Der erste Krebsimpfstoff
Dendreon Appoints Richard Ranieri as Senior Vice President of Human Resources
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{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Thursday April 15, 2010, 8:30 am
SEATTLE, April 15 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq:DNDN - News) today announced that Richard Ranieri has joined the company as senior vice president of human resources, effective April 19, 2010. Mr. Ranieri most recently served as the executive vice president of human resources and administration at Sepracor, Inc.
In his role at Dendreon, Mr. Ranieri will be responsible for overseeing the human resources team, leading the development and implementation of strategies for the recruitment of talent, training, development and growth of employees, and management of compensation and benefits.
"Rich's 20 years of experience managing large global human resource initiatives for commercial health care companies makes him the ideal fit as we transition into a world-class commercial enterprise," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon.
Prior to his position at Sepracor, Mr. Ranieri served as the senior vice president of human resources and chief administrative officer at Neurocrine Biosciences, where he was responsible for managing and directing the human resources, corporate communications, operations and purchasing functions of the company. Before he joined Neurocrine Biosciences, Mr. Ranieri served as senior vice president of human resources at Genencor International, where he managed and directed the organizations global human resources function, liaising closely with senior management and the board of directors to help guide the growth and development of talent for the company. Prior to assuming that role, Mr. Ranieri held several executive positions in human resources, sales management and sales operations at SmithKline Beecham.
Mr. Ranieri received a master's degree from Rider College and a bachelor's degree from Villanova University.
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. 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. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN
http://www.investors.com/NewsAndAnalysis/Article.aspx?id=530527
http://www.bloomberg.com/apps/...amp;tkr=DNDN:US&sid=a9AorZdut8ME
Presentation Abstract
Abstract Number: 2932
Presentation Title: Sipuleucel-T generates robust and persistent cellular and humoral immune responses - Results from the IMPACT trial
Presentation Time: Monday, Apr 19, 2010, 2:40 PM - 2:55 PM
Location: Room 144, Washington Convention Center
Author Block: Nadeem A. Sheikh, Corazon P. dela Rosa, Ling-Yu Kuan, Frances P. Stewart, Mark W. Frohlich, David L. Urdal, Nicole M. Provost. Dendreon Corporation, Seattle, WA
Abstract Body: Introduction. Sipuleucel-T is a patient-specific autologous cell product consisting of antigen presenting cells (APCs) loaded with a recombinant fusion protein (PA2024) comprising prostatic acid phosphatase (PAP) linked to GM-CSF. Reported here are immune response data from a randomized Phase 3 trial, D9902B (IMPACT). Methods. 512 subjects with metastatic castrate resistant prostate cancer were randomized (2:1) to receive sipuleucel-T or placebo intravenously every 2 Wks x 3. Serum and peripheral blood mononuclear cells (PBMCs) were obtained at Baseline and at Wks 6, 14, and 26 and cryopreserved; all samples from a single subject were evaluated in the same assay. Humoral responses in cryopreserved subject serum were assessed by ELISA. Cellular responses were assessed by IFNγ ELISPOT and 3H-thymidine T cell proliferation assays. Results. The median CD54 upregulation ratio increased after culture at all 3 treatment weeks in the sipuleucel-T, but not the placebo, arm. The magnitude of APC activation was significantly greater at Wk 2 (10.8-fold) and Wk 4 (11.0-fold) compared to Wk 0 (both P < 0.001). The proportion of subjects with a positive antibody response to PA2024 (antibody titer > 400) increased after treatment with sipuleucel T, rising from 2.0% at baseline to 73.9% at Wk 14. Titers for anti-PA2024 and anti-PAP increased significantly from Wk 0 to Wk 6 after treatment with sipuleucel-T (both P < 0.001), but not placebo. Anti-PA2024 titers increased approx. 60-fold from Baseline at Wks 6 and 14, and anti-PAP titers increased from 10- to 6-fold up to Wk 26. Further analysis of the PA2024-specific humoral isotype revealed class switching from an IgM to IgG response. The proportion of subjects with PA2024-specific IFNγ ELISPOT responses (> 10 spots) increased after treatment with sipuleucel-T. The maximal value observed was 50.8% of subjects at Wk 6 compared with 5.7% at baseline, and specific responses were present at Wk 26. There was little increase in the proportion of subjects with PAP-specific IFNγ ELISPOT responses from Wk 0 to Wk 6. 78.6% of sipuleucel-T subjects mounted anti-PA2024 proliferative responses (stimulation index [SI] > 5). T cell proliferative responses increased significantly from Wk 0 to Wk 6 (P < 0.001) and remained above Wk 0 levels at Wk 26 (SI = 61.5). The PAP-specific proliferative response rose from Wk 0 to Wk 6 (P = 0.071), and remained above Wk 0 levels at Wk 26 (SI = 30.5). Conclusion. Immunogen and PAP-specific responses were observed after treatment with sipuleucel-T but not placebo. The majority of subjects treated with sipuleucel-T had persistent cellular and humoral responses (26 Wks). In addition the humoral class switching data suggest the establishment of a memory response.
DNDN presentation right after FDA! 19-Apr-10 08:22 pm This is almost like FDA announcement!
FDA is using IMPACT as example for how other companies should set up end point!
Positive FDA Announcement in 3 days?
================================================== ===========================
CONGRESS DAY 4 – 22nd April - STREAM 2 – CANCER IMMUNOTHERAPIES: REDEFINING A MARKET
09.00
Chairman’s opening remarks
Dr Jeffrey Schlom,
Chief, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI, Vaccine Research Center / NIAID / NIH
09.05
Critical endpoints and response criteria for cancer vaccine clinical trial design
* Identifying endpoints and types of approvals and providing clinical evidence of effectiveness
* Why Phase III trials fail / novel Phase II trial designs to avoid a Phase III trial failure. Learning from the past
* Avoiding clinical hold and landmines in cancer vaccine development. Progressing through FDA
Dr Bindu George,
Medical Review Officer, Office of Cellular, Tissue and Gene Therapy, CBER, US Food and Drug Administration
09.30
Pivotal Phase III IMPACT study results in advanced prostate cancer
* Pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) meeting its primary endpoint of significantly improving overall survival compared to placebo
* IMPACT results confirming further potential for active cellular immunotherapy candidates
* Meeting criteria and specifications in its SPA agreement and amendments to its existing Biologic License Application to advance through regulatory process and seek licensure
Dendreon Presents Data at American Association for Cancer Research Supporting Mechanism of Action of PROVENGE
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{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} Press Release Source: Dendreon Corporation On Wednesday April 21, 2010, 8:00 am
SEATTLE and WASHINGTON, April 21 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq:DNDN - News) announced the presentation of additional data from the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical trial showing evidence of immune responses in patients treated with PROVENGE® (sipuleucel-T) and supporting its proposed mechanism of action. The data were presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C.
Data presented from 237 patients who participated in the immune monitoring protocol in the IMPACT study demonstrated that PROVENGE:
Generated antigen-specific responses, including responses to prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, that were not seen following treatment with placebo;
Triggered both cellular and humoral immune responses in vivo that were first detected at six weeks after dosing and persisted at 26 weeks after dosing;
Induced a T-cell response as further evidenced by antibody isotope class switching from IgM to IgG, suggesting the induction of immunologic memory; and
Demonstrated a cytokine profile indicative of T-cell activation in ex vivo culture over the course of therapy, with marked increases in IL-2, IFNgamma, TNFalpha, and IL-17.
These results were presented in a podium presentation titled, "Sipuleucel-T generates robust and persistent cellular and humoral immune responses: results from the IMPACT trial."
Data presented in the poster presentation "Sipuleucel-T treatment results in sequential ex vivo activation of APCs and T cells during the culture step: evidence for in vivo immunological priming" showed that PROVENGE:
Engages the immune system in vivo through ex vivo activation of antigen presenting cells (APC) and T-cells;
Primes the immune system with the first dose; and
Demonstrates engagement of T-cells at the second and third doses.
"These data strongly support our understanding of the proposed mechanism of action of active cellular immunotherapies," said David Urdal, Ph.D., senior vice president and chief scientific officer of Dendreon. "There is clear evidence that PROVENGE primes the T-cell component of the immune system in vivo through ex vivo activation, generating a successful and long-lasting immune response."
About Active Cellular Immunotherapy
PROVENGE and other active cellular immunotherapies (ACI) are designed to stimulate a T-cell response to cancer cells. An immune response is started by a specialized class of immune system cells called antigen-presenting cells (APCs). APCs take up antigen from their surroundings and process the antigen into fragments that are then displayed on the APC surface. Once displayed, these antigens can be recognized by specific classes of immune cells called T lymphocytes (T-cells), which are activated as a result of their engagement with APCs and combat disease by seeking antigen-bearing cells directly. PROVENGE is designed to target the prostate cancer antigen prostatic acid phosphatase (PAP), an antigen that is expressed in more than 95 percent of all prostate cancers.
IMPACT Study Detail
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) was a multi-center, randomized, double-blind, placebo-controlled study evaluating 512 men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that PROVENGE increased three-year survival by 38 percent compared to placebo (31.7 percent vs. 23.0 percent), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.
Safety Data Across Controlled Clinical Trials
In controlled clinical trials of PROVENGE, the most common adverse reactions were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
The most serious adverse reactions were acute infusion reactions (occurring within 1 day of infusion). Reported reactions included chills, fever, asthenia, dyspnea, hypoxia, bronchospasm dizziness, headache, hypertension, muscle ache, nausea, and vomiting. In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate. Fevers and chills generally resolved in less than or equal to 2 days (71.9% and 89.0%, respectively).
About PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Dendreon is seeking licensure for PROVENGE for men with metastatic CRPC and submitted an amended Biologics License Application for PROVENGE, for which the U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act date of May 1, 2010.
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. 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. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
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, developments affecting Dendreon's business and prospects, including progress on the commercialization efforts for PROVENGE and requisite receipt of FDA licensure for marketing and the risk that additional capital could be needed in the future for the potential commercialization of PROVENGE. 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 http://www.sec.gov/. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
Published online 21 April 2010 | Nature 464, 1110-1111 (2010) | doi:10.1038/4641110a
News
A shot in the arm for cancer vaccines?
Researchers anxiously await a decision by US regulators on a controversial cancer therapy.
Heidi Ledford
In the early 1990s, immunologist Edgar Engleman of California's Stanford University School of Medicine thought he had discovered a way to treat cancer using a vaccine that harnessed the body's immune cells. He co-founded a company — later named Dendreon — in 1992 to develop the vaccine, predicting that it would reach patients within a few years. "We were so naïve," he says. "We didn't know what to expect."
A vaccine using dendritic cells might be approved.D. SCHARF/SCIENCE FACTION/CORBISNow, after some 20 years of successes and setbacks, Dendreon's prostate-cancer vaccine Provenge (sipleucel-T) may finally be nearing the market; the US Food and Drug Administration (FDA) is expected to reach a decision on its approval by 1 May. If the vaccine is approved, it will mark a turning point for the field of therapeutic cancer vaccines, an approach that seemed promising but developed a disappointing reputation after several high-profile failures in clinical trials. Although a few vaccines have been licensed for use in other countries, none has broken through to the US market. An FDA-approved vaccine, says Theresa Whiteside, an immunologist at the University of Pittsburgh School of Medicine in Pennsylvania, "would sort of legitimize the field". It would also offer a potential new treatment for patients with advanced prostate cancer, which killed more than 28,000 US men in 2008.
Provenge is much more complex than familiar vaccines against viruses, such as measles or human papilloma virus, the cause of most cervical cancers. The vaccine is tailor-made for each patient by harvesting his dendritic cells — a type of immune cell — and exposing them to a cancer-associated protein called prostatic acid phosphatase. Once infused back into the patient, the exposed cells should trigger an immune assault on tumour cells.
The vaccine seemed to be on the cusp of approval three years ago, after an FDA advisory committee determined that it was both safe and effective for use in advanced prostate cancer. But the FDA had lingering concerns, noting that Dendreon's phase III clinical trials were relatively small. What's more, although Provenge extended the lifespan of men with advanced prostate cancer, it did not slow tumour growth, the endpoint that those trials were designed to address. In a highly controversial decision, the agency ordered Dendreon, headquartered in Seattle, Washington, to complete a further large clinical trial in 500 patients, this time designating overall survival as the trial's endpoint. The results of that trial, released last April, showed that Provenge lengthened the survival of patients with late-stage prostate cancer by four months.
Provenge has won the fervent support of patients with prostate cancer as well as their advocates, and the company's rising stock price (see 'Wild ride for a cancer treatment') is evidence that investors are optimistic about the vaccine's approval. However, it promises to be expensive. Dendreon has not yet set a price, but some analysts estimate that it will cost up to US$100,000 per patient. Meanwhile, many researchers are reserving judgement on its efficacy until Dendreon publishes the results of its latest clinical trial in a peer-reviewed journal.
Click to enlarge.FINANCIAL DATA: NASDAQThere are also questions over exactly how the vaccine works. Provenge is a relatively crude mixture of different cell types, including the dendritic cells that should stimulate the immune response. "It would be nice to know exactly what's in there and what these other cells are contributing," says Nina Bhardwaj, an immunologist at New York University's Langone Medical Center in New York.
Nevertheless, given that Provenge relies on nearly 20-year-old technology, the vaccine's performance is impressive, says Bhardwaj. Many first-generation cancer vaccines such as PANVAC, a pancreatic cancer vaccine, were deemed safe but failed to demonstrate that they significantly slowed the progression of cancer. Because cancer-associated antigens — such as those used in Provenge — are also found at low levels in healthy tissue, their ability to trigger a powerful immune response may be blunted.
A second generation of vaccines, designed to provoke a stronger immune response, is under development, with some scientists now focusing on antigens that are found only on tumour cells. One of the first vaccines to use this approach targets a mutant protein called EGFRvIII that is found in glioblastoma, an aggressive brain cancer. The vaccine is being jointly developed by drugs giant Pfizer, based in New York, and Celldex, a biotechnology firm headquartered in Needham, Massachusetts.
Over the past decade, researchers have reached a deeper understanding of how tumours actively suppress immune responses in their immediate environment, which can dampen responses to cancer vaccines. To overcome this, some therapies currently in development combine the vaccine with chemotherapies that are designed to counteract this immune suppression. For example, a Seattle-based biotechnology company called Oncothyreon has developed a cancer vaccine called Stimuvax that is administered in combination with the drug cyclophosphamide. The compound inhibits immune cells called T-regulatory cells, which block immune responses to the body's own molecules.
Compounds that modulate the immune response could have unwanted side effects, however. A patient in a clinical trial of Stimuvax involving high doses of cyclophosphamide developed an acute inflammation of the brain, which caused the FDA to put all Stimuvax trials on hold.
A clean safety profile is crucial if cancer-vaccine developers are to improve a vaccine's performance in clinical trials. To date, most of these trials have enrolled patients who are in the advanced stages of cancer, which may have limited the trials' effectiveness because such individuals may not be able to mount an effective immune response. Now that such vaccines have been established as safe in phase II trials, clinicians are more willing to test them in healthier patients. An ongoing large trial of a lung cancer vaccine by London-based pharmaceutical firm GlaxoSmithKline, for example, is enrolling patients at an earlier stage of the disease.
For some in the field, the struggle to create effective cancer vaccines conjures up memories of the long battle to develop antibody-based therapies, which are now a mainstay of the biotechnology industry. There, too, a series of clinical-trial failures initially soured the field's reputation, recalls Thomas Davis, chief medical officer at Celldex. In the early 1990s, when Davis worked to develop rituximab — a monoclonal antibody used to treat autoimmune disorders and some cancers — he recalls that researchers in the field learned to be resilient. "We realized you just have to test a lot of drugs to find one that works," he says, "and it's the same for a cancer vaccine."
Zacks' Voice of the People highlights opportunities with Dendreon Corp.
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DNDN 39.42 0.00
{"s" : "dndn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} MackTheKnife, On Thursday April 22, 2010, 6:55 am
For Immediate Release
Chicago, IL – April 22, 2010 – Zacks highlights commentary from People and Picks Trader “MackTheKnife.
For more Voice of the People, visit http://at.zacks.com/?id=5851
Featured Post
DNDN Presents Data on Provenge MOA
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical-trial data showing evidence of immune responses in patients treated with Provenge and supporting its proposed mechanism of action were presented by the Dendreon Corp. (NasdaqGM: DNDN - News) at the American Association for Cancer Research's 101st Annual Meeting, which began Saturday and ends today in Washington.
The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1 to Dendreon's amended biologics license application for Provenge, which the company is seeking to have licensed for men with metastatic castrate-resistant prostate cancer (CRPC). Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.
In a press release today, David Urdal, senior vice president and chief scientific officer of Dendreon, notes: "These data strongly support our understanding of the proposed mechanism of action of active cellular immunotherapies. There is clear evidence that Provenge primes the T-cell component of the immune system in vivo through ex vivo activation, generating a successful and long-lasting immune response
Wir sind doch hier sowieso fast alleine, oder. :-)
Ich muß ehrlich zugeben das ich langsam nervös werde. Egal wie es ausgeht, danke für Deine vielen postings, die waren meistens sehr aufschlußreich. Dafür 100 virtuelle extra Sterne von mir. Du kannst sie nachzählen.
**************************************************
Sagt David Miller von BSR.
https://twitter.com/BiotechStockRsr
Dendreon "buy"
Rating-Update:
New York (aktiencheck.de AG) - Die Analysten von Brean Murray, Carret & Co stufen die Aktie von Dendreon (ISIN US24823Q1076/ WKN 615606) weiterhin mit "buy" ein. Das Kursziel werde von 40 USD auf 50 USD erhöht. (26.04.2010/ac/a/u)
What to Expect From Dendreon’s Provenge
By Lisa LaMotta Apr 26, 2010 12:30 pm
Investors closely watch as the FDA decision concerning the long-awaited prostate cancer vaccine approaches this week.
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DNDN 41.90 +1.80 (+4.49%)
Get ready for Dendreon (DNDN) to take a major leap (or potential slump) this week as the FDA decision concerning its prostate cancer vaccine Provenge rapidly approaches.
Provenge’s PDUFA is set for May 1, but since that’s a Saturday, it’s likely that the FDA will come to a decision about the approval of the drug sometime this week. Investors should be at the ready -- any word from the FDA could tank the stock or send it soaring.
An outright approval -- which is what many investors and analysts expect -- will likely send the share price up beyond its current price of $42, but any sort of further delay in the approval of the cancer vaccine is more than likely to send the stock plummeting, even if it’s only a minor setback for the drug’s approval. (Shares of the drug fell more than 10% when rumors surfaced in early March that the FDA might hold another advisory panel for the drug.)
This isn’t the first go-around for Dendreon investors with Provenge -- the drug was infamously delayed two years ago and the FDA went on to seek more data. In the meantime, a slew of accusations were thrown around concerning conflicts of interest and some of the doctors on the original advisory panel. Hopefully for Dendreon, the second time is the charm. The company has been battling bears in the stock market and problems with FDA management over the past few years as the stock has gone from its current price above $40 to $2.55 and back again.
(See Dendreon and the Prostate Cancer Battle.)
Dendreon has said that it's ready to launch the drug within 24 hours of the approval and has three plants that will be in full manufacturing mode for Provenge by mid-2011 with 125 sales people ready to give the drug a hard-sell.
Analysts expect Provenge to break $1 billion in sales within the first year and to exceed $5 billion shortly after that. Yet, Provenge has the potential to be even bigger -- the company is currently testing it for several other types of cancer. It's also a radically different approach to how cancer is treated: Provenge stimulates the patient’s own immune system causing the body to kick into high gear and fight the cancer itself. The approval of Provenge could be just the beginning of a new wave of more effective drugs to treat cancer.
Provenge will target a patient population of about 103,000 men in the US. It's been shown in studies to prolong a patient's life by 4.5 months -- a huge period of time in the world of cancer treatments -- and to lower the risk of death by the cancer by 22.5%. Unlike chemotherapy, the drug works to boost a patient's own immune system, instead of introducing cell-killing toxins into the body. It's also more convenient than chemotherapy -- chemotherapy requires patients to get infusions every three weeks for several months, while Provenge only requires one infusion a month for three months.
Prostate cancer is the second leading cause of cancer death in men in the US. In 2010, almost 200,000 new cases of the disease are expected to be diagnosed and 28,000 men will die from the disease. On Thursday the House Committee on Oversight and Government Reform will be holding a hearing to discuss prostate cancer screening and treatment.
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http://www.nasdaq.com/aspxcontent/...px?symbol=DNDN&selected=DNDN
Settlement Date Short Interest PercentChange Average Daily Share Volume Days to Cover
04/15/2010 13,120,990 (1.35) 3,316,953 3.96 3.96
03/31/2010 13,301,124 2.82 2,672,186 4.98 4.98
http://www.investorvillage.com/...n=340927&pt=msg&mid=8912927
Da bleiben noch genug shortys, wobei AH ging ein 80000 block für 41.90 übern Tisch.....
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Approval oder Buyout!!!!Magnet viel Glück!
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Dendreons Provenge erhält Zulassung
http://www.favstocks.com/success-for-dendreon-dndn/2910774/
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U.S. FDA clears Dendreon's prostate cancer vaccine
Thu Apr 29, 2010 12:49pm EDTStocks Dendreon Corp
DNDN.O
$40.25
+0.63+1.59%Data as of 5:17pm UTC+0200
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CompetitorsNorthwest Biotherapeutics, Inc.
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Dendreon Corp
DNDN.O
$40.25
+0.63+1.59%
5:17pm UTC+0200
WASHINGTON, April 29 (Reuters) - Dendreon Corp (DNDN.O) won U.S. approval on Thursday to sell a vaccine to treat men with advanced prostate cancer and the company's shares soared 15 percent.
The Provenge vaccine is the first vaccine to treat any type of cancer. The Food and Drug Administration said in a statement Provenge offered a new option to men with advanced prostate cancer who have limited options. (Reporting by Lisa Richwine, editing by Maureen Bavdek)
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reichhaltigen Information rund um DNDN.
Jetzt müssen wir mal die Details abwarten.
Thu Apr 29, 2010 1:14pm EDTStocks
Dendreon Corp
DNDN.O
$45.50
+5.88+14.84%
5:34pm UTC+0200
* Product is first vaccine to treat cancer
* Dendreon shares jump 15 percent before halt
(Adds FDA comment, shares halted)
WASHINGTON, April 29 (Reuters) - Dendreon Corp (DNDN.O) won U.S. approval on Thursday to sell a vaccine to treat advanced prostate cancer and the company's shares soared 15 percent.
The Provenge vaccine is the first vaccine to treat any type of cancer.
The U.S. Food and Drug Administration said it cleared Provenge for use in certain men with advanced prostate cancer.
"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
Unlike traditional vaccines that prevent a disease, Provenge treats prostate cancer by stimulating the body's own immune system to attack malignant cells. It is produced by taking cells from a patient's tumor and incorporating them into a vaccine, which is then injected back into the patient.
Dendreon shares jumped 14.8 percent to $45.50 on Nasdaq before they were halted for pending news. (Reporting by Lisa Richwine, editing by Maureen Bavdek, Leslie Gevirtz)