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Abiraterone acetate improves survival in metastatic castration-resistant prostate cancer

Patients with metastatic castration-resistant prostate cancer who have progressed after chemotherapy live significantly longer if treated with the drug abiraterone acetate compared to placebo, the results of a large Phase-III clinical trial confirm.

11 Oct 2010

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Results from a pre-specified interim analysis of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

11 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

Teva Pharmaceuticals Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC).

30 Sep 2010

Further trials needed to determine clinical application of Abatacept in SLE

Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

29 Sep 2010

Japanese Patent Office issues patent for ZIOPHARM Oncology's darinaparsin

ZIOPHARM Oncology, Inc. today announced that the Japanese Patent Office has issued a patent, Patent No. 4,571,408, with claims covering pharmaceutical compositions, including oral formulations, of various organic arsenic compounds, including darinaparsin (Zinapar or ZIO-101), and the use of these compositions and the organic arsenic compounds for the treatment of cancer, including as part of a combination therapy.

28 Sep 2010

Pfizer ceases SUN 1120 Phase 3 trial of SUTENT in men with CRPC

Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.

28 Sep 2010

FDA grants ZIOPHARM's darinaparsin Orphan Drug Designation for peripheral T-cell Lymphoma treatment

ZIOPHARM Oncology, Inc. announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to darinaparsin (Zinapar™ or ZIO-101) for the treatment of peripheral T-cell Lymphoma (PTCL). The United States Orphan Drug Act of 1983 was created to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States.

23 Sep 2010

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

OncoGenex Pharmaceuticals, Inc. announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. The median overall survival for patients who were treated with custirsen plus first-line docetaxel/prednisone was 23.8 months compared to 16.9 months for patients treated with docetaxel/prednisone alone.

22 Sep 2010

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.

10 Sep 2010

Aflibercept Phase 3 VELOUR clinical trial for mCRC to continue to completion

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis.

9 Sep 2010

International study to improve treatments for Duchenne muscular dystrophy

A large international study aimed at improving the care of muscular dystrophy patients worldwide is being launched by physicians, physical therapists, and researchers at the University of Rochester Medical Center.

3 Sep 2010

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

24 Aug 2010

Soligenix’s net loss for second-quarter 2010 decreases to $1,577,000

Soligenix, Inc., a late-stage biopharmaceutical company, announced today its financial results for the second quarter of 2010.

13 Aug 2010

$Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released$

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.

30 Jul 2010

Allos reports net loss of $20.0 million for second-quarter 2010

Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010