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Scroll down to the Results sections (below) to see the outcome of this event.
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, gave guidance for data from the Belinostat program. He stated, "We are expecting that by the end of this year, we should have Belinostat data available. As I said, 6 patients are still on this study and the data lock is expected to occur by the end of this month or early in first week of December."
Source: Q3 2012 earnings conference call, 11/07/12.
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Spectrum Pharmaceuticals Provides Update on Belinostat Registrational Trial for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Final analysis of the Belinostat Registrational Trial has not been made and 7 patients continue on treatment
Database lock is expected to occur in November/ December 2012 , with definitive determination of the primary endpoint of objective overall response rate (ORR) to follow
Pending final data analysis and agreement with the FDA , NDA filing is anticipated by mid-2013, and an FDA decision is likely in 2014
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 provided an update regarding anticipated milestones for the analysis of data and potential regulatory filing related to the pivotal, registrational BELIEF trial of belinostat, a novel histone deacetylase (HDAC) inhibitor. On September 21, 2012 , Topotarget A/S, Spectrum's collaboration partner for the joint development of belinostat, reported preliminary clinical results for the BELIEF trial, which is evaluating the efficacy and safety of belinostat for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). Spectrum is continuing to collect and analyze the data from the trial, and database lock is expected to occur in November/ December 2012 , following which a definitive determination of the primary endpoint of overall response rate (ORR) will be calculated.
"We are very pleased with the ongoing data collection and its analysis from the BELIEF trial and look forward to a required meeting with the FDA once a definitive ORR has been determined," stated Rajesh C . Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Pending final data analysis and agreement with the FDA , we anticipate filing of an NDA application by mid-2013, and FDA decision is likely in 2014."
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Source: press release, 9/24/12. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=708953
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, gave guidance for the Belinostat PTCL phase III data read. He stated, "Belinostat is in pivotal trials. We expect data in the second half, 4th quarter of this year."
Source: ROTH 24th Annual OC Growth Stock Conference, 3/14/12.
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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.
Source: press release, 9/26/11. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=608026
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George Tidmarsh, M.D., Ph.D, SVP, CSO, responded to a question regarding the Belinostat - PTCL BELIEF trial enrollment completion and data read. He stated, "We are comfortable giving guidance that we will completely enroll the trial this year and file the NDA next year." He then responded to a question regarding the possability of seeing data at ASH. He stated, "No, we will not give top-line data at ASH."
Source: Q1 2011 earnings conference call, 5/4/11.
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IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the independent Data Monitoring Committee (DMC), per protocol, has performed a safety and futility analysis and has recommended that the pivotal, registrational study for belinostat in relapsed or refractory Peripheral T-Cell Lymphoma, the "BELIEF" Study, continue according to protocol until 100 evaluable patients are enrolled.
"We are pleased that the DMC found through their independent review that the data supports continuation of this pivotal trial," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "Belinostat is a novel HDAC inhibitor that has the potential to play an important role in cancer therapy in a variety of indications. It has activity as a single agent and in combination at full-doses with other chemotherapy drugs in multiple cancer clinical trials, has a favorable tolerability and safety profile, and is being studied via intravenous or oral administration. We continue to enroll patients into the pivotal registrational BELIEF study." Spectrum expects to file a rolling New Drug Application for Peripheral T-Cell Lymphoma in 2011/2012.
The interim futility analysis and safety assessments were performed after the first 45 patients were entered into the study and have received at least one dose of belinostat and had the opportunity to be followed for at least two cycles. Following its analysis of the data, the DMC recommended that the study should continue.
Source: press release, 3/28/11. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=560114
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, commented on the time-line for completion of the Belinostat PTCL program and regulatory filing. He stated, "With regard to our anti-cancer drug Belinostat a novel HDAC inhibitor, we have opened over 100 clinical sites and continue to enroll patients in the registrational pivotal trial. we expect to complete enrollment in the second half of 2011 and file a rolling NDA for PTCL in 2011/2012."
Source: Q4 2010 earnings conference call, 3/10/11.
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, commented on the Belinostat programs. He stated, "With Belinostat, currently we are aggressively enrolling these patients and we expect that we will start filing the NDA in 2011. A second phase II trial in carcinoma of unknown primary is completed and we expect the data to be available sometime in the second half of this year."
Source: 13th Bio CEO Investor conference, 2/14/11.
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, commented on the progress being made with Belinostat in PTCL. He stated, "With regard to our anti-cancer drug Belinostat which is a novel HDAC inhibitor, we have opened nearly 100 clinical sites and continue to enroll patients in the registrational pivotal trial for PTCL or peripheral T-cell lymphoma. Belinostat has received orphan drug and fast track designations from the FDA."
Source: Q3 2010 earnings conference call, 11/04/10.
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Rajesh Shrotriya , M.D., Chairman, CEO, and President, commented on the two phase II programs for Belinostat. He stated, "For Belinostat for PTCL our Peripheral T-cell Lymphoma indication we anticipate NDA filing in 2011. For carcinoma of unknown primary indication Topo Target reports that they are on track to complete enrollment by year end in the ongoing phase II trial."
Source: Q2 2010 earnings conference call, 8/10/10.
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Rajesh Shrotriya , M.D., Chairman, CEO and President, commented on the ongoing Belinostat PTCL program. He stated, "Belinostat is currently in a registrational trial for PTCL under a special protocol assessment from the FDA. Patient accrual from the trial is going well and we expect to file a new drug application next year."
Source: Q1 2010 earnings conference call, 5/11/10.
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Rajesh Shrotriya , M.D., Chairman, CEO and President, gave guidance for the enrollment for Belinostat in CUP. He stated, "For Belinostat for PTCL indication we expect to file an NDA next year in 2011; we also expect completion of enrollment in the CUP trial by year end."
Source: Q4 2009 earnings conference call, 4/06/10.
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IRVINE, Calif, Feb 02, 2010 (BUSINESS WIRE) -- Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor. Belinostat is currently in a registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication in which it has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). Additionally, the NCI is currently conducting several clinical trials of Belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
Source: press release, 2/02/10. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=441984
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A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Enrollment: 129
Study Start Date: December 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00865969?term=Belinostat&rank=12
| Compound/Device | Specialty | Indication | Compound Class | Target |
|---|---|---|---|---|
| Belinostat (3) PTCL | Oncology Hematologic | Peripheral T-cell lymphoma (PTCL) | HDAC inhibitor | Histone deacetylase (HDAC) enzyme |
Mechanism of action: Belinostat is a novel hydroxamic acid-type histone deacetylase (HDAC) inhibitor with antineoplastic activity. Belinostat targets HDAC enzymes, thereby inhibiting tumor cell proliferation, inducing apoptosis, promoting cellular differentiation, and inhibiting angiogenesis. This agent may sensitize drug-resistant tumor cells to other antineoplastic agents, possibly through a mechanism involving the down-regulation of thymidylate synthase.
Phase of Development: II
Event Type: Data: Phase II trial results
Dates: 2012-12-01 - 2013-01-31
Results:
January 28, 2013
Spectrum Pharmaceuticals Announces Presentation of Belinostat Safety Profile from BELIEF Registrational Phase 2 Trial at the Fifth Annual T-Cell Lymphoma Forum
Safety profile suggests belinostat is acceptable for patients with Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL), including difficult-to-treat patients with low platelet counts due to marrow involvement with their disease or poor marrow reserve.
Spectrum reported last month that the BELIEF trial surpassed the study's primary efficacy endpoint, an objective response rate (ORR) of at least 20%.
Primary efficacy endpoint of BELIEF trial was established under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Central review of response for efficacy assessment is ongoing with anticipated presentation at ASCO 2013.
Spectrum expects NDA filing by mid-2013, and an FDA decision in 2014.
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 safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor. As featured in an oral presentation at the T-Cell Lymphoma Forum held in San Francisco, January 24-26, the BELIEF trial safety evaluation showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), including patients who have received a previous allogeneic or autologous stem cell transplant.
The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with R/R PTCL. As announced in December 2012, the BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the study's primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
"We are pleased that the T-Cell Lymphoma Forum, one of the preeminent conferences for innovation in the treatment of blood cancers, highlighted the BELIEF study comprehensive safety profile," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Belinostat showed acceptable safety findings in the BELIEF trial which was designed to enroll relapsed or refractory PTCL patients; including those who received a previous stem cell transplant; with a platelet count greater than or equal to 50,000. Many of these refractory patients with low platelet counts were not eligible for treatment on trials with alternative agents. The BELIEF safety profile, as well as ongoing studies of belinostat in combination with cytotoxic regimens, may provide support to seek approval for indications in both monotherapy and combination therapy with belinostat for patients with PTCL. We look forward to progress of the program, including an anticipated NDA filing by mid-2013."
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Source: press release, 1/28/13. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=735961
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December 21, 2012
Spectrum Pharmaceuticals Announces Achievement of Primary Endpoint in Belinostat Registrational Trial
Trial surpassed an objective response rate (ORR) of at least 20% in Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) patients.
The primary efficacy endpoint was established under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
The Company expects NDA filing by mid-2013, and an FDA decision in 2014.
The complete safety evaluation has been accepted for presentation at the T- Cell Lymphoma Forum to be held in San Francisco, Jan 24-26, 2013.
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 surpassing the primary endpoint in the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). The BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the study's primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The complete safety evaluation has been accepted for presentation at the T-Cell Lymphoma Forum to be held in San Francisco, Jan 24-26, 2013.
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Source: press release, 12/21/12. http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=728303