Spectrum Pharmaceuticals - Chancen und Risiken? - Älteste Beiträge zuerst (Seite 402)

[vanville]

bin wieder drin, lass mich von raj überraschen.

[VaJo]

Ich habe noch welche von 4,80 EUR/Stück. Rest ist weg. Sind nur wenige, aber ganz ohne SPPI gehts bei mir auch nicht

[vanville]

Antwort auf Beitrag Nr.: 51.372.609 von VaJo am 28.12.15 09:23:31

Habs aufegeben. Steuerfrei hin oder her. Vermutlich irgendwann wieder für 90 cents zu haben.
Vanville

[biopadawan]

Warum hast du aufgegeben wenn man fragen darf?

[Ville7]

Langjährig dahindümpelnd. Nun 52Wochenhoch und es scheint big money sich mehr und mehr zu positionieren. Kein Wunder, denn es stehen 2018 mit eflapegrastim ( Rolontis) und poziotinib in exon20 NSCLC zwei möglicherweise transformierende Ereignisse an. Da kann selbst das gierige und inkompetente Management möglicherweise höhere Kurse nicht verhindern. Dennoch hohes Risiko, denn die Studien werden von SPPI oftmals underpowered gefahren. Zudem wird vom Management ständig ein viel zu rosiges Bild gezeichnet, daher eine Historie von shareholder lawsuits, und nebenbei unverschämt sich selbst Optionen zugeteilt...

[Ville7]

Zu ESMO 2017 gibt es die Ergebnisse zu der koreanischen Phase 2 Studie von poziotinib in HER-2 positive breast cancer.

Breast cancer, metastatic
Proffered Paper session
ESMO 2017 Congress, 09.09.2017, 11:00 - 12:30, Madrid Auditorium
237O - A phase II trial of pan-HER inhibitor Poziotinib, in patients with HER2-positive metastatic breast cancer who have received at least two prior HER2-directed regimens: The results of NOV120101-203 trial.

Um diesen trial geht es:
https://clinicaltrials.gov/ct2/show/NCT02418689?term=NOV1201…

Man darf gespannt sein, wie sehr Raj mal wieder seine Klappe gestopft bekommt nach all der Pusherei von poziotinib in dieser Indikation ("60% response rate" auf Basis von nur 10 Patienten)....

[Ville7]

Allzu schlecht können die Daten aber nicht sein... aus der ESMO Defintion der Präsentationskategorien:

Proffered Paper – Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.

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Also SPPI Aktien mal festhalten und nicht verkaufen. 2018f könnte payday (bzgl. Kursen) sein...

[Ville7]

Journal of Thoracic Oncology - August 2017Volume 12, Issue 8, Supplement, Page S1536

Preliminary Results of a Phase II Study of Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC

[Ville7]

SPPI Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim)

Nachrichtenquelle: Business Wire (engl.) | 01.08.2017, 13:00

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today the Company has completed enrollment with 405 patients randomized in the ROLONTIS Phase 3 ADVANCE pivotal study under a Special Protocol Assessment (SPA) with the Food and Drug Administration. The study is evaluating the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer.

“I am pleased to report that we have been able to complete enrollment in the ADVANCE study ahead of schedule,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “We plan to announce topline data early next year and expect to file a BLA in 2018. RECOVER, the second Phase 3 study for ROLONTIS, is a smaller study that will include sites in the U.S. and Europe, and is currently enrolling patients. RECOVER will leverage established relationships with U.S. sites from the ADVANCE study to help expedite enrollment. We believe ROLONTIS, if approved by the FDA, has the opportunity to change the growth trajectory of our Company because it targets a multi-billion dollar market and our team has a deep knowledge and understanding of the space. We are excited to be in the final stages of what could be a transformational development for the Company.”

Spectrum is conducting a second Phase 3 study, RECOVER, which is a multicenter, randomized, active-controlled study similar in design to the ADVANCE study that is currently enrolling in the U.S. and Europe. This study will enroll approximately 218 early-stage breast cancer patients, who will receive adjuvant or neoadjuvant TC (docetaxel and cyclophosphamide) chemotherapy every 21 days for up to 4 cycles. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term, disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to help shrink the tumor and potentially allow for breast-conserving surgery. The primary study endpoint is the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] <0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints include the incidence of neutropenic complications, incidence of febrile neutropenia, relative dose intensity, and safety.

Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim), a Novel Long-Acting GCSF | wallstreet-online.de -

Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/9786714-spectrum-…

[Ville7]

Erste Daten ("initital clinical data") zum NSCLC exon 20 (HER/EGRF) Trial in mit poziotinib sind in 71 Tagen hier zu erwarten ("oral presetantion"):

http://wclc2017.iaslc.org/

findet vom 15.-18.Oktober 2017 in Yokohama statt.

June 21, 2017
Abstract Submission Deadline

July 26, 2017
Abstract Notifications

August 4, 2017
Early Registration Deadline

August 31, 2017
Regular Registration & Housing Deadline

August 31, 2017
Late Breaking Abstract Submission Deadline