
of the program in order to determine next steps related to the further
development of bremelanotide for the treatment of ED.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia, and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. It is estimated that some degree
of ED affects one half of all men over the age of 40 and that 150 million
men worldwide suffer from ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on
discovering and developing targeted, receptor-specific small molecule and
peptide therapeutics. Palatin’s internal research and development
capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling
product development. Palatin’s strategy is to develop products and then
form marketing collaborations with industry leaders in order to maximize
their commercial potential. To date, Palatin has entered into
collaborations with AstraZeneca, King Pharmaceuticals, and Tyco Healthcare
Mallinckrodt. For additional information regarding Palatin, please visit
Palatin Technologies’ website at
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle management.
Palatin Technologies, Inc

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Some form of immunotherapy is expected to be available for peanut allergy within the next five years. But the reasons for the increasing prevalence of this allergic reaction remain unclear. The issues are discussed by Professor Wesley Burks, Duke University Medical Center, NC, USA, in a Seminar in this week’s edition of The Lancet.
Peanut allergy has become a major health concern worldwide, especially in developed countries, and affects around 1% of children under the age of five years. It is a disease modulated by the immunoglobulin E part of the immune system - once peanut protein is ingested, it crosslinks with these IgE antibodies and causes release of inflammatory molecules such as histamines. The mean age of diagnosis in children is 14 months, with symptoms occurring after the first known peanut ingestion in 75% of those children eating peanuts for the first time. Almost all initial reactions involve the skin, approximately half involve the respiratory tract, and a third the gastrointestinal tract.
Professor Burks says: "Because of the potentially severe health consequences of peanut allergy, those suspected of having had an allergic reaction to peanuts deserve a thorough evaluation. All patients with peanut allergy should be given an emergency management plan, as well as epinephrine and antihistamines to have on hand at all times. Buy generic zithromax Patients and families should be taught to recognise early allergic reactions to peanuts and how to implement appropriate peanut-avoidance strategies. It is imperative that severe, or potentially severe, reactions be treated promptly with intramuscular epinephrine and oral antihistamines. Patients who have had such a reaction should be kept under observation in a hospital emergency department or equivalent for up to four hours because of the possible development of the late-phase allergic response."
A study from the USA has shown that peanut allergy prevalence in young children doubled from 0???4% in 1997 to 0???8% in 2002. There are many theories regarding the increased prevalence of peanut allergy, none of them proven. Among them is the hygiene hypothesis, which says that not enough exposure to infectious agents in early childhood can increase susceptibility to allergic disease. And researchers have suggested that presence of peanuts in the mother’s diet before birth could be risk factor for developing the allergy.
Among the approaches being looked at to reduce the impact of this condition is development of transgenic plants to produce hypoallergenic peanuts. However, as several peanut proteins are involved in the allergic response, Professor Burks says: "The process of altering enough of the peanut allergens to make a modified peanut that is less likely to cause an allergic reaction would probably render the new peanut no longer a peanut."
Future treatments are all focused around the attempt to curb the immune response or induce tolerance by the immune system in response to a specific food allergen. Possible approaches include engineered peanut proteins used as immunotherapy and specific oral tolerance induction, in which the food is ingested in increasingly larger amounts on a regular basis. Professor Burks concludes: "It is likely that in the next five years there will be some type of immunotherapy available for peanut allergenic individuals."
"Peanut allergy"
Prof A Wesley Burks MD
The Lancet 2008; 371:1538-1546
DOI:10.1016/S0140-6736(08)60659-5
Click here to see Summary online

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Yale University researchers report in the journal Nature Genetics that they have discovered that rare genetic variants can be associated with a dramatically lower risk of developing high blood pressure in the general population.
The insight that rare mutations may collectively play a large part in the development of common yet complex diseases such as hypertension also has implications for the diagnosis and treatment of diseases such as diabetes and schizophrenia.
The team of researchers was led by Richard Lifton, chair of the Department of Genetics and Sterling Professor of Genetics and Internal Medicine at Yale, and Daniel Levy, director National Heart, Lung and Blood Institute’s Framingham Heart Study.
The scientists analyzed DNA samples from 3,125 people who participated in the Framingham Heart Study, a long-running epidemiology survey that has led to a treasure trove of information about the causes of heart disease.
They decided to study the health impact of three genes regulating the processing of salt in the kidney and each known to cause dangerously low blood pressure levels when inherited with two defective copies (one from each parent). The researchers speculated that people who carry only one defective copy might be less prone to hypertension.
Buy diflucan without prescription Lifton’s group found that 2 percent of the subjects carried one defective copy of one of the three genes. These individuals in general had lower blood pressure and a 60 percent lower risk of developing hypertension by the time they were 60 than the general population.
A major question in the field of many chronic diseases has been whether the risk of developing a disease is more closely linked to common or rare mutations. Recent studies have shown that for many diseases, common genetic variants can only explain a small fraction of an individual’s risk of developing the condition. In the case of high blood pressure, for instance, large genome-wide studies have thus far found no common variants that are associated with the risk of developing hypertension.
So, scientists like Lifton and his lab members Weizhen Ji and Jia Nee Foo have begun to search for the many rare mutations that might have a larger impact on the risk of inherited diseases on smaller groups of people.
"Collectively, common variants have explained a small fraction of the risk of most diseases in the population, as we would expect from the effects of natural selection,” Lifton explained. "The question this leaves open is whether many rare variations in genes will collectively account for a large influence on common disease.”
Lifton said the new study underscores the importance of sequencing the genome of many individuals in order to discover disease-causing mutations.
For instance, previous genetic studies of hundreds of families with severely low blood pressure enabled his team to identify the gene mutations used in the study. And one of the genes, ROMK, has turned out to be a particularly promising target for new high blood pressure therapy.
Eventually, scientists may find dozens of genes in which rare mutations individually account for a low percentage of common diseases among individuals, but may collectively account for the burden of common chronic diseases, Lifton said.
Added Levy, "We may have to march down the field from gene to gene to identify other genes where rare variants are contributing to blood pressure variations."
Nature Genetics, Advanced Online Edition, April 6.

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Buy generic acomplia Scientists funded by the Biotechnology and Biological Sciences Research Council (BBSRC) have discovered how evolution may have lumbered humans with allergy problems. The team from the Randall Division of Cell & Molecular Biophysics, King’s College London are working on a molecule vital to a chicken’s immune system which represents the evolutionary ancestor of the human antibodies that cause allergic reactions. Crucially, they have discovered that the chicken molecule behaves quite differently from its human counterpart, which throws light on the origin and cause of allergic reactions in humans and gives hope for new strategies for treatment. The work is published in The Journal of Biological Chemistry.
Researcher, Dr Alex Taylor said: "This molecule is like a living fossil - finding out that it has an ancient past is like turning up a coelacanth in your garden pond. By studying this molecule, we can track the evolution of allergic reactions back to at least 160 million years ago and by looking at the differences between the ancient and the modern antibodies we can begin to understand how to design better drugs to stop allergic reactions in their tracks."
The chicken molecule, an antibody called IgY, looks remarkably similar to the human antibody IgE. IgE is known to be involved in allergic reactions and humans also have a counterpart antibody called IgG that helps to destroy invading viruses and bacteria. Scientists know that both IgE and IgG were present in mammals around 160 million years ago because the corresponding genes are found in the recently published platypus genome. However, in chickens there is no equivalent to IgG and so IgY performs both functions.
Lead researcher, Dr. Rosy Calvert said: "Although these antibodies all started from a common ancestor, for some reason humans have ended up with two rather specialised antibodies, whereas chickens only have one that has a much more general function.
"We know that part of the problem with IgE in humans is that it binds extremely tightly to white blood cells causing an over-reaction of the immune system and so we wanted to find out whether IgY does the same thing."
By examining how tightly IgY binds to white blood cells the researchers have found that it behaves in a much more similar way to the human IgG, which is not involved in allergic reactions and binds much less tightly.
Professor Brian Sutton, head of the laboratory where the work was done said: "It might be that there was a nasty bug or parasite around at the time that meant that humans needed a really dramatic immune response and so there was pressure to evolve a tight binding antibody like IgE. The problem is that now we’ve ended up with an antibody that can tend to be a little over enthusiastic and causes us problems with apparently innocuous substances like pollen and peanuts, which can cause life-threatening allergic conditions."
The next stage of the work is to examine in very fine detail the interaction between the antibodies and the surface of the white blood cell. This is with a view to designing drugs that could alter this interaction and therefore ‘loosen’ the binding of IgE, making it more like its chicken counterpart.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Authors:
Dr Rosy Calvert,
Dr. Alex Taylor
Professor Brian Sutton
Notes
This research is published in The Journal of Biological Chemistry: Taylor et al., ‘Avian IgY binds to a monocyte receptor with IgG-like kinetics despite an IgE-like structure’, The Journal of Biological Chemistry, 283: 16384-16390
This research is funded by a ??300K grant from the UK’s Biotechnology and Biological Sciences Research Council (BBSRC).
About BBSRC
The Biotechnology and Biological Sciences Research Council (BBSRC) is the UK funding agency for research in the life sciences. Sponsored by Government, BBSRC annually invests around ??380 million in a wide range of research that makes a significant contribution to the quality of life for UK citizens and supports a number of important industrial stakeholders including the agriculture, food, chemical, healthcare and pharmaceutical sectors.
About King’s College London
King’s College London is one of the top 25 universities in the world (Times Higher 2007) and the fourth oldest in England. A research-led university based in the heart of London, King’s has 19,300 students from more than 130 countries, and 5,000 employees. King’s has an outstanding reputation for providing world-class teaching and cutting-edge research. The College is in the top group of UK universities for research earnings and has an annual income of approximately ??400 million. An investment of ??500 million has been made in the redevelopment of its estate.
King’s has a particularly distinguished reputation in the humanities, law, social sciences, the health sciences, natural sciences and engineering, and has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA. It is the largest centre for the education of healthcare professionals in Europe and is home to five Medical Research Council Centres - more than any other university.
King’s College London and Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts are working together to create the UK’s largest Academic Health Science Centre (AHSC). The AHSC will bring together the widest range of clinical and research expertise in the UK - strengths that will be used to drive improvements in care for patients, allowing them to benefit from breakthroughs in medical science and receive leading edge treatment at the earliest possible opportunity.
For further information visit:
Source: Nancy Mendoza
Biotechnology and Biological Sciences Research Council
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