Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 17)

[abgemeldet-577022]

Glückwunsch zum Gewinn Ville.
SPPI und Firstline hat ja Tradition (Zevalin). Die Frage ist halt wie es sich vermarktet. Aber das ist ja noch weit. Wenn man sieht woher SPPI kommt und welchen weiten Weg die Bude gegangen ist, seit 2008 freut mich der Erfolg total. Ich hatte früher schon immer gute Gewinne mit Spectrum. Das ist aber sehr lange her (GPC Biotech läßt grüßen) :-)

Mittlerweile habe ich nur noch einen ganz kleinen Restbestand (Hauptsache ich bin dabei)

[Ville7]

Antwort auf Beitrag Nr.: 55.974.954 von Ville7 am 18.10.17 15:14:40

1st line = erheblich höheres Potential. Erheblich bessere Ergebnisse und längere PFS und OS zu erwarten.

[Ville7]

SPPI wird versuchen bei der FDA eine Strategie zur schnellen Zulassung in 1st line zu erarbeiten.

[Ville7]

Extrem positiver CC und Präsentation von Dr. Heymach. Der Kurs zieht folglicherweise erneut an.

Spannend wie der Kurs sich dann in der Haupttradingsession verhält. Ein Riesen-Gap wird aufgerissen. Neues Mulitjahreshoch.

[Ville7]

Antwort auf Beitrag Nr.: 55.973.769 von abgemeldet-577022 am 18.10.17 12:47:32

Schau dir den Kurs an, war vorbörslich fast schon bei USD 20. Der Markt bewertet es sehr positiv. "Breakthrough designation" sollte drin sein.

Wenn alles gut läuft nächstes Jahr klar > 20 USD. Vielleicht sogar schon früher...

Dennoch habe ich 40% meiner Aktien vorbörslich zu 19-19.30 verkauft. Zu gut ist das hier gelaufen, nachdem ich einen Teil dieser verkauften Aktien erst Anfang August zu um die USD 8 gekauft habe.

Zudem bin ich zwar zufrieden über die 73% (unconfirmed) ORR, aber etwas Wasser im Wein ist, dass es alles nur knappe partial responses sind. Keine complete response. Das schmeckt mir nicht so.

Jetzt aktuell der CC...

[abgemeldet-577022]

Hallo Ville wie siehst du die Chancen?

[Ville7]

Spectrum Pharmaceuticals Highlights Poziotinib Data in Non-Small-Cell Lung Cancer (NSCLC)

October 17, 2017

Presented at the 18th IASLC World Conference on Lung Cancer in Japan
Poziotinib demonstrates evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with interim data showing an Objective Response Rate of 73%.
Evidence of central nervous system (CNS) activity in a patient with CNS metastasis and another with leptomeningeal disease (LMD).
On October 18th at 8:30 a.m. EDT/5:30 a.m. PDT, the Company will hold a conference call with Dr. John Heymach, from The University of Texas MD Anderson Cancer Center to discuss the study results.
HENDERSON, Nev.--(BUSINESS WIRE)-- 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 the oral presentation of interim data from a Phase 2 clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small-Cell Lung Cancer (NSCLC) by scientists from the MD Anderson Cancer Center which was presented in Yokohama, Japan, October 15-18, 2017. The Company will hold a conference call tomorrow, October 18th, at 8:30 a.m. EDT/5:30 a.m. PDT with Dr. John Heymach, M.D., Ph.D., Chairman, Professor, and David Bruton Junior Chair in Cancer Research, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, to discuss his study results.

"These data are remarkable for NSCLC patients with exon 20 insertion mutations," said John Heymach, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. "These patients currently have a poor prognosis, single-digit response rate on first generation tyrosine kinase inhibitors (TKI's), and a PFS of about two months. What is truly noteworthy is that all 11 study patients who received poziotinib at a 16mg daily dose and have reached their first scan, have seen some level of tumor shrinkage. Interestingly, we have also seen evidence of CNS activity. Toxicities have included rash, diarrhea, paronychia, and mucositis consistent with those previously described for poziotinib and other TKI's, which led to dose reduction in 55% of the patients. We believe that poziotinib specifically inhibits EGFR with exon 20 insertion mutations because it overcomes steric hindrance caused by exon 20 insertions, due to its smaller size and flexibility. To date poziotinib has shown promising results in patients with exon 20 insertion mutations and we are fortunate to be leading the efforts in the continuing development of this product."

"We are greatly encouraged with the clinical data emerging from poziotinib and plan to pursue its clinical development expeditiously and aggressively," said Rajesh C. Shrotriya, M.D., Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "In the near future, we plan to discuss the regulatory pathway for poziotinib with the FDA. At the same time, we are embarking upon an overall strategy for global clinical development and regulatory filings. With three promising drugs in late-stage development, Spectrum's pipeline has never been as exciting and our prospects never as bright."

Conference Call

Wednesday, October 18, 2017 @ 8:30 a.m. Eastern/5:30 a.m. Pacific

Domestic: [phone], Conference ID# 86093351

International: [phone], Conference ID# 86093351

For interested individuals unable to join the call, a replay will be available from October 18, 2017 @ 11:30 a.m. ET/8:30 a.m. PT through October 28, 2017, until 11:30 a.m. ET/8:30 a.m. PT.

Domestic Replay Dial-In #: [phone], Conference ID# 86093351

International Replay Dial-In #: [phone], Conference ID# 86093351

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals' website: www.sppirx.com on October 18, 2017, at 8:30 a.m. Eastern/5:30 a.m. Pacific.

About Poziotinib

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small-cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

About the WCLC

The World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians, and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration, and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of "Synergy to Conquer Lung Cancer," the conference covers a wide range of disciplines and unveils several research studies and clinical trial results. For more information, visit http://wclc2017.iaslc.org/.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

[Ville7]

Drug yields high response rates for lung cancer patients with harsh mutation

https://www.mdanderson.org/newsroom/2017/10/drug-yields-high…

MD Anderson Moon Shots Program finds poziotinib strikes EGFR exon 20 insertion

MD Anderson News Release 10/17/2017

A targeted therapy resurrected by the Moon Shots Program™ at The University of Texas MD Anderson Cancer Center has produced unprecedented response rates among patients with metastatic non-small cell lung cancer that carries a highly treatment-resistant mutation.

In a phase 2 clinical trial, the drug poziotinib has shrunk tumors by at least 30 percent in eight of 11 (73 percent) non-small cell lung cancer patients whose cancer includes an epidermal growth factor receptor (EGFR) mutation called an exon 20 insertion. Shrinkage ranged from 30 percent to 50 percent among the eight patients reaching partial response. One patient has progressed on the clinical trial, which began in March. All patients experienced some tumor shrinkage.

“We’ve had no effective drugs for these patients, who historically have progression free survival of about two months, and a response rate of less than 20 percent for other therapies,” said clinical trial leader John Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at MD Anderson and holder of the David Bruton Junior Chair in Cancer Research.

“These early results are highly encouraging, and our research shows that poziotinib’s structure makes it a great potential fit for attacking this mutation,” Heymach said. Preliminary results were presented at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Yokohama, Japan, by Yasir Elamin, M.D., assistant professor of Thoracic/Head and Neck Medical Oncology.

The investigator-initiated clinical trial marks the latest progress in the identification and development of poziotinib for this group of patients conducted by MD Anderson’s Lung Cancer Moon Shot™, which is co-led by Heymach as part of the institution’s Moon Shots Program™. The program was launched in 2012 to accelerate the development of new approaches to cancer based on scientific discoveries.

About 2 percent of non-small cell lung cancer patients (about 3,500 annually in the United States) have an EGFR exon 20 insertion. The trial has enrolled 27 patients and is expected to enroll up to 50. Other tyrosine kinase inhibitors against EGFR have been approved by the U.S. Food and Drug Administration, but none have proved effective against the exon 20 insertion.

Six of 11 patients have had their dose reduced due to side effects, mainly due to rash but also diarrhea, mucositis and paronychia – inflammation of the tissue around finger nails and toenails.

Preclinical research points to poziotinib vs. exon 20

Poziotinib had been tried and abandoned as a general EGFR inhibitor against lung cancer when Heymach’s team turned up evidence of its potential against exon 20 through a drug screening program that’s part of the moon shot.

Postdoctoral fellow Jacqulyne Robichaux, Ph.D., tapped the Genomic Marker-Guided Therapy Initiative (GEMINI), which includes tumor samples and detailed clinical information on more than 4,000 lung cancer patients treated at MD Anderson since 2012.

Robichaux developed EGFR exon 20 NSCLC cell lines as well as patient-derived xenograft models, and tested a variety of EGFR inhibitors against them under the Lung Moon Shot’s drug repurposing program.

“Poziotinib is the only drug we’ve ever found that was dramatically better for exon 20 than it was for the classical EGFR mutation, T790M, that everyone tests,” Heymach said.

Working with Shuxing Zhang, PHARMD, Ph.D., associate professor of Experimental Therapeutics, the multidisciplinary team identified structural aspects of the drug that explain that divergent impact.

Heymach and colleagues then contacted Spectrum Pharmaceuticals, a Nevada-based biotechnology company that initially developed poziotinib. Subsequent collaboration included compassionate use of poziotinib for some patients with advanced disease and rapid development of the phase 2 clinical trial.

The Lung Moon Shot has funded the effort from the beginning, from preclinical identification and confirmation through the clinical trial. A scientific paper describing the group’s preclinical research is pending with a major journal. Spectrum has provided poziotinib and also partially funds the trial.

Based on the MD Anderson team’s discoveries, the institution is developing intellectual property related to the use of poziotinib for the treatment of these mutant cancers.

Co-authors with Heymach, Elamin, Robichaux and Zhang are Vincent Lam, M.D., Anne Tsao, M.D., Charles Lu, M.D., George Blumenschein, M.D., Jonathan Kurie, M.D., and Monique Nilsson, Ph.D., of Thoracic/Head and Neck Medical Oncology; Zhi Tan of Experimental Therapeutics; Julie Brahmer, M.D., of the Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins, Baltimore; Anna Truini, Ph.D., and Katerina Politi, Ph.D., Yale School of Medicine; Adriana Estrada-Bernal and Robert Doebele, M.D., Ph.D., University of Colorado School of Medicine; Shengwu Liu, Ph.D., Ting Chen, Ph.D., Shuai Li, M.D., and Kwok-Kin Wong, M.D., Ph.D., of Perlmutter Cancer Center at New York University Langone Medical School, and Zane Yang, M.D., of Spectrum Pharmaceuticals, Henderson, Nev. Zhi Tan also is a graduate student in the MD Anderson UTHealth Graduate School of Biomedical Sciences.

[Ville7]

73% ORR (unconfirmed)

[Ville7]

Spannend auch wie der Kurs auf hervorragende oder enttäuschende Daten reagiert... man sollte sich auf beide Richtungen einstellen.