Tuesday, March 3, 2009

The Flag Company, Inc. Releases 'Feel Good' Light Lenses to Help Counter Gloomy Economic Outlook

The Flag Company, Inc. Releases 'Feel Good' Light Lenses to Help Counter Gloomy Economic Outlook

Perfect for any room, The Flag Company, Inc.'s new 'Feel Good' Light Lenses are perfect decorating pieces to stir up positive sentiments and lift spirits during this trying economical time.

(PRWEB) March 3, 2009 -- In light of the frustrating economical atmosphere that has gripped the nation, the Flag Company, Inc. recently launched 'Feel Good' Light Lenses as a cheerful decorating alternative. Perfect for waiting rooms and office buildings, 'Feel Good' Light Lenses are a simple, yet effective way to put a smile on faces and lift spirits.

In addition to providing a silent ray of feel-good light, Light Lenses (http://www.flagco.com/lightlenses/index.shtml) give any room better visual interest. Whether a doctor's office, conference room, classroom, or even a home basement, light lenses provide the extra pizzazz missing from any room.

The Flag Company, Inc. 'Feel Good' Light Lenses consist of colorful backlit designs that are fabricated to lay in the fluorescent ceiling fixture with a "drop-down door" opening: 24" x 48", 24" x 24", and 12" x 48". Any of the 70 Light Lenses designs (http://www.flagco.com/lightlenses/index.shtml) can easily be trimmed to fit non-traditional fixture spaces. Customized, one-of-a-kind light lenses can also be crafted from artwork or high resolution photos, giving clients versatility that is limited only by the imagination.

Originally created for doctors' office waiting rooms, Light Lenses provide a comforting sky or tree scene that give patients something soothing to look at while waiting. The result is a more relaxed, less anxious environment.

Today, Light Lenses are still used in doctors' offices around the country, but can also be used for a variety of purposes, including as educational tools. Schools and Day care centers can use Light Lenses as color, letter, or number recognition prompts for toddlers, and as more complex lesson aids - geometric shapes, math formulas, the periodic table, solar systems, and more - for older children. No matter the need, Light Lenses can enhance any learning environment.

Want to spruce up a conference room? Try the newly featured cloud set (http://www.flagco.com/lightlenses/clouds.shtml#cloudsets). The two- or three-panel set of clouds fit perfectly into drop-down door fluorescent lights and instantly rejuvenates the room, giving the impression of a sky light where there is none. This gives employees or clients a more relaxing and enjoyable environment.

About The Flag Company, Inc.:

The Flag Company, Inc. offers a complete range of flags and flag-related products. Custom screen printing and digital printing are available for special events, corporate logos, etc. Stock merchandise includes U.S., state, international and military flags and all types of accessories such as bunting, memorial cases, pennants and more. The Flag Company, Inc. is the nation's largest producer of message flags, offering over 300 different messages, which are used by realtors, restaurants, car dealerships and every other kind of company imaginable. Surprisingly, toothpick flags are a hot item - in stock and available for state, countries, and holidays and produced on a custom-order basis for corporations and special events. The complete product line can be viewed at the website, www.flagco.com.

For more information and to see the large selection of Light Lenses offered by The Flag Company, Inc., visit the website, www.flagco.com.

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Contact Information Mike Lawrence

The Flag Company Inc.

http://www.flagco.com

770-974-0507



Monday, March 2, 2009

German Medical Advancement Reflects Major Improvement in Individuals with Common and Chronic Illnesses Related to Immune System Dysfunction

German Medical Advancement Reflects Major Improvement in Individuals with Common and Chronic Illnesses Related to Immune System Dysfunction

A new preparation highly beneficial in patients with ailments from common skin disorders to hepatitis or HIV, is now available in the US without a prescription. Oral intake of the GKL03 synthetic peptides induces modulation and regulation of the immune system. GKL03 (Thymrevit) is a demonstrably potent immmunomodulator effective in the short term.

Mannheim, Germany -- A new preparation highly beneficial in patients with ailments from common skin disorders to hepatitis or HIV, is now available in the US without a prescription. Oral intake of the GKL03 synthetic peptides induces modulation and regulation of the immune system. GKL03 (Thymrevit) is a demonstrably potent immmunomodulator effective in the short term.

This preparation was first used in 2004 on tumor patients whose immune system was significantly weakened by chemotherapy or radiotherapy which had been carried out or recently administered. All subjects felt significantly better in several chemotherapy phases each time GKL-03 was taken, and also had better excersise tolerance in endurance test. Since 2004, ongoing clinical trials conducted in Germany, has shown GKL-03 to be adventageous in those with tumourigenic disease, cancer or immuno deficiencies. There are unambiguous findings indicating GKL-03 can protect the body from opportunistic infections where the body has been damaged from pre-existing conditions such as chemotherapy, x-rays, or bacterial, fungal or latent viral infections. "Since such a short term improvement of immune disorders is extremely difficult to achieve, I venture to assume with all reserve a positive effect of the GKL-03" --- Dr. Med Knut Briken, Oncology/Immunobiological Cancer Aftercare, Berlin Germany.

Klett-Loch GmbH, a medium size company, located in Mannheim Germany is a top leader in research and development against immune system disorders for over 25 years. Biotechne Complex, Inc. (www.biotechne.com) located in Georgia is designated the North American representative since 1995 assisting in continued support and informational programs.

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Contact Information Martin Wainright

Biotechne Complex, Inc.

http://www.biotechne.com

800-214-8631



Saturday, February 28, 2009

CheckOrphan Launches iWish to Commemorate Rare Disease Day

CheckOrphan Launches iWish to Commemorate Rare Disease Day

CheckOrphan, the leading news site for rare, orphan and neglected diseases, launches iWish, which allows people to visually (creative, artistic and realistic images) show their conception of these diseases through and image. In addition, people are invited to explain their imagery and add their iWish - which should convey creative solutions for a rare disease or for the community in general.

Basel, Switzerland (PRWEB) February 28, 2009 -- Today, CheckOrphan is launching one of its flagship features - iWish (http://www.checkorphan.org/content/iWish) - in conjunction with Rare Disease Day, February 28, which is an international effort to raise awareness for rare diseases and the needs of people affected by them.

To help commemorate this day, iWish is a way for people affected by, or working with, rare diseases to step forward and tell their stories through words and images. Currently, CheckOrphan is accepting iWish submissions in English, Spanish, French, German, and Italian.

Participants are asked to provide a text of up to 1,000 words describing a change or development they would like to see in the world of rare diseases - their iWish. They are also encouraged to discuss their experience with a rare disease or diseases, if applicable, and to provide and describe an image (a photograph or other creative image) that in some way complements or illustrates their text. Examples of some iWish contributions can be viewed at:

http://www.checkorphan.org/content/iWish

"People affected by a rare disease have the chance to show the world in an artistic or realistic way through a picture and words what it is like to have a rare disease," explains Ian Sowers, Head of Marketing and PR for CheckOrphan. "But, we also encourage industry professionals, physicians, researchers and others to explain want they encounter as well. This way the world will have a complete view of the problem, accompanied with ways to overcome the hurdles that rare, orphan and neglected diseases face."

CheckOrphan's goal is to allow people around the world to provide creative solutions, through their iWish. At the same time CheckOrphan offers people the opportunity to make an iWish come true. People who want to support an iWish can contact CheckOrphan and then CheckOrphan will contact the individual who submitted the iWish on behalf of the interested supporter.

"Rare, orphan and neglected disease need solutions. They are a huge drain on families and society in general," says Robert Derham, President of CheckOrphan. "So as the saying goes 'two heads are better than one' - we believe that 7 billion heads will be even better. Collectively we will be able to think outside of the box and start to bring solutions to the hundreds of millions of people that are affected with rare, orphan and neglected diseases."

Since its inception two years ago, CheckOrphan.org has become the leading online source of news about rare, orphan, and neglected diseases.

Recently re-launched with a new look and increased functionality, CheckOrphan is dedicated to being a complete web platform for rare diseases that unites and empowers researchers, physicians, professionals and, most importantly, those affected by rare diseases so that they can initiate change.

CheckOrphan's features include: a database of over 8,000 news articles (http://www.checkorphan.org/news) about rare diseases, events, clinical trials, treatments (http://www.checkorphan.org/node/8379), research publications, physician-researcher-hospital-organization-industry databases, videos, daily newsletters and more. Users can submit content for each feature

About CheckOrphan

CheckOrphan is the leading source of news about rare, orphan and neglected diseases. Its news database holds the largest concentration of articles about rare diseases, with over 8,000 entries. CheckOrphan's users benefit from several large databases that also include: events, treatments, research publications, physician-researcher-hospital-organization-industry databases, videos, daily newsletters and more. It is also home to iWish - every wish means hope for a better tomorrow.

CheckOrphan is a non-profit organization that encourages its visitors to submit content and information to the platform. CheckOrphan is always interested in meeting new partners and supporters. CheckOrphan would like to thank the Gebert Rüf Stiftung for its support. For more information about this foundation, please visit http://www.grstiftung.ch.

Contact:

CheckOrphan

Ian Sowers

Head of Marketing and PR

Tel: +41 61 267 0447

Mob: +41 79 719 5539

Robert Derham

President

Tel: +41 61 267 0447

Mob: +41 78 662 5231

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Contact Information Robert Derham

CheckOrphan

http://www.checkorphan.org

+41 61 267 0447

Ian Sowers

CheckOrphan

http://www.checkorphan.org



Friday, February 27, 2009

Local Gastroenterology Practice Gives Back to the Community During Colon Cancer Awareness Month

Local Gastroenterology Practice Gives Back to the Community During Colon Cancer Awareness Month

Digestive Health Specialists physicians will provide 50 free colonoscopies to patients impacted by the recent economic downturn.

Winston-Salem, NC (PRWEB) February 27, 2009 -- On Saturday, March 14, the physicians at Digestive Health Specialists (DHS) will donate their time and facilities to perform 50 free screening colonoscopies to help those in our communities who have recently lost their employment and health insurance. Anyone aged 50 or over who has not yet been screened for colon cancer and has been impacted by the recent economic downturn is eligible to apply for one of the 50 free colonoscopies.

Colon Cancer is one of the most preventable cancers if people, aged 50 and over, get screened regularly. According to the American Cancer Society (ACS), colorectal cancer is the third most commonly diagnosed cancer in the country and third leading cause of cancer death. While early screening has reduced the incidence of colorectal cancer, the ACS estimates that about half the eligible population has not been screened.

"During this economic crisis, people may have to postpone preventative medicine for reasons out of their control. A delay in screening can mean the difference in developing or preventing colon cancer," said William C. Bray, MD, Medical Director of Digestive Health Specialists. "We want to make sure that even in these difficult financial times, people have access to screening colonoscopy, a potentially life-saving procedure.". DHS has financial counselors available throughout the year to help patients manage the cost of healthcare within their budgets.

Residents in our community who are interested in signing-up for the free screening colonoscopy program can visit www.digestivehealth.ws to download a sign-up form, or contact DHS at 336-768-6211. Procedures will be performed in our Winston-Salem, Kernersville and Thomasville offices.

Founded in 1978, Digestive Health Specialists, PA is a physician-owned Gastroenterology practice based in Winston-Salem, NC. With nine board-certified physicians and five certified Physician Assistants, DHS is committed to providing cancer-preventing screening colonoscopies. The practice treats a variety of other digestive and liver related diseases, including Abdominal Pain, Heartburn, Reflux, Peptic Ulcer Disease, Inflammatory Bowel Disease, and Hepatitis.

Digestive Health Specialists, PA is located at 2025 Frontis Plaza Blvd, Suite 200. Winston-Salem, NC 27103. Phone 336-768-6211. Fax 336-768-6869. www.digestivehealth.ws.

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Contact Information Peter Donaldson

Digestive Health Specialists

http://www.digestivehealth.ws

336-765-4665



Prescription Copay Assistance for Patients taking Gleevec or Tasigna for Philadelphia chromosome-positive Chronic Myelogenous Leukemia (Ph+ CML)

Prescription Copay Assistance for Patients taking Gleevec or Tasigna for Philadelphia chromosome-positive Chronic Myelogenous Leukemia (Ph+ CML)

Novartis Pharmaceuticals Corporation offers a prescription copay assistance program for Ph+ CML (Chronic Myelogenous Leukemia or Chronic Myeloid Leukemia) patients through the My CML Circle Copay Assistance Program (www.mycmlcircle.com).

East Hanover, NJ (PRWEB) February 27, 2009 -- Novartis Pharmaceuticals Corporation is helping patients save money on out of pocket costs for GLEEVEC® (imatinib mesylate) tablets and TASIGNA® (nilotinib) 200-mg capsules prescriptions with My CML Circle (www.mycmlcircle.com). The program provides GLEEVEC and TASIGNA patients being treated for Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with prescription copay assistance. No matter where patients are in their Ph+ CML treatment journey, My CML Circle Copay Assistance Program is there for them. To participate, visit the My CML Circle Web site at www.mycmlcircle.com or call 1-888-625-2333.

Here's how it works:

•    If patients are starting on, or currently taking, GLEEVEC (http://www.mycmlcircle.com/patient/Gleevec-safety-information.jsp) (http://www.mycmlcircle.com/patient/Gleevec-safety-information.jsp) 400 mg, they can receive up to $15 per prescription refill for 12 refills. This is a total savings of up to $180 of prescription copay assistance.

•    If patients are already taking a higher dose of GLEEVEC or their healthcare provider increases their dose of GLEEVEC, they can receive up to $25 per prescription refill for 12 refills. This is a total benefit of up to $300 of prescription copay assistance.

•    If patients are currently taking TASIGNA (http://www.mycmlcircle.com/patient/Tasigna-safety-information.jsp) (http://www.mycmlcircle.com/patient/Tasigna-safety-information.jsp) or should their healthcare provider transition them to TASIGNA, they can receive up to $50 per prescription refill for 12 refills. This is a total savings of up to $600 of prescription copay assistance.

How to Enroll and Activate The Card

To participate in My CML Circle Copay Assistance Program, all patients need to do is call 1-888-625-2333 to request a card. If they already have a copay card from their doctor, just call the number to enroll and activate it. Patients will provide their 12 digit member ID number, in addition to their name and mailing address to enroll in the program and activate the card.

After activating their copay assistance card, present the card--along with their GLEEVEC or TASIGNA prescription--at their retail pharmacy, specialty pharmacy, and/or mail order pharmacy. Patients will then get valuable savings on their next 12 refill copayments for that prescription.

All pharmacies are invited to process the My CML Circle copay card for GLEEVEC and TASIGNA prescriptions, and there are no network requirements.

Patients whose medications are paid for in whole or in part by federal or state healthcare programs may not obtain prescription copay assistance under this program. Examples of these programs are Medicare, Transitional Assistance Program, Tricare, Medicaid, CHAMPUS, VA and State Maternal.

Patients in the state of Massachusetts are not eligible for My CML Circle Copay Assistance Program. My CML Circle Copay Assistance Program is only available in the U.S. and Puerto Rico.

Additional Benefits

In addition to prescription copay assistance, patients will receive a number of important benefits by enrolling in My CML Circle Copay Assistance Program. These benefits include:

•    Informative Ph+ CML brochures that cover topics including managing side effects and the best way to communicate with their healthcare provider

•    Regular updates about staying on Ph+ CML treatment

•    Healthy living tips

•    My CML Circle Copay Assistance Program features

Frequently Asked Questions

•    What if patients don't have insurance at all; can they still use the My CML Circle Card?

Yes. They can still use the My CML Circle copay card even if they don't have insurance.

•    How long does the My CML Circle Prescription Copay Assistance Program run?

The enrollment period ends on 12/31/09. The program expires on 12/31/10. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this program without notice.

•    What are the call center hours of operation?

The call center is open Monday through Friday 8 AM to 10 PM EST, Saturday 8 AM to 5 PM EST, and closed on Sundays.

Please see the full list of frequently asked questions for answers to any additional questions. (http://www.mycmlcircle.com/patient/FAQ-cml-patient-drug-assistance-program.jsp)

For more information about My CML Circle Copay Assistance Program, visit the My CML Circle Web site: www.mycmlcircle.com

About Tasigna

Tasigna (nilotinib) capsules is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. Tasigna has been approved in more than 50 countries. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Please see Important Safety Information below.

Tasigna important safety information

WARNING: QT PROLONGATION AND SUDDEN DEATHS

TASIGNA prolongs the QT interval. Sudden deaths have been reported in patients receiving nilotinib. TASIGNA should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to TASIGNA administration and should be periodically monitored. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. Use with caution in patientswith hepatic impairment. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Myelosuppression

Treatment with Tasigna is associated with Grade 3/4 neutropenia, thrombocytopenia, and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months, then monthly thereafter as clinically indicated. Myelosuppression with Tasigna was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction.

QT prolongation

Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Sudden deaths

There were sudden deaths reported in the safety population and the expanded access program. Ventricular repolarization abnormalities may have contributed to their occurrence.

Elevated serum lipase

Caution is recommended in patients with history of pancreatitis. Check serum lipase periodically.

Liver function abnormality

Serum bilirubin and hepatic transaminases

The use of Tasigna may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase. Check hepatic function tests periodically.

Electrolyte abnormalities

Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hyponatremia and hypocalcemia. Correct electrolyte abnormalities prior to initiating Tasigna and monitor periodically during therapy.

Hepatic impairment

Metabolism of Tasigna is mainly hepatic. Tasigna has not been investigated in patients with hepatic impairment. Caution is recommended in these patients and QT interval should be monitored closely.

Drug interactions

The concomitant use of QT prolonging drugs and strong inhibitors or inducers of CYP3A4 should be avoided as they may affect serum concentration of Tasigna.

Concomitant strong CYP3A4 inhibitors

The concomitant use of strong CYP3A4 inhibitors should be avoided (including, but not limited to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted. If interruption of treatment with Tasigna is not possible, patients who require treatment with a drug that prolongs QT or strongly inhibits CYP3A4 should be closely monitored for prolongation of the QT interval, and a dose reduction to ½ the daily dose is recommended (400 mg once daily). If the strong inhibitor is discontinued, a washout period should be allowed before Tasigna is adjusted upward to the indicated dose. Close monitoring for prolongation of the QT interval is indicated for patients who cannot avoid strong CYP3A4 inhibitors. Grapefruit products and other foods that are known to inhibit CYP3A4 should also be avoided.

Concomitant strong CYP3A4 inducers

The concomitant use of strong CYP3A4 inducers should be avoided (including, but not limited to, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital). Patients should also refrain from taking St John's Wort. If patients must be co-administered a strong CYP3A4 inducer, the dose of Tasigna may need to be increased, depending on patient tolerability. If the strong inducer is discontinued, the Tasigna dose should be reduced to the indicated dose. Tasigna is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and UGT1A1. Since warfarin is metabolized by CYP2C9 and CYP3A4, it should be avoided if possible. Tasigna inhibits human P-glycoprotein. If Tasigna is administered with drugs that are substrates of Pgp, increased concentrations of the substrate are likely and caution should be exercised. Tasigna may also induce CYP2B6, CYP2C8, and CYP2C9. Therefore, Tasigna may alter serum concentration of other drugs.

Food effects

Food increases blood levels of Tasigna. Patients should avoid food 2 hours before and 1 hour after taking dose.

Lactose

Since the capsules contain lactose, Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or of glucose-galactose malabsorption.

Pregnancy

Fetal harm can occur when Tasigna is administered to a pregnant woman. Women should be advised not to become pregnant when taking Tasigna.

Adverse reactions

In chronic phase patients, the most commonly reported adverse reactions (>10%) were rash (33%), pruritus (29%), nausea (31%), fatigue (28%), headache (31%), constipation (21%), diarrhea (22%), and vomiting (21%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (28%), neutropenia (28%), elevated lipase (15%), and hyperglycemia (11%). In accelerated phase patients, the most commonly reported adverse reactions (>10%) were rash (28%), pruritus (20%), and constipation (18%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (37%), neutropenia (37%), anemia (23%), and elevated lipase (17%). Other serious adverse reactions included pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, and pyrexia (Grade 3/4: 2%).

Dose adjustments or modifications

Tasigna may need to be temporarily withheld and/or dose reduced for QT prolongation, hematological toxicities that are not related to underlying leukemia, clinically significant moderate or severe nonhematologic toxicities, laboratory abnormalities, or concomitant use of strong CYP3A4 inhibitors. With concomitant use of strong CYP3A4 inducers, the dose of Tasigna may need to be increased, depending on patient tolerability.

Other patients in whom Tasigna should be used with caution

Tasigna should not be used during pregnancy. Sexually active female patients should use effective contraception during treatment. Women should not breast feed while taking Tasigna. There are no data to support the use of Tasigna in pediatric patients. Use with caution in patients with hepatic impairment.

About Gleevec

Gleevec (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy.

Gleevec important safety information (1)

Fetal harm can occur when administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.

Severe (NCI Grades 3/4) lab abnormalities - including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%), and hepatotoxicity (approx 5%)--and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced phase studies (where the dosage was 600 mg/day), and is more common in the elderly.

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.

Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of patients. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).

A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment. Patients with moderate renal impairment (CrCL = 20-39 mL/min) should receive a 50% decrease in the recommended starting dose and increased as tolerated. Doses greater than 600 mg are not recommended in patients with mild renal impairment (CrCL = 40-59 mL/min). For patients with moderate renal impairment doses greater than 400 mg are not recommended. Gleevec should be used with caution in patients with severe renal impairment.

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, acute respiratory failure, and GI perforation.

Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several post marketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.

Consider potential toxicities--specifically liver, kidney, and cardiac toxicity, and immunosuppression from long-term use.

Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored, in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include ketoconazole, acetaminophen, warfarin, erythromycin, and phenytoin. (Please see full Prescribing Information for other potential drug interactions.)

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron.

Common side effects of Gleevec tablets

The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%-49%), and rash and related terms (36%-47%)*†.

Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.

Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.

Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.

*Numbers indicate the range of percentages in 4 studies among adult patients, with newly diagnosed Ph+ CML, patients in blast crisis, accelerated phase, and in the chronic phase after failure of interferon-alpha therapy.

†For more detailed study information please see full Prescribing Information.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "suggesting," "may," "commitment," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Tasigna, the long-term impact of a patient's use of Tasigna or regarding potential future revenues from Tasigna. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Tasigna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Tasigna will be approved for any additional indications or labeling in any market. Nor can there be any guarantee regarding the long-term impact of a patient's use of Tasigna. Neither can there be any guarantee that Tasigna will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Tasigna could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The Company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

For more information

Additional information regarding Gleevec, Tasigna and Novartis Oncology can be found on the websites www.novartisoncologyvpo.com, www.gleevec.com, www.us.tasigna.com and www.novartisoncology.us.

Reference

1. Gleevec (imatinib mesylate) tablets prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Nov 2007.

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Contact Information Kim Fox

Novartis Oncology

http://www.mycmlcircle.com

(862) 778-7692



Stemedica Medical Team Cautions Patients About Stem Cell Therapy & Comments on PLoS Medicine Article

Stemedica Medical Team Cautions Patients About Stem Cell Therapy & Comments on PLoS Medicine Article

Stemedica provides its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed "brain tumors" (glioneuronal neoplasms) after undergoing repeated transplants of "fetal neural stem cells" in Russia starting in 2001.

San Diego, California (PRWEB) February 27, 2009 -- Stemedica Cell Technologies (http://www.stemedica.com), Inc. ("Stemedica") provided its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed "brain tumors" (glioneuronal neoplasms) after undergoing repeated transplants of "fetal neural stem cells" in Russia starting in 2001.

"All of us at Stemedica would like to extend our condolences to the young patient involved in this situation and our hope is for a speedy and positive outcome to this unfortunate experience. Never before have we or any of our Principal Investigators ever encountered such an occurrence either in our own research or in any of the published research", said Dr. David Howe, Stemedica's Vice President and Medical Director.

"We want to use this unfortunate incident to warn those seeking stem cell therapy abroad," warns Dr. Nikolai Tankovich, President & Chief Medical Officer of Stemedica, "to make certain that the manufacturer of the stem cells used in transplantation comply with the rigid standards that have been established by the FDA and other Internationally-recognized regulatory agencies. The future of this industry and the safety of all future patients depend on such adherence." FDA Compliance and Surveillance Standards can be referenced by visiting www.fda.gov/cber/compliance.htm (http://www.fda.gov/cber/compliance.htm).

The report in PLoS, Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.1000029), describes the development of multifocal glioneuronal neoplasms along the spinal nerves and brain stem in a 13-year-old patient who underwent repeated transplantation procedures in an attempt to treat ataxia-telangiectasia (A-T). A-T is a progressive neurodegenerative disorder known to have an increased risk of developing cancer.

Malignancy and neoplasia are common in A-T secondary to deficient cellular and humoral immunity. This immune deficiency is a contra-indication to stem cell transplant therapy. In addition, the mutations associated with A-T in the A-T mutation gene lead to mutations in nuclear protein, which normally repairs DNA. This loss of DNA repair combined with immune deficiency in A-T increases risk of neoplasia with and without cellular transplant therapy in A-T.

"Due to age, children and adolescents have significantly increased quantities of growth factors. Adding stem cells, known for their growth factor production capabilities, to a child with this presenting condition may have been a contributing factor. As in the administration of pharmaceuticals, many of which are not recommended for use in children and adolescents in the same way as in treating adults, great care must be taken in using stem cell therapy with this population of patients", said Dr. Michael Bayer, Stemedica's Director of Medical Services.

Based on the facts and references cited within the PLoS Medicine article, researchers have discovered that some of the cells were female and had two copies of the gene that causes A-T. Karyotype testing was reported in this case which confirms inadequate testing of the stem cells prior to transplantation. "The stem cell preparation protocol provided to the parents by the treatment team was reviewed and found to be inadequate by our standards", said Dr. Howe. "No cell characteristics, cell markers or bio-safety data was present. Mechanical desegregation in the 8-12 week age fetus is not recommended. Enzymatic separation is preferred, a process that also removes any dead cells that may be present. There is also a significant lack of detail on the number of cell passages as well as the dispersion of the neurospheres", Dr. Howe went on to say.

Dr. Alex Kharazi, Stemedica's Vice President for Manufacturing & Research observed, "Limited cell culturing in only 12-16 days as described in their protocol is like using a crude primary culture of cells. There are numerous risks associated with using crude cell preparations that have not been subjected to rigid manufacturing and testing protocols such as purity, identity and potency. In addition, the antibiotics used to manufacture the stem cells, are potentially neurotoxic." Dr. Kharazi went on to say, "Overall the description provided for the manufacturing protocol was vague and a poor example of what a well thought out manufacturing and safety-driven process should be. For example, there was no data provided relating to tumorgenicity, toxicity, or bio-distribution testing of the manufactured cells in nude mice which is a mandatory requirement as a first and critical step to assessing cell safety."

"Stemedica is committed to a manufacturing process that puts safety first at all times. Our stem cell product lines go through extensive testing during several stages of the manufacturing process and are also subjected to in-depth pre-clinical studies before filing with the FDA and other regulatory agencies for clinical trials", continued Dr. Kharazi. "Nothing is more important than the welfare of the patient and there is no explanation that can justify any deviance from compliance to FDA guidelines for the manufacturing and testing of stem cells prior to administration. These are the guidelines we follow and any patient considering stem cell therapy, at any location worldwide, should confirm that the manufacturer is in full compliance before they decide to undergo stem cell transplantation." warns Dr. Kharazi.

About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (http://www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Stemdedica complies with the standards and guidelines established by the FDA and the FDB (Food and Drug Board) in the manufacturing and testing of its stem cells. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative diseases, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910



Thursday, February 26, 2009

AIG Supports Jade Goody in Her Battle Against Cancer

AIG Supports Jade Goody in Her Battle Against Cancer

AIG supports Jade Goody in her fight against cancer, as her grandfather, John Caddock, declares she is a "battler".

(PRWEB) February 22, 2009 -- AIG supports Jade Goody in her fight against cancer, as her grandfather, John Caddock, declares she is a "battler".

In an interview with the Sun, the 70-year-old from Bermondsey, south London, responded to the latest news that the ex-Big Brother contestant's cervical cancer had spread to her bowel, groin and liver.

Mr Caddock told the paper the information had hit the family very hard and he wished he could make his granddaughter well again.

He commented: "She's so brave and stronger than me and she'll keep fighting until there is no fighting left to do."

Goody's grandfather, who is the father of her mother Jackiey, explained the family is pulling together and making sure her sons are well-looked after during these troubled times.

Mr Caddock concluded he is "stewing" over the fact doctors are not allowing him to go and visit his "beautiful girl" in hospital.

According to the NHS, cervical cancer is most commonly diagnosed in women who are under 35-years-old. This age group may wish to invest in health insurance (http://www.aigdirect.co.uk/health/) and have annual smear tests.

Women's medical cover (http://www.aigdirect.co.uk/health/) is vital for all women over the age of 18, and it's also a good idea to invest in a good breast cancer cover (http://www.aigdirect.co.uk/health/) policy.

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Contact Information Simon Macsis

AIG

http://www.aigdirect.co.uk

+44 (0)208 995 7878