American Lung Association Collaborates With Leading Vaccine Manufacturer On New Initiative

The American Lung Association announced today it will collaborate on a new, far-reaching influenza public awareness initiative with sanofi pasteur, the nation’s leading influenza vaccine manufacturer. As the nation’s oldest voluntary health organization, the Lung Association will expand its annual influenza awareness efforts to educate the public about influenza and the need for vaccination through support and resources from sanofi pasteur.

This American Lung Association educational initiative, Faces of Influenza, will be launched this fall to encourage influenza vaccination among high-risk groups such as the elderly and children, their contacts, the general public, and health care providers. The Faces of Influenza campaign will also be available online, where it will feature a number of interactive components, including the Lung Association’s Flu Clinic Locator (the largest online directory of public influenza clinics on the Web).

“Influenza can be a deadly disease that many people do not take seriously,” said John L. Kirkwood, president and CEO of the American Lung Association. “Through this collaboration, the Lung Association is able to embark on an aggressive public awareness and education effort for the upcoming season to educate healthy and high-risk people about the dangers of influenza and the need to get vaccinated every year.”

As part of the initiative, the American Lung Association will work on a variety of activities this fall to provide public awareness programs to encourage annual influenza immunization.

About Influenza

Influenza is a serious respiratory illness with associated complications that kills an average of 36,000 Americans and puts more than 200,000 in the hospital each year, according to the U.S. Centers for Disease Control and Prevention (CDC). Adults and children with a chronic medical condition, such as asthma, COPD (chronic obstructive pulmonary disease) and diabetes, are at higher risk for complications from influenza. Persons age 50 and older; pregnant women and children 6 through 59 months of age, as well as anyone wishing to reduce their risk for contracting influenza, should be vaccinated to help prevent complications from influenza.

About the Flu Clinic Locator

In addition to the new campaign, the Lung Association continues to offer its Flu Clinic Locator as a public service. The Flu Clinic Locator at http://www.lungusa.org is an online resource for finding flu shots. The Lung Association’s Flu Clinic Locator is the largest interactive Web site of its kind, enabling individuals to find the most convenient location to obtain a flu shot. Last year more than 30,000 public clinics were promoted from this site from across the country.

By typing in their 5-digit zip code, site visitors can receive a list of clinics in their surrounding area offering the vaccine. The Flu Clinic Locator is active from September through May.

About the American Lung Association

Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined.

The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is “Improving life, one breath at a time.”

For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872) or log on to http://www.lungusa.org.

American Lung Association
http://www.lungusa.org

Immune Responses Spread From One Protein To Another In Type 1 Diabetes

Type 1 diabetes (T1D) is caused by the immune system inappropriately attacking the cells in the pancreas that produce insulin, the hormone that controls blood sugar levels. Although many of the proteins attacked by the immune system during T1D have been identified, it has not been determined whether immune responses to the individual proteins develop independently or whether a response to just one protein then spreads to other proteins. But now, in a study appearing in the December issue of the Journal of Clinical Investigation, researchers from St. Vincent’s Institute, Australia, have shown that in a mouse model of T1D the immune system first attacks a single protein, known as proinsulin, and then expands its attack to other proteins.

Using mice that develop a disease very similar to T1D (NOD mice), Thomas Kay and colleagues showed that NOD mice that were unable to mount an immune response to proinsulin also had no immune cells that recognized a second protein IGRP and did not develop diabetes. By contrast, NOD mice that were unable to mount an immune response to IGRP had immune cells that recognize proinsulin and developed diabetes. This study demonstrates that diabetes in NOD mice is triggered by an immune response to a single protein that then spreads to other proteins. This study therefore has important implications for the development of therapeutics designed to make individuals with T1D no longer mount an immune response to a particular protein.

In an accompanying commentary, Lucienne Chatenoud and Sylvaine You from the Hopital Necker-Enfants Malades, France, discuss how it is important to determine the molecular and cellular events that underlie this spreading of the immune response so that the information can be translated to therapeutics for T1D and perhaps other autoimmune diseases.

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TITLE: Responses against islet antigens in NOD mice are prevented by tolerance to proinsulin but not IGRP

AUTHOR CONTACT:
Thomas W. H. Kay
St. Vincent’s Institute, Fitzroy, Victoria, Australia.

ACCOMPANYING COMMENTARY

TITLE: Proinsulin: a unique autoantigen triggering autoimmune diabetes

AUTHOR CONTACT:
Lucienne Chatenoud
Hopital Necker-Enfants Malades, Paris, France.

Contact: Karen Honey
Journal of Clinical Investigation

Asthma, Allergies May Reduce Risk of Brain Cancer

Having asthma, hay fever or another allergic condition may reduce the risk of developing one fatal form of brain cancer, a new study suggests.

New evidence for this relationship is found in the normal variation of two genes, the scientists say.

“Variations in certain genes may make a person more prone to develop asthma or allergies and those same variations may protect adults against the most common kind of brain cancer,” said Judith Schwartzbaum, the study’s lead author and an associate professor of public health at Ohio State University .

Glioblastoma multiforme (GBM) affects three out of 100,000 people, a rate that quadruples to 13 out 100,000 among people who are 65 and older. The average five-year survival rate from the time of diagnosis for GBM is only 3.3 percent, and is lower for people 65 and older.

The current study supports several years’ worth of research by other scientists who have suggested an inverse relationship between asthma, allergies and GBM. But those studies were based only on information that participants gave about their history of asthma and allergies, not on information from DNA testing.

“We needed an objective way to measure the accuracy of allergy self reports, one that isn’t affected by the presence of a brain tumor” Schwartzbaum said. “Looking at genetic variation is one way to do this.”

The study is the first to include a genetic component in addition to participant self-reports of asthma and allergy. The findings appear in the current issue of the journal Cancer Research.

The kind of genetic variant Schwartzbaum is talking about is called a polymorphism. While a mutation consists of a rare and abnormal DNA pattern, a polymorphism consists of common patterns, each considered normal.

Polymorphisms can offer protection against certain diseases or render a person more vulnerable to particular conditions. For example, researchers suspect that several polymorphic forms of key genes may increase susceptibility to Alzheimer’s disease.

“People who have polymorphisms in the two genes that we examined may be susceptible to allergic conditions and may also have a lower risk of GBM,” Schwartzbaum said.

She and her colleagues analyzed DNA samples from 533 people, 111 of whom had been diagnosed with GBM. The other 422 randomly selected participants served as controls. All of the subjects were asked if they had ever been diagnosed with asthma, hay fever or eczema and, if so, how long each of these conditions had lasted.

The researchers looked for polymorphisms on two genes associated with asthma and allergies, IL-4RA and IL-13. In this study, individuals with one or two specific polymorphisms on the IL-4RA gene that increase asthma susceptibility seemed to have a lower GBM risk. The same was true for two polymorphisms on the IL-13 gene.

“Our results suggest that self-reports of asthma and allergy are a pretty accurate way to determine someone’s susceptibility to this particular type of cancer,” Schwartzbaum said. “It’s also important to realize that someone could have these asthma-susceptibility polymorphisms and never experience asthma or allergies.”

Schwartzbaum’s next goal is to figure out the relationship between these allergy-inducing polymorphisms and GBM.

IL-4RA and IL-13 genes code for chemical messengers called cytokines, which control how immune system cells communicate and behave. Ironically, these cytokines may calm the immune system in the brain by helping to inhibit inflammation, even though they also eventually lead to increased inflammation in the lungs, which is a primary symptom of asthma.

It’s possible, Schwartzbaum said, that the anti-inflammatory role of these cytokines may hinder tumor growth.

“I’m not sure if these cytokines play independent roles in both allergies and the development of brain tumors, if allergies and GBM share a common pathway in the immune system, or if it is allergies themselves that reduce GBM risk,” she said.

At any rate, having asthma or other allergic conditions may be somewhat beneficial.

Schwartzbaum conducted the study with researchers from Sweden , England and Wake Forest University in Wake Forest , North Carolina . The group received funding from the National Cancer Institute, the Swedish Council for Working Life and Social Research, the Swedish Cancer Society, the Swedish Research Council, the European Union Fifth Framework Program and the International Union Against Cancer.

Judith Schwartzbaum
schwartzbaum@sph.osu.edu
614-293-3878
Ohio State University
http://researchnews.osu.edu

Researchers Develop Blood Test To Detect Lung Cancer

Lung cancer is the leading cause of cancer death for both men and women in the United States and around the world, mainly because lung cancers are found in late stages and the best treatment opportunities already have been missed. In Kentucky, the incidence of lung cancer is 49 percent higher than the national rate. However, a new blood test being developed at the University of Kentucky could soon change all that.

For the past five years, Drs. Edward A. Hirschowitz and Li Zhong have led a team developing the blood test, which could potentially help detect lung cancer in early stages in people with high risk factors for developing the disease.

“Early detection of lung cancer is the key to improving survival,” said Zhong, who was the lead author of a study appearing in the July issue of the Journal of Thoracic Oncology that described how the test is 90 percent accurate in correctly predicting non-small-cell lung cancer in patients years before any CT scan can detect it.

Although the researchers have received almost $1.5 million in funding for the development of the test from various sources, they recently received an additional $175,000 National Institutes of Health grant to transform the blood test into a format that real-world clinicians could easily use. And with further studies confirming the reliability of the new format, it could become the first blood test to predict cancer since the prostate specific antigen (PSA) test was introduced in the 1970s.

The multi-biomarker blood test, which works by identifying the body’s own immune response to tumors, would help diagnose lung cancer at the earliest stage in those with high risk factors such as age, smoking and genetic history.

Globally, lung cancer is by far the biggest cancer killer, with 10 million people diagnosed each year. In the U.S. alone, the number of lung cancer deaths has risen for each of the past five years to nearly 164,000. The main reason for such a high fatality rate is that 85 percent of lung cancers are found in stages too advanced for best treatment opportunities, Zhong said. Half of all patients die within a year of diagnosis.

For the next two years, the UK research team will collaborate with the private biotechnology company 20/20 GeneSystems to develop the clinical application for the blood test.

“We are hoping in the next several years this test would become available to the public,” Zhong said.

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Both Hirschowitz and Zhong are faculty in the Division of Pulmonary, Critical Care and Sleep Medicine in the UK.

Contact: Hollye Staley
University of Kentucky

Physicians Say Treating Obesity Vital For Public Health

Physicians who once treated mainly elderly patients for health problems such as diabetes, heart disease and stroke are seeing increasingly younger patients who have the same ailments.

A review in the December issue of Mayo Clinic Proceedings focuses on the increasing prevalence of metabolic syndrome, a state characterized by cardiovascular risk factors such as obesity, high blood pressure and abnormal levels of glucose (sugar) and fats in the blood. Authors Lewis Johnson, M.D., and Ruth Weinstock, M.D., Ph.D., of SUNY Upstate Medical University in Syracuse, N.Y., say physicians and public institutions must work in tandem to curb the obesity epidemic.

“Unfortunately, as the population becomes less active and more obese, we’re seeing a rise in this constellation of risk factors for cardiovascular disease,” says Dr. Weinstock, chief of Endocrinology, Diabetes and Metabolism at the university. “That’s of great concern because of the increased risk for heart attack, stroke and diabetes, and we’re seeing this occur in younger and younger individuals.”

Cardiovascular disease is the leading cause of death and disability among adults in the United States. The number of U.S. adults who are overweight or obese increased from 47 percent of the adult population in 1976-1980 to 65 percent in 1999-2002.

An estimated 1 million U.S. adolescents meet the criteria for metabolic syndrome. Based on these and other numbers, Drs. Weinstock and Johnson say a major increase in cardiovascular disease could occur in the next two decades.

“Increase of heart disease and stroke is of particular concern,” says Dr. Weinstock. “If that tide can be reversed, then hopefully we can make an impact in terms of improving public health in the future.”

The obesity epidemic has been making headlines for years, authors note, and strides have been made to address the problem. Schools are serving healthier meals, health insurers are offering price reductions to members who exercise, and cities are being designed so that residents can leave their cars at home and safely traverse trails and paths.

But more needs to be done, physicians say, including further research on how to prevent metabolic syndrome. Dr. Weinstock says physicians agree that treatment should be aggressive and urge patients to modify their lifestyles to include weight loss, physical activity and a healthy diet. Medications are important in treating risk factors such as diabetes and high blood pressure.

Another important component is informing the public that becoming obese can bring serious health problems, Dr. Weinstock says. Ultimately, helping prevent people from becoming obese is the top goal for physicians and other health officials, she says, especially because maintaining weight loss is the toughest challenge for people who are obese.

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A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally.

Contact: John Murphy
Mayo Clinic

FDA Approves Orally Disintegrating Prescription Antihistamine, Re-Formulated CLARINEX(R) (desloratadine) REDITABS(R) Tablets

REDITAB Dissolves Without Water to Treat Indoor and Outdoor Allergies and Hives of Unknown Cause –

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and 5 mg) REDITABS(R) tablets for the treatment of allergy symptoms caused by both perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria (CIU), or hives of unknown cause, in adults and children 6 years of age and older. The tablet disintegrates orally, is taken once-daily for 24-hour relief, and now comes in a new “tutti frutti” flavor. This convenient new formulation will be available in both a 2.5 mg and a 5 mg dose, and will be in pharmacies nationwide in September 2005.

“The CLARINEX REDITABS formulation offers my patients a new, convenient treatment option for their allergies,” said William Berger, M.D., a clinical professor in the Division of Allergy and Immunology at the University of California, Irvine. “An orally disintegrating tablet allows my patients the convenience to take their medication anytime and wherever they are even without water, and the once-daily dose helps them start each day with their symptoms under control.”

The tablet dissolves rapidly allowing allergy sufferers to take their medication when it is convenient for them, even when they do not have access to water. Patients who have active lifestyles or dislike swallowing pills may prefer REDITABS for their allergy treatment. Options like REDITABS, make it possible to identify the most appropriate allergy treatment for each patient given their lifestyle and preferences.

“This new formulation, along with the currently available CLARINEX family of products, helps physicians tailor the treatment regimen to patients’ specific needs and allows them to provide a variety of safe and effective allergy treatments for both children and adults,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

CLARINEX is the only prescription nonsedating antihistamine approved for patients as young as 6 months old and is available in different forms to accommodate patient preference and symptoms. The CLARINEX family of products includes CLARINEX (0.5 mg per 1 mL) Syrup for children as young as 6 months old, CLARINEX REDITABS for both adults and children starting at 6 years of age and CLARINEX (5 mg) Tablets and CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets for patients 12 years of age and older. CLARINEX-D 24 HOUR combines an antihistamine with a decongestant for patients suffering from nasal congestion associated with seasonal allergic rhinitis.

CLARINEX also is the only prescription nonsedating, 24-hour antihistamine approved for the treatment of indoor and outdoor allergies and hives of unknown cause. The efficacy and safety of CLARINEX in outdoor allergies has been established in four double-blind, randomized, placebo-controlled studies involving more than 2,300 patients with seasonal allergies. CLARINEX was also studied in indoor allergies in two double-blind, randomized, placebo-controlled studies involving more than 1,300 patients with perennial allergies. A single 5 mg dose of CLARINEX taken once daily provides 24-hour nonsedating relief from nasal and non-nasal symptoms of indoor and outdoor allergies. The approval for CLARINEX in chronic idiopathic urticaria (CIU) was based on two double-blind, randomized, placebo-controlled studies involving more than 400 patients.

In clinical trials, CLARINEX provided significantly greater symptom relief than placebo. Also, CLARINEX provided powerful morning symptom relief with significant improvement in morning symptom scores over placebo.(1) The most common side effects in allergic rhinitis were sore throat, dry mouth and fatigue, with an incidence rate similar to placebo. In CIU studies, the most common side effects were headache, nausea and fatigue.

About Allergies and Hives

Seasonal allergies affect an estimated 36 million people in the U.S.2 Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

Chronic idiopathic urticaria (CIU) refers to ongoing outbreaks of hives that last longer than six weeks, with no known cause. They can develop anywhere on the body and are usually associated with itching. The itchy, red spots appear quickly and usually disappear within 24 hours and may reappear elsewhere on the body.(2)

About the CLARINEX Family of Products(3)

CLARINEX is available in a regular tablet, an orally disintegrating tablet, as syrup and in combination with a decongestant.

CLARINEX Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX REDITABS tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older. CLARINEX Syrup, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children two years and older, and indoor allergies and hives of unknown cause in children as young as six months. CLARINEX-D(R) 24 HOUR Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.

Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue.

Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.

Due to its pseudoephedrine component, CLARINEX-D 24 HOUR Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure, or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their health care provider before taking CLARINEX-D 24 HOUR Extended Release Tablets. Care should be used if CLARINEX-D 24 HOUR Extended Release Tablets is taken with other antihistamines and decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 24 HOUR Extended Release Tablets were dry mouth, headache, insomnia, fatigue, sore throat, and drowsiness.

Please see full prescribing information at: spfiles.com/piclarinex.pdf.

CLARINEX builds upon Schering-Plough’s heritage as a leader in discovery and development. Products from the company’s research efforts include the CLARITIN(R) (loratadine) family and NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg. *

* Calculated on the anhydrous basis

About Schering-Plough Corporation

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including information relating to the market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events and use words such as “may” and “estimate.” Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering- Plough’s business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough’s forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, the regulatory process for new products and new indications, and matters impacting patents on Schering-Plough products. For further details about these and other factors that may impact the forward- looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including the first quarter 2005 10-Q.

References:

(1) Meltzer E.O., Prenner B.M., Nayak A., and the Desloratadine Study Group. “Efficacy and tolerability of once-daily 5 mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons.” Clin Drug Invest (2001) 21:25-32.

(2) Natahn, R.A., Meltzer, E.O., Selner, J.C., Storms, W. “Prevalence of Allergic Rhinitis in the United States.” Journal of Allergy and Clinical Immunology (1997) 99:S808-14.

(3) CLARINEX(R) Product Information. Schering Corporation.

http://www.schering-plough.com

GPC Biotech Initiates Phase 2 Randomized Trial Evaluating Satraplatin Plus Tarceva(R) In Patients With Advanced Non-Small Cell Lung Cancer

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced the initiation of a Phase 2 randomized trial evaluating the Company’s lead drug candidate, satraplatin, in combination with Tarceva(R) (erlotinib) as a first-line therapy in patients with inoperable advanced non-small cell lung cancer (NSCLC) who are 70 years of age and older. A Phase 3 registrational trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has completed patient enrollment. GPC Biotech continues to open additional clinical studies to explore the potential of satraplatin in a variety of tumor types.

The Phase 2 study in advanced NSCLC is a randomized trial that is expected to involve over 20 centers in the U.S. and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety.

“Platinum-based combination therapies are often used to treat patients with advanced non-small cell lung cancer. However, elderly patients are frequently not treated with standard chemotherapy due to concerns about their ability to tolerate treatment,” said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical Officer. “A combination regimen of satraplatin — an oral, well-tolerated platinum-based compound — in combination with another oral, well-tolerated drug such as Tarceva could, if effective, offer an important new treatment option for this under-served patient group.”

Patients in the Phase 2 trial will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 162,000 deaths expected from the disease in 2006. Over 170,000 new cases are expected to be diagnosed in 2006. The five-year survival rate for lung cancer in the U.S. is only 15 percent. Recent statistics for Europe estimated over 375,000 cases annually of lung cancer and over 345,000 deaths from the disease. NSCLC accounts for over 80% of all lung cancer cases, and over 50% of patients present with inoperable disease.

Standard first-line chemotherapy for patients with advanced NSCLC typically involves a combination regimen, frequently with a platinum-based therapy. For elderly patients or patients with a poor performance status, a single-agent chemotherapy may be recommended due to concerns about these patients’ ability to tolerate a combination regimen. Thus, there is a need for well-tolerated, effective combination treatments.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

In December 2005, GPC Biotech completed accrual to the SPARC trial that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer. Also in December 2005, GPC Biotech initiated the rolling submission of an NDA for satraplatin with the FDA. The Company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.

Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company’s Web site at http://www.gpc-biotech.com.

About GPC Biotech

GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company’s lead product candidate — satraplatin — has achieved target enrollment in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and GPC Biotech has begun the rolling NDA submission process for this compound. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company’s wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company’s Web site at http://www.gpc-biotech.com/.

This press release may contain forward-looking statements, including, without limitation, statements about the progress and results of the outcome of the SPARC trial and other clinical development activities, regulatory processes and commercialization efforts for satraplatin. Forward-looking statements are based on the Company’s current expectations and projections about future events and are subject to risks, uncertainties and assumptions in light of which the forward-looking events discussed in this press release might not occur. We direct you to the Company’s Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect these statements and the Company’s future results, performance and achievements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Except as required by law, the Company does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Tarceva(R) (erlotinib) is a registered trademark of OSI Pharmaceuticals, Inc.

GPC Biotech AG
http://www.gpc-biotech.com/

Diabetes Drug Rimonabant Controls Blood Sugar And Body Weight – Second Study Confirms

A second study on the diabetes drug rimonabant confirms that it significantly controls blood sugar and body weight in patients with type 2 diabetes who have not been treated for diabetes before.

Sanofi Aventis who manufacture the drug under the name Acomplia, announced the results of the study, known as the SERENADE trial, at an international diabetes congress in Cape Town earlier today, Tuesday.

The trial achieved not only significant reduction in blood sugar levels but also in patient body weight – 6.7 kg compared to 2.7 kg in the placebo group. Results also showed improvements in (good) HDL cholesterol and triglicerides. This is unlike many currently approved diabetes treatments, where weight gain is a common and unwelcome side effect.

“This study suggests that rimonabant can achieve improvement in blood glucose with the added benefit of significant weight loss and improvement in other risk factors” said trial investigator Julio Rosenstock, MD, Director of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine at the University of Texas Southwestern Medical School, Dallas.

Nearly 300 patients throughout the US and six other countries took part in the SERENADE trial. The drug rimonabant is not currently available in the US although it has been approved in Europe.

There are two main types of diabetes. Type 1 is often diagnosed in childhood as a result of the body’s inability to produce enough insulin for it to make effective use of blood sugar. Type 2, which used to be called “late onset diabetes”, develops as we get older and is caused by the body not being able to use insulin effectively. It is usually associated with being overweight or having an overly sedentary lifestyle. Thus weight reduction is often a desirable part of the treatment of Type 2 diabetes.

Click here to see a summary report of the study.

Written by: Catharine Paddock
Writer: Medical News Today

Sesame Allergy Is Significant, Serious and Growing Globally

Sesame allergy is a significant and serious problem found to be growing globally according to a report published this month in Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).

Venu Gangur, D.V.M., M.V.S., Ph.D., and colleagues at Michigan State University in East Lansing, Mich., through a literature search using the PubMed database, found a significant increase in the number of reports of hypersensitivity to sesame since the first report from the United States in 1950.

Sesame has been added to the list of major food allergens for use in food labeling in European Commission (EC) and Canada, but it is not yet included in the Food and Drug Administration’s (FDA) listing of allergenic foods for labeling purposes in the United States.

According to the authors, in spite of the growing use of sesame seed and oil in the food, pharmaceutical and cosmetic industries, research and public awareness on sesame allergy are very limited. It is widely used in the baking industry, where there are reports of occupational allergy (asthma and urticaria) to sesame involving bakers. Sesame oil in injections, ointments and cosmetics has been reported to cause contact allergic dermatitis.

A prevalence study of immediate hypersensitivity in Australian children found that sesame was in fourth place, following egg, milk and peanut, and was more common than that to any single tree nut studied.

Among Israeli children sesame was the third most common food causing sensitization following egg and cow’s milk, and it was second only to cow’s milk as a leading cause of anaphylaxis – a severe, system-wide allergic reaction that is potentially fatal.

Almost any food can trigger a hypersensitivity reaction in sensitized people, but most food allergies in the United States are caused by eight major foods: milk, eggs, fish, wheat, tree nuts, legumes (particularly peanuts and soybeans), crustaceans and mollusks.

Food allergies affect up to 4 percent of American adults and 6 percent of infants under 3 years of age. Although food allergy occurs most often in infants and children, it can appear at any age and be caused by foods that have been eaten for years without problem.

Many parts of the body may be affected by food allergy, and the frequency and severity of symptoms can range from mild to life threatening. Among the symptoms of food allergy are vomiting, nausea, stomach cramps, indigestion, diarrhea, hives, skin rash, headaches, asthma and respiratory symptoms such as nasal congestion, sneezing and runny nose. In rare cases, systemic anaphylaxis can occur that is potentially fatal if untreated in a timely manner.

Patient information on allergic diseases including food allergy and anaphylaxis is available by calling the ACAAI toll free number at (800) 842-7777 or visiting its Web site at http://www.acaai.org, or the Food Allergy & Anaphylaxis Network (FAAN) at http://www.foodallergy.org.

The ACAAI is a professional medical organization comprising nearly 5,000 qualified allergists-immunologists and related health care professionals. The College is dedicated to the clinical practice of allergy, asthma and immunology through education and research to promote the highest quality of patient care.

Citation: Gangur V, et al. Sesame allergy: a growing food allergy of global proportions? Ann Allergy Asthma Immunol 2005;95:4-11.

American College of Allergy, Asthma and Immunology (ACAAI)
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org

Spectrum Pharmaceuticals Announces Initiation Of Phase 2 Trial For Patients With Inoperable, Advanced Non-small Cell Lung Cancer

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that its partner, GPC Biotech, has initiated a Phase 2 randomized trial evaluating satraplatin in combination with Tarceva(R) (erlotinib) as a first-line therapy in patients with inoperable, advanced non-small cell lung cancer (NSCLC) who are 70 years of age and older. A Phase 3 registration trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has completed patient enrollment. Additional clinical studies are being explored to explore the potential of satraplatin as a single agent or in combination with different drugs and other treatment modalities in a variety of tumor types.

The Phase 2 study in advanced NSCLC is a randomized trial that is expected to involve more than 20 centers in the U.S. and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety. Patients in the Phase 2 trial will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.

“We are pleased that our partner is committed to rapidly advancing satraplatin through clinical development in multiple indications,” stated Rajesh Shrotriya, M.D., president and chief executive officer of Spectrum. “Our partnership for the development of satraplatin is consistent with our risk-reduced drug development strategy, and it provides us with a potential source of non-dilutive funding with which we will advance our proprietary oncology pipeline. If successful, we expect to begin receiving milestone and royalty payments for satraplatin as early as next year, starting with the acceptance by the FDA of the NDA submission of the drug for hormone-refractory prostate cancer. The rolling NDA filing remains on track, and is expected to be completed by end of the year”

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 162,000 deaths expected from the disease in 2006. Over 170,000 new cases are expected to be diagnosed in 2006. The five-year survival rate for lung cancer in the U.S. is only 15 percent. Recent statistics for Europe estimated over 375,000 cases annually of lung cancer and over 345,000 deaths from the disease. NSCLC accounts for over 80% of all lung cancer cases, and over 50% of patients present with inoperable disease.

Standard first-line chemotherapy for patients with advanced NSCLC typically involves a combination regimen, frequently with a platinum-based therapy. For elderly patients or patients with a poor performance status, a single-agent chemotherapy may be recommended due to concerns about these patients’ ability to tolerate a combination regimen. Thus, there is a need for well-tolerated, effective combination treatments.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, the accrual to the Phase 3 registrational trial was completed and the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA) was initiated. Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories outside the U.S.

Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.

About Spectrum

Spectrum Pharmaceuticals is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at http://www.spectrumpharm.com.

Forward-Looking Statement

This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire and develop its portfolio of drug candidates, the Company’s promising pipeline, that Spectrum will receive royalties from sales of satraplatin, the expected number of centers and patients involved in the Phase 2 study, that satraplatin provides us with a potential source of non-dilutive funding with which we will advance our proprietary oncology pipeline, that we will begin receiving milestone and royalty payments from GPC Biotech for satraplatin as early as next year, the acceptance by the FDA of the NDA submission of satraplatin for hormone-refractory prostate cancer, that the rolling NDA filing will be completed by end of the year, that other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers will be initiated and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

Spectrum Pharmaceuticals, Inc.
http://www.spectrumpharm.com