Pharmacyclics Submits New Drug Application For Xcytrin For The Treatment Of Lung Cancer Brain Metastases

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug Application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection with the U.S. Food and Drug Administration (FDA). The company is seeking approval to market Xcytrin for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., cancer that has spread to the brain from another part of the body).

The NDA data packet includes efficacy and tolerability data from two Phase 3 randomized, controlled trials involving 805 patients, which compared the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin. These studies utilized an innovative clinical benefit endpoint that measured neurologic outcomes.

“The clinical development program with Xcytrin continues on multiple fronts,” said Richard A. Miller, M.D., president and CEO of Pharmacyclics. “In addition to the completed trials in brain metastases, which form the basis of our NDA submission, several other ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development.”

About Lung Cancer and Brain Metastases

According to the National Cancer Institute, over 170,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer patients. Spread of lung cancer to the brain may occur early in the course of disease or may be a later complication of this illness.

Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Standard therapy for patients with brain metastases from lung cancer involves the prompt use of cranial radiation, which is used to prevent neurological deterioration and improve neurologic outcomes.

About Xcytrin

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity for Xcytrin to be used in a broad range of cancers. Xcytrin has been granted Fast Track designation by the FDA for use in the treatment of lung cancer brain metastases. This designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.

About Pharmacyclics

Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. Its lead product, Xcytrin(R), has completed Phase 3 clinical trials and several ongoing Phase 1 and Phase 2 clinical trials are evaluating Xcytrin as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types. More information about the company, its technology, and products can be found at http://www.pharmacyclics.com. Pharmacyclics(R), Xcytrin(R) and the “pentadentate” logo(R) are registered trademarks of Pharmacyclics, Inc.

Other than statements of historical fact, the statements made in this press release about enrollment and future plans for our clinical trials, progress of and reports of results from preclinical and clinical studies, clinical development plans and product development activities are forward- looking statements, as defined in the Private Securities Litigation Reform Act of 1995. The words “believe,” “will,” “may,” “continue,” “plan,” “expect,” “intend,” “anticipate,” variations of such words, and similar expressions also identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. The forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward- looking statements. Factors that could affect actual results include risks associated with the possibility that the FDA refuses to accept or approve any NDA we submit; because our Phase 3 clinical trial known as the SMART (Study of Neurologic Progression with Motexafin Gadolinium and Radiation Therapy) trial failed to meet its primary endpoint, the FDA may require additional data, analysis or studies before the NDA is accepted for filing or approved by the FDA; the outcome of any discussions with the FDA; the initiation, timing, design, enrollment and cost of clinical trials; unexpected delays in clinical trials and preparation of materials for submission to the FDA as part of our NDA filing; the fact that data from preclinical studies and Phase 1 or Phase 2 clinical trials may not necessarily be indicative of future clinical trial results; our ability to obtain future financing and fund the preparation of our NDA filing and the product development of our pipeline; our ability to establish successful partnerships and collaborations with third parties; the regulatory approval process in the United States and other countries; and our future capital requirements. For further information about these risks and other factors that may affect the actual results achieved by Pharmacyclics, please see the company’s reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to its annual report on Form 10-K for the period ended June 30, 2006. Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Pharmacyclics, Inc.
http://www.pharmacyclics.com

The Right Balance Drives The Field Of PPAR Agonist R&D

The commercial success of the two peroxisome proliferator-activated receptor (PPAR) gamma agonists pioglitazone and rosiglitazone from Takeda & Lilly and GlaxoSmithKline approved for treatment of type 2 diabetes with 2005 global sales of more than US$ 5 bln fuels the R&D of next generation PPAR agonists. Safety concerns and regulatory impediments caused Big Pharma companies to discontinue their first generation, close to market dual PPAR alpha and gamma agonists. The next generation fine-tuned dual PPAR alpha/gamma agonists prefer agonists with full alpha and partial gamma activity with Sanofi-Aventis and AstraZeneca as protagonists. Research is shifting into the field of novel PPAR delta agonists and combinations of PPAR delta with PPAR gamma (dual) or with PPAR gamma and delta (Pan PPAR agonists). GSK leads this field which has already ten projects in clinical development. These results were found in a Competitor Analysis conducted by La Merie Business Intelligence. The report can be found at http://www.pipelinereview.com, La Merie’s News Center and Online Store.



Sales of the two approved PPAR gamma agonists in 2006 are further growing at double digit rates stimulated by the growing number of patients and by label extensions and fixed dose combinations with metformin and glimepiride. The use of insulin sensitizing, first generation PPAR gamma agonists is associated with an increased incidence of edema and weight gain. Clinical data with improved modulators of PPAR gamma from Metabolex indicate that this side effect can be avoided. At least six clinical programs with next generation PPAR gamma modulators are on the way followed by new non-TZD partial PPAAR gamma ligands with preferential recruitment of PPAR gamma co-activator.



Major pharma companies BMS & Merck, AstraZeneca, Takeda, Eisai and Eli Lilly discontinued their first generation dual PPAR alpha and gamma agonist projects for the treatment of type 2 diabetics with dyslipidemia due to regulatory requests of long term preclinical and clinical safety data. The next generation of dual PPAR alpha/gamma agonists shows a fine-tuned agonist profile with preference on PPAR alpha and little PPAR gamma activity. At least eight clinical programs are running in this field. The impact of FDA’s requests on the pipeline of PPAR alpha agonists with fenofibrate-like actions on triglycerides and HDL cholesterol is not evident as there are at least nine clinical stage projects ongoing.



GlaxoSmithKline leads the field of companies with interest in PPAR delta agonism which affects cholesterol transport. PPAR delta mono-agonists as well as triple PPAR alpha, delta and gamma agonists are in clinical development with at least ten clinical stage development projects.




About PipelineReview.com



http://www.pipelinereview.com is the News Center and Online Store of La Merie Business Intelligence focused on R&D in the biopharmaceutical industry. Visitors of PipelineReview.com will find R&D relevant press releases and can receive selected R&D News by subscribing to the daily R&D Newsletter or to one of the RSS Feeds.



About La Merie



La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit http://www.lamerie.com.

Human Trial Results Show Excellent Safety Data, From Geovax’s DNA/MVA AIDS Vaccines

GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax’s AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease (“AIDS”) caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.

Early results from GeoVax’s preventative HIV/AIDS vaccine human trials:

* Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006

* indicate that as low as 1/10th of a full dose of GeoVax’s HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients

* Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006

* Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007

* Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated

The 1/10th dose trial, begun April, 2006, is evaluating GeoVax’s AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.

“We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine,” said Dr. Harriet Robinson, GeoVax’s Chief Scientific Advisor and developer of the AIDS vaccine. “This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax’s DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax’s MVA vaccine at week 16 and again at week 24.”

The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.

Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non-human primates for more than 3 ВЅ years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax’s vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.

More information will be released on the full dose trial when available later in 2007. GeoVax’s AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV-1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.

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The human trials, utilizing GeoVax’s AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax’s DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.

Safe Harbor Statement

All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax’s vaccines will be determined to be safe for use in humans, GeoVax’s vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.

Contact: Melanie Nimrodi
Financial Relations Board

Progress In Battle Against Life-threatening Acute Allergy

Up to 15% of the population has to contend at some time with Anaphylaxis: a suddenly serious allergic reaction that can be life-threatening. Researchers from the Flanders Interuniversity Institute for Biotechnology (VIB) connected to Ghent University have uncovered mechanisms that underlie this reaction. Their research offers new perspectives for the treatment of anaphylactic shock.

Anaphylaxis

Some people have allergic reactions to certain substances that can be so pronounced that they affect the entire body. Such a reaction – called anaphylaxis – can be so severe that it becomes life-threatening. An injection of adrenalin is currently the only effective remedy known for this condition. But adrenalin often has no, or insufficient, effect on the cardiovascular collapse that is a consequence of the allergic shock.

Anaphylaxis occurs fairly frequently and strikes up to 15% of the population. It can be caused by a bee sting, by medications, by contact with latex, or by certain foods such as peanuts. Because more and more people are being confronted with anaphylactic shock, and given the limitations of the current treatment methods, scientists are searching for better remedies.

Several leading actors

Scientists are aware of the possible role of PAF (Platelet Activating Factor) in blood pressure and heart disorders that result from shock like anaphylactic shock. They also know that extreme amounts of nitric oxide (NO) can lie at the basis of shock. The so-called NOS enzymes are responsible for the production of NO in the body. However, the role of NO in producing anaphylactic shock, or how shock is induced by PAF, has always been unclear. So, Anje Cauwels and her colleagues, under the leadership of Peter Brouckaert, have been focusing their attention on anaphylaxis to try to shed more light on these matters.

The mechanism exposed

The Ghent researchers used mice to study PAF and anaphylactic shock. To their great surprise, the hyper-acute PAF-induced shock was completely dependent on NO. Furthermore, the production of NO was not regulated by iNOS (the expected activator) but by the constitutive eNOS, which is activated via the PI3K pathway. Up to now, scientists have thought that this pathway only plays a role in normal blood pressure regulation, and not in shock.

The research team then set out to verify whether inhibition of the several leading actors could prevent anaphylactic shock. And indeed, from their research it turns out that inhibition of eNOS or PI3K provides total protection.

New perspectives for future therapies

The research of Cauwels and Brouckaert has yielded an unexpected new finding: namely, that eNOS-derived NO plays a key role in anaphylactic shock. This discovery opens new perspectives for treatment – it’s now clear that eNOS and PI3K are prime targets for new drugs against anaphylaxis.

About the VIB – FLANDERS INTERUNIVERSITY INSTITUTE FOR BIOTECHNOLOGY

VIB, the Flanders Interuniversity Institute for Biotechnology, is a research institute where 800 scientists conduct gene technological research in a number of life-science domains, such as human health care and plant systems biology. Through a joint venture with four Flemish universities (Ghent University, the Catholic University of Leuven, the University of Antwerp, and the Free University of Brussels) and a solid funding program for strategic basic research, VIB unites the forces of nine university science departments in a single institute. VIB manages an extensive patent portfolio and distributes scientifically substantiated information about all aspects of biotechnology to a broad public.

VIB – FLANDERS INTERUNIVERSITY INSTITUTE FOR BIOTECHNOLOGY
Rijvisschestraat 120
B-9052 GENT

http://www.vib.be

Antibody Extends Life Of Mice With Breast Cancer

A monoclonal antibody developed by researchers at the University at Buffalo has been shown to extend significantly the survival of mice with human breast-cancer tumors and to inhibit the cancer’s spread to the lungs in the animals by more than 50 percent.

The antibody, named JAA-F11, targets a particular disaccharide, an antigen known as TF-Ag, which aids the adhesion and spread of certain cancer cells. While the antibody did not kill the cancer cells, it blocked stages of cancer-cell growth that allow the cells to adhere to organ tissue, the research showed.

Results of the research appeared in the November 2006 issue of the journal Neoplasia.

Mice with breast-cancer tumors that received the antibody had a median survival time of 72 days, compared to 57 days for the animals that did not receive JAA-F11, the study found. In addition, exposing cultures of tumor cells to the antibody inhibited cell growth by a statistically significant 16 percent.

Kate Rittenhouse-Olson, Ph.D., associate professor of clinical and laboratory sciences in the UB School of Medicine and Biomedical Sciences, is senior author on the study.

“This antibody binds with a carbohydrate on the tumor cell surface that is involved in adhesion of the cell during the metastatic process,” said Rittenhouse-Olson. “Not only would drugs attached to the antibody JAA-F11 bind to the tumor cell surface to direct their cytotoxic effect, but the binding of the antibody itself would block the cell from metastasizing.”

The antibody was tested using in vitro models of tumor cell growth, in assays to determine its ability to damage or kill cells (cytotoxicity), in various models of cancer metastasis, and, finally, in mice with metastatic breast cancer.

“In addition to providing a survival advantage,” said Rittenhouse-Olson, “JAA-F11 immunotherapy reduced the metastatic tumor burden significantly, reflected by both a dramatic decline in the overall incidence of spontaneous metastasis to the lung — 88 percent to 47 percent — and fewer macroscopic metastatic lesions.”

The research group currently is determining if JAA-F11 could increase the effectiveness of existing cancer drugs, she said, as well as studying the possibility of using the antibody as a vehicle for the targeted delivery of drugs to aid cancer diagnosis and therapy.

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Jamie Heimburg and Jun Yan, co-first authors on the paper, were graduate students in Rittenhouse-Olson’s lab at the time of the study.

Also contributing to the research were Susan Morey and Robert Klick, Ph.D., from the UB Department of Biotechnical and Clinical Laboratory Sciences; Linda Wild, M.D., from UB’s Pathology Department; Olga V. Glinskii, M.D., Vladislav V. Glinsky, M.D., and Virginia H. Huxley, Ph.D., from the University of Missouri, and Rene Roy, Ph.D., from the University of Quebec in Montreal. Glinsky also is affiliated with the Harry S. Truman Memorial Veterans Hospital in Columbia, Mo.

The research was supported by grants from the National Institutes of Health to Rittenhouse-Olson, Glinskii and Huxley; from the VA Merit Review Program to Glinsky, and from the U.S. Department of Defense to Heimberg and Rittenhouse-Olson.

The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York. The School of Medicine and Biomedical Sciences is one of five schools that constitute UB’s Academic Health Center.

Contact: Lois Baker
University at Buffalo

Governors, Lawmakers Pressure FDA To Ease Market Entry Of Generic Insulin

Some federal lawmakers and governors have been lobbying FDA to ease the way for the production and sale of generic insulin, which analysts say would reduce the cost of diabetes treatment by 25%, the New York Times reports. Generic insulin could mean spending reductions for Medicaid programs — which spent $500 million on the treatment in 2005 — as well as for people with diabetes. In addition, some observers say that the availability of generic insulin could ease development of other drugs in the class of biologics, which are medicines made from living organisms. However, many scientists say duplication of such drugs could be difficult, as they are variable and could cause allergic reactions in patients. The drug companies Novo Nordisk, Eli Lilly and Sanofi-Aventis “dominat[e]” the insulin market, the Times reports. Of the five insulin products sold in the U.S. in 2005, only Lilly’s Humulin and Novo Nordisk’s Novolin have lost their 20-year patent protection, while patents on other products “exten[d] into the next decade.” Generic manufacturers say the first step to creating a competitor drug would be for FDA to adopt guidelines explaining the testing and documentation required to approve a generic version of insulin. In 2001, the agency announced it would develop guidelines for generic insulin and the human growth hormone, but those guidelines were never released, in part because of pressure from the Biotechnology Industry Organization, the Times reports. The group has said that some exemptions granted to conventional generic drugs that speed their market entry are not applicable for biologics. FDA has said that it might be more appropriate to develop guidelines applying to all biologics rather than individual treatments. According to the Times, the agency has said it will release a scientific background paper on the issue this spring. Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) last year said in a letter to FDA, “There is simply no excuse — scientific, legal or otherwise — for the FDA to delay the release of these guidelines.” Mississippi Gov. Haley Barbour (R), one of 11 governors who have asked FDA to speed approval of generic insulin, said, “To have a lower-cost solution for our very large diabetic population is in the interest of the state and the interest of these people” (Saul, New York Times, 1/11).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

World Bank To Provide Thailand With $750,000 For HIV/AIDS Treatment Programs

The World Bank plans to provide Thailand with a $750,000, three-year grant aimed at providing HIV-positive people with increased access to antiretroviral drugs, Viroj Tangcharoensathien, program director for international health policy at the country’s Ministry of Public Health, said recently, Thailand’s Nation reports. More than 130,000 HIV-positive people in Thailand need access to antiretrovirals, and the number is increasing annually, according to the Nation. Under the grant partnership, the bank will help address funding issues associated with the country’s universal health care system, Viroj said. “We can’t rely on the ministry’s budget allocation alone,” Viroj said, adding that the partnership will seek other resources for health services. In addition, the project will provide training for nurses and doctors in an effort to overcome the shortage of health care personnel in the country, health ministry senior adviser Suwit Wibulpol-prasert said. The collaboration is a “step forward to sustainable development in this field and improving the country’s health care,” Suwit said. A separate partnership between the Thailand Center of Excellence for Life Sciences and the World Health Organization will aim to standardize clinical research into tropical diseases, the Nation reports. The partnership will focus on the prevention, diagnosis and treatment of diseases such as malaria, tuberculosis and dengue fever (Nation, 2/6).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

AllermistTM / Avamys(R) (fluticasone Furoate) Significantly Improved Symptoms Of Seasonal And Perennial Allergic Rhinitis In Clinical Studies

GlaxoSmithKline (GSK) announced it has submitted applications for both U.S. and European marketing approval for a new medicine to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The medicine (fluticasone furoate) is an enhanced affinity intranasal corticosteroid with the proposed name of AllermistTM in the US and Avamys(R) in Europe.

The efficacy and safety of Allermist / Avamys have been evaluated in seven clinical trials with 2,555 adult and pediatric patients two years of age and older with symptoms of SAR and PAR. Patients taking the medicine reported significant improvements in a range of nasal symptoms compared to those taking a placebo. In adult patients with SAR, in addition to nasal symptom improvement, Allermist / Avamys use was also consistently associated with significant improvement in ocular symptoms such as watery, itchy eyes.

This is an important milestone in our respiratory research and we hope this medicine will offer help to millions of seasonal and perennial allergy patients,” said Kathy Rickard, M.D., Vice President Clinical, Respiratory Medicine Development Center (North America).

Developed after ergonomic testing, Allermist / Avamys is dispensed using a novel nasal device, designed with the patient in mind. There is minimal or no aftertaste with Allermist / Avamys and the product is unscented and alcohol-free.

About Allergic Rhinitis

Allergic rhinitis is an inflammatory disease characterized by the symptoms of runny nose (rhinorrhea), nasal congestion, watery eyes, sneezing and itching of the nose and ocular symptoms of red, itching/burning and watery eyes. Symptoms occur after exposure to allergens such as mold spores and pollens which cause SAR, or to year-round allergens such as dust mites or animal dander which cause PAR.

One of the most prevalent and chronic diseases in the U.S., allergic rhinitis affects up to 40 million people annually, including 10 to 30% of adults and up to 40% of children. In Europe, more than 1 in 5 adults are estimated to suffer from allergic rhinitis, of which nearly half are undiagnosed.

Allergic rhinitis can limit productivity, resulting in both work absenteeism and reductions in effectiveness among adult patients. In children, allergic rhinitis can significantly reduce energy, negatively affect behaviour, and impair learning.

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in the company’s Annual Report on Form 20-F for 2005.

www.gsk.com

Novel EGFR Ectodomain Mutations In Glioblastoma

The Epidermal Growth Factor Receptor (EGFR), a so-called kinase protein, is often abnormally active in cancer. A new class of anticancer drugs inhibiting the activated EGFR kinase have shown to be effective against such cancers, especially lung cancer. In a new study in PLoS Medicine, researchers have catalogued and characterized the mutations in the EGFR gene that occur in glioblastoma, a deadly type of brain tumor. The researchers sequenced the whole coding sequence of the EGFR gene in more than 100 glioblastomas. Nearly 15% of the tumors contained missense mutations – changes that altered the amino acid sequence of EGFR.

But the mutations were mostly different from the ones commonly seen in other cancers: rather than changing the kinase domain, most of the gliobastoma-associated mutations mapped to the extracellular domain of the protein. These findings identify missense mutations in the extracellular domain of EGFR as a new way to oncogenically activate this protein. Fortunately, the drugs developed to inhibit EGFR have broad activity, which bodes well for the use of these drugs in patients with glioblastoma.

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PLEASE MENTION THE OPEN-ACCESS JOURNAL PLoS MEDICINE (http://www.plosmedicine.org/) AS THE SOURCE FOR THESE ARTICLES AND PROVIDE A LINK TO THE FREELY-AVAILABLE TEXT. THANK YOU.

All works published in PLoS Medicine are open access. Everything is immediately available without cost to anyone, anywhere – to read, download, redistribute, include in databases, and otherwise use – subject only to the condition that the original authorship is properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License.

Citation: Lee JC, Vivanco I, Beroukhim R, Huang JH, Feng WL, et al. (2006) Epidermal growth factor receptor activation in glioblastoma through novel missense mutations in the extracellular domain. PLoS Med 3(12): e485.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/

CONTACTS:
Ingo Mellinghoff
David Geffen School of Medicine
University of California, Los Angeles
700 Westwood Plaza, B3-399 BRI
Los Angeles, CA 90095 United States of America

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world’s scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/

Contact: Andrew Hyde
Public Library of Science

Growth Hormone Doesn’t Help You Live Longer

A new study has indicated that not only does growth hormone not help you live longer, but it comes with a substantial potential for adverse side effects, such as diabetes, carpel tunnel syndrome and swollen joints. Growth hormones have been promoted for years as wonder products that can prevent, even reverse, the aging process.

You can read about this study in the Annals of Internal Medicine.

Researchers from the University of Stanford looked at 31 studies. In all the studies growth hormone had been used on elderly patients. The patients were slightly overweight, but none had any serious health problems at the beginning of each study. The researchers found that growth hormones did bring about a slight reduction in body weight and a slight increase in muscle. They did not detect, however, any change in the patients’ cholesterol levels, aerobic capacity or bone density.

The researchers did find that there was an increase in developing soft tissue edema (swelling), arthralgias, carpal tunnel syndrome and gynecomastia. They were also more likely to experience the onset of diabetes mellitus and impaired fasting glucose.

Dr Hau Liu, team leader, said “There is certainly no data out there to suggest that giving growth hormone to an otherwise healthy person will make him or her live longer. We did find, however, that there was substantial potential for adverse side effects. In short, the studies provided no real evidence that the therapy resulted in increased fitness.”

The study looked at t total of 220 participants who received growth hormone (GH). Their average age was 69.

We all produce GH in the pituitary gland. Production peaks during our childhood years and wears off in our thirties.

“Systematic Review: The Safety and Efficacy of Growth Hormone in the Healthy Elderly”
right arrow Hau Liu, MD, MBA, MPH; Dena M. Bravata, MD, MS; Ingram Olkin, PhD; Smita Nayak, MD; Brian Roberts, MD; Alan M. Garber, MD, PhD; and Andrew R. Hoffman, MD
Annals of Internal Medicine
16 January 2007 | Volume 146 Issue 2 | Pages 104-115
Click here to see the review online

Written by: Christian Nordqvist
Editor: Medical News Today