Home Set as Homepage Add to Favorite Contact Submit  
           20 November, 2008
 
 
search for
 
 


Categories
Agriculture »
Arts »
Automotive »
Business »
Career »
Computers »
Education »
Entertainment »
Fashion »
Finances »
Food & Drinks »
Health & Fitness »
Hobbies & Crafts »
Home & Family »
Industry »
Internet »
Kids & Teens »
Legal »
Machinery »
Marketing »
Miscellaneous »
Music »
Nanotechnology »
Non-profit »
Politics & Government »
Real Estate »
Recreation & Sports »
Religion & Faith »
Science »
Shopping »
Society »
Software »
Technology »
Telecommunications »
Transportation »
Travel & Leisure »
    
Category:  Press » Education

 
Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients Popularity:
         Views: 40
2007-08-18 16:31:44     
Dendreon Corporation

Dendreon Corporation (Nasdaq: DNDN) today announced publication of results from a Phase 1 study of NEUVENGE, an investigational active cellular immunotherapy, in the August 20 issue of the Journal of Clinical Oncology. The article highlights the safety profile, immune response and clinical activity of NEUVENGE in women with HER2/neu-positive breast cancer who have failed standard therapy.

"In addition to demonstrating that NEUVENGE was safe and well tolerated, the T-cell responses seen in these patients and the prolonged disease stabilization in the absence of other anti-cancer therapies in many patients is promising," said John W. Park, M.D., associate clinical professor of medicine and neurosurgery at the University of California, San Francisco and lead author of the publication. "These observations are encouraging and are suggestive of the clinical benefit of NEUVENGE, particularly in light of the aggressive cancer seen in these patients who had progressed while on standard therapy. The findings warrant additional studies of NEUVENGE for the many women with advanced breast cancer who have exhausted many of their treatment options."

Study Design

The Phase 1 study (D2000-2) was conducted to evaluate the safety and immunologic activity of NEUVENGE in patients with HER2-overexpressing metastatic breast cancer who had failed standard therapy, including prior treatment with chemotherapy and trastuzumab. All patients had experienced disease progression while on standard therapy. There were 19 patients enrolled in the study with 18 patients receiving treatment with NEUVENGE. Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through Week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. Endpoints included safety, immunologic activity and antitumor activity.

Study Results

Treatment with NEUVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion. No patient discontinued the trial because of toxicity.

Treatment with NEUVENGE stimulated significant immune responses, which were shown to be enhanced following booster infusions. Twenty-two percent of patients had evidence of anti-cancer activity. This included one patient who experienced a partial response lasting approximately 6 months and three patients who had stable disease for over a year ( weeks) without the addition of any other cancer therapy other than the continuation of bisphonates. Two additional patients had stable disease for up to 20 weeks. The study concluded that NEUVENGE was feasible, well-tolerated and showed evidence of anti-cancer activity.

"We are pleased that the results from this Phase I study of NEUVENGE demonstrate its potential as a treatment for advanced breast cancer patients," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "These data, together with the data we have published on the use of Provenge(R) (sipuleucel-T) in prostate cancer, further substantiate the promise of active cellular immunotherapies as new treatments for different types of cancer."

About NEUVENGE

NEUVENGE (lapuleucel-T) is an investigational product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful clinical benefit with low toxicities. NEUVENGE is designed to stimulate cellular immune responses against HER2/neu. HER2/neu is over-expressed in a variety of solid tumors, including breast, colorectal and ovarian cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Breast Cancer

Breast cancer is the most common non-skin cancer among women. The chance of developing invasive breast cancer at some point in a women's life is about 1 in 8 or 13% of women. It is estimated that in 2007 about 178,480 new cases of invasive breast cancer will be diagnosed among women in the United States. Breast cancer is the second leading cause of cancer death in women, exceeded only by lung cancer.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit .

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, the efficacy of PROVENGE or sipuleucel-T, the company's lead product candidate to treat men suffering from prostate cancer, the efficacy of NEUVENGE or lapuleucel-T, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE or NEUVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the results of a clinical trial for PROVENGE, NEUVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at .

Specialized in: Dendreon - Dndn - Provenge - Androgen Independent Prostate Cancer - Breast Cancer Side Effects - Apc8024 - Cancer Clinical Trials - Antigen Delivery Cassette Technology - Clinical Trial D9902b - Trp-p8 - Therapeutic Vaccines - Monoclonal Antibodies
URL:
Print press release      Send to a friend      Bookmark this page
Related Press releases 
Northeast Georgia Bank to Offer Educational Loans (Popularity: ): June 2 /-- Northeast Georgia Bank has partnered with NextStudent Inc., a Phoenix-based premier education funding company, to offer a complete portfolio of educational lending products and services. Northeast Georgia Bank will introduce the new program in each of its individual locations. Interested customers will have several options of obtaining information including in-branch collateral and online access to scholarship and student loan information. "We developed this partnership because it offers new ...
Scientific Evidence Based, Online Intervention for Cognitive Skills Enhancement Now Available for Public Subscription (Popularity: ): June 3, 2006 -- Cognitive Enhancement Systems' research evidence based, online system for cognitive skills enhancement of normal and special needs school children (3rd grade and above) and cognitive rehabilitation intervention for those with mild cognitive impairment or decline is now available for public subscription at www.challenging-our-minds.com. Challenging Our Minds (COM) was spawned out of computer presented clinical applications for rehabilitation therapy with those who had experienced brain injury, stroke, ...
Challenge Your Child to Say 'Picky Pretzel People Pick Pretzel Perfect Pretzels' This Summer to Win Auntie Anne's National Pretzel Perfect Tongue Twister Contest (Popularity: ): Kids nationwide will contort and twist their tongues this summer for a chance to win a $2,500 educational scholarship, a $500 shopping spree, a year's supply of Auntie Anne's pretzels and reign the National Pretzel Perfect Tongue Twisting Champion. Between June 5 and July 23, kids age 6-12 years can submit a video or DVD of themselves reciting the tongue twister -- "Picky Pretzel People Pick Pretzel Perfect Pretzels." All ...
Nelnet's LoanSTAR Promotes Hendee, Durstine to Lead Marketing Efforts (Popularity: ): Nelnet recently announced the promotions of Richard (Dick) Hendee to Senior Vice President Texas Market Development and Managing Director Strategic Sales Planning and George Durstine to National Director for Sales Development and CollEDGE Loans Brand Manager. Hendee began his tenure with LoanSTAR in 1995. His responsibilities have ranged from managing national marketing efforts and lender/vendor relationships to working with President Bill Jeffery on strategic planning initiatives. Having begun his extensive ...
The Results Are In and They Are Bright for Students Using the Smart Way Reading and Spelling Program (Popularity: ): In less than forty-two hours of one-on-one tutoring, participating elementary school students within the School District of Lancaster (SDOL), PA, raised their reading proficiency scores by an average of 1.14 grade levels. The grade-equivalent reading scores for alternative education middle school students in the same school district jumped 1.52 grades in only 27 hours. In another part of the Commonwealth, 9th grade students at Chester High School showed a 1.3 ...

Press release home snapshot 


Related Business 
WIN Against Breast Cancer - winabc.org (Popularity: ): The Women's Information Network Against Breast Cancer is a non-profit organization and excellent resource for information and support for breast cancer survivors, families, and newly diagnosed patients.
Breast Imaging of Oklahoma (Popularity: ): Clinic in Edmond provides breast imaging using dedicated breast MRI, breast ultrasound, and breast mammography for early breast cancer detection. Provides articles and information for patients.
Eurekalert: Light-to-Moderate Drinking Appears to Have Little Effect on the Risk for Breast Cancer (Popularity: ): A new study in 'Alcoholism: Clinical & Experimental Research' confirms that heavy drinking increases risk for breast cancer, but that light to moderate drinking appears to have little effect on a woman's risk for breast cancer.
Study finds drug can help young breast cancer patients (Popularity: ): [CNN]
Roche: Herceptin Trial (Popularity: ): Gives details about the clinical trial involving the use of Herceptin as adjuvant therapy in HER2-positive patients with primary breast cancer. This resource is designed for use by patients and investigators.
HealthDay: Red Wine May Protect Against Breast Cancer (Popularity: ): An animal-based study published in the journal Cancer Research says that a natural chemical found in grape skins and seeds may have a preventative effect on breast cancer, by reducing estrogen formation.
Nottingham University : Pathology (Popularity: ): Provides undergraduate teaching and research into neurodegenerative diseases and the pathology and clinical management of patients with breast cancer.
Cryoma Labs: Cancer Vaccines and Live Cancer Cell Storage (Popularity: ): Helps cancer patients enroll in investigational cancer vaccine clinical trials by storing live cancer cells, deriving malignant cells lines, and assisting patients in locating vaccine trials.
Breast Cancer Prevention Institute (Popularity: ): Online publication, fact sheets and information on breast cancer prevention
Breast Cancer Research (Popularity: ): Online and print journal covering topics of basic and clinical research relevant to breast cancer. Research articles are free to all users.


 
 
Home | Top | Set as Homepage | Bookmark this Page | Privacy | Contact | Submit Press Release
© 2003-2008 ABC Directory.Com. All Rights Reserved