Belinostat News and Research

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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 1 BelCHOP study shows belinostat and CHOP chemo regimen as first-line treatment for PTCL

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, and Onxeo S.A., an innovative company specializing in the development of orphan oncology drugs, today jointly announced the results from their Phase 1 combination trial of belinostat (Beleodaq) with the CHOP (Cyclophosphamide, Hydroxyl-doxorubicin; Vincristine, and Prednisone) chemotherapy regimen as first-line treatment for newly diagnosed peripheral T-cell lymphoma (PTCL).

8 Dec 2015

Mayo Clinic researchers study HDAC inhibitors to find effective treatments for anaplastic thyroid cancer

In their bid to find the best combination of therapies to treat anaplastic thyroid cancer (ATC), researchers on Mayo Clinic's Florida campus demonstrated that all histone deacetylase (HDAC) inhibitors are not created equal.

24 Jul 2015

Beleodaq gets FDA approval for treatment of patients with peripheral T-cell lymphoma

The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency's accelerated approval program.

3 Jul 2014

Celldex announces final results from CDX-011 Phase 2b study on GPNMB-expressing breast cancer

Celldex Therapeutics, Inc. today announced final results from the Company's randomized Phase 2b EMERGE study of CDX-011 in patients with glycoprotein NMB (GPNMB)-expressing, advanced, heavily pretreated breast cancer.

9 Dec 2012

Celldex to present results from CDX-301 Phase 1 study in healthy volunteers

Celldex Therapeutics, Inc. today announced an upcoming data presentation at the American Society of Hematology 54th Annual Meeting and Exposition to be held in Atlanta, GA from December 8 through December 11, 2012.

6 Nov 2012

Positive results from Celldex’s CDX-1401 Phase 1 study on solid tumors

Celldex Therapeutics, Inc. today announced positive results demonstrating promising clinical effects in a Phase 1 study of CDX-1401 in solid tumors in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC.

30 Oct 2012

New clinical data for ZEVALIN Injection for intravenous use presented at 17th EHA Congress

Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced new clinical data presented in an oral presentation for ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use at the 17th Congress of the European Hematology Association (EHA).

19 Jun 2012

Spectrum initiates enrollment in RenaZorb Phase 1 trial in healthy volunteers

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb in healthy volunteers.

29 May 2012

Preliminary results from Celldex’s CDX-011 Phase 2b breast cancer study

Celldex Therapeutics, Inc. today announced preliminary results from the Company's randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.

24 May 2012

Spectrum initiates ZEVALIN and MGd Phase 2 combination study in NHL

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the initiation of a Phase 2 study evaluating ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma.

18 May 2012

Topline, interim results from Celldex Phase 2b EMERGE study of CDX-011 for advanced breast cancer

Celldex Therapeutics, Inc. today announced that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast Cancer Research Program at Weill Cornell Medical College and the lead investigator of the EMERGE study, will join Celldex on the webcast to discuss data from the study.

2 May 2012

Spectrum’s apaziquone Phase 3 trials on bladder cancer do not meet primary endpoint

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the two double blind, randomized, placebo controlled, Phase 3 clinical trials for apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms.

6 Apr 2012

Spectrum signs definitive agreement to acquire Allos

Spectrum Pharmaceuticals and Allos Therapeutics, Inc. today announced that they have signed a definitive agreement under which Spectrum will acquire all of the outstanding shares of Allos for $1.82 per share in cash plus one Contingent Value Right.

6 Apr 2012

Celldex fourth quarter net loss increases to $12.7 million

Celldex Therapeutics, Inc. today reported financial results for the fourth quarter and the year ended December 31, 2011.

8 Mar 2012

Celldex begins rindopepimut and Avastin Phase 2 combination trial in EGFRvIII-positive GB

Celldex Therapeutics, Inc. today announced that patient screening has initiated in a Phase 2 trial of rindopepimut in combination with Avastin in patients with recurrent epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, called the "ReACT Study."

5 Jan 2012

NYUCI experts present latest research findings about hematologic cancers at 53rd ASH meeting

Experts from the NYU Cancer Institute, an NCI-designated cancer center at NYU Langone Medical Center, presented their latest research findings about hematologic cancers at the 53rd ASH Annual Meeting and Exposition held December 10-13, 2011 in San Diego, California.

14 Dec 2011

Spectrum seeks FDA IND approval for SPI-014 to treat hyperphosphatemia

Spectrum Pharmaceuticals today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).

5 Dec 2011

Celldex launches rindopepimut Phase 3 trial in EGFRvIII-positive glioblastoma

Celldex Therapeutics, Inc. today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the "ACT IV Study."

1 Dec 2011

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Celldex Therapeutics, Inc. today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB).

21 Nov 2011

ZEVALIN treatment for Non-Hodgkin lymphoma becomes simpler with removal of bioscan requirement

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, received approval from the U.S. Food and Drug Administration (FDA) on November 18, 2011 to remove the pre-treatment biodistribution evaluation requirement using Indium-111 ZEVALIN imaging dose followed by a gamma scan before administering the ZEVALIN therapeutic dose.