Der erste Krebsimpfstoff
Nun scheint sich tatsächlich das zu bewahrheiten, was wir bereits am 12. Januar in Erwägung gezogen und hier veröffentlicht hatten. Die jüngsten Daten sprechen zumindest dafür, dass der Kursverlust von 19 Prozent, den die Aktie von Dendreon (Nasdaq: DNDN; WKN: 615606) am 11. Januar bereits in der Vorbörse erlitten hatte, tatsächlich nicht gerechtfertigt war. Da die meisten Verkäufe, wie so oft bei solchen Szenarien, auch in diesem Falle vor Beginn des regulären Handels statt gefunden hatten, waren es wieder einmal die Kleinanleger, die die größten Verluste schlucken mussten.
Vor allem diejenigen, die sich aufgrund fehlender fachkundiger Informationen auf Spekulationen und Gerüchten aus Aktienboards und Chatrooms verlassen mussten, verkauften aus Angst nicht selten beim Tiefststand der Aktie, und nahmen damit einen dicken Verlust von bis zu 27 Prozent in Kauf. Wer allerdings mit den Geschehnissen bei Dendreon und seinem Krebsimpfstoff Provenge® vertraut war und dessen Entwicklung von Anfang an mit verfolgen konnte, wie dies beispielsweise die Abonnenten von www.Biotech-Experte.de konnten, der ließ sich weniger von der Panik der Masse anstecken.
Ganz im Gegenteil, ein wissender Anleger hätte den Kursabschlag eher als günstige Einstiegsgelegenheit gesehen. Wie wir bereits am 12. Januar mitgeteilt hatten, verfehlte Provenge® zwar den primären Endpunkt einer Phase III Studie, doch diese hätte Provenge® nur zusätzliche Patienten, nämlich die weniger Kranken mit Gleason Score <7, bringen sollen. Die primäre Zielgruppe für Provenge® sind aber schon von Anfang an Patienten mit einem bereits metastasierten, also fortgeschrittenen Prostatakarzinom. Bei diesen Patienten hätte Provenge® das Überleben, bei gleichzeitiger Verbesserung der Lebensqualität, verlängern sollen.
Diese überlebensverlängernde Wirkung konnte Provenge® auch in allen bisherigen Studien zeigen. Auch beim Corpus delicti, der Studie D9902B, konnte Provenge® das Überleben aller Patienten, auch der mit Gleason Score <7, verlängern. Die exakten Daten ließ Dendreon damals allerdings noch offen. Gestern am späten Abend wurde das Geheimnis endlich gelüftet, was den Aktienkurs diesmal in die Gegenrichtung, nämlich um mehr als 15 Prozent nach oben schießen ließ.
Das Immuntherapeutikum Provenge® scheint das Immunsystem eines Patienten tatsächlich auf die 95 Prozent Krebszellen aufmerksam zu machen, die das Enzym PSA (Prostatic Acid Phosphatase) synthetisieren. Provenge® fällt in die Klasse der individuellen Impfstoffe, da es körpereigne Immunzellen enthält, die außerhalb des Körpers trainiert und dann als Medikament verabreicht werden. Studienleiter Eric Small und seine Kollegen präsentierten die Daten gestern auf einem wichtigen Krebskongress in den USA.
Studienteilnehmer waren 127 Männer mit metastasierten Prostatakarzinom, welches bereits eine Hormonresistenz aufwies. Für diese Patienten gibt es bisher keine einzige Behandlungsalternative, umso ermutigender die Ergebnisse der Studie. Nach drei Jahren Provenge®-Therapie waren noch 34 Prozent der Patienten am Leben, während es in der Kontrollgruppe nur noch 11 Prozent waren. Im Hinblick auf die Tatsache, dass Provenge® das Überleben, ohne die schwerwiegenden Nebenwirkungen von Chemotherapeutika, verlängert, sollte es sowohl für Patienten als auch für Mediziner eine echte Alternative sein.
Auch Studienleiter Dr. Eric Small von der University of California, San Francisco School of Medicine, sieht in Provenge® eine echte Behandlungsalternative beim metastasierten Prostatakarzinom. Provenge® ist deshalb wohl noch lange nicht aus dem Rennen.
Wäre aber eine Überlegung wert einzusteigen (Miniposition)
UBS Cuts Dendreon Corp. To Reduce From Buy >DNDN
Friday, July 22, 2005 6:06:55 AM ET
Dow Jones Newswires
NEW YORK (Dow Jones)--UBS cut biotech company Dendreon Corp. (DNDN) to reduce from buy, saying it is likely that the U.S. Food and Drug Administration will require a confirmatory trial for Provenge and thus delay the product launch to the first quarter of 2008 from the first quarter of 2007.
Management Will Host Conference Call at 11:00 am ET
8/8/2005 8:01:42 AM
SEATTLE, Aug 08, 2005 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (DNDN) today reported results for the quarter ended June 30, 2005. Revenue for the second quarter of 2005 was $58,000 compared to $212,000 for the quarter ended June 30, 2004. Revenue for the six months ended June 30, 2005 was $115,000 compared to $4.9 million for the six months ended June 30, 2004. The decrease in revenue for the six months ended June 30, 2005 was attributable to revenue recognized in 2004 for our license agreement with Nuvelo, Inc. related to our novel anticoagulant, recombinant nematode anticoagulant protein c2 (rNAPc2) and all other rNAPc proteins.
The net loss for the quarter ended June 30, 2005 was $17.5 million, or $0.30 per share, compared to a net loss of $15.7 million, or $0.27 per share, for the quarter ended June 30, 2004. The net loss for the six months ended June 30, 2005 was $37.0 million, or $0.63 per share, compared to $30.6 million, or $0.55 per share for the six months ended June 30, 2004.
Dendreon's total operating expenses for the six months ended June 30, 2005 were $39.4 million compared to $38.5 million for the same period in 2004. Included in operating expenses in the first six months of 2004 was a charge of approximately $3.3 million related to the closure of Dendreon's San Diego facility. Net cash used in operations in the six months ended June 30, 2005 was $38.3 million compared to $32.1 million in the same period in 2004.
Cash, cash equivalents, short-term, and long-term investments as of June 30, 2005 totaled $155.9 million.
SEATTLE, WA, November 7, 2005 – Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track review status to PROVENGE® (sipuleucel-T) for its proposed use in the treatment of asymptomatic men with metastatic, androgen-independent prostate cancer.
The FDA determined that PROVENGE meets the criteria for Fast Track designation in that PROVENGE shows the potential to improve survival in the intended patient population of men with asymptomatic, metastatic, androgen-independent prostate cancer. The potential of PROVENGE to provide a survival benefit was based on results from the primary Phase 3 efficacy study, D9901, and supporting data from D9902A, which were recently discussed with the FDA in a pre-BLA meeting.
Under the FDA Modernization Act of 1997, designation as a Fast Track drug product provides for expedited regulatory review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Under Fast Track, Dendreon is now eligible to submit a U.S. biologics license application (BLA) on a rolling basis. This permits the FDA to review sections of the BLA in advance of receiving the complete submission.
"Fast Track designation for PROVENGE is an important step and acknowledgement of the potential for this active cellular immunotherapy to impact survival in men with advanced prostate cancer," said Mitchell H. Gold, M.D., Dendreon's president and chief executive officer. "We look forward to working closely with the FDA to bring what could be the first active immunotherapy agent to market as soon as possible to help the many men with advanced prostate cancer who have few appealing treatment options."
Prostate cancer is the number one non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease.
About PROVENGE (sipuleucel-T)
PROVENGE (sipuleucel-T) is an investigational product that may represent the first 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 survival benefit with low toxicity. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com.
.Sorry für das Crossposting, aber im Hotstockforum scheint sich niemand dafür zu interessieren.
Im Mai kommt die Entscheidung der FDA.
FDA panel votes in favor of Dendreon cancer drug
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By Carolyn Pritchard, MarketWatch
Last Update: 6:02 PM ET Mar 29, 2007
SAN FRANCISCO (MarketWatch) -- A Food and Drug Administration advisory committee on Thursday found Dendreon Corp.'s experimental prostate-cancer drug, Provenge, to be safe and effective.
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DNDN5.22, +0.60, +13.0% ) is asking the FDA to approve Provenge, which acts by stimulating the body's immune system, for the treatment of asymptomatic men with advanced prostate cancer who have stopped responding to hormone treatment.
Though the agency isn't bound by the recommendations of its advisory committees, it typically follows them.
The FDA granted the Provenge application priority-review status in mid-January, taking its review deadline to May 15. Priority review is intended for products that address unmet medical needs.
The advisory committee on Thursday voted 17-0 that Provenge was safe and 13-4 that it was effective.
There was concern that both of the late-stage studies submitted for consideration failed their endpoints, including the first study's primary endpoint of slowing the cancer's progression, noted Celia Witten, director of the FDA's Office of Cellular Tissue and Gene Therapies division. But that study, though small, "...did show a survival difference," she said in a telephone interview after the meeting.
In the study, which evaluated 127 patients, median survival of Provenge-treated patients was found to be 4.5 months longer than those who were given a placebo.
The committee will want to see the results of an ongoing trial involving 500 patients, the results of which are due out in 2010, Witten said.
"Today marks an important milestone for men with advanced prostate cancer," Dendreon Chief Executive Mitchell Gold said in a statement. "If approved, Provenge could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options. We look forward to working closely with the FDA."
Prostate cancer is the most common malignancy and second-most common cause of cancer mortality in men.
The FDA had sought the committee's opinion on the persuasiveness of the data as well safety concerns over signs of increased incidence of stroke in Provenge-treated patients.
In addition to concerns over the failure to meet the primary endpoints, the agency said that African-American and Hispanic subjects were underrepresented in the studies.
Chart of DNDN
And although Provenge was found to be "relatively well-tolerated" overall, with chills, fatigue and back pain as the most common side effects, the FDA expressed concern that patients treated with the drug showed a higher rate of cerebral vascular accidents, or strokes -- 3.9% vs. 2.6% in patients given a placebo.
Banc of America analyst William Ho thinks the FDA's most likely to issue an approvable letter, essentially a request for additional information before a final evaluation is made, for Provenge.
"With controversial data and a large, Phase III IMPACT trial ongoing, we believe the FDA will wait for confirmatory data prior to approval," he wrote in a research note after the FDA's documents were posted. "We expect that Dendreon will require additional capital later this year."
Shares of Dendreon ended Wednesday's regular trading session at $5.22, up 60 cents, or 13%. They were halted before the start of trading Thursday, ahead of the committee meeting and vote.
Da wollen offenbar wieder einige schlauer sein als der Markt ....
Optionen
| Boardmail an "Trüffelschwein07" |
Wertpapier: Dendreon |
Call volume in DNDN was hot this morning in the first 30 minutes alone, as 6,700 calls traded against 1,000 puts, according to OptionMonster's Heat Seeker system, which tracks unusual options activity. By comparison, Dendreon traded 4,600 calls in yesterday's entire session and averaged 7,000 per day for the month of December.
Dendreon is scheduled to present Thursday at a major health care conference held by JP Morgan in San Francisco this week. Rumors have followed many companies in the biotech and pharmaceuticals space as the industry continues to see M&A activity, including announcements earlier today that Elan may explore a sale and that the Medicines Company intends to buy Targanta.
(RTTNews) - Thursday, while addressing the JPMorgan Healthcare Conference, Dendreon Corp.'s (DNDN) chief executive Mitchell Gold said that the final, late-stage trial results of the company's investigational prostate cancer vaccine Provenge are expected by April of this year. Earlier, the company was expecting the final analysis to be completed in mid-2009. Shares spiked over 6% in the after-hours.
Provenge, an investigational therapeutic cancer vaccine belongs to a new class of therapy known as Active Cellular Immunotherapy. It works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells.
There are two types of vaccines namely therapeutic and prophylactic. While a therapeutic cancer vaccine is given to patients to treat existing cancers, a prophylactic cancer vaccine is given to healthy subjects to prevent infection with cancer-causing viruses. Merck & Co. Inc's (MRK) Gardasil and GlaxoSmithKline's (GSK) Cervarix, which are approved to prevent cervical cancer, are examples of prophylactic cancer vaccine.
In October of 2008, an independent data monitoring committee, or IDMC, completed encouraging interim analysis of the Phase 3 trial dubbed IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) designed to assess the safety and efficacy of the Provenge in men with metastatic androgen-independent prostate cancer.
The primary end point of the IMPACT study is overall survival, and time to disease progression is the secondary endpoint.
Hormone resistant prostate cancer commonly referred to as Androgen independent prostate cancer, or AIPC, is an advanced stage of prostate cancer in which the tumor growth is no longer regulated by androgens, or male hormones.
According to the interim analysis results revealed last October, advanced prostate cancer patients treated with Provenge had a 20% reduction in the risk of death, compared to patients treated with a placebo. No safety concerns were observed by the IDMC. Dendreon at that time said that the trial will be successful if Provenge can reduce the risk of death by 22%, compared to placebo.
Ongoing Provenge Trials
Besides the late-stage trial IMPACT, Provenge is also being studied in two mid-stage clinical studies.
-- ProACT (PROstate Active Cellular Therapy) or P07-2 trial in men with metastatic, androgen independent prostate cancer and
-- NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1 trial in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy.
In The Pipeline...
Other than Provenge, Dendreon's yet another cancer vaccine, which is at the forefront, is Lapuleucel-T also known as Neuvenge, for breast cancer. According to results published in August 20, 2008 issue of the Journal of Clinical Oncology, in a phase I clinical trial of Neuvenge, four of 18 breast cancer patients who were administered the Neuvenge vaccine had their tumors shrunk or stabilized.
Trp-p8-related compound, known as D3263 is another investigational drug on which Dendreon is "spending fair amount of resources right now." According to Dendreon, D3263 could have therapeutic benefits in lung, breast, prostate and colon cancers. Last May, the company presented pre-clinical data showing that its Trp-p8-related compound, D-3263, could be beneficial in patients with BPH (benign enlargement of the prostate). The company filed an investigational new drug application in December 2008 to evaluate D-3263 in a Phase 1 dose escalation study in cancer.
According to research reports, there is enormous market for BPH or benign prostatic hyperplasia as more than 50% of men in their 60s and as many as 90% in their 70s and 80s have some symptoms of BPH. The National Institutes of Health estimates that there are currently more than 28 million men suffering from BPH in the United States. Common symptoms of BPH include urinating problems and in severe cases, urinary tract infections, bladder or kidney damage, bladder stones, and incontinence.
Some of the current treatment options available for BPH are Boehringer Ingelheim's Flomax, Pfizer Inc.'s (PFE) Cardura, Abbott Labs (ABT) Hytrin, Merck & Co. Inc. (MRK) Proscar and GlaxoSmithKline's (GSK) Avodart.
Provenge - A new hope?
Though there are a number of potentially curative treatment options for early stage prostate cancer, the main alternatives available to men with metastasized prostate cancer known as Androgen Independent Prostate Cancer or AIPC include radiation, and Taxotere, a chemotherapy drug made by Sanofi-Aventis (SNY) in combination with a steroid drug prednisone. But these treatments generally are considered to have severe side effects.
Taxotere injection in combination with prednisone, which prolongs the life span of men with advanced prostate cancer by 2.5 months, is associated with toxicities such as edema, liver damage, and neutropenia and carries a black box warning.
Since there are no treatment options currently for Androgen Independent Prostate Cancer, Provenge promises a hope for men who are battling advanced stage prostate cancer, without having to suffer the side effects of traditional chemotherapy.
According to some analysts, Provenge has U.S. sales potential of $1 billion a year. Prostate cancer is the second leading cause of cancer death in American men, next to lung cancer. It is estimated that 29,000 men die of prostate cancer every year. Statistics reveal that over 2 million men in the United States have been diagnosed with prostate cancer.
Will the much-touted Provenge be able to pass the FDA muster this year? Well.... the final trial results due out in April will decide its fate. Till then, it's a waiting game for Dendreon.
DNDN has been trading in the range of $4.44 - $4.75 in the last 12 months. The stock closed Thursday's trade at $4.61, up 0.22% on an above-average volume of 2.48 million shares. In the after-hours, the stock gained 6.29% and was at $4.90.
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