ASCO - Meeting 31.5. - 03.06.03 - 500 Beiträge pro Seite

[kurttilly]

An alle Biotech-Freunde:

Wer hat schon Neuigkeiten vom ASCO Meeting in Chicago oder wer weiß, wo man nachschauen kann?

mfg
kurttilly

[buschkuckuck]

Asbach-Cola ?

kuckuck

[kurttilly]

Auf welch geistigen Niveau sich manche befinden, zeigt ja die erste Antwort auf meine Frage.

Habe jetzt einen Artikel zum Meeting gefunden:


01.06.2003 10:06


WDHLG-Merck - Erbitux könnte auch bei Lungenkrebs wirksam sein

Frankfurt, 31. Mai (Reuters) - Das neue Krebsmedikament Erbitux des Darmstädter Pharma- und Spezialchemiekonzerns Merck könnte nach Angaben des Unternehmens auch bei fortgeschrittenem Lungenkrebs erfolgreich eingesetzt werden.

Im Rahmen einer Präsentation in Chicago beim Jahreskongress der Amerikanischen Gesellschaft für Klinische Onkologie (ASCO) teilte Merck am Samstag mit, dass Erbitux in Kombination mit einer Chemotherapie als Hauptbehandlung die Therapie von fortgeschrittenem Lungenkrebs verbessern könnte. In einer klinischen Lungenkrebsstudie sei das Medikament in Kombination mit einer Chemotherapie bei 73 Patienten im Vergleich zu einer alleinigen Chemotherapie geprüft worden. Vorläufige Ergebnisse bei 61 Patienten dieser Studie der Phase II zeigten eine Ansprechrate von 53 Prozent, im Vergleich zu einer Ansprechrate von 32 Prozent bei alleiniger Chemotherapie.

In der Studie sei bei lediglich zwei der berichteten 21 Nebenwirkungen ein ursächlicher Zusammenhang mit Erbitux feststellbar gewesen. "Diese Ergebnisse zeigen das Potenzial des Medikaments auch bei anderen Krebsarten neben Darmkrebs", sagte ein Merck-Sprecher auf Anfrage. In die noch laufende Lungenkrebsstudie sollen nach Merck-Angaben einmal 40 Patienten pro Behandlungsgruppe einbezogen werden. Erbitux, ein so genannter monoklonaler Antikörper, der das Tumorwachstum hemmen soll, ist das am weitesten entwickelte Medikament aus der noch jungen Merck-Krebssparte. Am Sonntag will Merck auf der ASCO lang erwartete Daten aus einer europäischen Darmkrebsstudie mit dem Medikament präsentieren. Für das Mittel soll nach früheren Angaben noch in diesem Sommer die Zulassung für die Behandlung von Darmkrebs bei den europäischen und schweizerischen Behörden beantragt werden. Bei erfolgreicher Zulassung soll das Mittel dann möglicherweise schon zu Jahresende in der Schweiz und dann nächstes Jahr in Europa auf den Markt kommen.

Für ihre Lizenzgebiete rechnen die Darmstädter mit Erbitux (C225, Cetuximab) mit jährlichen Spitzenumsätzen von 250 Millionen bis 500 Millionen Euro.

frs/mit

Quelle: REUTERS

[meislo]

Dendreon`s Phase 1 Results Of APC8024--anti-Her-2--Therapeutic Vaccine Demonstrate Ongoing Clinical Benefit in Women with Advanced, Metastatic Breast Cancer
Sunday June 1, 11:00 am ET
Long-term follow-up data presented at ASCO show meaningful clinical benefit


CHICAGO--(BUSINESS WIRE)--June 1, 2003-- Dendreon Corporation (NASDAQNDN - News) today announced that results from its ongoing Phase 1 trial of APC8024, the company`s investigational therapeutic vaccine for breast, colon and ovarian cancer, indicate the product is well-tolerated, stimulates T-cell immunity and is continuing to show ongoing clinical benefit in patients with advanced, metastatic Her-2 positive breast cancer. These findings were presented during an oral presentation today by Michelle Melisko, M.D., senior oncology fellow at University of California, San Francisco and study co-investigator, at the American Society of Clinical Oncology 2003 Annual Meeting.
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Data was presented on 16 patients with advanced, metastatic, Her-2 positive breast cancer whose disease had progressed after receiving chemotherapy. Fifteen of these patients had progressive disease following Herceptin therapy and one patient had not received Herceptin.

Following treatment with APC8024, four patients demonstrated clinical benefit defined as a partial response or prolonged stable disease. This included one patient who experienced a partial response as measured by a 50 percent reduction in tumor size that lasted 25 weeks, and three patients who have experienced ongoing stable disease. Of the three patients with stable disease, one has had stable disease for more than 48 weeks (11 months) and two patients have had stable disease for more than one year following treatment with APC8024. In addition, an anti-Her-2 T-cell immune response was detected in all patients evaluated who did not have a pre-existing immune response to Her-2. Overall, treatment with APC8024 was shown to be well tolerated, with no significant side effects reported and no evidence of any cardiotoxicity.

"It is extremely encouraging to see in this Phase 1 trial that four patients with advanced, progressive Her-2 positive breast cancer have shown clinical benefit from APC8024 treatment - including one patient whose tumor was reduced and 3 patients whose disease has been stable for more than 48 weeks following treatment. In addition, all patients evaluated in this study have demonstrated an immune response against Her-2," said Melisko. "We look forward to continued study with this promising therapy in this patient population."

"In this population of Her-2-positive patients who are also heavily pre-treated, including progression on various chemotherapy regimens as well as Herceptin treatment, the expected median time to progression is at best 3-6 months. For such patients, having stable disease for a year or more without chemotherapy is a meaningful benefit," said John Park, M.D., assistant professor of medicine at the University of California San Francisco Comprehensive Cancer Center, and principal investigator of the study.

"This promising data on APC8024 further supports our therapeutic cancer vaccine program and its applicability to multiple cancer types," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "We look forward to additional data from this trial and are hopeful this vaccine, like Provenge®, our investigational therapeutic vaccine for prostate cancer, will continue to show positive clinical results in patients with advanced disease."

The APC8024 vaccine targets tumors that express the Her-2/neu marker. In humans, Her-2/neu is overexpressed in approximately 25 percent of metastatic breast, ovarian, pancreatic and colon cancers. APC8024 uses the company`s proprietary Antigen Delivery Cassette(TM) technology to genetically engineer antigens such as Her-2/neu to bind to antigen presenting cells and stimulate T-cell immunity. Patients received three vaccinations with APC8024 over the course of a one-month period. The APC8024 approach is similar to the approach used in the development of Provenge, Dendreon`s therapeutic prostate cancer vaccine, which has produced promising results in a Phase 3 clinical trial.

For more information on Dendreon`s clinical trials, please visit the "Clinical" section at www.dendreon.com or call 206/829-1640.

About Breast Cancer

Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. Approximately 203,000 women in the United States will be diagnosed with breast cancer and approximately 40,000 women will die from the disease in 2002.

About Dendreon

Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The company`s lead investigational product candidate, Provenge®, is a Phase 3 clinical trial cancer immunotherapy for the treatment of advanced-stage prostate cancer. In addition to its therapeutic vaccines 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 established important research and development alliances with industry leaders Genentech, Inc. and Kirin Brewery Co., Ltd. For more information about the company and its programs, visit www.dendreon.com.

[meislo]

http://biz.yahoo.com/rb/030601/health_genentech_tarceva_1.ht…

[puhvogel]

SuperGen Reports Results of Phase III Study of Orathecin(TM)
In Patients With Advanced Pancreatic Cancer

Responses noted in highly refractory patients

DUBLIN, Calif., May 30 /PRNewswire-FirstCall/ --
SuperGen Inc. (Nasdaq: SUPG) today reported results in the company`s Phase III
clinical study of Orathecin(TM) (rubitecan) capsules, an investigational oral,
topoisomerase I-inhibiting chemotherapeutic compound, as a treatment for
refractory or resistant pancreatic cancer. The study randomized 409 patients,
most of whom had previously failed two or more chemotherapies, to Orathecin or
`best choice`. Approximately ninety percent of patients in the `best choice`
group received a chemotherapeutic agent such as gemcitabine, 5-FU, mitomycin
C, capecitabine, or docetaxel. The primary study end-point was overall
survival with secondary end-points of tumor response and time to disease
progression.
The results of this Orathecin study were presented at a satellite
symposium entitled, "Evolving Strategies -- Management of Pancreatic Cancer,"
by Dr. Howard Burris, Director of Drug Development at the Sarah Cannon Cancer
Center in Nashville, Tenn. The symposium -- chaired by Dr. Daniel Haller,
Professor of Medicine at the University of Pennsylvania School of Medicine,
underwritten by SuperGen through an unrestricted educational grant and
reviewed and approved by the American Society of Clinical Oncology (ASCO) --
was held in Chicago one day prior to the opening of ASCO`s 39th Annual
Meeting.

Dr. Burris highlighted several clinical findings:

-- Seven percent (13/196) of patients randomized to Orathecin experienced
either a complete or partial tumor response (shrinkage of tumor by 50%
or more), versus less than 1 percent (1/211) for patients receiving
`best choice`. This finding is statistically significant and
independently verified.

-- Median time to disease progression was 57 days for patients receiving
Orathecin, versus 47 days for patients receiving `best choice`. This
finding is statistically significant.

-- Median survival time for patients receiving Orathecin was 108 days
versus 93 days for patients receiving `best choice`. This difference in
the primary end-point was numerically superior but not statistically
significant. The results were confounded by the fact that approximately
half of the patients randomized to the `best choice` treatment received
Orathecin when they failed `best choice`. As a result of this `rescue
therapy`, 74 percent (302/409) of all patients received Orathecin.

-- Among the 13 patients receiving Orathecin who experienced a complete or
partial response, the median survival time was 336 days, and the median
time to disease progression was 246 days.

Dr. Burris also presented an overview of the observed toxicities, which
were generally manageable for patients with advanced stage pancreatic cancer.
Less that 5 percent of patients in either arm discontinued therapy for drug
related toxicity. Severe or most frequent adverse events with an incidence
greater than 5 percent in patients who received Orathecin versus the `best
choice` included: asthenia (20% vs. 18%), abdominal pain (17% vs. 12%), pain
(5% vs. 6%), sepsis (5% vs. 7%), deep thrombophlebitis (5% vs. 5%), nausea
(14% vs. 9%), anorexia (6% vs. 10%), diarrhea (9% vs. 5%), vomiting (12% vs.
8%), leucopenia (22% vs. 13%), anemia (16% vs. 9%), thrombocytopenia (9% vs.
10%), dehydration (15% vs. 12%), bilirubinemia (7% vs. 2%) and dyspnea (8% vs.
6%), respectively.
"There are currently no approved treatments for refractory pancreatic
cancer patients in the third-line setting," said Dr. Burris. "The patients
enrolled in this study were very ill and had few viable treatment options. Any
compound that demonstrates an impact in time to tumor progression and
objective response is an important finding for patients.
"As these data indicate, Orathecin will not help everyone," added Dr.
Burris. "However, in those who do respond, there is an improvement in survival
approaching one year."
"We are actively finalizing the third and last section of our New Drug
Application for the FDA, which should be completed shortly," said Dr. Joseph
Rubinfeld, Chairman and Chief Executive Officer of SuperGen.
"Refractory or resistant pancreatic cancer patients currently have no
therapeutic alternatives. The results from the Phase III study indicate that
Orathecin may be of clinical benefit to this disadvantaged patient population,
especially given its oral administration," added Dr. David Alberts, Director,
Cancer Prevention and Control at the Arizona Cancer Center (University of
Arizona) and Chairman of the Scientific Advisory Board of the Pancreatic
Cancer Action Network (PanCAN). "Pancreatic cancer is perhaps the most feared
of all cancers, with patients having an average life expectancy after
diagnosis of only three-to-six months."

[meislo]

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52 Wochentief 21 cent Aktuell 2,54 Dollar




Press Release Source: Vion Pharmaceuticals, Inc.


Vion Presents Clinical Data on Triapine(R) In Combination with Gemcitabine at ASCO(R) Meeting
Monday June 2, 9:06 am ET


NEW HAVEN, Conn., June 2 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) announced today that clinical data from a Phase 1 trial of its anti-cancer agent Triapine® in combination with gemcitabine were presented in a poster session at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. The trial was conducted at the City of Hope National Medical Center in Duarte, California and the Moffitt Cancer Center in Tampa, Florida.
In the study, Triapine® was administered intravenously over 2-4 hours followed by a 30-minute intravenous infusion of gemcitabine. Treatment was repeated weekly for three weeks followed by a week of rest. The trial enrolled 26 patients with advanced cancer of different origins whose disease had progressed after standard therapy or for which standard therapy was not considered effective.

The major observations from the trial include:
* Triapine(R) achieves serum concentrations which are capable of enhancing
gemcitabine activity in tumor cell lines.

* A standard dose and schedule of gemcitabine can be administered with
Triapine(R) and produces a toxicity profile similar to that expected for
gemcitabine alone.

* Among 22 patients that were evaluable for tumor response, three
confirmed objective responses were observed, including one complete
response in a patient with adenocarcinoma of unknown origin, and partial
responses in a patient with non-small-cell lung cancer and a patient
with esophageal cancer.


Dr. Mario Sznol, Vice President, Clinical Affairs, stated, "Viewed in the context of the preclinical data, the Phase 1 data are encouraging and support further development of Triapine® in combination with gemcitabine." He added, "We have initiated Phase 2 trials in non-small-cell lung cancer and pancreatic cancer. If the data from the Phase 2 trials provide additional evidence that Triapine® can enhance the anti-tumor activity of gemcitabine, we will initiate Phase 3 trials."

Triapine® is designed to be a potent inhibitor of ribonucleotide reductase, an enzyme important to DNA synthesis. Gemcitabine is sold under the brand name Gemzar® by Eli Lilly & Company.

Vion Pharmaceuticals, Inc. is a biopharmaceutical company developing novel agents for the treatment of cancer. Vion`s portfolio of agents includes: Triapine®, a potent inhibitor of a key step in DNA synthesis; VNP40101M, a unique DNA alkylating agent; and TAPET®, a modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its research and product development programs, visit the company`s Internet web site at www.vionpharm.com .

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion`s plans to differ or results to vary from those expected, including Vion`s ability to continue as a going concern, which is dependent on securing external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion`s filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion`s Annual Report on Form 10-K for the year ended December 31, 2002. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Howard B. Johnson, CFO
[phone] phone

[meislo]

Krebsmedikament mit Mehrfach-Wirkung
2C4 schrumpft verschiedene Tumore

Chicago, Illinois (pte, 2. Jun 2003 12:21) - Ein experimentelles Medikament hat bei einer Reihe verschiedener Krebsformen zu bemerkenswerten Ergebnissen geführt. Von dem Medikament 2C4 (Handelsname Omnitarg) profitierten nicht nur Brust- und Prostatakrebs-Patienten, sondern auch von Darm-, Lungen-, Pankreas- und Bindegewebskrebs Betroffene. 2C4 schrumpfte in der ersten Phase-I-Studie am Cendars-Sinai Medical Center http://www.csmc.edu die Tumore. Unter den Forschern herrscht Optimismus, dass das Medikament zu einer neuen Behandlung für verschiedene Krebsformen führt.

"Interessant ist, dass das Medikament wirksam völlig verschiedene Krebsarten schrumpfte", berichtet der Studienleiter David Agus auf dem 39. Jahrestreffen der American Society of Clinical Oncology in Chicago. Das heißt, das Medikament zielt auf jenen Signalweg in Krebszellen ab, der das Wachstum bewirkt und den die meisten Tumore gemeinsam haben, so Agus weiter.

Bei dem vom Biotech-Unternehmen Genentech entwickelten Medikament handelt es sich um einen monoklonalen Antikörper. Dieses Protein greift ein Protein-Netzwerk in Krebszellen an, das für gewöhnlich das Tumorwachstum stimuliert. In der Studie erhielten 21 Patienten mit fortgeschrittenem Tumorwachstum drei Wochen lang eine 2C4-Infusion in der Höhe von 0,5 bis 15 Milligramm pro Kilogramm Körpergewicht. Zwei Patienten starben während der Behandlungszeit, bei 42 Prozent der restlichen Probanden schlug die Behandlung allerdings an. Die Tumore schrumpften entweder um 50 Prozent oder das Tumorwachstum stoppte in einem gewissen Zeitraum. Die Nebenwirkungen waren laut Agus sehr gering. Die Wissenschaftler vermuten, dass Omnitarg die Immunabwehr stimuliert, demnach Tumorzellen erkennt und angreift, gesunde Zellen aber nicht schädigt.

Im Mai lief am Cedars-Sinai Medical Center die klinische Phase-II-Studie an. Es gilt zu evaluieren, ob das Medikament bei einer größeren Zahl an Patienten mit fortgeschrittenem Prostatakrebs Wirkung zeigt. Noch im Juni sollen Versuche mit Eierstockkrebs-Patienten starten. Die Ergebnisse werden erst in einigen Jahren erwartet. (Ende)