Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 112)

[Ville7]

Zitat von VaJo: McNicoll, Lewis & Vlak maintained its Spectrum Pharmaceuticals (NASDAQ: SPPI) Buy rating and $20.50 price target in a research report published today.

Gebt mir 30% weniger und ich renne ....

[VaJo]

McNicoll, Lewis & Vlak maintained its Spectrum Pharmaceuticals (NASDAQ: SPPI) Buy rating and $20.50 price target in a research report published today.



In the report, McNicoll, Lewis & Vlak states, " This morning, before markets opened, Spectrum Pharmaceuticals, Inc. (SPPI; Last close: $8.07) announced that it achieved target enrollment of a minimum 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registrational trial. This announcement comes a bit early as we had expected enrollment to complete by year-end. Recall, BELIEF is evaluating belinostat (PXD 101), a novel hydroxamate-class, Class I and II histone deacetylase (HDAC) inhibitor, as a monotherapy treatment candidate for relapsed/refractory PTCL."

http://www.benzinga.com/analyst-ratings/analyst-color/11/09/…

[Tommi33]

Spectrum Pharmaceuticals Completes Enrollment in the Belinostat Pivotal Trial for Relapsed/Refractory Peripheral T-Cell Lymphoma


Registrational Trial Under a Special Protocol Assessment
Granted Fast Track and Orphan Drug Designation by FDA
On Track to File New Drug Application in 2012

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it has achieved the target enrollment of the minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registration trial. Belinostat, a novel HDAC inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as monotherapy treatment for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). Central review of pathology for all patients entered onto the trial is currently ongoing.

"We are pleased to announce that belinostat's pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, an often lethal disease with significant unmet medical need, and in a variety of other indications. It has shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug Application in 2012. If approved, we believe belinostat will add value to our existing hematology/oncology portfolio, increase our current sales efforts in hematology/oncology, and demonstrate our commitment to developing novel treatments for lymphoma."

According to the Lymphoma Research Foundation (www.lymphoma.org), lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they reside in the lymph glands. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). PTCL comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the United States.

[VaJo]

Wie kommen die dann auf die Idee?
Der Aktie tut das jedenfalls gar nicht gut.

[Ville7]

Macht gar keinen Sinn. Wieso sollten sie Allos kaufen, die nur den HDAC Hemmer Folotin haben und nicht wirklich profitabel sind? Sie haben mit Belinostat ein Konkurrenzprodukt dazu in der Pipe. Und außerdem gar nicht so viel Cash.

[VaJo]

SPPI will Allos Th. (ALTH) kaufen !

Allos Therapeutics(ALTH_) is thinking about leaving Amag Pharmaceuticals(AMAG_) at the merger altar to run away with another suitor.
The suitor is offering more money for Allos than Amag but remains officially unidentified. The new bidder, however, is believed to be Spectrum Pharmaceuticals(SPPI)

http://www.thestreet.com/_yahoo/story/11255309/1/spectrum-ph…

[Oberlaendler]

... und

Spectrum Pharmaceuticals Receives Approximately $25 Million from Warrant Exercise

Nearly $160 Million in Cash, Cash Equivalents, and Investments as of September 16, 2011, Up From Approximately $119 Million in Cash, Cash Equivalents, and Investments as of June 30, 2011

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that it received approximately $25 million in proceeds from the exercise of long-term warrants issued in 2005. The warrants had a strike price of $6.62, and were exercised on or before the September 15, 2011 expiration date.

“Unlike many companies at our stage of development, we generate cash from operations. We market two proprietary anticancer drugs, FUSILEV® for colorectal cancer and ZEVALIN® for non-Hodgkin’s lymphoma, and continue to build value for our shareholders,” said Rajesh C. Shrotriya, MD, Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals. “The proceeds from the exercise of these warrants will further enhance our financial position. We continue to maintain strong fiscal discipline. The revenues generated from FUSILEV and ZEVALIN help provide the necessary financial resources for development of our late stage drugs apaziquone and belinostat as well as advancing the other products in our pipeline and funding other corporate growth initiatives.”
...

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

Oberländler

[Oberlaendler]

Hatten wir das schon?

Spectrum Pharmaceuticals Announces Impressive Responses in Difficult to Treat Carcinomas with SPI-1620 in a Phase I Study
Top-Line Phase 1 Data Was Presented in an Oral Presentation at the 12th Annual Meeting of the International Endothelin Conference
Among Other Responses, Two Prostate Cancer Patients Experienced a Prolonged Duration of Response of Approximately 12 and 18 Months
SPI-1620 Was Well Tolerated as a Single Agent and in Combination With Docetaxel
Further Phase 2 Development is Planned
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12thInternational Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011. Part one of the study has been completed, while part two is ongoing.

The primary objective of this Phase 1 study was to assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. Secondary objectives of the study include assessing the pharmacokinetic and pharmacodynamic profiles of SPI-1620 and identifying the optimum dose of SPI-1620 to be used in future Phase 2 studies.

A total of 30 patients were enrolled in this study. Patients ranged in age from 41 to 77 years (median 61), and had prostate cancer (9/30), breast cancer (3/30), female reproductive malignancies (4/30), gastrointestinal cancer (3/30), and pancreatic cancer (2/30), among other types.

Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapy, and the principal investigator of the Phase 1 study, said, “SPI-1620, a novel anti-tumor endothelin-B agonist agent, when combined with docetaxel, has had impressive responses in difficult to treat carcinomas. These preliminary observations deserve confirmation in a Phase 2 study, which is under development. In addition, lung cavitation suggesting necrosis at previous tumor sites was noted in responding patients.”

Among the 30 patients, all of whom were treated with SPI-1620 and docetaxel, 5 partial responses (PR) were seen. Of the 5 partial responses, two were in prostate cancer, and those patients experienced a prolonged duration of response of approximately 12 and 18 months. Encouraging antitumor activity was also seen in patients with cholangiocarcinoma, transitional cell urothelial carcinoma, and ovarian cancer.

“We are very pleased with the promising top-line data from the SPI-1620 study and believe that it could be an effective drug in the treatment of solid tumors,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Spectrum is committed to bringing safe and effective treatment options to cancer patients. We look forward to continuing the development of SPI-1620, and we currently expect to initiate a Phase 2 study for SPI-1620 in 2012.”

About the Phase 1 Study

In part one of this two-part, open-label, single-arm, dose-escalation study, eligible patients received SPI-1620 delivered intravenously over one minute on days 1, 8, and 15. On day 8, patients underwent a series of four H215O PET Blood Flow scans to assess alterations in blood flow induced by SPI-1620 in tumor and non-tumor regions. Fifteen minutes after receiving SPI-1620 on day 15, patients received docetaxel, 60mg/m2, administered by infusion over 1 hour.

SPI-1620 was well tolerated, both as a single agent as well as with docetaxel. Encouraging anti-tumor activity was seen in docetaxel pretreated patients.

Part two of this Phase 1 study will further focus on safety and tolerability of SPI-1620. CT or MRI scans will be used to assess the patient’s tumor size. A series of dynamic contrast enhancer pattern MRI scans will be used to measure the effects of SPI-1620.

About SPI-1620

According to the American Cancer Society’s Cancer Facts & Figures 2011 estimates, there will be approximately 1.6 million new cases of cancer in the U.S. in 2011 and almost 572 thousand cancer related deaths. Cancer is the second most common cause of death in the US, exceeded only by heart disease. In the US, cancer accounts for nearly 1 of every 4 deaths. Chemotherapy is one of the mainstays of therapy for solid tumors. However, chemotherapy often fails because adequate tissue levels of the cytotoxic agents are not achieved in the tumor, and serious side effects result from toxicity to normal cells. Consequently, any means to increase the delivery of a cytotoxic agent selectively to tumors, while minimizing its concentration in normal tissues would be beneficial.

SPI-1620 is believed to be a highly selective endothelin-B agonist that causes a selective and transient increase in blood flow to tumors, thereby increasing the delivery of anticancer agents to the tumor, and as a result increasing the efficacy of these drugs. In pre-clinical studies, when anti-cancer drugs, such as paclitaxel, doxorubicin, cisplatin, 5-FU, cyclophoshamide and others were administered shortly after SPI-1620, the anti-cancer drug concentration in the tumor increased several fold. This resulted in increased anti-tumor efficacy at a given dose of a cytotoxic agent. This might allow physicians to maximize efficacy with reduced doses of cytotoxic agents with resultant decreased toxicity to the normal organs. Proof of principle studies have been successfully conducted in a wide variety of indications such as breast, ovarian, melanoma, and prostate cancer.

Spectrum has proprietary worldwide rights to SPI-1620.

Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

Grüße
Oberländler

[Ville7]

Ich glaube die werden gar nicht (viel) kaufen. Das war lediglich ein Schachzug, die Aktie oben zu halten. Denn morgen werden die Warrants fällig.

[VaJo]

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 oncology and hematology, today announced that it has initiated its previously announced stock repurchase program. On June 15, 2011, Spectrum's Board of Directors authorized the purchase of up to $25 million of its common stock through the end of 2012.