02.26.09
Posted in Uncategorized at 8:26 am by hope
Pharmaceutical News
As influenza season shifts into high gear, with 24 states now reporting widespread activity, the nation's infectious diseases experts are urging supermarket pharmacies with free-antibiotics promotions to educate their customers on when antibiotics are the right prescription-and when they can do more harm than good.
Several grocery store chains nationwide began offering free antibiotics this winter. Some are linking the promotion to cold and flu season, despite the fact that antibiotics do not work against these viral illnesses. Furthermore, antibiotics can have serious side effects, and their misuse is contributing to the increase in antibiotic-resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA).
Therefore, the Infectious Diseases Society of America (IDSA) and the Centers for Disease Control and Prevention (CDC) have written to supermarkets with free-antibiotics promotions asking them to join "Get Smart: Know When Antibiotics Work," a campaign from CDC to educate consumers about the importance of using antibiotics appropriately.
"Taking an antibiotic when you don't need it won't help you, and may in fact do more harm than good," said IDSA President Anne Gershon, MD. "At a time when antibiotic overuse is helping to create drug-resistant superbugs such as MRSA and few new antibiotics are being developed, supermarkets need to be responsible in how they promote antibiotics."
Studies show many people believe that antibiotics can cure a cold or the flu, and tend to ask or pressure their clinicians to provide them. Every year, tens of thousands of people are prescribed antibiotics for these conditions, even though they will do no good and can be harmful. A recent study in Clinical Infectious Diseases estimates that antibiotics are responsible for 142,000 emergency department visits each year, mostly because of allergic reactions.
"Supermarkets have the power to protect their customers' health," said Lauri Hicks, DO, medical director of CDC's "Get Smart" program. "If they sought to educate people about when antibiotics work and when they don't, they would be doing a great public service."
In letters to Wegmans, ShopRite, Stop and Shop, and Giant, IDSA and CDC suggest that supermarkets could begin with CDC's easy-to-understand posters, brochures, and other educational materials.
IDSA suggests supermarkets offer free flu shots rather than free antibiotics as a way to save customers money while protecting their health. "We applaud supermarkets' desire to look out for their customers in these difficult economic times," Dr. Gershon said. "As flu season heats up, free influenza vaccinations would be a proven-effective way to keep customers healthy."
http://www.idsociety.org/
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Posted in Uncategorized at 8:26 am by hope
Drug Trials
Medivation, Inc. has announced the presentation of new efficacy and safety data from an ongoing Phase 1-2 clinical trial of the Company's novel androgen receptor antagonist MDV3100 in castration-resistant prostate cancer (CRPC) patients.
The new efficacy data cover all 114 patients who have been followed for 12 weeks or longer, and show that MDV3100 consistently demonstrated encouraging anti-tumor activity across dose levels and endpoints.
"The data thus far suggest a favorable benefit/risk ratio for MDV3100 in treating castration-resistant prostate cancer patients," said Howard Scher, M.D., principal investigator of the trial and chief of the Genitourinary Oncology Service and the D. Wayne Calloway Chair in Urologic Oncology at Memorial Sloan-Kettering Cancer Center. "These men have a limited life expectancy, and currently their only approved treatment option is chemotherapy. Given these encouraging results and the large unmet medical need for men with castration-resistant prostate cancer, I am enthusiastic about working with Medivation to advance MDV3100 into Phase 3 clinical development this year."
All patients had progressive disease upon enrollment and were heavily pretreated, with 77 percent having failed at least two lines of prior hormonal therapy and 43 percent having also failed one or more chemotherapy regimens. Efficacy endpoints in the study included circulating tumor cell (CTC) counts, serum prostate specific antigen (PSA) levels, soft tissue and bony metastases, and time on treatment.
Almost all patients with favorable CTC counts (four or less) at the start of treatment maintained favorable counts at week 12 (89 percent of chemotherapy naive patients and 100 percent of post-chemotherapy patients). Importantly, a significant number of patients with unfavorable CTC counts of five or higher at baseline converted to favorable counts of less than five at week 12 (73 percent of chemotherapy naive patients and 40 percent of post-chemotherapy patients). This CTC conversion rate is encouraging in light of a recently published study in the October 2008 issue of Clinical Cancer Research, in which post-treatment conversion to a CTC count below five was associated with a 15-month survival benefit in castration-resistant prostate cancer patients.
MDV3100 also produced significant PSA declines (50 percent or more from baseline) and radiographic control (partial response or stable disease) in both chemotherapy naive and post-chemotherapy patients at week 12, as follows:
PSA response > 50% Radiographic Radiographic control: soft control: bony tissue lesions lesions Chemotherapy naive 57 percent 80 percent 61 percent Post-chemotherapy 45 percent 70 percent 64 percent
Thus far, the median time on treatment for chemotherapy-naive patients and post-chemotherapy patients is 276 and 145 days, respectively.
The new safety data include all 140 patients enrolled in the trial. MDV3100 has been generally well tolerated at doses of up to and including 240 mg/day. The most frequently reported adverse event was fatigue. Two witnessed seizures occurred in patients taking doses of 600 mg/day and 360 mg/day. Both patients were taking concomitant medications that can cause seizures. A possible but unwitnessed seizure was reported in a patient taking a dose of 480 mg/day.
"We are pleased to continue to see concordance of data across endpoints -- CTC changes, PSA declines, radiographic findings and time on treatment," said David Hung, M.D., president and chief executive officer of Medivation. "We continue to move forward with clinical development of MDV3100 and expect to seek U.S. Food and Drug Administration approval to advance to a pivotal Phase 3 registration study this year."
The new MDV3100 efficacy and safety data will be presented in a poster session on Friday, February 27 at 11:45 a.m. Eastern Time at the American Society of Clinical Oncology's (ASCO) 2009 Genitourinary Cancers Symposium in Orlando, Fla.
Teleconference/Webcast Details
Dr. Scher will participate in a teleconference and webcast of a slide presentation today at 4:30 p.m. Eastern Time. He will discuss the new MDV3100 data and the recent research regarding the association between changes in the number of CTCs and the prediction of survival and response to treatment in patients with advanced prostate cancer.
To participate in the live call by telephone, please dial 877-719-9810 from the U.S. or +1-719-325-4785 internationally. Individuals interested in listening to the live call via webcast may do so by visiting http://www.medivation.com/. A slide presentation that will accompany today's teleconference can be accessed via the Web by accessing the webcast and will also be posted as a PDF next to the event listing in the Investor section of the Medivation website. A replay of the webcast will be available on the Company's website for 30 days.
About Prostate Cancer and MDV3100
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than 1 million men in the United States have prostate cancer. In 2008, an estimated 186,320 new cases were expected to be diagnosed and approximately 28,660 men were expected to die from the disease. Patients with castration-resistant (also known as hormone-refractory) prostate cancer have few treatment options and a poor prognosis.
Overexpression of the androgen receptor is believed to contribute to the progression of castration-resistant prostate cancer. MDV3100 is a novel small-molecule androgen receptor antagonist that inhibits androgen receptor function by blocking nuclear translocation of the androgen receptor and DNA binding.
http://www.medivation.com/
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Posted in Uncategorized at 8:26 am by hope
Women's Health News
You've probably heard of postpartum depression - a common problem after pregnancy, suffered by about one in seven new mothers.
But did you know there is a much more common form of distress that can also be harmful for pregnant women, parents and newborns?
Perinatal anxiety - unhealthy distress experienced during or soon after pregnancy - is the subject of a major new study being conducted by psychologists at the University of North Carolina at Chapel Hill and Florida State University.
"We call perinatal anxiety the hidden disorder," said Jonathan Abramowitz, Ph.D., co-principal investigator for the study, associate professor of psychology and director of the Anxiety Disorders Clinic in UNC's College of Arts and Sciences. Abramowitz is also a research associate professor in the UNC School of Medicine's psychiatry department.
"This is not new, but it's not been discussed or studied very much, even though it's a lot more common than postpartum depression," Abramowitz said.
Symptoms of perinatal anxiety may include general uncontrollable worries during pregnancy or the early stages of parenthood. First-time parents encounter many unknowns which can make them fearful, Abramowitz said. "They may think: is the baby going to be healthy? Is the baby normal? Am I going to be a good parent?"
"About 60 to 70 percent of new mothers and fathers have these kinds of thoughts," he said. "It's normal to think these things, dismiss them and move on. But when you can't control your thoughts, or they interfere with your sleep, your health or your ability to care for your baby, then you may need help."
In some cases, such anxiety results in panic attacks. In the most serious cases, parents may become obsessed with senseless, intrusive negative thoughts which they can't seem to control no matter how hard they try, Abramowitz said. "They may begin to worry about all kinds of things: What if the baby dies during sleep? What if I lose control and harm or molest the baby? What if I do something terrible to the baby? Worse, they may feel scared and confused about what these thoughts mean - fearful that they will act on these obsessional thoughts."
Abramowitz, an expert on anxiety disorders, has been studying perinatal anxiety since 2001. First he identified symptoms and explored how to predict if new parents were susceptible to the condition.
Now he and colleagues are trying to determine if first-time parents experiencing significant anxiety can be helped by cognitive behavior therapy (CBT). This form of psychological treatment is effective in treating other forms of anxiety, including panic attacks and obsessive compulsive disorder.
"Cognitive behavior therapy involves helping patients learn strategies to change maladaptive thinking and acting patterns that contribute to anxiety and obsessions," Abramowitz said.
All participants in the six-week study will receive helpful childbirth counseling as part of free weekly prenatal classes. Half of the participants will receive elements of CBT as well. Those who complete the study will also receive a modest fee at the end.
First-time pregnant women over the age of 18, and their partners, can learn more and complete a screening questionnaire online at www.babyprepstudy.com.
The Anxiety Disorder Clinic is part of UNC's psychology department. In addition to engaging in studies, the department's clinics provide low-cost therapy services to adults and children on a sliding-fee scale. They can be reached at (919) 962-6906.
http://www.unc.edu/
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Posted in Uncategorized at 8:26 am by hope
Medical Research News
Two compounds developed by Northwestern University chemists have been shown to be effective in pre-clinical trials in protecting against cerebral palsy, a condition caused by neurodegeneration that affects body movement and muscle coordination.
"The results were just stunning, absolutely amazing," said Richard B. Silverman, John Evans Professor of Chemistry in the Weinberg College of Arts and Sciences at Northwestern, who led the drug development effort. "There was a remarkable difference between animals treated with a small dose of one of our compounds and those that were not."
The findings, which are published online by the journal Annals of Neurology , suggest that a preventive strategy for cerebral palsy may be feasible for humans in the future. (The paper also will appear in the journal's February issue, in print the week of March 2.)
None of the fetuses born to animals treated with the two compounds died; more than half of those born to untreated animals died. Eighty-three percent of animals treated with one of the compounds were born normal, with no cerebral palsy characteristics. Sixty-nine percent of animals treated with the other compound were born normal. There was no sign of toxicity in the treated animals, and their blood pressure was normal.
Cerebral palsy is caused by an injury to the brain before, during or shortly after birth, although it typically is not diagnosed until after the age of one. Approximately 750,000 children and adults in the United States have a form of cerebral palsy, with the majority having been born with the condition.
The new compounds Silverman and his team developed inhibit an enzyme found in brain cells that produces nitric oxide, thus lowering nitric oxide levels. At normal levels, nitric oxide acts as a neurotransmitter and is important to neuronal functioning, but at high levels it has been shown to damage brain tissue. An overabundance of nitric oxide is believed to play a role in cerebral palsy.
After a lengthy drug development process, Silverman went to his collaborator Sidhartha Tan, M.D., a neonatologist from NorthShore University HealthSystem, to test the two best compounds on Tan's cerebral palsy animal model. A diminished supply of oxygen (hypoxia) from mother to fetus causes an increase in nitric oxide levels in the brain, which leads to brain damage and newborns with cerebral palsy characteristics.
Silverman and Tan wanted to see if they could prevent brain damage in the fetuses by administering one of the compounds to the mother before the hypoxic event. They expected some degree of success but were surprised by how effective the treatment was. The researchers attribute the protection from cerebral palsy to the decrease in the brain enzyme and the nitric oxide that is produced.
"We still have to bring the phenomenon to humans, which would be very exciting," said Tan, who has been investigating the impact of nitric oxide on neuronal damage. "There is such a dire need. If we could safely give the drug early to mothers in at-risk situations, we could prevent the fetal brain injury that results in cerebral palsy."
In developing the potential drugs, Silverman and his team were able to produce something that pharmaceutical companies so far have not: highly selective compounds that inhibit the enzyme found in brain cells that produces nitric oxide but that do not affect similar nitric oxide-producing enzymes found in endothelial and macrophage cells.
Endothelial cells regulate blood pressure, and macrophage cells play an important role in the immune system. Reducing their production of nitric oxide would have deleterious effects on an animal, such as increasing blood pressure or compromising the immune system.
"The challenge was to lower only the nitric oxide in the brain and not in the other cells where the nitric oxide is very important," said Silverman, a member of Northwestern's Center for Drug Discovery and Chemical Biology.
"Early compounds developed by drug companies to target the brain enzyme actually bound to all three nitric oxide enzymes," he said. "This made me think that the three enzymes must be very similar in structure. We decided to look for differences away from the normal binding site to get selectivity for only the brain enzyme."
This approach paid off. Silverman and his team started with a molecule that showed good selectivity of the brain enzyme over the macrophage enzyme but with no selectivity over the endothelial enzyme. The researchers then made modifications to the molecule and built a library of 185 different compounds that could be tested for the selectivity they wanted. They found 10 good ones. More modifications were made until they had a few compounds that were very selective and very potent for the brain enzyme.
Silverman then started collaborating with Thomas Poulos, Chancellor's Professor of Molecular Biology and Biochemistry and a crystallographer from University of California, Irvine, who had been working on the structure of the neuronal brain enzyme. Silverman sent him several potent and selective compounds, and Poulos produced crystal structures showing each compound bound to the brain enzyme.
"Thanks to the talents of Tom and his associate Huiying Li we could, for the first time, see visually why these compounds were selective and also see the difference between them," said Silverman.
Haitao Ji, a postdoctoral fellow who is an expert in structure-based design, joined Silverman's team. Ji took the crystal structures of their molecules bound to the enzyme and, using computer modeling, designed new structures with even better properties.
These compounds were more potent and much more selective than earlier ones. Poulos produced crystal structures of the new compounds. These are the compounds that Tan tested on his cerebral palsy animal model with such promising results, as reported by the research team in the Annals of Neurology paper.
"This is a great example of a multi-institutional collaboration that could not have been done without each of the parts -- we each contributed something different," said Silverman. "Science is going in that direction these days."
The researchers caution that taking the compounds to human clinical trials is a lengthy and complicated process. Silverman says they next plan to make the compounds even more potent, selective and bioavailable and then envision partnering with a company that would want to develop the drugs further.
http://www.northwestern.edu/
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Posted in Uncategorized at 8:26 am by hope
Medical Research News
Stem cells scientists at UCLA showed for the first time that human induced pluripotent stem (iPS) cells can be differentiated into electrically active motor neurons, a discovery that may aid in studying and treating neurological disorders.
Additionally, the motor neurons derived from the iPS cells appeared to be similar in function and efficiency to those derived from human embryonic stem cells, although further testing needs to be done to confirm that. If the similarities are confirmed, the discovery may open the door for new treatments for neurological disorders using patient-specific cells.
The study appears today in the early online edition of the journal Stem Cells. It can be accessed here: http://www.stemcells.com/view/0/index.html.
"It is clear from the literature that you can make at least immature versions of many different kinds of cells from human iPS cells," said William Lowry, a Broad Stem Cell Research Center scientist, an assistant professor of molecular, cell and developmental biology and senior author of the study. "But there is not a lot of data published describing the generation of fully functional cells from human iPS cells."
Lowry and his team used skin fibroblasts and reprogrammed them back into an embryonic state, with the ability to differentiate into any cell type in the human body. They then took those cells and differentiated them into motor neurons.
Neurons are the responsive cells in the nervous system that process and transmit information by electrochemical signaling. Motor neurons receive signals from the brain and spinal cord and regulate muscle contraction.
The study demonstrates the feasibility of using iPS-derived motor neurons and their progenitors to replace damaged or dead motor neurons in patients with certain disorders. It also opens the possibility of studying motor neuron-related diseases in the laboratory to uncover their causes. Motor neurons are lost in many conditions, including spinal cord injury, Amyotrophic Lateral Sclerosis and Spinal Muscular Atrophy.
"A primary objective of human embryonic stem cell and human iPS cell technology is to be able to generate relevant cell types to enable the repair of tissue damage and in vitro modeling of human disease processes," the study states. "Here, we demonstrate the successful generation of electrically active motor neurons from multiple human iPS cell lines and provide evidence that these neurons are molecularly and physiologically indistinguishable from motor neurons derived from human embryonic stem cells."
Much may be learned from studying the iPS-derived motor neurons and comparing them to motor neurons derived from patients with neurological disorders to see how they differ. The next step for Lowry and his team is to combine the motor neurons with muscle cells to see if they can stimulate a response. If they do, researchers should be able to see the muscle cells contract.
http://www.ucla.edu/
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