Pfizer Presents New Data from HIV AIDS Portfolio at Conference on
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HIV patients infected with a certain type of HIV. Selzentry is known as Celsentri(R) outside of the United States.
The data highlight potential advances in the treatment of HIV that has become resistant to currently available therapies.
"Viral resistance is a major issue in treating HIV. This past year, the community welcomed breakthrough therapies, including Selzentry, that are giving patients infected with resistant virus new hope of controlling this disease," said Dr. Martin Mackay, president of Pfizer Global Research and Development. "Pfizer is continuing to invest in research that we hope will help physicians remain one step ahead in their fight against HIV."
Data Presentations on Pfizer's Investigational HIV Compounds
New data from phase I studies on PF-232,798, a second generation CCR5 antagonist, suggest that this molecule is well tolerated in healthy volunteers with a dosing profile that holds the potential for once daily administration. Preclinical data on PF-232,798 demonstrated the molecule's activity against a broad spectrum of HIV-1 subtypes with similar in vitro potency to Selzentry, the first member of the CCR5 antagonist class to receive approval. PF-232,798 also showed activity against isolates of HIV that demonstrated resistance to Selzentry. Pfizer is further characterizing the clinical profile of PF-232,798 with phase II studies.
Additionally, phase I data on UK 453,061 further characterized the profile of this molecule in combination with other commonly used HIV medicines. UK 453,061 is a second generation NNRTI that has demonstrated in vitro activity against a variety of HIV-1 subtypes, including strains resistant to first generation NNRTI treatments. Based on these data, Pfizer continues to explore how to further characterize the clinical profile of UK 453,061 with longer-term phase II studies.
Data Presentations on Selzentry
New data that were presented from the ongoing Selzentry clinical program reinforce its sustained efficacy and tolerability in treatment-experienced adults infected with CCR5-tropic HIV-1. A combined 48-week analysis of the MOTIVATE 1 and 2 trials shows that nearly three times as many patients receiving Selzentry in addition to an optimized background regimen achieved undetectable levels of virus compared with those receiving an optimized regimen alone.
A subanalysis from the 48-week results of the MERIT trial, which was conducted in treatment-naive patients, was also presented. The analysis suggests that Selzentry may have minimal impact on lipid profiles and is at least lipid neutral compared with efavirenz in this patient population.
Additional data examining the pharmacology of Selzentry in the female genital tract and treatment failures on Selzentry in the MOTIVATE and MERIT trials were also presented during CROI.
In 2007, Selzentry / Celsentri was approved in the U.S., the EU, and other regions as the first in a new class of oral HIV medicines in over a decade. In the U.S., Selzentry is indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents.
Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS and those at risk around the world. This commitment is embodied in Pfizer's products, partnerships, pipeline and philanthropy.
Important Safety Information
Selzentry does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Although there was no overall increase in serious liver function test abnormalities in patients treated with Selzentry, hepatotoxicity has been reported with Selzentry use. Evidence of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated IgE) prior to the development of hepatotoxicity may occur. Patients with signs or symptoms of hepatitis or allergic reaction following use of Selzentry should be evaluated immediately.
The safety and efficacy of Selzentry have not been specifically studied in patients with significant underlying liver disorders. However, caution should be used when administering Selzentry to patients with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.
In clinical studies, more cardiovascular events, including myocardial ischemia and/or infarction, were observed in patients who received Selzentry as compared to placebo. Selzentry should be used with caution in patients at increased risk for cardiovascular events.
Caution should be used when administering Selzentry in patients with a history of postural hypotension or who receive concomitant medication known to lower blood pressure. Patients should be advised that if they experience dizziness while receiving Selzentry, they should avoid driving or operating machinery.
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
Selzentry antagonizes the CCR5 co-receptor located on some immune cells, and therefore could potentially increase the risk of developing infections and malignancy.
For full prescribing information for Selzentry, including boxed warning, go to www.Selzentry.com.
For more information on Pfizer's patient assistance program in the U.S., call 1-888-327-RSVP (7787) or visit the RSVP section of www.PfizerHelpfulAnswers.com.
DISCLOSURE NOTICE: The information contained in this release is as of February 6, 2008. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about two investigational HIV compounds, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such compounds as well as their decisions regarding labeling and other matters that could affect their availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and in its reports on Form 10-Q and Form 8-K.
New Data on Investigational HIV/AIDS Compounds Presented;
Phase III Data Reinforce Selzentry Efficacy
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Kelaodebeierna
Clinical medicine is the origin of great interest to historians have imposed on the issues, on the subject of literature is voluminous, many of whom are excellent, also discussed the perspective of the author of clinical medicine as a science, and the awareness of the problem different. Although the literature background and the difference between the starting point of the various medical people do not have the historical status of the same evaluation, but one thing is the same: a clinical history is a scientific method into clinical practice of history, but also from the Metaphysics of Medicine to the enlightenment of the history of science, and rational eventually created today s medicine. However, things really that simple? History is so dull?
Science is first and foremost a human activities, although the neutral scientific facts, but found it in the history of the concept of long-term change in the movement. If not before and after the succession, how to explain bring out as the emergence of new concepts will be a problem. More importantly, when history is simplified because some heroes who create, when the history of a dual polarization immediately, we will lose will not grasp the true, the spirit of science itself requested by the constant recourse and exploring also will no longer exist.
1963 of a small book so that we simplify the cheers from the sober, medical historians have also begin to address-label compilation of the superficial and harmful, and re-examine the prehistoric era of medical science, said the statement. The birth of clinical medicine has become a medical history unique in the literature works.
This is the concept of a medical history, but also on the medical and social history of the Evolution of the structure. The birth of modern medicine were placed in the context of the era of enlightenment, in the classification of disease Zhaoduan thinking of the change.
Since ancient Greece, biologists discovered that, in order to grasp the complex and Wuza life phenomena and understand the diversity of life virtually unlimited, the first in accordance with the similarity of a category concept, similar to investigate see the difference, and this established to study biological diversity and unique basis of the taxonomy, it is another well-known modern biologists is the name of systematic. Because only in a certain organism taxonomy can be established by following the scientific method to study and deal with , and because taxonomy of the various branches concentrated, use, and summarizes all the organisms known knowledge 2 system as a result of all the basic biology disciplines and some of the most wide-ranging, and thus have an enormous impact on the development of biological disciplines. There is no doubt that Linnai the taxonomy of biological effects reached a peak in the 1760 s, he created a pair of stringent practical method for the more stringent unified naming laid the foundation, he easily confuse a synonym for standardization, biological Jurists started using the same set of language exchange a word, he has biological How to say no longer an issue.
Taxonomy of the tremendous impact of the biological sciences affected almost all areas, areas of study as an integral part of life in the medical is no exception. Category medical thus becoming the mainstream of this period, the disease is regarded as the status of an independent entity, has become one of the patient s body, are independent of the disease and hinder doctors discovered the truth obstacles. From the disease by such a concept of Foucault found that the medical classification, faced by the people (disease), some are natural, is the type of philosophy. And Nature linked to the concept of the nature of so that the disease is not in line with the taxonomic status of the intervention as anti-nature, and thus is harmful. Therefore, the observations and expectations, and at the right time to complete its natural disease process has become a matter of course. To achieve this objective, since the family is diseases and emerging space, the promotion of disease extinction is of a special significance. Thus, (disease) on the structure and political thinking in relief Problems of a fully fit.
Since families to promote the best place for rehabilitation disease, originally from the poor into a specialized hospital treated poor patients the hospital would have no raison d
Economists were found in the physician and Classification of the common discourse: the 18th century has long been recognized economist and fixed assets of the hospital because of the mobility of non-poverty and unable to adapt to the changing demands of this nature and to donate their property as a public contrary to the nature of the property - a unique and sacred melting in the general fund should help space, the community is one of the only managers and the proceeds are non-discriminatory. because everyone is facing the burgeoning problem Direct aid and must rely on the support of the social fabric, with the national health care will need to combine and become a national task. Clearly, there has been a modern health system contributed to the idea, but in order to achieve the social health of the operation of the process also need another kind of driving force - plague or what we call a special kind of infectious diseases diseases.
As infectious diseases quickly, each pandemic similar to the symptoms and lead to a high degree of unanimity of course, but at different times and regions popular, its intensity and characteristics also vary widely, it does not have general of the independent nature of the disease all by Category Medical upon which to build a single observation, recording and classification method can not understand it. It is a collective phenomenon, and always have a unique history, from their special needs and, occasionally, to describe the nature of the accident. In other words, the need for sensitive detection and comprehensive and full records, which resulted in the epidemiological monitoring system in the embryonic form of the 18th century to build. Because, in essence, that the epidemic is by the time the specific local climate, soil and water, community conditions and the behavior pattern of symptoms caused by a comprehensive process, therefore, the control of the epidemic is only through social intervention, and a series of coercive means can be achieved. Therefore, Foucault pointed out that although in all aspects of epidemiology and classification of medical contrary, it is involved in the disease, medical doctors, as well as experience in the monitoring of the social structure of these third-tier distribution structure of the epidemic disease pathology and disease classification Science will have the same requirements: determining the political status of medicine, build the national level of awareness of Medicine. it is these calls for the promotion of the medical academic structure reform, and thereafter social change hastened the development of new medical concepts and systems.
1790 in a watershed, social unrest and led to a reorganization of the new requirements for medical practice, and the general political concepts and tenets of the medical concept has also caused lasting impact and change the mode of the medical observation, in the end, the medical classification concepts are what we call modern medical concept of physiological - pathological medicine alternative model.
Revolution to the concept of human liberation of the people, the concept of natural rights thinking promote inequality and disease, a health verify the scale of social justice. So the political mission of the medical self-evident, doctors also the primary task is therefore political: the fight against the disease must first and the fight against bad government. Must first obtain the liberation, can be a comprehensive and thorough treatment.
While this ideal was eventually proved to be unrealistic, but it is important that, through this process, which finally realized medicine and the fate of their country with, and then by a series of political and reinvented the practice of clinical medicine. The abolition of the old system of medical education and medical practice system is the first step in these reforms. However, the practice eligibility restrictions and the abolition of the old medical education has not been accompanied by the closure of an effective new system, the results Jianghuyisheng popular, and the war has brought bloodshed, the creation of new hospitals and medical become a problem that must be solved. The re-establishment of the School of Medicine beginning to emerge, and in the new environment in the running: This time, managers and supervisors from the trip may become national. As classical university education has been abolished, the new Medical Education in the reconstruction of clinics. The difference is that, the former medical education here only implemented at the clinics have to shoulder responsibility for the treatment, medical students learn is based on the real show in front of the cases, the study of the theory of classification has been relegated to a secondary position. Patients with symptoms of the disease entities replace a compass to guide clinical judgement. Evolution of the medical classification for which medical symptoms.
We should try to make scientific visualization is the medical symptoms of the most representative period of Proverbs, visual has become the core of this period medical concepts, its diagnostic techniques and the concept of the formation is of decisive significance. Only a doctor can help Ruju eyes found deep in the body of the disease, although the darkness of space containing only revealed to the light of day. It is not difficult to find, in fact reflect this understanding of enlightenment spirit of the times. This perception of the disease depends on the signs and symptoms of the disease understanding, in other words, the signs and symptoms of the disease are presented to the way the observer. Here, Foucault distinguish symptoms (symptome) and signs (signe). Symptoms are more of the superficial nature, or that it performance in the disease itself. In addition to no longer have any symptoms of pathological nature: all diseases in itself is a phenomenon in this context, plays a simple symptoms, the most natural role: They constitute a collection of the so-called diseases of the people . Therefore, the disease Ontology be cancelled and replaced by a collection of symptoms. Signs are slightly different, if the symptoms of the disease itself reflects the existence of the disease by doctors is for the indirect perception of the disease.
Symptoms and signs of the formation of the concept of modern medicine is extremely important role. Today, all doctors in its clinical medical education will be the first lesson taught remember and understand signs and symptoms (of modern medicine signe translation) concept. Modern diagnostic symptoms will be defined as patient perception and the expression of discomfort or abnormal signs objective examination by a doctor through the body found abnormal phenomenon. By placing doctors objective and neutral observer status, signs in today s diagnosis of symptoms was more than a significant position. Because symptoms is the focus of attention of medical doctors vision, direct and indirect, and modern medicine is very concerned about the perception of the objectivity and subjectivity, therefore, the symptoms and signs to give different status was not strange. As direct representatives of the symptoms in patients with the disease to the suffering caused by disease and is therefore evidence of the existence, and reflects the signs already exist abnormal, and therefore performance of the disease. Therefore, whether the signs or symptoms of the disease can be the same, which are telling the same things.
In the symptoms - symptoms of an in-depth analysis on the basis of Foucault s use of symbols of further investigated the concept of medical symptoms, and one pair of famous introducing the concept of awareness of the disease to the structure of the analysis, and this is referred to means. In simple terms, the former can be understood as we attempt to grasp the perception and the existence of the latter is that we imposed on the existence of the name (or by Saussure said, and referred to refers to the existence of the representative the concept of image and audio), and the overall things, that the meaning and to be able to refer to the complex to form a human can grasp the symbol. This, as a symptom of the disease symptoms, it has become the disease can mean. At the same time, because the symptoms of the disease itself is set, it is referred to and described as a disease of this duality all the facts symbol. Thus, pathological process should adjust themselves to become the target of the full statement said, the authenticity of the disease is fully explained. As the expression of language will take time, the symptoms appear dynamic evolution of the process is, therefore, the disease should be a time dimension includes the concept of the medical classification of diseases result in static flow together.
Symptoms belief in the 18th century in the final years of their physician. However, it was quickly discovered that the signs and symptoms are so numerous and, uncertainty is so desperate everywhere - Uncertainty is the complexity of the object characteristics, which is scientific and imperfection of the character; addition to its own and the extreme narrow information over the relationship between the rich, medicine speculative nature has no objective basis. disharmony contingencies become increasingly visible, people urgently need to be able to deal with the new problems in new ways and new concept. The right time, a new mathematical probability of the emergence of problems to solve provides the best perspective - statistics which began a process of integration of Medicine, and eventually become an important pillar of scientific medicine.
With the process of the industrial revolution, modern state began to take shape, how to measure a country s strength, become a political calculation, the major tasks. Special investigative bodies have emerged, population, production, as well as diseases such as avalanche of words followed as emerging, before and after 1660, statistics as a political arithmetic mounting the stage of history. Expansion ambitions, the desire for profit and the achievement of the greatest happiness, the ideal of the European countries collectively push the number of management processes, statistics, it s becoming a significant study. Every country, the happiness or unfortunately, in their own way statistically demonstrated. 3 This is a show of the times statisticians, Laplace (Laplace), Poisson (Poisson) created for the work of the statistics as a scientific basis, and the number of characters from the de measurements trigger a Positive concept and, thereafter, history shows that its modern science, philosophy and social thinking in general have taken place in a far-reaching impact .
The task is to understand an open field events, as well as endless and this is clinical.
However, the concept of medical symptoms still exist understanding of the fog: disease as language analogues, no body, the symptoms only as a symbol in the operation, the doctor s attention merely on the body surface. Clearly, this is the lack of visual depth, the body of the maze remain in darkness. Opened to the fog, it is necessary to open the body, with bright as the excellent insight into the dark corners of the hidden disease. Bishi (glance) to replace visual become the next period of the core concept of clinical practice, anatomy also replace the symptoms of the disease become analytical Keen Edge: medical symptoms will gradually diminish, until on the organs, and causes lesions in the medical before, in full accordance with pathological anatomy of the clinical setting up before the final demise.
Classic on the history of medicine in clinical medicine to the modern period of change, happy that exist in the pathological Jiepouhuajia and social conservative forces between the theatre of conflict, and thus prove that it is precisely because the old social forces in the way, the only medicine in a hundred years time no progress, and break the taboo on the body only for the clinical brought the hope of finding the truth. However, Michel Foucault s history of literature through meticulous research found that these historical narrative is not true, at least from the mid-18th century, the anatomy for medical purposes has never obstacles. The reason why there will be written the history of these illusory, as is often compiled from future clinical and anatomical interpretation of the close relationship to find traces the historical development of, and in accordance with the conclusions of a pre-historical literature on the selective presentation, neglected and ignored their own concepts and the records do not match, so the Construction of the reverse causality of the hero and a fool, progress and setbacks of history.
In fact, back in the 17th century, the Andean Vesalius stay has been issued anatomy masterpiece On the human body structure, 1760 Moerjiani lesion location and the reasons for the disease has been linked to the pathological anatomy . The dominant concept is not concerned about the patient s body structure and the relationship between the disease, in 40 years to prevent medical listen to the teachings of the Moerjiani is clinical thinking. Conflict is not in the new knowledge and between the old belief, but in two different types of knowledge between.
Than the summer (Bichat) of the book is the most representative of this period and the most important medical literature. He will organize as the basic unit of body composition, and that the disease can eventually restore the damage process for the organization, each disease has been given an anatomical position. By examining every system in the history of the changes in general, the eventual establishment of pathological anatomy of the physical structure of a disease classification system. Therefore, in a sense, the basic concept of the medical classification by the freshmen were pathological anatomy. There is no doubt that here, each system generally change history is extremely important value, which prompted people to understand that different organs in the pathogenesis of similar, and become today pathology fundamental pathological process and the use and development to the basic rules of discovery and profound understanding of various diseases and the special nature of the law 4 the concept of sources.
In anatomy - pathological medicine, death occurred, the status of the changes: a body on the truth of life and the source of the disease, death is no longer merely a passive Terminator, and a be on the real life of the only truth One possible way. Death comes from the fact that an awkward become a hundred lives in the process, so life, disease and death which formed the concept of a technically and on the Trinity. As a researcher pointed out that , in here, Foucault found dead in the medical sense to assume the new role of a disease and to clarify the relationship between life
Through pathological - Anatomy of Medicine on the whole concept has been and, renovation and reconstruction, the modern concept of clinical disease has begun to take shape, but there are still a group of diseases, it can not be incorporated into the framework of the early Jiepouhuajia They were unable to locate, is the fever - a category contains a wide range of inflammatory diseases. Red, swelling, heat, pain is the common feature of these diseases, but often can not find fever associated with specific organs, the doctors were puzzled heated discussions, and sometimes even in the fierce dispute, but the issue has not been finally resolved, until 1816. This year, Bulusai a recognized doctrine of the inspection, and specifically pointed out the need to understand inflammation, we must realize that this is not in a scalpels can see with the naked eye physiology reality, and therefore the need for a Physiology or Medicine observation methods to grasp. Inflammation is first and foremost a dysfunctional Therefore, the bulk of the disease once again been cancelled, the physiological responses in the views of the interpretation of a dominant position. People need to find in the physiology of the disease characteristics, and through the analysis to distinguish between skilful sick organ is a mixed group often cries. Therefore, the definition of normal to achieve a physiological analysis of the disease s priority tasks. Do not know will not be able to understand the abnormal normal, starting from this line of thought, we can easily understand why the entire 19th century in the history of medicine and Luoyiba de Claude Bernard, reached peak. Therefore, the following conclusions on Foucault is particularly convincing medical disease has been to the end of the road; There is now a pathological response of Medicine. Structure of this experience to dominate the 19th century because it will be inclusive agent Medicine, Although it can not be amended in the methodology, it is still to some extent dominated the 20th century.
Wrote the article here, it seems to be a summary of the time. However, the birth of clinical medicine is not the kind of two will be able to use a generalization books. Here, the show is a dazzling screen, thinking of the change is no longer a one-way degrees, the concept of mutual penetration, a staggered row again showed both staggering tectonic faults. The birth of science is no longer just a constant advances in technology by means of catalytic and to promote the process of building a conceptual framework of the pivotal role.
Clearly, we see here a profound similarity, the birth of clinical medicine, which reveals the picture and between the above thesis, it seems that Both have some kind of a tacit agreement.
The birth of clinical medicine is a person subject accessible object as a knowledge of history. Thus, Foucault will be incorporated into the medical humanities perspective, and pointed out that the whole person in the medical, scientific, and occupied buildings on the basis of location: it is closer than other scientific support all these scientific anthropological framework. The development of human thought as a part of the ups and downs, was a result of Medicine also a broader meaning, a real sense of the dialectical view of history which can be established - in the last few years of the 18th century, outlining a European culture The structure has not yet been clarified; we have only just begun to untie a few clues, we still do not understand them, so we do not put them as a novelty thing is that ancient times, in fact in the past 200 years they have been posed to our experience the dark and a solid network.
Main References
1. The birth of clinical medicine, Liu Bei-cheng, in the translation Forest Press, 2001 Nanjing
2. History of the development of biological thinking, Tu Nagaakira such as translation, Sichuan Education Press, Chengdu 1990
3.The Taming of Chance, Hacking I, Cambridge University Press, 1990
4. Pathological Wu Zhong Bute editor-in-chief, fourth edition, People s Health Press, Beijing 1996
5. Foucault: Portrait thinking, Liu North-compiled, the Shanghai People s Publishing House, Shanghai 2001
Related: Pfizer Presents New Data from HIV AIDS Portfolio at Conference on
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