Patient Adherence An Essential Factor For Successful Tuberculosis Treatment

Nearly 2 million people die from tuberculosis each year, mainly in the poorest countries. The pathogen, Koch's bacillus, can pass easily by aerial infection from one individual to another. The spread of the disease, favoured by the Aids epidemic and the appearance of multi-resistant strains, has led WHO to make tuberculosis control one of the world's main health priorities. The existing treatment, which combines several antibiotics prescribed for a period of 6 to 8 months as against 18 months to 2 years still only a few years ago - has proved efficient in 95 % of cases. However, this efficacy is called into question by the low adherence of patients to treatment, particularly in the most deprived areas, which are often indeed the worst hit by the disease. In spite of the WHO recommendation to administrate the treatment under the direct supervision of health care personnel who play the role of supporter (DOT : Directly observed therapy), more than 10% of patients stop the treatment before the prescribed period. This defaulting, along with irregularity in taking the medicines, creates increased risk of serious relapse, which opens the way to a rise in transmission events and the emergence of bacteria resistant to the prescribed antibiotics.


Starting from the principle that tuberculosis control must involve the identification of the obstacles to full comprehensive access to treatment, IRD researchers and their partners (1) studied, in Senegal, the different geographical, behavioural and socio-cultural factors that enter into the perception of the treatment and adherence to it. In these countries, where over 9000 new cases of tuberculosis are diagnosed every year, access to free treatment is provided by the National Tuberculosis Control Programme through government health districts (2). However, nearly 30 % of patients do not follow this treatment correctly and scarcely 60% of people ill from the disease receiving a prescription manage to be cured. What are the reasons for this? Long distances from the health centres are among the first difficulties encountered. However, insufficient emphasis on listening to patients, counselling and information provision by health district personnel, associated with shortfalls in following up the DOT strategy also combine to discourage patients from taking the treatment right to the end of the prescribed course. In this context, the researchers looked simultaneously into the relations between health-care staff and the tuberculosis patients, the perception of the disease and its treatment in the community in which they live. They thus proposed action consisting of four major strands: training of health-care personnel, aiming to improve communication and support to patients, the decentralization of access to treatment to offer availability at local medical posts by involving health personnel who are attached to these, reinforcement of the DOT strategy by allowing patients to choose their supporter from among the staff or from within their community (imam, family relation, teacher…) and improved coordination of the activity of medical posts from the district centres.


To test the effectiveness of this action, a randomized controlled clinical trial was run between June 2003 and January 2005 on 16 district health centres and 1522 patients, who were separated at random into two groups. The first group was treated according to the action procedure proposed by the researchers, the second according to the usual strategy of the National Tuberculosis Control Programme (control group). After one year, a distinct improvement in adherence to treatment was observed in the first case: the rate of cure from tuberculosis rose by 20% and the proportion of patients defaulting fell by two-thirds (from 16.8 to 5.5 %).


The training of health-care personnel, communication to inform patients and make them aware of their responsibilities, just as the taking into account of the local, social and cultural context of communities, clearly appear to be essential factors for the sound running of the therapy and the long-term efficacy of actions geared to tuberculosis control. This action strategy, by improving adherence to treatment and the rate of successful patient outcomes, should thus help restrict the spread of the disease and prevent the arrival on the scene of new resistant strains of bacteria. Research work is continuing, in the form of a trial conducted by the IRD in conjunction with WHO, aiming to make available a shorter, 4-month treatment which could lead to still a further improvement of adherence and outcome results.


References


(1)This research involved IRD research unit UR 145 (Programme Tuberculose), the London School of Hygiene and Tropical Medicine, the Programme National de Lutte anti-tuberculeuse of Senegal, and the International Union against Tuberculosis and Lung Diseases, based in Paris.


(2)The standard treatment recommended here lasts 8 months: a 2-month phase to attack the disease by combining rifampicin, isoniazid, pyrazinamid and ethambutol followed by stabilizing phase of 6 months involving combined treatment with isoniazid and ethambutol.


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Privacy Concerns Could Limit Benefits From Real-Time Data Analysis

Society will be unable to take full advantage of real-time data analysis technologies that might improve health, reduce traffic congestion and give scientists new insights into human behavior until it resolves questions about how much of a person's life can be observed and by whom, a Carnegie Mellon University computer scientist contends in a commentary published in the journal Science.



In a "Perspectives" column, Tom M. Mitchell, head of the Machine Learning Department in Carnegie Mellon's School of Computer Science, notes that data-mining techniques, once used for scientific analysis or for detecting potential credit card fraud, increasingly are being applied to personal activities, conversations and movements, such as information that can be deduced about an individual by monitoring that person's smart phone.



"The potential benefits of mining such data range from reducing traffic congestion and pollution, to limiting the spread of disease, to better using public resources such as parks, buses, and ambulance services," Mitchell wrote. "But risks to privacy from aggregating these data are on a scale that humans have never before faced."



Technical means can help limit threats to privacy and misuse of data, Mitchell said. One approach is to mine data from many different organizations without ever aggregating the data into a central repository. For instance, individual hospitals might analyze their medical records to see which treatments work best for a particular flu strain, then use cryptography to encode the results and protect patient privacy; only then would the findings be combined with those from thousands of other hospitals.



"Perhaps even more important than technical approaches will be a public discussion about how to rewrite the rules of data collection, ownership, and privacy to deal with this sea change in how much of our lives can be observed, and by whom," Mitchell wrote. "Until these issues are resolved, they are likely to be the limiting factor in realizing the potential of these new data to advance our scientific understanding of society and human behavior, and to improve our daily lives."



Mitchell pointed out that the use of real-time data from individuals already has begun. In many cities, anonymous location data from smart phones is being used to provide up-to-the-minute reports of traffic congestion. Researchers have shown that by analyzing health-related Google queries from particular geographic areas, they can estimate the level of flu-like illnesses in regions of the U.S. before government agencies such as the Centers for Disease Control and Prevention can provide estimates. Scientists are beginning to use real-time sensing of routine behavior to study interpersonal interactions as people go about their daily lives.



Combining data sets could open up many new possibilities, as well as new privacy issues, Mitchell said. "For example, if your phone company and local medical center integrated GPS phone data with up-to-the-minute medical records, they could provide a new kind of medical service using phone GPS data to detect that you have recently been near a person who is just now being diagnosed with a contagious disease - then automatically phoning to warn you."



A former president of the Association for the Advancement of Artificial Intelligence (AAAI), Mitchell is a member of an AAAI panel that is exploring the potential societal impacts of advances in artificial intelligence. A pioneer in artificial intelligence and machine learning, Mitchell was named a University Professor, the highest distinction that faculty can achieve at Carnegie Mellon, in May 2009. He has been head of the Machine Learning Department since the first-of-its-kind department was established in 2006. His research focuses on statistical learning algorithms for understanding natural language text and on understanding how the human brain represents information.



Source: Byron Spice


Carnegie Mellon University

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Poor housing reason for high asthma rate in the UK

One in twelve children in Britain is at increased risk of developing asthma and other respiratory diseases because of poor housing, according to a new report by Shelter.


The homelessness charity found that more than one million children in England, Wales and Scotland are living in accommodation that jeopardises their health, because it is damp, cold, dirty or infested. People with asthma are twice as likely to live in damp homes, says the report, 'Toying with their future'. Children living in these conditions are also more at risk of developing TB and bronchitis.


'My 10-year-old's asthma is getting worse because of the damp,' one mother in Flintshire was quoted as saying. 'Mould is growing on the carpets and I have to spend loads on heating instead of proper food for my kids.'


'The kids have got used to it because they've grown up here,' said another. 'But if they go to somebody else's house they come back and say why is our flat all black down the walls and theirs' isn't?'


The number of homeless families has increased by 17% since 1997, said Shelter; over a million houses are not fit to live in and more than half a million families live in housing that is officially overcrowded.



The charity said that the rise in house prices and the depletion of affordable social housing means that the number of people living in emergency accommodation has reached record levels.



The UK has the highest rates of childhood asthma in the world, with one in eight children currently being treated for the condition. Research has shown a clear association between poverty and asthma.



'We know that asthma is affected by factors associated with poorer socioeconomic backgrounds and social exclusion, such as damp housing,' said Kate Webb, senior policy and information officer at the National Asthma Campaign.



'Asthma is the most common long term medical condition among children in the UK today,' she added. 'All agencies should be working together to ensure that kids' health does not suffer because of their living environment.



'We shouldn't just be thinking about the asthma symptoms that children are experiencing today, but also about the long-term lung damage that this may be causing.'



asthma/news/news132.php

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Presumptive Republican Presidential Nominee McCain Promotes Health Care Proposal At Miami Children's Hospital

Presumptive Republican presidential nominee Sen. John McCain (Ariz.) on Monday at the Miami Children's Hospital promoted his health care proposal, which he said would "put families in charge," USA Today reports (Jackson, USA Today, 4/29). McCain has proposed to replace a tax break for employees who receive health insurance from employers with a refundable tax credit for the purchase of private coverage and to allow the purchase of health insurance across state lines -- both of which he maintains would promote competition among health insurers, reduce costs and improve quality.

According to McCain, the proposal is "responsive to the needs of American families -- not the government, not the insurance companies, not the tort lawyers, not even the doctors and hospitals" (CNN, 4/28). He added, "I've made it very clear that what I want is for families to make decisions about their health care, not government," which he cited as the major difference between his proposal and the plans announced by Democratic presidential candidates Sens. Hillary Rodham Clinton (N.Y.) and Barack Obama (Ill.) (Reinhard, Miami Herald, 4/29).

Health care is "too expensive," McCain said, adding, "These costs are a threat to the ability of Americans to have health insurance, the gateway to better health care" (CNN, 4/28). In addition, he said, "We must move away from a system that is fragmented and pays for expensive procedures, toward one where a family has a medical home, providers coordinate their efforts and take advantage of technology to do so cheaply, and where the focus is on affordable quality outcomes." McCain added, "America can have a health care system that is characterized by better prevention, coordinated care, electronic health records, cutting edge treatments -- and lower costs" (Reuters, 4/29).

Criticism
In response to the comments from McCain, the Democratic National Committee said that he is "promising four more years of the Bush health care agenda" (CNN, 4/28). Critics argue that the McCain proposal would limit access to health insurance for low-income residents and those with pre-existing medical conditions. In addition, they maintain that his proposal would prompt health insurers to relocate to states with fewer coverage requirements.

On Tuesday, McCain will deliver a policy speech at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla., that will focus on health care. According to an advance copy of the speech obtained by the Associated Press, McCain will argue that his proposal "would help change the whole dynamic of the current system, putting individuals and families back in charge, and forcing companies to respond with better services at lower costs" (Quaid, AP/Houston Chronicle, 4/29).

Clinton Opinion Piece
Medicare represents a "sacred promise to our seniors and to future generations of American workers," but "the biggest threat" to the program is "skyrocketing health costs," Clinton writes in a Charlotte Observer opinion piece. She writes, "Protecting and strengthening" Medicare "will be a top priority of my administration." According to Clinton, "I will allow imports of certain drugs, remove barriers to generic competition and work to close the 'doughnut hole' in the Medicare prescription drug program," as well as "crack down on overpayments to HMOs in Medicare, which will save more than $10 billion a year."

She adds, "My health plan includes the most aggressive cost-cutting measures of all the candidates," with a focus on "prevention, electronic medical records and chronic care management." In addition, "I have the only plan that will cover every single American," Clinton writes, adding, "Universal health care is essential for lowering health care costs" because when "the uninsured get sick and go to the emergency room for care, we all end up paying in health premiums" (Clinton, Charlotte Observer, 4/28).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Poorer Women More Likely To Get Reduced Chemotherapy Dose

Breast cancer patients who have a lower household income and less education may be more likely to receive reduced doses of chemotherapy, according to a new study from a University of Michigan Comprehensive Cancer Center researcher.


In addition, severely obese women were four times as likely as lean women to receive less chemotherapy. Doctors calculate chemotherapy doses for each patient based on her height and weight.


The study looked at 764 women enrolled in the Awareness of Neutropenia in Cancer Study Group Registry, a prospective, multicenter study of cancer patients starting chemotherapy. The researchers looked at women with early breast cancer who were beginning chemotherapy. Study participants enrolled at 115 hospitals and doctors' offices across the country.


Results of the study appear in the Jan. 20 issue of the Journal of Clinical Oncology.


The study authors used U.S. Census Bureau statistics and the women's zip codes to assign each woman a median household income, poverty status and level of education. Information about individual women's actual educational attainment was also collected as part of the study. The researchers then calculated the standard chemotherapy dose, based on each woman's height and weight, and compared that to the initial dose each woman received. A reduced dose was noted for those who received 85 percent or less of the expected standard dose, based on their height and weight.


Researchers found that doctors were more likely to reduce the chemotherapy dose for heavier patients and those who were less educated, and lived in zip codes with lower median household income and higher levels of poverty. Severely obese patients were four times more likely to receive a reduced dose, and women with less than a high school education were three times as likely to have a dose reduction.


When it comes to obese patients, the researchers suggest that doctors reduce the chemotherapy dose because they do not want to give those patients the large dose that their weight would indicate. The motivation is to avoid potential severe and harmful side effects in their patients. For those patients of lower socioeconomic status, doctors may be anticipating the patient's attitude toward treatment, the researchers suspect.


"We speculate that physicians have concerns about a patient's ability to tolerate the side effects of chemotherapy and that the physician's uncertainty about a patient's tolerance increases with increasing social distance. One might just as well ask why we are willing to give full doses to someone with more education. It may be that negotiating side effects and continued doses of treatment is easier when there is more shared culture," says lead study author Jennifer Griggs, M.D., MPH, associate professor of internal medicine at the U-M Medical School. Griggs was at the University of Rochester in Rochester, N.Y., when she completed this research.


Previous studies have shown a connection between obesity and reduced chemotherapy doses. Griggs' work is the first to look at socioeconomic status.


Reduced doses of chemotherapy may reduce its effectiveness in preventing breast cancer from returning. Women seeking treatment for breast cancer can advocate for full doses by indicating their commitment to treatment, Griggs suggests.


"A patient might say to her physician that she is fully committed to her treatment, and in particular, to full doses of chemotherapy. I do not think it is the responsibility of the patient to ensure that she receives full weight-based doses, but physicians may be more comfortable dosing a patient fully when they are assured the patient is committed to her treatment," says Griggs, a member of the U-M Comprehensive Cancer Center.


An estimated 214,640 women will be diagnosed with breast cancer this year.


In addition to Griggs, study authors were Eva Culakova, Ph.D., University of Rochester; Melony E.S. Sorbero, Ph.D., MPH, RAND Corporation; Michelle van Ryn, Ph.D., MPH, University of Minnesota; Marek S. Poniewierski, M.D., University of Rochester; Debra A. Wolff, University of Rochester; Jeffrey Crawford, M.D., Duke University Medical Center; David C. Dale, M.D., University of Washington; and Gary H. Lyman, M.D., MPH, University of Rochester.


The study was not funded, but Amgen Inc. funded the data collection for the ANC Study Group.


Reference: Journal of Clinical Oncology, Vol. 25, No. 3.


University of Michigan Health System

2901 Hubbard St., Ste. 2400

Ann Arbor, MI 48109-2435

United States

med.umich.edu/

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NeurogesX' NGX 4010 MAA Filed And Accepted For Review By EMEA For Treatment Of Peripheral Neuropathic Pain

NeurogesX, Inc.
(Nasdaq: NGSX), a biopharmaceutical company focused on developing novel
pain management therapies, announced that the Marketing Authorization
Application (MAA) submitted by NeurogesX for NGX-4010, the Company's lead
product candidate for peripheral neuropathic pain, has been accepted for
review by the European Medicines Agency (EMEA).


NGX-4010 is a dermal patch that has been studied successfully in three
Phase 3 clinical trials in patients suffering from peripheral neuropathic
pain conditions. Two Phase 3 clinical trials for the treatment of pain
associated with postherpetic neuralgia (PHN) and one for the treatment of
pain associated with painful HIV distal sensory polyneuropathy (HIV DSP)
demonstrated that a single 30 or 60 minute treatment with NGX 4010 applied
directly to the site of pain may provide pain relief for up to 12 weeks.



Completion of the acceptance period (or validation) signifies that the
EMEA will now begin review of NeurogesX' MAA. The review process is being
coordinated by the EMEA under the centralized procedure, which, if
resulting in approval, provides one marketing authorization for all
European Union (EU) Member States, as well as Iceland, Liechtenstein and
Norway.



Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We believe that
the data included in our MAA filing, which includes data from more than
1,400 patients studied in our clinical trials, demonstrates the benefit of
NGX-4010 in treating patients suffering from peripheral neuropathic pain."



Anthony DiTonno, Chief Executive Officer, said, "Validation of our MAA
signifies a critical step in our worldwide NGX-4010 development strategy
and we look forward to productive interactions with the EMEA in order to
potentially gain marketing approval for this novel therapy. We also remain
focused on securing a partnering relationship in Europe prior to market
approval and are currently in active discussions with potential partners
for the commercialization of NGX-4010 in Europe. In addition to our
European filing, we anticipate filing a new drug application or (NDA) for
marketing approval in the United States in 2008."



NeurogesX recently announced that its second Phase 3 trial of NGX-4010
in postherpetic neuralgia (PHN) met its primary and all of its secondary
endpoints. In addition to the Company's PHN studies, NeurogesX has also
conducted a successful Phase 3 clinical trial of NGX-4010 in painful
HIV-DSP. As recently announced, the Company's second, ongoing confirmatory
Phase 3 trial for this indication has reached full enrollment and top-line
results are expected near the end of the first quarter of 2008. NGX-4010
has been granted orphan status and has received fast track designation from
the U.S. Food and Drug Administration (FDA) for HIV-DSP.
















About NGX-4010



NGX-4010 is a non-narcotic, locally-acting analgesic formulated in a
dermal patch containing capsaicin, a highly selective TRPV1 agonist.
Capsaicin is released from the patch and absorbed into the skin without
significant absorption into the bloodstream. Accordingly, users of NGX-4010
may be able to avoid the systemic side effects of anti-convulsants,
anti-depressants and opioids, including sedation and the potential for
abuse and addiction associated with some of these drugs. NGX-4010 is
administered in a physician's office in a non-invasive process. In three
Phase 3 clinical trials, NGX-4010 has been shown to reduce peripheral
neuropathic pain for up to 12 weeks.



About PHN and HIV-DSP



PHN is a painful condition affecting sensory nerve fibers. It is a
complication of shingles, a second outbreak of the varicella-zoster virus,
which initially causes chickenpox. Following an initial infection, some of
the virus can remain dormant in nerve cells. Years later, age, illness,
stress, medications or other factors that are not well understood can lead
to reactivation of the virus. The rash and blisters associated with
shingles usually heal within six weeks, but some people continue to
experience pain for years thereafter. This pain is known as postherpetic
neuralgia. PHN may occur in almost any area, but is especially common on
the torso.



HIV-DSP is caused primarily by three factors: direct activation of
cells known as sensory neurons by the HIV virus, the immune system's fight
against the infection, and the drugs administered to treat HIV. Painful
HIV-DSP is characterized by significant pain in the feet and hands.



About NeurogesX, Inc.



NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on
developing novel pain management therapies. Its initial focus is on chronic
peripheral neuropathic pain, including PHN, painful HIV-DSP and painful
diabetic neuropathy (PDN). NeurogesX's late stage product portfolio is led
by product candidate NGX-4010, a dermal patch designed to manage pain
associated with peripheral neuropathic pain conditions, that the Company
believes offers significant advantages over other pain therapies. Three
Phase 3 clinical trials with NGX-4010 have been completed and have met
their primary endpoints, two in PHN and one in HIV-DSP.



Safe Harbor Statement



This press release contains forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX
disclaims any intent or obligation to update these forward-looking
statements, and claims the protection of the Safe Harbor contained in the
Act for forward- looking statements. Examples of such statements include,
but are not limited to, statements regarding NGX-4010 clinical trials,
including the timing of completion of such trials; filings for regulatory
approval in the United States and the timing of such filings as well as the
scope of the indications that the Company is seeking approval for with
respect to its filing with the EMEA; the potential markets for NGX-4010;
the potential efficacy and benefits of NGX-4010; and NeurogesX' plans to
enter into commercial partnerships. Such statements are based on
management's current expectations, but actual results may differ materially
due to various risks and uncertainties, including, but not limited to,
subsequent analysis of data from NeurogesX' C117 trial may cause the
results to be viewed less favorably as compared to NeurogesX' initial
analysis of such trial's results; past results of clinical trials may not
be indicative of future clinical trials results; NGX-4010 may have
unexpected adverse side effects or inadequate therapeutic efficacy;
positive results in clinical trials may not be sufficient to obtain FDA or
European regulatory approval; physician or patient reluctance to use
NGX-4010, if approved, or the inability of physicians to obtain sufficient
reimbursement for such procedures; potential alternative therapies and
changing standards of care; maintaining adequate patent or trade secret
protection without violating the intellectual property rights of others;
NeurogesX' ability to obtain additional financing; NeurogesX' ability to
obtain and maintain future commercial partnerships; and other difficulties
or delays in clinical development, obtaining regulatory approval, market
acceptance and commercialization of NGX-4010. For further information
regarding these and other risks related to NeurogesX' business, investors
should consult NeurogesX' filings with the Securities and Exchange
Commission.


NeurogesX, Inc.

neurogesx

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Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions In Blood Pressure In Hypertensive Patient

Pharmacopeia (Nasdaq:
PCOP), an innovator in the discovery and development of novel small
molecule therapeutics, announced that PS433540, its first-in-class
Dual Acting Receptor Antagonist (DARA), showed statistically significant
blood pressure reductions in a Phase 2a study in patients with mild to
moderate hypertension. PS433540 is being developed as a potential treatment
for both hypertension and diabetic nephropathy and is a novel blood
pressure product candidate that possesses two validated mechanisms of
action in a single molecule. The data will be presented today at the Recent
and Late Breaking Clinical Trials Session at the American Society of
Hypertension (ASH) Twenty-Third Annual Scientific Meeting and Exposition in
New Orleans.


The Phase 2a study met its primary endpoint by showing a statistically
significant reduction in mean 24-hour systolic ambulatory blood pressure
over placebo. The study also showed statistically significant improvements
over placebo in mean 24-hour diastolic ambulatory blood pressure as well as
seated blood pressure. In this double-blind, placebo-controlled study,
patients treated with 200 mg of PS433540 once daily experienced a 12/9mmHg
drop in mean 24-hour systolic and diastolic blood pressure and those
treated with 500 mg experienced a 15/10mmHg drop in mean 24-hour systolic
and diastolic blood pressure. These reductions were highly statistically
significant vs. placebo (P








"These positive results indicate that PS433540 may be a unique new
treatment option for physicians and patients," said Joel Neutel, M.D.,
Associate Professor of Medicine in the Department of Medicine at the
University of California in Irvine, and Medical Director of Clinical
Pharmacology at the Orange County Research Center in Tustin, CA, who was
the lead investigator of the Phase 2a study. "The magnitude of the blood
pressure reductions we saw in this study were very impressive, and we look
forward to further evaluating the benefits of this novel compound."



An estimated 73 million Americans suffer from high blood pressure, a
major risk factor for cardiovascular events and heart disease.(3) More than
half of people diagnosed and treated with high blood pressure never reach
suggested treatment goals and those who do often require two or more
medications.(4) PS433540 is the first and only compound specifically
designed to incorporate two proven mechanisms -- endothelin (ETA) and
angiotensin (AT1) receptor blockade -- in one molecule to treat high blood
pressure.



"We are very pleased with the results of this important Phase 2a trial
and look forward to future studies which will further assess the potential
of PS433540, perhaps even beyond blood pressure lowering," said Joseph A.
Mollica, Ph.D., Chairman of the Board and Interim President and Chief
Executive Officer of Pharmacopeia. "We believe PS433540's dual mechanism of
action may have a positive effect on diabetic kidney disease."



Patients with diabetes are at an increased risk for many complications,
including high blood pressure and diabetic kidney disease. Up to 73 percent
of patients with diabetes have been or are being treated for high blood
pressure,(5) and an estimated 20-30 percent of diabetic patients will
progress to diabetic kidney disease,(6) a devastating disease that may
require patients to undergo dialysis or a kidney transplant.(7)



Pharmacopeia recently initiated a 12-week, Phase 2b clinical trial with
PS433540 to evaluate the compound's safety and efficacy at three different
doses versus placebo in 375 subjects with Stage I and Stage II
hypertension. The study will also compare blood pressure reductions for
each dose with irbesartan. Pharmacopeia anticipates completion of the Phase
2b trial at the end of 2008.



About the Phase 2a study



In this prospective study, 234 men and women with Stage I and Stage II
hypertension entered into a single blind placebo run-in period for 3-4
weeks, after which 114 were randomized to receive double blind study
medication for four weeks. At the time of the database lock, 108 subjects
were available for evaluation, 93 of whom had both baseline and follow-up
ambulatory blood pressure measurements (placebo: 25; PS433540 200mg: 35;
PS433540 500mg: 33). The primary endpoint was the subjects' change from
baseline in mean 24-hour systolic ambulatory blood pressure after 4 weeks
of treatment. Additionally, investigators evaluated 24-hour diastolic
ambulatory blood pressure and mean seated office systolic and diastolic
blood pressure as well as a number of other endpoints.



About PS433540



PS433540 is the first and only blood pressure product candidate in a
new class of antihypertensives known as Dual Acting Receptor Antagonists
(DARAs). PS433540 is being developed as a potential treatment for
hypertension and diabetic nephropathy. PS433540 possesses two clinically
validated mechanisms of action in a single molecule. There is preclinical
and initial clinical data suggesting that compared to either mechanism
alone, simultaneously blocking angiotensin II and endothelin 1 at their
respective receptors, AT1 and ETA, may provide an improved treatment option
for several cardiovascular diseases. Because PS433540 is highly selective
for the AT1 and ETA receptors it is able to block the blood
pressure-raising actions of angiotensin and endothelin when they bind to
these receptors.



About Pharmacopeia



Pharmacopeia is a clinical development stage biopharmaceutical company
dedicated to discovering and developing novel small molecule therapeutics
to address significant medical needs. The company has a broad portfolio of
clinical and preclinical candidates under development internally or by
partners including eight clinical compounds in Phase 2 or Phase 1
development addressing multiple indications including hypertension,
diabetic nephropathy, muscle wasting, inflammation and respiratory disease.
The company is leveraging its fully integrated drug discovery platform to
sustain the growth of its development pipeline. Pharmacopeia has
established strategic alliances with major pharmaceutical and biotechnology
companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more
information please visit the company's website at
pharmacopeia.


This press release, and oral statements made with respect to
information contained in this press release, constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements include those which express
plan, anticipation, intent, goal, contingency or future development and/or
otherwise are not statements of historical fact. These statements are based
upon management's current expectations and are subject to risks and
uncertainties, known and unknown, which could cause actual results and
developments to differ materially from those expressed or implied in such
statements. These forward- looking statements include, but are not limited
to, statements about the results of Pharmacopeia's Phase 2a clinical study
of PS433540, a product candidate from its DARA program, Pharmacopeia's
plans to develop PS433540, Pharmacopeia's other Phase 2 and Phase 1
clinical studies with respect to PS433540, including timing and expected
outcomes of such studies, Pharmacopeia's estimates of the market
opportunities for PS433540, the implementation of Pharmacopeia's strategic
plans, Pharmacopeia's plans to develop PS178990, a product candidate from
its SARM program, Pharmacopeia's Phase 1 clinical studies with respect to
PS178990, including timing and expected outcomes of such studies,
Pharmacopeia's plans to develop PS031291, a product candidate from its
chemokine receptor CCR1 program, Pharmacopeia's estimates of the market
opportunities for its other product candidates, including PS178990 and
PS031291, Pharmacopeia's ability to raise additional capital,
Pharmacopeia's anticipated operating results, financial condition,
liquidity and capital resources, Pharmacopeia's ability to successfully
perform under its collaborations with Bristol-Myers Squibb, Cephalon,
GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia's ability to build
its pipeline of novel drug candidates through its own internally-funded
drug discovery programs, third party collaborations and in-licensing,
Pharmacopeia's expectations concerning the development priorities of its
collaborators, their ability to successfully develop compounds and its
receipt of milestones and royalties from the collaborations, Pharmacopeia's
expectations concerning the legal protections afforded by U.S. and
international patent law, Pharmacopeia's ability to pursue the development
of new compounds and other business matters without infringing the patent
rights of others, additional competition, and changes in economic
conditions.



Further information about these and other relevant risks and
uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia
urges you to carefully review and consider the disclosures found in its
filings which are available in the SEC EDGAR database at sec
and from Pharmacopeia at pharmacopeia. All forward-looking
statements in this press release and oral statements made with respect to
information contained in this press release are qualified entirely by the
cautionary statements included in this press release and such filings.
These risks and uncertainties could cause actual results to differ
materially from results expressed or implied by such forward-looking
statements. These forward-looking statements speak only as of the date of
this press release. Pharmacopeia undertakes no obligation to (and expressly
disclaims any such obligation to) publicly update or revise the statements
made herein or the risk factors that may relate thereto whether as a result
of new information, future events, or otherwise.


References


(1) Prescribing Information for Coreg CR(R), Lotensin(R), Avapro(R),
Benicar(R) and Norvasc(R)


(2) American Heart Association news release.
americanheart.mediaroom/index.php?s=43&item=59. Accessed
April 7, 2008.


(3) AHA 2007 Heart Disease and Stroke Statistics, p. 3.


(4) Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the
Joint National Committee on Prevention, Detection, valuation, and
Treatment of High Blood Pressure. Journal of the American Medical
Association. 2003;289:p.2560-2572.


(5) American Diabetes Association:
diabetes/utils/printthispage.jsp?PageID=STATISTICS_233192.
Accessed April 4, 2008.



(6) Diabetes Care, Volume 27, Supplement 1, January 2004.



(7) National Institute of Diabetes and Digestive and Kidney Diseases.



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